Global Medical Device Podcast powered by Greenlight Guru (Greenlight Guru + Medical Device Entrepreneurs)
Explore every episode of Global Medical Device Podcast powered by Greenlight Guru
| Pub. Date | Title | Duration | |||||
|---|---|---|---|---|---|---|---|
| 07 Nov 2019 | An Overview of What Device Makers Need to Know About CAPA | 00:37:50 | |||||
Today we will be talking about a topic that seems to be an area of continual concern and, in some cases, struggle – CAPA. CAPA is an acronym for corrective action, preventative action.
When there’s a problem with a process or a product, certain steps need to be taken so we can identify the issue, find a way to correct it, then determine how to prevent it from happening again.
The process can be overwhelming, and today we’re going to go into in exactly what CAPA is, what the intent is, and some advice for medical device companies who aren’t sure where to start.
Our guest is Mike Drues, who has been on the show frequently. He’s the president of Vascular Sciences and an expert on medical device technology and regulatory affairs. You won’t want to miss today’s show, because it’s chock-full of insights on CAPA.
Some of the highlights of the show include:
● The mechanics of a CAPA investigation or system, and what the results of addressing the problems in a product or process should be.
● Advice for new and existing medical device companies who aren’t sure if their CAPA systems are going to meet FDA requirements.
● Some common mistakes that companies make when developing their CAPA systems and criteria.
● An overview of the CAPA process, including what might trigger a CAPA investigation, ways to get to the root cause of the issue, and the case study approach.
● Why being proactive (rather than reactive) is so important when it comes to CAPA.
● Thoughts on whether CAPA is being overused or underused, with data from the FDA.
● Why the thought and intent behind CAPA is more important than a set of checkboxes on a form. | |||||||
| 07 Nov 2019 | Understanding FDA’s Proposed Conformity Assessment Pilot Program | 00:32:22 | |||||
Today on the Global Medical Device Podcast, we’ll be talking to Mike Drues, who is a frequent guest on our show. He’s the president of Vascular Sciences and a guru on all things related to regulatory compliance for medical device companies.
We’ll be chatting about a new program that’s just been announced. It’s a pilot program on accrediting test organizations. The potential is that test compliance will be more consistent and that the process will be streamlined.
Some of the highlights of the show include:
● The background of the Accreditation Scheme for Conformity Assessment (ASCA): When it came about, when it should be implemented, and what it’s going to be used for.
● How current politics have impacted the development of this new program.
● Some of the challenges that the ASCA will likely bring about.
● The importance of asking the right questions and running the right tests.
● Thoughts on what to do if a regulation or a particular type of test is not appropriate or not possible.
● The potential pitfalls of putting testing labs into a position where conflict of interest is a real concern. | |||||||
| 07 Nov 2019 | What Devicemakers Need to Know About Medical Device Reporting (MDR) | 00:31:58 | |||||
Medical device reporting, or MDR: what is it? What isn’t it? Why is it important?
The FDA recently released a guidance on medical device reporting, and today we’re talking to Mike Drues, president of Vascular Sciences, about MDR and what it means to medical device companies.
Mike is a frequent guest on our show and really knows just about everything there is to know about medical device reporting. Sit back and enjoy today’s episode of the Global Medical Device podcast.
Some of the highlights of the show include:
● Why the 2016 FDA guidance on MDR is so important to post-market surveillance.
● What types of events are supposed to be reported, including tips on trying to find the relationship between a device and potential adverse effects.
● The relationship between complaints and MDRs: The MDR is a subset of complaints, but not all complaints will lead to MDRs.
● Mike’s thoughts on the timeliness of the reports when it comes to severity and frequency of the adverse events.
● Why the FDA is putting out this new guidance now, even though the process has been around for a long time.
● Who counts as a manufacturer in terms of the FDA guidance. Mike answers whether dentists, hospitals and physicians must report problems according to the letter of the law vs. the spirit of the law.
● How reprocessors fit into the reporting requirements.
● Mike’s thoughts on why medical device reporting might eventually become a moot point. | |||||||
| 24 May 2021 | Meet a Guru: Etienne Nichols | 00:30:26 | |||||
The Guru edge: it's what makes Greenlight Guru so unique and valuable to the medical device companies it serves. The Guru team is comprised of industry experts with a knack for helping companies succeed; each of whom have a specific skillset and knowledge base that companies can tap into and leverage throughout their medical device journey. In this episode of the Global Medical Device Podcast, Jon Speer talks to Etienne Nichols, a Medical Device Guru at Greenlight Guru, to learn more about his expansive industry knowledge, experience, and passion, of which he uses in his approach to help customers work through the design and development process to bring safe, high quality products to market. | |||||||
| 31 Mar 2021 | Understanding the Investigational Device Exemption (IDE) Process | 00:57:09 | |||||
Does your medical device qualify for an investigational device exemption (IDE)? What does this process involve and what does FDA expect of these manufacturers? There is plenty to consider when it comes to the IDE timeline and process. In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill “Mr. Regulatory” who sheds valuable light on the topic of IDE, which allows an investigational device to be used in a clinical study to collect safety and effectiveness data, and how to navigate this process in an efficient and compliant manner. Some highlights of this episode include:
Memorable quotes by David Pudwill:“Everybody wants to be breakthrough, but not everybody is breakthrough.” “There are a lot of clinical studies that are just exempt from IDE regulations.” “Even high-risk devices could fall into a not significant risk kind of a study.” “There’s always a chance that the FDA is going to disagree with you, if you think it’s non-significant risk. FDA is going to lean, in general, towards a slightly more conservative judgement on gray area issues.” “Specifically, if it’s a new sort of category of device or a significant departure from the existing technology, you’re probably going to need clinical information.” Links: | |||||||
| 02 Feb 2023 | Implementing an eQMS after Switching from Paper | 00:31:04 | |||||
What’s involved in switching from a paper-based QMS to an eQMS? What kinds of difficulties do companies experience when making that change? Today’s guest will explain her experiences with making that switch. In today’s episode, you’ll hear a conversation with Kendyl Williams on the topic of Implementing an eQMS. Kendyl is a Medical Device Guru at Greenlight Guru. When it comes to implementing an eQMS - Kendyl has experienced the sales process and has also implemented it for her company, and now she works with companies to help them implement the new software as well. Listen to the episode to hear what Kendyl has to say about the pain points of a paper QMS that can prompt making a switch to eQMS, challenges at the beginning of the switch, and a realistic timeline for implementing the new system. Some of the highlights of this episode include:
Memorable quotes from Kendyl Williams:“I know Greenlight has definitely changed a lot since we used it last, and I love all the new features that have come out because I think they really help to set people up for success when getting into Greenlight.” “I think my team struggled initially with the nomenclature of documents.” “The sandbox is also just a fun place to poke around.” “What I usually tell people building an eQMS is to be intentional in your setup.” Links: | |||||||
| 26 Nov 2019 | FDA is Expanding its Case for Quality Program... Should Your Company Participate? | 00:36:45 | |||||
Depending on the level of quality and compliance, medical devices can impact patients’ lives for better or for worse. Fortunately, FDA recently announced plans to open up and expand participation for its Case for Quality Initiative.
Today’s guest is Mike Drues of Vascular Sciences. We discuss the benefits and incentives for compliant and noncompliant companies to participate in the Case for Quality program. Compliance doesn’t necessarily ensure quality.
Some of the highlights of the show include:
● Pilot Program Premise: Partnership between FDA, MDIC, and CMMI Institute to promote compliance and focus on true quality products and processes.
● Case for Quality is newer program with somewhat skewed participation from larger companies due to incentives favoring PMA Class III products.
● Case for Quality: Advantages for participating include being excused from routine FDA inspections when state of compliance was demonstrated previously.
● Making changes to positively impact PMA products involves challenging process to submit a supplement. Are regulatory requirements for changes necessary?
● Micromanage Case for Quality: Root cause for such regulations is to prevent shortcuts and oversee those that don’t know what or how to be in compliance.
● Why are some companies not in compliance? They should participate in the Case for Quality Initiative to learn what they need to do. | |||||||
| 20 May 2022 | Building a Culture of Quality | 00:45:25 | |||||
How do you build a company that puts culture before function? Results before profit? Building a culture of quality to improve lives for a better world is more than just a slogan, it's a shared mission. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Dan Purvis, CEO and co-founder of Velentium, about building quality-centric, life-changing products for the medical device space. Velentium is a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices. Its staff does meaningful work on clients’ behalf to bring products to market. Some of the highlights of this episode include:
Memorable quotes from Dan Purvis:“In our space, quality really, really aligns itself well with risk and safety.” “Quality - it really is driving your organization towards perfection. That doesn’t mean perfect people. That doesn’t exist. We’re all fallible. But how have I created the processes, the thinking, and ultimately, the culture that gives us the best shot at removing risk and creating devices that are not only ethical and helpful to people but safe for the long haul.” “You could be fully compliant, and still unsafe. You could be fully safe, and not compliant, and so compliance obviously matters. You can’t go to market with non-compliant devices because you’ll get shut down, and you should be shut down.” “The only rules in this company should be rules that are inspiring.” Links:28 Days to Save the World by Dan Purvis | |||||||
| 04 Nov 2022 | The Importance of Cervical Cancer Screening in the U.S. | 00:19:47 | |||||
The importance of cervical cancer screening in the U.S.Why is cervical screening so important in the U.S. and globally? And how has the pandemic affected that screening? Today’s episode features Chris Beddard, VP of US Marketing at BD. She joins the podcast today to discuss a product she and her team have been working on to improve the lives of women. Chris is passionate about bringing awareness about health options to women around the world. Listen to the episode to hear what Chris has to say about why the test she’s been working on is special, what kinds of challenges a team faces when developing these tests, and why cervical cancer screening is so important. Some of the highlights of today’s episode include:
Memorable quotes from Chris Beddard:“Extended genotyping provides different information, information that’s critical to a clinician to basically manage a woman’s risk for developing cervical cancer or precancer.” “In order to get all three testing paradigms approved through the FDA, there was an extensive clinical trials that did take place, again spanning many years.” “HPV is the most common sexually transmitted infection in the United States.” “We’re seeing women returning to testing; we’re seeing –again –our view of healthcare changing based on the pandemic.” Links: | |||||||
| 07 Nov 2019 | Tips for Avoiding Problems with the First-In-Human Study Process with Mike Drues | 00:32:15 | |||||
When it comes to moving from the conceptual phase of developing a medical device and actually doing first in-human studies, you first need to prove that your device is safe and effective.
The documentation that goes along with that can be cumbersome, but, as Michael Drues, today’s guest, says, it’s necessary to prove that what you’re doing is safe.
Mike Drues is the president of Vascular Sciences. He consults with FDA, Health Canada and other regulatory bodies and also works with medical device companies to help them get their products ready for approval. He has the unique perspective of seeing medical device issues from both sides, because he works with regulatory agencies as well as development companies.
Today we’re discussing the topic of first in-human studies and what needs to go into the development process before devices can be used on and in actual people.
Some of the topics that you’ll hear discussed include:
-Some of the logistics that go along with those in the proof-of-concept phase: how to meet regulatory and ethical obligations without constructing too many barriers.
- The importance of objective evidence that a new device is safe, and how to balance that with the potential burden of documentation.
- How to handle offshore trials if you want to submit the data later as part of your FDA regulatory data submission.
- Hints on how to choose a country as a place to perform your offshore trials.
- Tips on avoiding problems with the first-in-human study process.
- How to handle the pre-submission process? | |||||||
| 11 May 2021 | Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program | 00:41:02 | |||||
What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program (BDP) and Safer Technologies Program for Medical Devices (STeP)? In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Director of Regulatory Affairs for Proxima Clinical Research (CRO). Together, Isabella and Jon discuss the FDA’s Breakthrough Devices Program and Safer Technologies Program and how manufacturers can determine if one or either is worth pursuing for their medical device. BDP is popular, STeP has the potential to be, but is not quite there yet given it’s a much newer program. Some highlights of this episode include:
Memorable quotes from Isabella Schmitt:“When you have more of a general indication statement, it’s more of an intended use and not really indication specific, that’s probably more along the lines of STeP than it is a breakthrough device.” “FDA really hones in on the indication statement for a lot of breakthrough devices.” “Being safer than the current technology out there–having the STeP designation can be beneficial for them because that’s really their selling point.” “The FDA’s bar can get a little bit higher for your clearance or approval because you’re focusing on specific language...and you’re basically making claims that need to be proven.”
| |||||||
Do you have a regulatory strategy to help your company prepare for the new European Medical Device Regulation (EU MDR)? With the May 2020 deadline right around the corner, a main area of focus for medical device companies will be transitioning to the new European regulation.
Today’s guest is Isabella Schmitt, regulatory affairs consultant with Proxima Clinical Research. Isabella joins Jon Speer in this episode to share what listeners need to do to prepare for EU MDR, despite the recently announced two-year delay of EUDAMED.
Some of the highlights of the show include:
- Why EU MDR? Effort to address uproar over ruptured implant devices with unknown materials that made some patients sick.
- What is EU MDR? The purpose is increased focus on safety and the entire lifecycle approach, not only pre-market approval (PMA).
- Compliant Equivalency: Isabella describes biological and technological factors, as well as data and test requirements for clinical use and support.
- Preparation - First Step: Assess general safety and performance requirements (GSPRs) via gap analysis of existing, needed, and publicly available data.
- Startup vs. Established Products/Companies: Understand compliance of GSPRs, intended use, description of device, standard of care, and alternative options.
- EUDAMED: Medical database with access to and reporting of clinical investigation information, post-market surveillance, universal device identifiers (UDIs). | |||||||
| 07 Nov 2019 | Streamlining The Device Marketing Authorization Process | 00:38:01 | |||||
There are a few additional steps to take when it comes to the Medical Device Single Audit Program (MDSAP) and ISO 13485-2016 regulatory process to get appropriate marketing clearances or approvals.
If you go through a regulatory process and get a product cleared, you still need to make sure your product is properly registered with the appropriate regulatory agencies. These extra steps to actually sell your product can be complicated.
On today’s episode, I talk to Jim Gianoutsos of RIMSYS Regulatory Management Software, about how to improve and streamline the device marketing authorization and facility registration process to gain efficiencies.
Some of the highlights of the show include:
● To be a global leader or company, you need to have a solid system in place to manage marketing authorizations worldwide.
● As part of the MDSAP process, you’re expected to answer specific questions and show evidence of compliance.
● Your regulatory team may be perceived as a bottleneck. Everyone needs to be on the same page about when the product can be released.
● Connection between marketing authorization and facility registration required for various countries - United States, European Union, or elsewhere.
● Get organized, have systems in place, and stay in compliance in case an auditor comes through your door or if you plan to sell in particular markets.
● FDA is moving away from 21 CFR 820 regulations to adopt ISO 13485 as quality system requirements via an MDSAP audit.
● Small companies have too much information to maintain, organize, and track. Large ones may have resources, but suffer from miscommunication.
● Don’t be complacent or afraid to change systems. RIMSYS was created to help regulatory professionals successfully and efficiently handle documentation. | |||||||
| 18 Nov 2020 | Are you Spending Enough Time Defining and Managing Requirements for your Medical Device? | 00:35:32 | |||||
Some sources claim that one-third of your product development project should be spent on defining good requirements. Why? Requirements are key determinants of success for any new product that’s being developed, especially a medical device.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Devin Mack, mechanical engineer and owner of Enqual, about the importance of spending enough time defining and managing requirements for medical devices.
Some of the highlights of the show include:
Story Behind Business Name: Enqual is a combination of Devin’s background in engineering plus quality to provide a balance between both.
A picture (or graph and diagram) is worth a 1,000 words to describe product development and design controls for medical devices.
A challenge that medical device companies tend to miss is the establishment of well-defined requirements during the product development process.
Best Practices: Open communication between internal and external customers and the product development team as well as cross-functional involvement to define good requirements early in the process.
Potential Pitfalls: What if stakeholders, engineers, and end users are not adequately considered in the development process? Everyone needs to voice their opinion to meet end user satisfaction and create a competitive edge to achieve goals.
Stop Light, Agile, or Six Sigma Methodology? Track team’s progress versus focusing on customer specifications. Constantly evaluate where you are with respect to your requirements.
Mantra: Invest time and money in useability/engineering models to get it right the first time to prove indications and meet proper requirements. | |||||||
| 07 Nov 2019 | Preparing for the Changes to the EU Medical Device and In-Virto Diagnostics Regulations | 00:26:47 | |||||
Agreement was reached on the eagerly awaited new EU Medical Device Regulations (MDR) and In-Vitro Diagnostics Regulations (IVDR) earlier this year.
This represents the single largest regulatory change in the EU in decades and it will affect ALL device manufactures selling in Europe.
The new MDR and IVDR are expected to be formally published any month now, and there will be a three-year transition period to be compliant.
Today we’re talking to Richard Young, the managing director of Acclaim Biomedical Consulting. He’s speaking to us today about some of these changes in the EU. With over 20 year in the medical and in-vitro device regulation industry, Richard has good insight on what these changes are, how they came about, and how the new MDR and IVDR will affect medtech companies.
Some of the topics you’ll hear about today include:
● An overview of what’s happening in Europe as far as MDR and IVDR.
● How these changes are impacting the burden of clinical evidence.
● How the periodic reporting regulations are changing.
● Richard’s thoughts on whether the EU regulatory processes will become more like the FDA processes.
● Whether there will be changes on how medical and in-vitro devices are classified.
● How software and technology is playing into the decisions made to change some of the regulations.
● Economic influences and impacts that have affected some of the changes. | |||||||
| 16 May 2024 | #367: Interviewing the Interviewer | 00:39:44 | |||||
In this special episode of the Global Medical Device Podcast, Etienne Nichols switches roles from host to guest as Devon Campbell turns the tables to explore the invaluable lessons Etienne has learned from over 100 podcast episodes. Delve into key insights on product development, quality management, and the power of vulnerability and networking. Etienne shares practical tips and personal anecdotes that reveal the nuances of the MedTech industry, making this episode a treasure trove of knowledge for both new and seasoned professionals. Key Timestamps:
Quotes:
Takeaways: Key Insights on the Latest MedTech Trends:
Practical Tips for MedTech Professionals:
Questions Predicting Future Developments:
References:
Beginner's Section: MedTech 101
Questions for the Audience: | |||||||
| 25 Jul 2024 | #377: Designing a Medical Device for a Global User | 00:43:44 | |||||
In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Matthew Wettergreen, Director of the Global Medical Innovation Master of Bioengineering program at Rice University. Dr. Wettergreen shares his extensive experience in developing client-based engineering design courses and discusses the importance of global and contextual perspectives in medical device innovation. They delve into the unique approaches of the Global Medical Innovation program, highlighting the critical role of diverse healthcare settings in shaping future medtech innovators. Key Timestamps:
Quotes:
Key Takeaways: Latest MedTech Trends:
Practical Tips for MedTech Enthusiasts:
Questions Predicting Future Developments:
References:
MedTech 101:
| |||||||
| 07 Nov 2019 | An Overview of What Medical Device Developers Need to Know About Human Factors | 00:35:58 | |||||
The topic of human factors can be confusing: How does it relate to design factors and risk? Why is it included in the regulations and how can this factor be handled?
On today’s episode, we have Bryant Foster, the Vice President of Research & Design at Research Collective. Bryant applies the principles of cognitive psychology to the design of new technologies and is a great resource on the topic.
Some of the highlights of the show include:
● What Bryant does as the VP of Research & Design at Research Collective and what his main focus is.
● The differences, overlaps, and intersections between human factors, design controls, project development, and research and development as these processes fit into the medical device industry.
● How companies should address the human factors standpoint.
● Common mistakes to avoid when considering the human factors.
● Human factors in usability and ergonomics as well as the difference between formative studies and validation.
● What a task analysis is and how that relates to the overall risk assessment.
● The importance of considering the various users of the product or device.
● What human factors has to do with post-market usability. | |||||||
| 26 May 2021 | Understanding the Value of a Medical Device Guru | 00:32:06 | |||||
Have you ever wondered, what does a medical device guru actually do? What role do they play within Greenlight Guru and what value do they bring medical device companies in the context of the QMS software? In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rish, a senior medical device guru and manager of the guru team at Greenlight Guru. Tom shares his unique insights into the life of a medical device guru at Greenlight Guru, how the guru team engages with customers beyond the software itself, and how the "Guru Edge" has come to be one of Greenlight Guru's most valuable offerings to medical device companies around the world. Some highlights of this episode include:
Memorable quotes by Tom Rish:“Greenlight Guru is more of an experience and not just buying software. We feel like the gurus are a big part of that experience and we want to make sure that we hold up our end of the bargain to that.” “We found early that our customers are coming to us with a lot of different questions.” “It’s very humbling and also encouraging to see how many people out there are just really passionate about their ideas.” “You can do a lot of work to get your product ready to launch knowing that you can add stuff on later.” Links: | |||||||
| 29 Jun 2022 | Early Stage Territory Planning for Medical Device Companies | 00:47:13 | |||||
Do your field teams still rely on map, spreadsheet, and note apps? How medical device companies have historically generated sales is no longer adequate for selling medical devices in today's market...and there's a new revenue intelligence tool to help you bridge the gap. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Skylar Talley and Mark Mescher from MedScout, a territory prioritization and sales enablement platform. Skylar and Mark discuss early stage territory planning to get more medical device sales, different aspects of go-to-market strategies, and building and demonstrating meaningful value by understanding pain points. Some of the highlights of this episode include:
Memorable quotes from this episode:“Sales reps aren’t always the best at Excel spreadsheets. Most of them don’t have any idea what a pivot table is.” Mark Mescher “I don’t hear from a lot of reps out there in the field that they’re just over the moon with how they have to use Salesforce on a day-to-day basis and if they use it on a day-to-day basis.” Mark Mescher “No two health systems are created equal when it comes to product approval.” Mark Mescher “Marketing teams are really at the forefront of being very creative in finding and generating leads through really interesting means that weren’t necessarily accessible previously.” Mark Mescher “Anytime you’re in an early stage environment, or doing something entrepreneurial, go talk to 20 to 30 people that you’re going to be trying to create an impact for.” Skylar Talley Links:The Rise of the Next Generation of Medtech “Milkmen” | |||||||
| 12 Nov 2020 | Positive and Negative Impacts of EUA on the Medical Device Industry | 00:37:44 | |||||
As the COVID-19 global pandemic continues, emergency use authorization (EUA) has become a highly utilized regulatory pathway to market in the United States.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Erica Loring, a medical device guru at Greenlight Guru.
Jon and Erica discuss the positive and negative impacts of the EUA program on the medical device industry as well as the need for increased responsiveness to streamline distribution of in-demand products and services, such as tests, masks, and ventilators.
Some of the highlights of the show include:
EUA and PPE: Erica comes from a regulatory background and describes how the huge influx of EUA applications for ventilators and masks to in-vitro diagnostic device (IVD) and lab developed tests affect FDA tiers that reach consumers and companies.
The FDA is government-funded and has a limited amount of resources. As a result, it’s scrambling to allocate people to review EUA submissions and 510(k)s for COVID-19 related tests to be legally marketed.
Due Diligence: FDA’s review periods on other products have slowed down, but timelines still need to be met. Also, the quality of reviews has declined, not only with the EUAs but 510(k)s because of limited resources.
FDA Statistics: A 510(k) review is supposed to take up to 90 days from the point of submission to an official response from the agency. However, EUA applications are being reviewed quickly to address a global public health crisis. Maybe too quick for regulatory quality and risks to be properly evaluated.
Compare and Contrast: Erica describes the pros and cons of false-negative and false-positive results for COVID-19 and/or IVD tests. What risks do those results pose to the public?
Research Use Only (RUO) to IVD: Companies that are not or have never been a medical device company need to have a quality management system (QMS), appropriate resources, and manufacturing transfers that can scale. This process takes time.
FDA EUA Guidance: Proper development and design control provisions should not be viewed as optional. Companies should not cut corners but be expected to follow best practices and post-market challenges for quality events.
EUA Impact Everywhere: Non-EUA products, procedures, and supplies were delayed, costs increased, and biocompatibility testing was affected due to the push for COVID-related products and services and eventual lift of those EUAs? | |||||||
| 07 Nov 2019 | Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway | 00:29:05 | |||||
This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510(k). The question is, is this really anything new? Today, we’ll be talking to Mike Drues, president of Vascular Sciences, and he’s going to help us all understand what’s different about this fast track and how it might benefit you.
Some of the highlights of the show include:
● What the new draft is about and how long this fast track has really been around.
● Some thoughts on the ramifications for the FDA and medical device companies since President Trump came into office.
● The FDA’s revised definition of “least burdensome.”
● Why, despite increased marketing and hype, the “new” path is not really new at all.
● What “abbreviated” means in this case and why it doesn’t necessarily mean faster or easier.
● Some questions to ask yourself if you want to know if you are working on something new or novel. | |||||||
| 07 Nov 2019 | How To Improve Your Medical Device Design Reviews | 00:24:03 | |||||
With nearly half a century of combine experience performing medical device Design Reviews between them; Michael Drues Ph.D., Jason McKibbin, and Jon Speer have the battle scars they want to help you to avoid.
They peel back the lens on what has worked for them over the years and how you can implement their proven strategies at your organization.
Design Reviews are clearly a topic that this group has some strong, and at times, counter intuitive thoughts on.
In this 24 minutes episode, our experts really get down to sharing actionable tips and advice that your team can start using today to help improve your Design Reviews.
They reveal their candid opinions and advice on a range of Design Review related topics including:
• Why Design Reviews are important?
• How do Design Reviews fit within Design Controls?
• Explain the concept of an “independent reviewer” and why this is necessary?
• When should Design Reviews take place? And how often?
• What should not be included within a Design Review?
• How are Design Reviews the same (or different) from a Phase Review?
• What actionable tips & advice do you have to improve Design Reviews? | |||||||
| 07 Mar 2024 | #357: The State of UDI Across the World | 00:52:49 | |||||
In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Gary Saner, a seasoned expert in medical device Unique Device Identification (UDI) and regulatory compliance. They embark on a comprehensive exploration of the ever-evolving landscape of UDI requirements, shedding light on crucial deadlines, common pitfalls, and strategic insights for achieving global compliance. From the intricacies of European UDI requirements to the specifics of implementing UDI systems in markets like Australia and beyond, this episode is a treasure trove of actionable insider knowledge for medical device professionals navigating the complexities of UDI compliance. Quotes:
Takeaways:Latest MedTech Trends:
Practical Tips for Listeners:
Predicting Future Developments:
References:
Beginner's Section: MedTech 101For new listeners, UDI (Unique Device Identification) is a system used by regulatory authorities to identify and track medical devices through their distribution and use. It's a crucial component of medical device regulation, ensuring the safety, efficacy, and traceability of devices. Questions for the Audience:
Feedback and Future Topics:We value your feedback and ideas for future episodes. Please email us at podcast@greenlight.guru with your suggestions and thoughts. Sponsors:This episode is brought to you by Greenlight Guru, the MedTech industry's leading solution for product development and compliance. Discover how Greenlight Guru can accelerate your product's journey to market by visiting www.greenlight.guru | |||||||
| 06 Jan 2022 | Understanding the UDI System for Medical Devices | 00:34:05 | |||||
Do you understand how the Unique Device Identification (UDI) system in the medical device industry works? The overall concept can be best understood by learning how it is used and why it exists. TIn this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box. Listen to Jon, Etienne, and Mark discuss key points every medical device professional should know about the UDI system. Some of the highlights of this episode include:
Memorable quotes from Mark Rutkiewicz:“Every part that you use in the hospital room has a barcode on it.” “If this patient was prescribed something, then you scan everything that they do. If somebody made a mistake, they would catch it right away.” “Nobody's really standardized." “You can scan it to make sure that you are using the right product with the right other products and with the right patient.” Links:Medical Device Company In A Box: The Case For Consiliso FDA - Unique Device Identification System (UDI System) European Union Medical Device Regulation (EU MDR) | |||||||
| 26 Jan 2022 | A Regulatory Gap Analysis of FDA's Systems & Policies | 00:53:12 | |||||
What’s missing in the current FDA regulatory framework? Are there areas and opportunities for improvement? In this episode of the Global Medical Device Podcast Greenlight Guru founder and host Jon Speer talks to Mike Drues of Vascular Sciences about what an ideal regulatory system would look like, and provide a gap analysis of the FDA's current regulatory systems and policies for a more proactive perspective rather than a reactive approach. Some of the highlights of this episode include:
Memorable quotes from Mike Drues:“One of my many frustrations with the regulatory environment that we live in is that so much of the regulation that we have is created retrospectively, reactively.” “As we all know, the 510(k) is the workhorse of the medical device industry.” “I’m a huge advocate of communication with the FDA.” “We have tons of regulation already. We don’t need more regulation. What we need is more people understanding the regulation that we already have and figuring out ways to apply it.” Links:FDA - Corrective Action/Preventative Action (CAPA) FDA - Overview of Device Regulation FDA - Premarket Notification 510(k) FDA - Premarket Approval (PMA) 14 Sep 2023 | #336: From Academia to FDA Clearance (True Quality Roadshow - Boston) | 00:42:23 | | ||||
Description: In this episode recorded in front of a live audience in Boston, MA, we speak with Christy Sheehy-Bensinger, the CEO & Founder of C-Light Technologies, Inc. about their recently cleared eye movement monitor. Listen as we unpack her journey from academia to startup life, explore the complexities of medtech communication, and delve into the intricate dance of securing FDA clearance. This was a fun conversation, with good Q&A at the end where we discuss the highs and lows of pioneering digital health solutions, the significance of a quality-first mindset in MedTech, and the art of crafting a passionate team. Some of the highlights of this episode include:
Quote: "Management, speaking their language is super important. If I can compare it to what I already know, then that's easier." - Christy Sheehy-Bensinger Reference Links:
*Interested in sponsoring an episode? Use this form and let us know! | |||||||
| 07 Apr 2022 | Bringing Augmented Reality MedTech to Market | 00:32:27 | |||||
Today’s innovative medical technology is more like a video game and makes a minimally invasive ablation so easy it could be done by a 12-year-old. In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mina Fahim, CEO and President of MediView, about bringing augmented reality (AR) medical technology to market. MediView gives clinicians X-ray vision and leverages AR and artificial intelligence (AI) to simplify, democratize, and inform healthcare delivery. Previously, Mina worked at Medtronic, Abbott, Beckman Coulter, and Excelen. Mina is a serial entrepreneur in the medtech and fintech spaces. He approaches his life with a foundation of trust, team, transparency, and track record to encourage collaboration and innovation focused on advancing people’s everyday lives. Some of the highlights of this episode include:
Memorable quotes from Mina Fahim:“We are hardware agnostic. So, we don’t depend, actually, on any one specific headset because of the unique algorithms that we built in.” “We have an algorithm that combines the digital world in AR with the physical world.” “The interventionists are not comfortable taking a needle, sticking it into the abdomen, trying to hit a grape inside of a watermelon blindly to get that tumor ablated.” “We give clinicians imaging modalities they trust and are comfortable with today to validate the new way we’re providing them to practice and exercise medicine.” “If a company’s exit strategy is acquisition, having a robust QMS that someone can look at effectively, efficiently, and simply…that has a mental impact, an emotional impact, a burden impact." Links:Code of Federal Regulations (CFR) | |||||||
| 07 Nov 2019 | Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey | 00:24:45 | |||||
In episode 10 of the Global Medical Device podcast we welcome Matt Romey from the Azzur Group. Matt is a project manager for the Azzur Group and has been involved with many medical device projects. He was a founding employee and executive team member at GluMetrics, a venture-backed startup that raised over $67M.
Matt has 20 years experience in the medical equipment design industry and has plenty of knowledge to share with new startups. During today’s conversation Matt and Jon will discuss the importance of Design Controls, which they both share a passion for.
"Design controls are yes, required by law, but they also represent good business practices." - Matt Romey
Matt believes so much in the importance of design controls that at one of his companies he had a line from the FDA Design Control guidance document taped to his wall that stated, “It is a well established fact that the cost to correct design errors are lower when errors are caught earlier in the design and development process.”
"The 1 - 10 -100 rule. That's where if you catch it early in the process it may cost you a dollar to fix, then a little bit later in the process it will be maybe 10 dollars. Once you get into production... 100 dollars." - Jon Speer
The most important thing to keep in mind while working on medical device design is user needs. These user needs will guide you to the right questions so that design inputs are effective and relevant.
Today’s highlights include:
● Matt explains how good quality design control is just part of good business practices.
● You will hear why the classic “waterfall diagram” may not be the best guideline for a project.
● Why when you find design inputs, they need to be testable.
"Design inputs should be a translation of your user needs to some sort engineering specification that can be measurable." - Matt Romey | |||||||
| 07 Nov 2019 | Helping Prepare Biomedical Engineers Entering the Workforce | 00:33:00 | |||||
Students offer hope for our future. They will be developing products that can save our lives, or at least improve our quality of life. We need to give them as much guidance and advice as possible.
On today’s episode, we have Associate Professor Andrew DiMeo, who shares his mission and what he is trying to do with the biomedical program at the University of North Carolina and North Carolina State University.
Some of the highlights of the show include:
● Andrew’s biomedical product development course is based on quality and regulatory.
● It is possible to be creative and innovative in a restrictive regulated environment, like biomedical engineering.
● Some people believe regulations/controls and the status quo prevent them from getting things done.
● The reasons why controls and regulations are necessary.
● How to prepare biomedical engineers entering the workforce.
● Andrew teaches students by using a real-life medical system.
● Regulations should be kept simple to avoid being too restrictive.
● Andrew describes a siloed world where collaboration is key. | |||||||
| 22 Feb 2021 | How does EU MDR impact your Quality Management System? | 00:36:06 | |||||
The new medical device regulation in the European Union (EU MDR) has introduced a host of new challenges for medical device companies. One challenge, in particular, has to do with the quality management system of a medical device. In this episode of the Global Medical Device Podcast, Jon Speer talks to Monir El Azzouzi, founder and CEO of Easy Medical Device. Also, Monir is a prolific podcaster, blogger, and YouTuber that helps medical device companies achieve compliance. Together, Monir and Jon discuss the ways in which EU MDR impacts a quality management system and best practices medical device companies can follow to maintain compliance with new requirements. Some highlights from this episode include:
Memorable quotes from Monir El Azzouzi:“A quality management system is not just a bunch of documents.” “When you are, for example, manufacturing some medical devices, you have to respect some rules, some regulations.” “Don’t pay something twice (choose certification vs. notified bodies wisely).” “EU MDR is a regulation that is...raising the bar in terms of requirements and things that you need.” “When everything goes well, nobody will recheck what you are doing. But as soon as there is an issue on the market, as soon as there is a... | |||||||
| 10 Feb 2023 | Part 1: The Theranos Loophole & Lab Developed Tests | 00:37:37 | |||||
What’s the difference between an LDT and an IVD and what does that have to do with the Theranos case? In this episode, we dig deep into this topic. Mike Drues, a frequent returning guest to the Global Medical Device podcast is the president of Vascular Sciences. He has a Ph.D. in biomedical engineering and extensive experience with Regulatory Strategy, the FDA, and the history behind most of the regulations. In today’s episode, Mike Drues and I spoke about the topic of Lab Developed Tests (LDTs), the ongoing Theranos case, and the state of LDTs & IVDs. Listen to the episode to learn more about Lab Developed Tests and what some examples of them are, what testing and regulations are required for LDTs, and how Theranos was able to market a test without the typical testing rigor. Some of the highlights of this episode include:
Memorable quotes from Mike Drues:“A lot of people like to talk about what FDA regulates. I like to talk about what FDA doesn’t regulate.” “Remember, regulation is about the interpretation of words.” “There is no difference in terms of the technology between an IVD and an LVT. The difference primarily is who uses it and where it’s developed.” “If the hospital does one thing, they’re treated one way; if a company does exactly the same thing, they’re treated another way. Something’s not quite kosher about that logic.” Links: | |||||||
| 26 Jan 2023 | Essentials of Sterilization for Med Device Professionals | 00:37:01 | |||||
What tools do sterilization engineers need the most? What’s the difference between sterilization modalities? Those are some of the points that our guest will be talking about in today’s conversation. Laura Maher previously appeared on the podcast to talk about UDI, and now she’s here to talk more about sterilization. Laura is a Medical Device Guru at Greenlight Guru and is a self-proclaimed sterilization enthusiast. Listen to the episode to learn what Laura has to say about Gamma vs. EO, new modalities recognized by the FDA, and the sterility pitfalls Laura has experienced or heard of. Some of the highlights of this episode include:
Memorable quotes from Laura Maher:“Biology is my main passion with chemistry kind of like behind it.” “People will talk your ear off about sterility all day, which is super fun.” “Packaging is a huge component of sterility because it IS your sterile barrier.” “If you have a chance to see a Gamma source, take it. It is really cool.” Links: | |||||||
| 23 Jun 2021 | Preparing Your Pre-Submission with the Content FDA Wants to See | 00:36:28 | |||||
A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can use to guide product development and marketing submission planning. There is an art to preparing a Pre-submission, though, so it's important to include the necessary contents (and avoid common pitfalls) that will yield the best possible results. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about Pre-submissions. Listen as the two share recommendations about what content to include in a Pre-sub request to FDA as well as costly pitfalls to avoid with this particular Q-submission type. Some highlights of this episode include:
Memorable Quotes from Mike Drues:“A Pre-submission meeting is an opportunity to talk to the FDA before you actually make your submission.” “Clearly, the popularity of the program is increasing.” “A Pre-sub is purely optional. It is never required. A company can choose to do a Pre-sub or not.” “Unlike 510(k) and PMA submissions, unlike 513(g) requests, and so on, there is no user fee associated with the Pre-sub—although at least not yet.” Links: | |||||||
| 02 Mar 2023 | DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact | 00:27:56 | |||||
DHF, DMR, and DHR are easy to mix up when you’re just using the abbreviations – they sound a lot alike! And they are connected. But it’s important to understand the differences between them as well as how they interact with each other. Medical Device Guru Laura Court joins the podcast today to discuss these three documents – what you need to know about them, what to do with them, and why it matters. Listen to the episode to learn how Laura thinks about best practices, what companies get wrong, and how to improve when dealing with these three different kinds of documentation. Some of the highlights of this episode include:
Memorable quotes from Laura Court:“I am on the onboarding and implementation side of our team for the gurus here, so I help get our customers started in the software.” “Your design history file is truly the history of how your product was developed.” “Don’t assume that you know everything. Even if you’ve been reading your DHF, you’re not going to know everything.” “Everything should go through document control.” Links: | |||||||
| 07 Nov 2019 | Lessons to Be Learned From Recent FDA Inspections | 00:36:32 | |||||
Something that you might find surprising is the number of medical device companies that are simply not prepared for an FDA inspection. The bottom line is that you should expect to be inspected. Today we’re going to be talking to Mike Drues, the president of Vascular Sciences, about the lessons that companies have learned from their not-so-successful FDA inspections. You can learn from them, too!
Some of the highlights of the show include:
● Jon’s story of a situation where a company was completely unprepared for an FDA inspection years after their product went to market.
● The difference between not having the required information and having the required information in a format that’s unacceptable to the FDA.
● What companies can do to prevent problems with FDA inspections.
● The importance of knowing what you know and knowing what you don’t know and knowing the difference between the two.
● Why it’s so important to consider the root cause of troubles with FDA inspections. Many times, the root cause is a tick-the-box mentality.
● Best practices for being prepared for an inspection.
● Why an independent audit might not be an effective way to know that you’re prepared for an inspection, as well as tips on knowing whether your auditor is beneficial.
● Why it’s good to purposely inject a problem into your process to be sure that your quality control system will detect it.
● The importance of taking a holistic approach rather than only looking at issues one at a time. | |||||||
| 07 Nov 2019 | 2016 Medical Device Regulatory Trends Year in Review | 00:34:06 | |||||
We’re in the last days of 2016, and it’s a good time to look back as we plan for the future. On today’s episode, Mike Drues and Jon go over the many happenings in the medical device industry over the past year. Mike is a frequent guest on our show, and today we will be talking about the year in review.
Some of the topics you’ll hear discussed include:
- Some of the significant guidance documents that were new in 2016, including one on medical device reporting for manufacturers.
- Two guidances on when to submit a 510K and why these in particular are important.
- General wellness devices: What they are and what makes them different from regulated devices.
- Thoughts on the Use of Real-World Evidence guidance document.
- Why the guidance on 3D printing is so impactful.
- What might happen from a regulatory perspective in 2017, including more specific guidances and focusing on usability.
- Thoughts on whether the FDA should be in the business of putting out guidance documents. | |||||||
| 16 Jun 2022 | What Impact Does a QMS & Regulatory Have on Fundraising and Pre-money Valuation? | 00:48:44 | |||||
How does a quality management system (QMS) and regulatory factors impact fundraising, pre-money valuation, market access, and commercialization for medical device companies? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Cristiano Fontana, founder and CEO of ThreeBridges. ThreeBridges is a consulting firm that provides business development advisory services for startups, distribution companies, and subject matter experts (SMEs) in the global medtech market. Also, Cristiano is a co-founder of CrossBay Medical, Inc., and partner of IStarter and ClubDealOnline. Some of the highlights of this episode include:
Memorable quotes from Cristiano Fontana:“Come up with a business plan that is reliable as far as a business plan can be reliable.” “You need a deep understanding of your business model, your market potential, your value position, so that you understand what really is the potential of the product.” “Many times, people are not succeeding in fundraising or are delaying the time for getting their money because they’re not targeting the right people.” “You need, also, to show that you know what a QMS is, you have that in place already, and it is really efficient and well managed. Having something that is well structured that is tailor made but is well recognized on the market that is working.” Links:EU Medical Device Regulation (MDR) Greenlight Guru YouTube Channel | |||||||
| 25 Aug 2023 | #333: Exploring Breakthrough Device Designation | 00:35:01 | |||||
Description: In this episode, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. They discuss pursuing breakthrough status, aligning marketing strategies with FDA review, and navigating the medical device industry. This episode provides a roadmap for this complex regulatory terrain. Learn about the benefits and scrutiny of the breakthrough designation, hear examples that emphasize the need for precise data and quality in the application process, and listen as we explain the planning and considerations for success, and how innovation can thrive within regulation. Some of the highlights of this episode include:
Quote: "Say you are a direct competitor with someone else, and they got breakthrough but they're not on the market yet... You can still get breakthrough for the same indication. FDA does not consider that as a cleared or approved alternative - even if they're miles ahead of you." Reference Links:
*Interested in sponsoring an episode? Use this form and let us know! | |||||||
| 27 Jan 2021 | 5 Actionable Lessons Learned from the RADx Initiative by NIH | 00:47:51 | |||||
Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Health (NIH) aimed at accelerating the development, commercialization, and implementation of COVID-19 testing technologies that shorten viral detection cycles and increase access to reliable, accurate testing on a widespread scale.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Devon Campbell, founder of Prodct, who has been a major contributor in supporting the efforts being made by RADx teams. Listen as Jon and Devon share five actionable lessons learned from Devon’s involvement with RADx, each of which can be applied by medical device companies across the board. | |||||||
| 07 Nov 2019 | How to Design for Compliance with IEC 60601 | 00:34:02 | |||||
Have you ever designed a medical device that has electrical components? Was it frustrating to go through the electrical safety testing - the IEC 60601 standards?
Claus Roemer Andersen, a compliance expert from Roemer Consulting, shares his experiences and advises us on how to design for compliance with IEC 60601.
After all, a lack of electrical compatibility can be detrimental to medical devices and the patients who use them.
IEC 60601 documentation is a lot to digest, which is a major challenge. But that does not mean you should neglect those standards. Applying the standards and making changes early on adds value and saves your company a lot of money.
Some of the Highlights of the show include:
-Road to Compliance: Design specific technical requirements during the early phases of product development, and perform design reviews and pre-testing.
-How to integrate design input requirements from a risk-management perspective.
-Why IEC 60601 standards are difficult for most people to navigate.
IEC 60601 has 8 specific things you have to address in your risk-management process, but they don’t fit into or make sense in a typical risk analysis table.
-The reason why the FMEA tool is not a useful tool regarding electrical safety: It is a single-fault failure, which is not sufficient.
-Understand who will be using a product and in what kind of environments because that shapes what you need to do regarding electrical safety.
-If you don’t follow standards, you face expensive and time-consuming redesign or you have to defend the effectiveness of your risk analysis.
-The days of “I Promise” statements for electrical safety are gone, and they make for delays and redesign challenges. | |||||||
| 09 Jun 2021 | How Mindset Training Can Help Your Team Operate at Peak Performance | 00:28:30 | |||||
Close your eyes, take a deep breath in, and imagine your team operating at peak performance, exceeding goals and each member feeling and working at their best. Now, breathe out, letting out a sigh of relief knowing that's fully within the realm of possibility — through mindset training. In this episode of the Global Medical Device Podcast, Jon Speer talks to Kevin Bailey, mindset coach and founder of Dreamfuel, a mindset coaching solution for high growth companies. Kevin is the mindset coach for Greenlight Guru and has worked with Jon and Greenlight Guru employees over the years by providing mindfulness tools and techniques that teams can use to improve overall mindset. Listen to what Jon has learned from this mindset training and how the medical device community, too, can benefit from engaging in mindset practices at work. Some highlights of this episode include:
Memorable quotes by Kevin Bailey:“Mindset is such an important practice for success in a company.” “We’re trying to kind of take these practices that have been utilized for ions to help people be happier and perform better, wrap them with some neuroscience, so that people can accept and understand them, but there’s still that stigma.” | |||||||
| 08 Jul 2020 | How to Build a QMS for a Medical Device | 00:44:22 | |||||
Where do you begin when building a quality management system (QMS) for a medical device? It’s a task that is often delayed until later stages of development. Don’t wait to implement a QMS; the consequences of waiting too long can lead to irreparable damage to your processes and, in some cases, product failures.
In this episode of the Global Medical Device Podcast, Jon Speer talks to quality and regulatory expert Mike Drues, president of Vascular Sciences. Together they discuss why a QMS is so important to a company as it sets up its business and processes. Laying a proper foundation for a QMS to operate at its full capacity is just as critical, which involves a shared mindset and philosophy across the organization that reinforces a culture of True Quality.
Some highlights of this episode include:
• A QMS is not a system of compliance. It should describe how business is conducted through policies, procedures, processes, and philosophies.
• If a QMS consists of devices not manufactured by the company, it’s an example of the copy-and-past approach to be compliant, but not customized.
• A QMS is important to describe, document, and demonstrate roles, responsibilities, and rules to make decisions about products for patients.
• A QMS focuses on four key areas: Accountability, traceability, consistency, and continuity.
• Preamble/Introduction: One company’s QMS should not be a carbon copy of another company’s QMS. It should focus on its own mindset and philosophy.
• Every QMS should include complaints, change management, and customer feedback to trigger notifications that affect safety, efficacy, and performance.
• Product Lifecycle: During research and development, conduct post-market surveillance, beta test change management, and review risk management plan.
• Document Management Control: All complaints and conflicts are not created equal. Get it right to make sure it’s effective and efficient. | |||||||
| 07 Nov 2019 | What You Need to Know About The FDA CDRH Experiential Learning Program | 00:31:17 | |||||
FDA has a new program called, The Experiential Learning Program, which involves CDRH going to medical device companies, manufacturers, and service providers to discuss biocompatibility, in vitro diagnostics, clinical trials, and other areas.
On today’s episode, Mike Drues of Vascular Sciences and Jon talk about the advantages and disadvantages of this program that encourages reviewers and companies to spend more time together.
The better the reviewers understand the development processes that medical devices go through, the better they can work effectively with the companies to get medical devices on the market.
SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE:
● Who’s job is it to teach CDRH staff on how medical devices are developed?
● When an FDA visitor is in the building, will the visit be realistic to open and honest discussion? Or filtered and sanitized?
● Visits could work to your advantage. You can “toot your own horn” as a medical device company that has a good regulatory process and sets the bar for quality.
● Skeptics may view the program as a sneaky way for FDA to come in, inspect what’s going on, and force changes - involves companies taking calculated risks.
● CDRH wants to teach staff about certain areas. They should already have subject matter expertise, but may have never been trained.
● CDRH should share information and experiences with medical device companies to improve collaboration without disclosing confidential details.
● Visits offer opportunities for two types of companies: 1) device manufacturers and 2) service providers.
● No good deed goes unpunished. So, make sure you have all your “ducks in a row.” If you want to schedule a visit, there’s a submission deadline of Sept. 26. | |||||||
| 17 Dec 2020 | Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near | 00:31:21 | |||||
The end of 2020 is near, which will close out a year that’s been fraught with challenges and difficulties. However, 2021 will bring its own set of new challenges for those implementing the European Union Medical Device Regulation/In-Vitro Diagnostics Regulation (EU MDR/IVDR). What do device companies still need to do to be prepared for the transition?
In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-Owner of QUNIQUE Group, a quality and regulatory consultancy.
Bassil offers expert advice on how device companies need to prepare for these regulatory deadlines and transition to meeting the requirements of EU MDR/IVDR sooner rather than later.
Some of the highlights of the show include:
COVID-19 is an additional burden by impacting implementation, increasing requirements, and not being transparent about limited notified body capacity.
EU MDR/IVDR Readiness: Under the new legislation, every device needs to receive re-certification by notified bodies to keep market access.
EU MDR/IVDR Challenges:
Additional guidance needed during transition to apply these regulations.
Regulations put expectations that are not ready, such as EUDAMED.
Increased requirements on clinical evidence via higher clinical and performance evaluation requirements.
Continuous reporting increases expectations on resources for new and existing medical devices.
EU MDR/IVDR Timeline: Number of notified bodies isn’t the most important part. How much capacity do those notified bodies have to address market needs?
Tips for Medical Device and In-vitro Diagnostic Companies:
Read the regulation(s).
Understand implication(s) of regulation(s) on system(s).
Identify/re-evaluate notified bodies that can address needs.
Manage timeline/deadline for submission, implementation, certification. | |||||||
| 11 Jul 2023 | #327 Understanding the ROI of an eQMS | 00:51:20 | |||||
In this episode with Fran Cruz, Chief Customer Officer at Greenlight Guru, we explore the investment of a purpose-built electronic Quality Management System (eQMS). Some of the topics we explore are:
"I think ultimately this whole study was really illuminating because it was able to give executive teams, buying teams the numbers that they needed to make a smart decision." ~Fran Cruz Reference Links: pKtQjeyoDImuAoc2OjH5 | |||||||
| 04 Jan 2024 | #350: The Evolving Landscape of AI in MedTech | 00:49:20 | |||||
In this insightful episode, Eric Henry and Etienne Nichols delve into the evolving landscape of AI in MedTech, focusing on regulatory compliance and the future of AI in medical devices. They discuss the role of the FDA, FTC, and other regulatory bodies, and explore the implications of AI in product development and quality assurance. Quotes
Takeaways
References
Listeners are encouraged to leave a review on iTunes and reach out to Etienne Nichols on LinkedIn for feedback. | |||||||
| 07 Nov 2019 | The Difference Between Intended Use and Indications of Use with Mike Drues | 00:20:35 | |||||
It’s time to break down the how and why of intended use and indications of use statements for your new medical device.
On this episode of the Global Medical Device podcast we’ll explain the differences between these two statements and how you can design your labels around them.
Mike Drues, Ph.D. is our guest today giving some great examples of these use statements and successful label designs. He’s the President of Vascular Science, consulting for medical devices and regulatory bodies like FDA, and he travels the globe to set everyone straight on medical device regulations.
Your intended use and indications of use statements are integral to getting your medical device to market.
These statements help insure your device meets regulation when used properly.
If you want to bypass any hiccups in your marketing plan, you need to understand the key differences between these two statements:
First, intended use is EXACTLY what your product is used for. Don’t focus on what it COULD be used for. Rather, define exactly what it is in as few words as possible.
Second, your indication of use statement are the precise situations and reasons where and why you would use this device. Again, being very clear and definitive here is extremely important.
“They think they understand what intended use means, but they really don’t…Intended use is all about what we say this device is to be used for, and indications for use is under what circumstances or under what conditions you would use that particular product.” – Mike Drues
Mike Drues goes into what he calls “high level labeling” with tips on how to get your label to market with as few words as possible.
Little words do matter, and sometimes it may take you 6 different use statements before you find the right ones that work for your device.
Breaking down examples, using clear-cut definitions, and using a trick Mike calls “label expansion” are all ways you can use your intended use and indication of use statements to your advantage.
“The single most important thing that people should remember is to apply the same concepts and philosophies that we learned as engineers to product design [and] apply that same kind of thinking to label design…and indication of use statements.” – Mike Drues
Mike also discusses the reimbursement pathway and how it is often overlooked in the beginning of our development processes.
Changing up when you approach regulation can really make it easier to design and write the right kinds of use statements, and focusing on regulation this early on will often make it easier for marketing further down the road.
Tune in now to hear how these tips can be applied to you, your team, and your medical device.
To get in touch with Mike Drues, find him on LinkedIn. | |||||||
| 07 Nov 2019 | Regulatory Tips & Observations from a Former FDA Reviewer | 00:32:03 | |||||
What are some recent trends and observations in the medical device industry regarding regulatory affairs and strategies? On today’s episode, we have Allison Komiyama of Acknowledge Regulatory Strategies. She shares her perspective on them, especially as a former FDA reviewer, current consultant who helps companies with regulatory strategies and submissions, and patient of life-saving medical devices.
Some of the highlights of the show include:
● The regulatory path to get devices approved has been under scrutiny for decades. Companies may think it’s too hard or cut corners with FDA regulations.
● Get a second opinion, conduct research, and ask questions about medical devices because your or your loved one’s life may depend on the device.
● FDA reviewers may go into industry because they know how to regulate devices. They understand why regulations are in place to make devices safe, effective.
● If a company does testing, gives the FDA what it needs, and participates in the pre-submission process, the likelihood of a device being approved is greater.
● When preparing regulatory documents, review information available on the FDA’s Website and contact DICE and/or regulatory consultant.
● Consider pre-submission if your company isn’t confident about testing needed or is an early startup that needs guidance on its regulator strategy.
● AI Letter: Puts your device submission on hold for issues and deficiencies that need to be addressed within 180 days. Avoid getting an NSE letter!
● Update your 510(k) summary if a predicate device has been subject to a recall. FDA wants to make sure the new device does not have the same issues. | |||||||
| 19 Aug 2020 | Meet a Guru: Wade Schroeder | 00:26:09 | |||||
What sets Greenlight Guru apart from other quality management solutions? It’s Guru edge—a team of medical device professionals with more than seventy years of combined industry experience.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Wade Schroeder, a medical device Guru at Greenlight Guru.
As an electrical engineer and risk management enthusiast, Wade shares his unique approach to medical device product development and complying with regulations. He also shares a few of his favorite customer stories and offers his key recommendations to listeners on how to find success in the medical device industry. | |||||||
| 30 Mar 2021 | Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry | 00:22:08 | |||||
Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself? There’s a supplier management solution that will make your job a whole lot easier. In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-owner of QUNIQUE, a quality and regulatory consultancy. Previously, Bassil worked with the notified body, TÜV SÜD. Bassil discusses QUNIQUE’s Quality Engine (QE) solution for supplier management, which helps manufacturers find compliant solutions to fulfill obligations and achieve continuity that puts medical devices on the market. Some highlights of this episode include:
Memorable quotes from Bassil Akra:“We are helping manufacturers and we are finding solutions toward getting them really compliant, but getting them also in a lean way fulfilling their obligation and being able to achieve the target of market continuity and getting their device on the market.” “Every one of us is nowadays struggling to find things.” “It is not the end list, this is the beginning. We’re going to extend this platform to get more transparency on the market.” “We have a large number of service providers who are unknown and they are available when we need them but we don’t know about them.” “Transparency is all what we need in life to have fair competition and a clear supplier selection.” Links: | |||||||
| 07 Jun 2023 | Leaning into Lean Documentation | 00:55:36 | |||||
What is lean documentation and how can you achieve it? Our guest on today’s live podcast is an expert on quality management systems, audits, and most importantly for today’s conversation, documentation. Steve Gompertz is a partner at QRX Partners and has led initiatives in project management, engineering automation, configuration management, audit, and software development. During today’s episode, we’ll talk about the most important parts of a QMS, what differentiates a good QMS from a bad one, and how to prove ROI on a QMS. Steve will also discuss what he would do if he were starting a medical device company today. Listen to the episode to learn more about lean documentation and how you can learn to write for your actual audience – the workers – while still pleasing the auditors. Some of the highlights of this episode include:
Memorable quotes from Steve Gompertz:“I’m fond of telling people, ‘The auditors don’t work here. That’s not who these documents are for.’” “Done correctly, efficiency and effectiveness are not enemies.” “Everybody has a customer internally; everyone produces a product.” “On the quality systems pyramid, the smallest piece is the quality manual. So why is it the biggest document.” Links: | |||||||
| 07 Nov 2019 | Understanding the Difference Between a General Wellness Device and a Regulated Medical Device | 00:31:26 | |||||
Today Jon Speer and Mike Drues are going to be discussing general wellness devices. Mike is the president of Vascular Sciences, and he’s a guru on all things regarding compliance and medical device development. General wellness device development is relevant right now because they’re so popular and widely used in today’s health-conscious population. It’s important to understand what a general wellness device is, when it becomes a regulated medical device, and how the two are different when it comes to FDA regulation.
Some of the highlights of the show include:
- The FDA’s definition of a general wellness device, as well as Mike’s simpler definition.
- What makes a wellness product low-risk, and what “low-risk” really means when it comes to both causing harm and the potential for providing incorrect information.
- How to know if you’ve crossed a line with your wellness device and actually need to classify your product as a regulated medical device. Mike also gives examples to paint the difference more clearly.
- How marketing a wellness device as a 510k can be beneficial for label expansion purposes, as well as how marketing it first as a wellness device can improve the 510k process -- with a caveat as to how to handle the submission.
- The importance of prudent engineering with wellness devices; the lack of regulation is not an excuse to cut corners or take shortcuts. | |||||||
| 10 Mar 2021 | Building a Startup in the MedTech Industry | 00:30:03 | |||||
What does it take to build a successful MedTech startup? It’s a multi-million dollar question and the answer involves strong execution of a highly strategic plan. In this episode of the Global Medical Device Podcast, Jon Speer talks to Duane Mancini, president and founder of Project Medtech, and host of the Project Medtech Podcast. Listen as Jon and Duane talk about building a startup in the MedTech industry and why it’s so important for MedTech startups to be strategic in their approach to bringing a device to market, like taking advantage of reimbursement opportunities and leveraging a QMS to support all efforts along the way. | |||||||
| 27 Jul 2022 | Examining FDA’s Refusal to Accept (RTA) Policy and Guidance | 00:44:41 | |||||
After three “Refusals To Accept” Guidance Documents from the FDA, why are there still so many submission issues? Who’s to blame? Learn from other people’s mistakes. In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences about the FDA’s Refusal to Accept (RTA) policy and guidance. Some of the highlights of this episode include:
Memorable quotes from this episode:“If a submission gets rejected on an administrative review, that is 100% the company’s fault, it is not FDA’s fault.” Mike Drues “Approximately 60% of 510(k)s are rejected on RTA part of the administrative review.” Mike Drues “An eTool should help facilitate the process. However, caveat—it still is contingent on humans entering information.” Jon Speer “I would like the FDA to be just as careful with the claims that they put on their own website as they are when they are evaluating claims on a device coming in for a submission.” Mike Drues “One of the most common reasons why submissions are rejected is because a particular section is left out. Put yourself in the shoes of the reviewer. They have no idea why you are leaving out that section.” Mike Drues Links:How To Avoid Having Your FDA Submission Rejected (And What To Do If It Is) Guidance: Refuse to Accept (RTA) Policy for 510(k)s Guidance: Acceptance Review for De Novo Classification Requests Guidance: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) Acceptance Checklists for 510(k)s | |||||||
| 21 Dec 2023 | #349: Climbing the MedTech Career Ladder - How to Get to the Top | 01:10:28 | |||||
In this episode of the Global Medical Device Podcast, we’re joined by Elena Kyria, a talent acquisition specialist and CEO of Elemed. Elena delves into what it takes to climb the career ladder in the medtech industry, whether you're early or late in your career journey. Our host, Etienne Nichols, engages in a rich discussion on career paths, leveraging personal strengths, and the importance of networking and personal branding. Quotes
Takeaways
Reference Links: Remember to engage with the hosts and guests on LinkedIn for feedback and further discussions. Don’t forget to leave a review on iTunes! *Interested in sponsoring an episode? Use this form and let us know! | |||||||
| 30 Aug 2024 | #380: Navigating the Complex World of Combination Products with Subhi Saadeh | 00:38:53 | |||||
In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Subhi Saadeh, host of the Combinate Podcast and an expert in the field of combination products. They explore the complexities of combination products—those that integrate drugs, devices, and biologics—highlighting the regulatory challenges and industry growth. Subhi shares his personal journey in podcasting, the impact of consistent content production, and the importance of lifelong learning. They also dive into the intricacies of combination product definitions, regulatory pathways, and trends, offering listeners a well-rounded view of the current state and future potential of this evolving industry. Key Timestamps:
Quotes:
References:
| |||||||
| 24 Nov 2021 | Why Usability Matters | 00:25:27 | |||||
Usability is essential. If you design something, anything used by humans, it needs to be designed for the users. This is especially true for medical devices. In this episode of the Global Medical Device Podcast Jon Speer talks to Michaela Kauer-Franz, CEO of Custom Medical, which offers usability engineering and testing for medical devices. Listen as the two medical device industry veterans discuss the topic of usability and how companies should be designing medical devices with usability in mind so they are easy to use, safe, and supportive for the end user. Some of the highlights of this episode include:
Memorable quotes from Michaela Kauer-Franz:“It’s not about me being excited about it, but about the user being excited about it. Being able to understand it. I think this is a very valuable insight.” “You have so much impact on the quality of life of so many people. You can save life, you can improve life, you can prevent damage if you do your work right.” “Usability is the translation from the capacity that an expert or user has into a device that is being easily used and intuitive, understood, and safe.” “See usability as something that you have to do constantly. It’s not a one-time activity that you do.” Links:MedTech True Quality Stories Podcast | |||||||
| 27 Apr 2022 | Achieving Operational Readiness through Good Project Management | 00:27:41 | |||||
In this episode of the Global Medical Device Podcast Etienne Nichols talks to Patrick Hayes, Associate Director of Program and Project Management at Commissioning Agents (CAI), about how to achieve operational readiness in a manufacturing setting. CAI is a professional service provider that helps medical device companies get their quality products to market through operational readiness. The company provides expertise to get products out the door and qualified in a safe, effective, and cost-efficient manner. Some of the highlights of this episode include:
Memorable quotes from Patrick Hayes:“Everybody strives for operational excellence, but yes, a strong package with operational readiness is the key.” “In a project, especially with startups, I’d say there’s no such thing as over communicating.” “Anything in the medical device industry directly affects, correlates, and supports the public. It’s a huge market and it’s a very important market.” “Never make any shortcuts to your quality.” Links:South Carolina Bio Conference (SCBio) Project Management Institute (PMI) Greenlight Guru YouTube Channel | |||||||
| 07 Nov 2019 | Significant Risk vs. Nonsignificant Risk Devices - What's the Difference? | 00:34:16 | |||||
Do you understand the difference between significant risk and nonsignificant risk when it comes to the development and design of your medical devices?
It’s important to classify devices properly, and the difference between SR and NSR is not always well-defined.
Today, our guest will help medical device companies differentiate between these two classifications.
Mike Drues, president of Vascular Sciences, has been a frequent guest on our show. He’s an expert in compliance, medical technology and regulatory compliances.
Mike works regularly with the FDA, Canada Health, and other international regulatory agencies, and today he is sharing his insight on SR vs. NSR, as well as how this affects your development processes for your medical devices.
Some of the topics you’ll hear about today include:
- The difference between significant and nonsignificant risk, and how you can differentiate between the two.
- Who decides whether a device has a significant or nonsignificant risk. (Hint: It’s not the FDA!)
- Tips on analyzing, documenting, and finding experts to help you determine whether you are dealing with SR and NSR, as well as tips on notifying the FDA through the pre-submission process.
- Information about the Institutional Review Board and how they are involved in the SR vs. NSR differentiation.
- Thoughts on running clinical trials outside of the USA: advantages, disadvantages, and practicalities. | |||||||
| 30 Nov 2022 | What "Exempt" Means with Respect to Medical Devices & Regulatory | 00:52:01 | |||||
How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a device is classed? This is the focus of today’s episode with recurring guest Mike Drues, in a conversation with host Jon Speer, founder of Greenlight Guru. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. Listen to the episode to learn how Mike is thinking about the meaning of 510(k) exemptions, how classifications do and don’t intersect with exemptions, and why some items are exempt. Some of the highlights of this episode include:
Memorable quotes from Mike Drues:“An exempt device, whether it’s a Class I exempt or a Class II exempt device, it doesn’t matter, is still a regulated medical device.” “Instead of calling these special controls, we should call them specific controls.” “One of my frustrations with a lot of folks in this business is they just follow the regulations like a recipe, like a computer executing lines of code one by one without asking does this make sense?” “What is much much more important than the answer is the logic you use to get the answer.” Links:CDRH Website: Class I and Class II Device Exemptions Webinar: When do we need FDA’s permission to market our device and when do we not? (Nov 2020) Webinar: Special Controls: What are they, and how can we use them to our advantage? (May 2022) Webinar: Understanding the Medical Device Classification System (July 2020) | |||||||
| 12 May 2022 | Demystifying the De Novo Process | 00:37:30 | |||||
How do you navigate the De Novo process for your medical device? When do you decide to go that route rather than with other FDA submission pathways, such as Q-Sub, 510(k), premarket approval (PMA), and device designations? In this episode of the Global Medical Device Podcast Etienne Nichols talks to Rob MacCuspie, Manager of Regulatory Affairs at Proxima CRO, about the De Novo submission process. Rob oversees high-quality regulatory submissions to the FDA and other regulatory agencies and is passionate about bringing products to market in a safe, effective, and efficient manner. Some of the highlights of this episode include:
Memorable quotes from Rob MacCuspie:“So new, so innovative, so cool, there’s nothing else like that out there - that’s when the De Novo pathway might be the right choice for bringing this to market.” “The real opportunity with the De Novo pathway is that you are getting a chance to really create a new product category and you’re going to be helping the FDA figure out how to regulate this product category for people that want to try to copy you in the future.” “The desire that I have to want to just launch that perfect product with all the bells and whistles at the first stop, that can really slow down the time to market.” “Sometimes, it’s better to get something out there that helps and then get the full benefit out there a little bit later.” “Don’t be afraid of the De Novo process. It’s actually a really great tool.” Links:FDA - De Novo Classification Request FDA - Q-Submission Program Guidance FDA - Premarket Approval (PMA) | |||||||
| 07 Nov 2019 | Understanding the New FDA Guidance on Changes to 510(k) | 00:35:53 | |||||
What happens you need to make a change to a device that’s been cleared via 510(k)?
We discuss the importance of decision making during this process and relevant guidance from the FDA.
The FDA just released updated guidelines on procedures regarding changes to 501(k) devices and software.
Such changes in design or manufacturing are very common in the industry, so it’s important to understand the regulations as it pertains to your device.
Our guest today is Mike Drues, president of Vascular Sciences and international regulatory affairs consultant. He works with governmental agencies and medical device companies around the world.
Some of the topics discussed today include:
- New FDA guidance on changes to 501(k) devices and software
- Difference between FDA draft and final guidance
- Keeping track of changes to medical devices in a “letter to file”
- Limitations to FDA guidance flowcharts
- Ways to notify the FDA of a change
- Multiple changes made to an existing medical device
- Going above and beyond to introduce quality controls for device changes | |||||||
| 07 Nov 2019 | Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong | 00:27:19 | |||||
Today on the Global Medical Device Podcast we have a very interesting and highly debated topic for you around research vs. development for medical device companies.
We’ll challenge some conventional wisdom on the subject and dig into when ‘R’ should end and ‘D’ begin.
Our guest on the show today is David Amor, a medtech/biotech consultant and mobile health entrepreneur. David is the founder of Medgineering, a consultancy specializing in implementing new quality systems, design control processes, and risk management for both startups and larger companies.
Recently David also launched QuickConsult, an online consulting platform that pairs up medtech experts with startups or large companies. The online consulting model allows clients to work with the consultants of their choice who will help them understand their specific quality and regulatory needs.
The subject of today’s episode is loosely based on a well written and thoughtful article David authored a few months back titled, “When does the ‘R’ end and the ‘D’ begin for medical device companies?”
Jon and David touch upon a lot of the points in that post (which I encourage you to go read after listening to today’s episode) and really dig into why the conventional wisdom regarding ‘R’ and ‘D’ in medical device product development is often wrong.
Specifically, today Jon and David get into:
-Why should you start design controls early in development?
-Are your thoughts about research wrong?
-Will doing design controls early slow you down?
-When do design controls ACTUALLY start?
-How to view design controls as more than a paperwork heavy process.
-The shift in traditional R&D roles.
-What outcomes you should be focused on BEFORE research. | |||||||
| 06 Jul 2022 | Shifting Sands of SaMD Cybersecurity Regulations | 00:33:50 | |||||
FDA has issued new draft guidance on cybersecurity for software as a medical device (SaMD). If the FDA releases that draft guidance ‘as is,’ it will massively and negatively impact the SaMD industry and it’s imperative that manufacturers understand how to prepare. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Gates, director of product security at Velentium, about the shifting sands of medical device cybersecurity regulations for SaMD. Some of the highlights of this episode include:
Memorable quotes from Chris Gates:“Legally-backed cybersecurity requirements by a regulatory agency are necessary to ensure secure devices are entering the marketplace and hopefully replacing the insecure legacy devices.” “This clause is going to have a huge impact on medical device manufacturers (MDMs) and I find it amazing how many MDMs are completely unaware of this.” “An SBOM is a software bill of materials. It’s an ingredients list for your application.” “This isn’t just one-and-done testing in your life cycle.” “You’re going to have a lot of extra work coming your way.” Links:Medical Device Cybersecurity for Engineers and Manufacturers Regulations (Submit comments to the FDA) Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions International Electrotechnical Commission (IEC) ISO (International Organization for Standardization) | |||||||
| 29 Jul 2020 | Addressing Clinical Trial Challenges & Concerns during COVID-19 | 00:38:48 | |||||
The current COVID-19 pandemic and its impact on clinical trials has created a sense of chaos amongst medical device companies worldwide. Are there creative ways to stay on track while ensuring the safety of those involved?
In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Regulatory Affairs Consultant, and Stephanie Mull, Director of Clinical Project Management, from Proxima Clinical Research (CRO).
Together, they discuss the challenges and concerns for medical device companies conducting clinical trials during the COVID-19 pandemic and offers new perspectives for listeners to consider in terms of potential efficiencies and cost savings to gain.
Some of the highlights of the show include:
- Challenges related to COVID-19 include sites suspending operations of clinical trials, and restricting CROs and subjects from traveling or coming to sites.
- Some medical device spaces, products, and technologies have been impacted more than others. It’s more difficult than normal, but not impossible, to perform elective procedures, especially in hospitals.
- Widespread, Worldwide: Clinical trials continue to be conducted in the United States, but in a different atmosphere with changes compared to other areas that have completely suspended trials temporarily, such as Europe and China.
- Subject safety is the primary issue to be considered and evaluated related to risks, reasons, and causes to suspend clinical trials.
- Staff Availability: Sites must have adequate and properly qualified and trained staff to conduct and provide oversight to continue clinical trials safely.
- Electronic data capture (EDC) versus paper management of sites and studies for clinical trials is a more controllable way to document and collect data from patient monitoring and different types of visits.
- Protocol deviations and amendments should be approved by the FDA before proceeding with a clinical trial. Subject safety, again, is always the first priority.
- Human Factors: Changes should make medical device and clinical trial design more usable, such as patient monitoring from a safe distance due to COVID-19. | |||||||
| 09 Dec 2021 | How Augmented Reality (AR) is Revolutionizing Healthcare | 00:25:04 | |||||
Technology can accelerate the transformation of healthcare to improve health, quality of life, safety, and security. Augmented reality (AR) is finding its way into the healthcare ecosystem and there’s greater potential for it to be revolutionary, not just evolutionary. In this episode of the Global Medical Device Podcast Jon Speer talks to Jennifer Esposito, Vice President and Managing Director of Magic Leap's Health business unit, about AR in healthcare, explaining what it is and is not, as well as how it compares and contrasts to virtual reality (VR), machine learning (ML), and artificial intelligence (AI). Some of the highlights of this episode include:
Memorable quotes from Jennifer Esposito:“There are places where the differences between those technologies is actually really important in terms of deciding which one you would use for a certain use case.” “What we’re doing isn’t really just about AR. It is this convergence of these other capabilities.” “Augmented reality is also going to be the catalyst to generate additional new sources of data that we don’t currently have.” Links:Magic Leap: Augmented reality platform for Enterprise Medical Device Innovation Consortium (MDIC) The Greenlight Guru True Quality Virtual Summit MedTech True Quality Stories Podcast | |||||||
| 25 Mar 2021 | Why the PMA Process is so Dreaded by Manufacturers in the US Market | 00:46:22 | |||||
Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that has historically been known to evoke a fearful, negative response by medical device professionals. In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, known in the industry as Mr. Regulatory, about the reasons why the PMA process is so dreaded by manufacturers bringing a Class III medical device to market in the United States. | |||||||
| 07 Nov 2019 | Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner | 00:27:34 | |||||
Standards are absolutely critical when you are developing a medical device.
You need to understand why these standards are important when developing your product for your regulatory submission. You need to know what they are and understanding how to incorporate them as part of your design and development process at the beginning rather at the end.
Today's guest Leo Eisner from Eisner Safety Consultants is a leading expert in medical device safety standards. He even has built a database to help you navigate the process. I encourage you to take a look.
“The standards are rigorous and it’s for good reason.” - Leo Eisner
Leo has over thirty years of experience in product safety and is a leading speaker and author when it comes to medical device safety. He knows quality systems, knows how to audit and test. He has recently released the “Standards Reconnaissance Database” so that medical companies can leverage his expertise.
“Your indications for intended use [of your device] are directly impacted by the markets where you plan for your product to be used.” -Jon Speer
Today Leo & Jon discuss:
-How Leo’s career in standards began
-Why standards are important
-Why should I care about standards regarding my medical device
-Standard IEC-60601
-Standards Reconnaissance Database
-Benefits of standards
-Updates to standards
-Classifying your product, drafting a test plan, checking against standards
"The most important reason you should care about standards is because of your regulatory submissions and your design process." - Leo Eisner
Leo’s best recommendation when it comes to standards is to know your product well enough to know what standards apply early in the development process - from there you’ll know how much preparation and testing it will take.
To get in touch with Leo please be sure to check out his website at Eisner Safety Consultants or feel free to shoot him an email at Leo at EisnerSafety dot com. | |||||||
| 07 Nov 2019 | Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner | 00:22:45 | |||||
If you are part of an organization developing or producing Class II medical devices, you should know that on September 24, 2016, your UDI submissions are due to the FDA.
“I don’t mean to scare anyone, but we only have 78 working days left.” - Gary Saner
UDI stands for “unique device identification,” and the new labeling regulations have been put into place to increase patient safety, reduce medical errors, and provide a foundation for secure global distribution of devices.
Today’s guest, Gary Saner, is an expert on UDI submissions and other regulatory topics. As the Senior Manager of Information Solution at Reed Tech, Gary is speaking to us today about the UDI submission procedures and other relevant topics.
“The UDI submission is not a one-time effort.” - Gary Saner
With over 30 years’ experience in software management and data conversion, Gary is the go-to person if you have questions about UDI, and his company can help medical device companies of any size be sure that their submissions are in order.
Some of the topics you’ll hear discussed on today’s podcast include:
- What UDI is and what information needs to be included in each of its components.
- The timeline of deadlines leading up to now and up to September 2016 as they pertain to different types of devices.
- Some of the challenges that apply to larger and smaller companies when it comes to meeting the 9/24/16 deadline, as well as how the Reed Tech tool can help organizations of all sizes.
- The importance of knowing and understanding the UDI submission process.
- The two submission methods that the FDA has in place.
- Tips and pointers to keep in mind as you go through the submission process. | |||||||
| 01 Mar 2021 | Everything you Need to Know about SaMD from an FDA Perspective | 00:46:18 | |||||
Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are interested in entering the SaMD space, what do you need to know when it comes to FDA regulations and guidance? In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, “Mr. Regulatory”, who has nearly a decade of firsthand experience working for FDA. Listen to Mr. Regulatory and Jon discuss all things related to SaMD from the perspective of FDA and how the agency is regulating these emerging medical device technologies. | |||||||
| 07 Nov 2019 | Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies | 00:37:07 | |||||
Regulatory compliance is critically important. However, some think product liability is just as important, if not more.
Today’s guest is Mike Drues of Vascular Sciences and we discuss how companies shouldn’t fear the FDA and its regulations. Instead, they should have a healthy respect for the FDA. Who should they fear? Product liability attorneys because they can cause much more damage to a company than the FDA.
Some of the highlights of the show include:
● You may not be limited to what the FDA requires. For product liability, passing FDA’s regulations isn’t enough or include everything that should’ve been done.
● When designing a product, consider product liability. Would you recommend the product to a friend or family member? Would you use it yourself?
● Product risks to consider include labeling. Does the device function normally and is it safe and effective when used according to its label?
● Manufacturers are liable when a customer doesn’t follow instructions or intended uses for the device, if they knew/should have known it could be used off label.
● Documentation is important from a regulatory/quality perspective. But for product liability, it can be the kiss of death. Be careful about what you document.
● Companies should report adverse events with a device to the FDA in a timely manner. Or, they should face regulatory and product liability consequences.
● Do you want to be proactive or reactive? Prevent issues, rather than have to correct them. Adopt a true quality culture.
● Engage regulatory guidance into the product development process early on. It’s easier, faster, and cheaper to make changes sooner than later. | |||||||
| 14 Jul 2021 | Meet a Guru: Ryan Behringer | 00:27:50 | |||||
Guru Edge. It's what makes Greenlight Guru so unique and particularly valuable to medical device companies. These Gurus form an elite team of medical device experts who serve Greenlight Guru customers in a variety of ways to ensure success throughout their product journey. In this episode of the Global Medical Device Podcast, Jon Speer talks to Ryan Behringer, a Training and Onboarding Medical Device Guru at Greenlight Guru. Listen to this episode to learn about Ryan's professional journey which brought him to Greenlight Guru and how he's helping companies with design of experiments, design controls, contextual inquiry, FDA QSR and ISO 13485 compliance, protocol/report writing, protocol execution, and quality system implementation and maintenance. Some of the highlights of this episode include:
Memorable quotes by Ryan Behringer:“I love the entrepreneurship element in the medical device space.” “I had the pleasure of developing a device, getting 510(k) clearance, and getting to market utilizing Greenlight Guru. It was really instrumental in our development of the product and kind of my personal development as an engineer - gave me loads of confidence.” “I really enjoy the technical element of things.” “I always make sure that the things I’m doing, I know why I’m doing them. They have a purpose, and I can find value in those things.” Links:21 CFR Part 820 (Quality System Regulation/Medical Device) The Greenlight Guru True Quality Virtual Summit | |||||||
| 03 May 2023 | Complaint Handling with Medical Device Guru, Brittney McIver | 00:38:41 | |||||
What would you think about dealing with complaints all day? Today’s guest has some ideas. Brittney McIver is a Medical Device Guru at Greenlight Guru where she helps guide companies through the various quality and regulatory requirements and challenges that are unique to MedTech companies and Medical Device Professionals - like QMS implementation. Brittney has a bachelor’s degree in Biological Science, a master’s degree in Bioengineering from Clemson University, and is an ISO 13485 Lead Auditor. Listen to the episode to learn about Brittney’s experience shadowing doctors and watching surgery, the part of her job that involves handling complaints, and how complaints are related to post-market surveillance. Some of the highlights of this episode include:
Memorable quotes from Brittney McIver:“One of the things I wasn’t prepared for was the sheer volume of complaints sometimes.” “You always look at a complaint and try to determine whether it is a complaint or not.” “Any decision you’re making, you want to make sure that it’s informed and you have a rationale behind it.” “One of the things that you don’t want to happen is your customer not report the complaint to you, but they report it to the FDA.” Links: | |||||||
| 28 Oct 2020 | Meet a Guru: Erica Loring | 00:38:24 | |||||
What makes Greenlight Guru unique? It’s Guru edge—a team of medical device professionals with decades of industry experience whose primary role within the company is to enable customer success.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Erica Loring, a medical device guru at Greenlight Guru. Erica shares her unique career journey working in the healthcare sector, which ultimately led her to enter the medical device and in-vitro diagnostic device space where she now provides world-class quality and regulatory support to device companies.
Prior to joining Greenlight Guru, Erica worked in both the pharmaceutical and the biotech industry, serving as senior manager of quality and regulatory where she was responsible for implementing eQMS platforms for global enterprise companies.
Some highlights of this episode include:
As a medical device guru, Erica enjoys working with a wide range of companies, learns about various products, and helps those companies reach their goals by using a robust QMS.
Erica’s superpowers, specialities, and strengths as a medical device guru revolve around all things regulatory and quality management to help companies function better and offer a sense of security.
Conventional Wisdom: Are regulatory affairs and quality assurance the same or two different disciplines? Know it all and provide cross-functionality from product development to regulatory where quality doesn’t get in the way of productivity.
Thought Process: Manufacturers, engineers, and others don’t have the mindset or systemic way to document inputs, outputs, and design development activities.
Gentle hand or strict hindrance? Quality can enable or be an obstacle, but it’s the right thing to do. Check documentation, make changes, and meet demand.
DiSC: If you have a hard time staying still, breathe and meditate for business development and personal growth. Strut industry knowledge to help companies.
How can medical device companies be successful in today’s market?
Time: Don’t rush or overlook anything. Plan for extra time and failures.
People: Invest in the right and enough people, equipment, and space.
Quality: Research and investigate suppliers. Make sure to have backups. | |||||||
| 09 Dec 2020 | How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes? | 00:39:22 | |||||
Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related to medical devices, especially during the ongoing pandemic?
In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, senior director of regulatory affairs at ConvaTec and industry thought leader who has been coined the name “Mr. Regulatory.”
Listen to this episode as Mr. Regulatory shares his predictions on potential policy changes or updates we may begin to see from FDA, as influenced by the Emergency Use Authorization (EUA) response to address the current health crisis caused by the COVID-19 pandemic. | |||||||
| 07 Nov 2019 | Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation? | 00:25:08 | |||||
Superbugs.
Reprocessing.
The White House.
And Design Controls.
Probably not a combo of topics you see grouped together very often.
But we have them all for you on today’s Global Medical Device Podcast.
This is the 2nd edition in our series focused on Design Controls and related topics within the Medical Device Industry.
During this episode, we’ll surface some interesting and potentially controversial views on the subject with our three industry thought leaders.
If you’re like many, you may very well have already heard about the high profile superbug outbreak connected to reprocessing.
You may also have already seen some of the industry’s reactions with lawsuits being filed, FDA alerts being issued...and even the White House getting involved.
That’s where we kickoff today’s conversation with our amazing guests Mike Drues, Jon Speer and Jason McKibbin along with moderator Bill Loss.
All three guests share some very insightful and through provoking responses to Bill’s questions like:
1. What’s the background behind this reprocessing tragedy anyway?
2. How do our experts see the responsibility panning out at the manufacture’s level as well as those ultimately handling the reprocessing?
3. Could better orchestrated design controls have potentially prevented this tragedy?
4. Do existing design controls apply to problems like this, and if they don’t, should they?
5. Was this problem a design control failure or possibly different steps that should have been handled during the design review process?
6. How do you feel the Design Verification and Design Validation process should fall into place?
You’re going to want to listen closely because these guys really dive deep on some important and controversial topics. | |||||||
| 11 Jan 2024 | #351: The State of AI & Clinical Investigations | 00:39:21 | |||||
In a today's conversation on the Global Medical Device Podcast, host Etienne Nichols engages with Dr. Maria Nyakern on the burgeoning integration of AI in medical devices. They delve into the European AI Act, discussing its impact on innovation and the critical role of trustworthy systems in clinical research. The episode also touches upon the challenges and opportunities AI presents in MedTech, from data integrity to job displacement, and the human-centric approach to technology. Key Timestamps:
Quotes:
Takeaways: Latest MedTech Trends:
Practical Tips:
Future Predictions:
References: Questions for the Audience:
We value your thoughts - if you enjoyed this episode, would like to give feedback, or have suggestions for future episodes, please email us at podcast@greenlight.guru Sponsors: Today's episode is brought to you by Greenlight Guru, the only MedTech-exclusive Quality Management Software designed with the direct input of industry insiders. Dealing with cumbersome product development cycles? Facing the maze of regulatory compliance? Greenlight Guru is your guiding light. Our comprehensive software... | |||||||
| 07 Nov 2019 | Challenges with Applying Risk Management Throughout the Manufacturing Process | 00:21:12 | |||||
Today we’re going to be taking the topic of risk management to the next level. We are talking to Jim Gianoutsos with Regality Consulting. We are going to explore some of the challenges with a company’s approach to manufacturing processes as they apply to risk management.
Some of the highlights of the show include:
● Information about Jim’s background and about Regality Consulting.
● Thoughts on how risk is sometimes a box to check rather than an integral part of every discussion and every decision that’s made throughout the manufacturing process.
● Why the adoption of ISO 14971 has been so problematic for medical device companies.
● Why it’s important to consider risk management before planning design.
● Considerations to keep in mind when outsourcing or getting components and materials from other organizations.
● Thoughts on validating processes and sampling based on risk assessment and management.
● An example that Jim has seen regarding a lack of sufficient risk management: the takeaway is to address risk management now; don’t wait until you get a warning letter. | |||||||
| 02 Dec 2021 | Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care | 00:31:11 | |||||
At the top of the FDA’s agenda for the next 12 months is clinical decision support (CDS) software — what is it, why now, and why should those in the medical device and other life science industries care about it? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences about the importance of CDS software. The FDA’s Clinical Decision Support Software Guidance was released in draft form in 2019 and is at the top of the FDA’s list of priorities to be finalized in 2022. Some of the highlights of this episode include:
Memorable quotes from Mike Drues:“I’ve got a growing number of my customers and potential customers wanting to play in this space or asking me about the possibility of playing in this space.” “Right now, much of this is not being regulated by the FDA. The FDA - they’re using their enforcement discretion to not regulate.” “FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person.” “As soon as the practice of medicine is being practiced by a device or in this particular case, software, now all bets are off.” Links:Clinical decision support guidance tops FDA’s agenda for 2022 (Med City News) (Oct. 29, 2021) FDA's 2022 A-list guidance plan hits on software, post-pandemic future CDRH Guidance: Clinical Decision Support Software (September 2019) Software as a Medical Device (SaMD) | |||||||
| 14 Dec 2023 | #348: Considerations for IVD | 00:36:43 | |||||
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Carmen Brown, the regulatory and quality affairs manager at Proxima Clinical Research. They delve into the specifics of In Vitro Diagnostics (IVDs) and explore the challenges and considerations faced by medical device manufacturers in the IVD pathway. Whether you're an industry veteran or new to the field of medical diagnostics, this conversation will enlighten you about the nuances of IVD regulatory compliance, risk assessment, and FDA interactions. Episode Highlights:
Quote: "With IVDs, you're looking at it from the perspective of what's the risk of a false result or an inaccurate result. So you're looking at who's interpreting the results and the type of condition." ~Carmen Brown Reference Links: *Interested in sponsoring an episode? Use this form and let us know! | |||||||
| 07 Nov 2019 | Medical Device Product Development Project Management Best Practices with Peter Sebelius | 00:23:26 | |||||
Another brilliant mind joins us today on the Global Medical Device Podcast. Peter Sebelius is the founder of Gantus.com and today we’ll talk medical device product development and project management.
Peter is a certified PM and has vast experience in the industry and extensive knowledge of medical device standards. He is also a member of the joint working groups on ISO 13485 and Iso 14971.
Today we’ll talk about lean management and agile as it applies to the development of medical devices. Can you be lean and compliant at the same time?
“Medical device product development is far from a straight line.” - Jon Speer
Knowing when to turn on the design controls is a delicate balance. Design controls should be a framework - they don’t necessarily need to stifle the creative process. It doesn’t have to be restrictive.
“It was never intended in product management or design control to be changing technical solutions fundamentally while you’re in that process.” - Peter Sebelius
Today we’ll talk about:
- Can you be lean?
- Finding the right balance with design controls
- Using “TBDs”
- Project Management and Design Controls as ‘best practices’
- “Guide for the Project Management Body of Knowledge”
- “Shared responsibility is no responsibility”
“You can’t write something down that you haven’t thought through well.” - Peter Sebelius
Peter suggests that project managers should learn more about qualitative management and regulatory affairs. Make sure you know what’s good enough.
Peter provides online training on risk management, project management and design control. You can find him and learn more at gantus.com. | |||||||
| 07 Jun 2021 | Examining the HHS Proposal for Premarket Notification Exemptions | 00:37:06 | |||||
What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS) proposal that impacts the medical device industry? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the HHS proposal, which focuses on down-classifying and exempting more than 80 types of devices such as exam gloves, thermometers, imaging systems, infusion pumps, and ventilators. Some highlights of this episode include:
Memorable quotes from this episode:“Changing medical device classification, whether we’re going down or up, doesn’t matter, without notifying or consulting the folks that are responsible for evaluating these medical devices...politics aside, Jon, it’s hard to connect those dots. What sense does that make?” Mike Drues “You don’t have to have a Ph.D. in biomedical engineering...to appreciate that gloves and thermometers and other forms of PPE—these are not the most complicated kind of products in the world.” Mike Drues “It should not take a Ph.D. in biomedical engineering or an RAC after somebody’s name to appreciate that maybe it doesn’t make sense to lump gloves and thermometers into the same category as infusion pumps and ventilators.” Mike Drues “Isn’t evaluating changes or the potential for changes, in this case in a medical device, always a good thing?” Mike Drues “Things... | |||||||
| 07 Nov 2019 | AI Explainability: What that Means and Why it Matters in the Medical Device Industry | 00:32:24 | |||||
What is AI explainability? Why does it matter in health care?
On today’s episode, we have Marla Phillips, director of Xavier Health, who shares why AI will transform how the medical device industry operates. Xavier Health brings the FDA and pharmaceutical and medical device industries together in a collaborative setting to break down barriers and improve patients’ health.
Overcome the media-generated hype and fear of AI to discover its benefits when using it responsibly. We can do better with it, than without it.
SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE:
● AI Explainability: Part of transparency of how end user can have confidence in the outcome of AI. Explainability links credibility of input to the output.
● AI has been around since the 1950s, but its use is new to some people. The AI Summit shows how it works.
● Pivoting from being reactive to proactive: Advancing use of AI to identify correlations between data for improvement of the quality of products/patients.
● Some devices have digital health components. There’s movements around real-world data for information to go to manufacturers to evaluate performance.
● Continuous Product Quality Assurance team encourages review and assessment of all the data. AI can be used to identify conditions that lead to failure.
● Where is the data? GMP, non-GMP, financial, weather, and other kinds of data that impacts product quality. Use AI to take out garbage, find what’s meaningful.
● AI is a continuously learning system. How to evaluate it? How did it reach its outcome? How to demonstrate credibility? How to train algorhythm?
● Challenges of implementing AI include figuring out how to demonstrate credibility of AI output when not using validation and not having access to electronic data. | |||||||
| 19 Jul 2021 | Tips for Running Better Management Reviews | 00:24:34 | |||||
How efficient are your management reviews? Could improvements be made? It might be time to reevaluate and reconfigure your system processes to eliminate burdens and extract utmost value from these critical checkpoints while still satisfying compliance needs. In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, senior medical device guru at Greenlight Guru. Together, Taylor and Jon discuss the nuances of management reviews to help medical device managers and executives make better decisions for teams to achieve greater outcomes. Some of the highlights of this episode include:
Memorable quotes from this episode:“The standard is pretty general on how often you should be doing management reviews.” Taylor Brown “Management review is really a platform to escalate issues.” Taylor Brown “Pulling off a management review last minute is a lot easier than trying to pull off all of your internal audits last minute.” Jon Speer “Executive management needs to be aware of and involved with the health of the quality system.” Jon Speer Links:FDA - 21 CFR Part 820 Quality System (QS) Regulation The Greenlight Guru True Quality Virtual Summit MedTech True Quality Stories Podcast | |||||||
| 26 Nov 2020 | What Goes into Designing Devices for Military and Emergency Applications? | 00:38:49 | |||||
There’s one niche market within the device industry that rarely gets the attention it deserves: products designed for military applications and use in other emergency settings.
In this episode of the Global Medical Device Podcast Jon Speer and his cohost, colleague and medical device guru Wade Schroeder, talk to guests Monti Leija and Robert Futch from the Delta Development Team, manufacturers of ruggedized thermal systems who specialize in military applications.
Listen to this episode to learn about the Delta Development Team’s journey designing their latest product the Autonomous Portable Refrigeration Unit (APRU) that provides a cooling and heating systems for extreme environments.
Some of the highlights of the show include:
APRU is medical refrigeration for medical professionals. It provides constant cooling of blood products, vaccines, virus samples, and temperature-controlled medications.
APRU applications include military operations, disaster relief response, and emergency medical systems (EMS) because the device meets AABB guidelines and FDA regulations.
The military provided end-user feedback on how it wants the APRU to function and perform. Therefore, the APRU is unique because it’s small and runs on a battery that can be charged.
Power of Innovation: The biggest power consumers are refrigerators and air conditioners—both require refrigeration.
Obstacles and Challenges: Every time somebody goes through the medical device journey it involves learning and becoming aware of regulatory guidelines.
Recommendations: Find the right consultants, team members, and standards management tools. Wade Schroeder, Greenlight Medical Device Guru, has been a major asset to the Delta Development Team by providing regulatory guidance.
Testing Methodologies: Motivation is to meet extreme environment requirements and standards. Some manufacturers choose to not meet some standards to make mobile medical devices that don’t work as well. APRU is the new standard.
Root Cause and Right Configuration: Make minor adjustments to prototypes to reduce complexity, cost, and failure points via due diligence rather than rebuild. | |||||||
| 07 Nov 2019 | How to Think About Quality and Regulatory as Your Company Scales | 00:38:00 | |||||
As companies transition from being a start-up or small company to a more established business and bring new medical devices to market, they tend to not put a lot of thought into their processes, systems, and approaches for regulatory strategies and quality systems.
Regardless of the shape and size of your company, these factors are foundational to the growth and success of your business.
Host Jon Speer and Mike Drues of Vascular Sciences discuss key tips on what to think about regarding regulatory and quality during a transition. It is about doing the right thing - prudent engineering.
SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE:
-Theoretically, regulatory agencies have an independent approach, no matter the nature of the company they are working with.
-When starting to work with agencies, it is like a first date - and first impressions make a difference. Pre-submission process is a great place to start.
-FDA is now much more interested in building collaborations with medical device companies, but it still has a responsibility to uphold regulations.
-Cleaning up after someone else’s mess and doing damage control; bumps in the road with FDA, but let’s start with a clean slate.
-Eyes glaze over when small companies are told to have a quality management system (QMS). Right size your QMS: There are things you can do now.
-Evaluate your company’s regulatory strategy and QMS to make sure they can be integrated in a minimally burdensome way.
-Focus on content/information and intent behind what you are doing. -----Forms and procedures are important, but focus on what matters most.
-Companies measure efficacy of a device, but how often is the efficacy of systems and processes measured? Implement failures/errors to measure efficacy. | |||||||
| 28 May 2022 | Approaching Cybersecurity & Usability as a SaMD Company | 00:36:16 | |||||
How do you balance security and usability of software as a medical device (SaMD)? It’s not easy and trade-offs may need to be made by device companies in order to give users what they want and need to safely use it as intended. In this episode of the Global Medical Device Podcast Etienne Nichols talks to Abbas Dhilawala, a cybersecurity and SaMD expert with Galen Data, about a new approach to cybersecurity and usability for SaMD companies to ensure products are both secure and user-friendly. Abbas has 18 years of experience developing enterprise-grade software for the medical device industry and is well-versed with technology, industry standards, and the privacy of data. Some of the highlights of this episode include:
Memorable quotes from Abbas Dhilawala:“Ultimately, if you make the product in a way that’s hard to use, you can be secure. If nobody uses it, it doesn’t really matter.” “There’s lots of standards, just no harmonization.” “What can you do to minimize stress? Health care is already a stressful environment.” “The fundamental layer of security is to know who the user is.” “Having standards is a nice thing because then you can develop tooling around that.” Links:The Greenlight Guru True Quality Virtual Summit Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Global Medical Device Podcast Email | |||||||
| 23 Mar 2023 | Most Common Problems Found During FDA Inspections in 2022 | 00:44:30 | |||||
Why do the same types of problems show up again and again in FDA medical device inspections? In today’s episode, Mike Drues joins the podcast to talk about the FDA's Fiscal Year Report for 2022 Inspections and discusses the most common problems found during these inspections. Recurring guest Mike Drues is the President of Vascular Sciences where he works to educate the industry and offers help to bring medical devices to market in the most effective way possible. Mike is a medical device professional possessing regulatory expertise who understands the ins and outs of the regulation systems in the medical device industry and is passionate about helping others better understand it as well. Listen to the episode to learn more about the most common mistakes companies make that result in Form 483s, what companies can do to avoid these mistakes, and how you should be thinking about root cause analysis. Some of the highlights of this episode include:
Memorable quotes from Mike Drues:“The emphasis should be on prevention, not correction.” “I consider myself to be a medical device professional, and I do not use the word “professional” lightly. Along with it comes the responsibility, including knowing what the heck you’re doing.” “What is the point of getting complaints or post-market surveillance or anything else if you’re not going to act on it?” “I hate to say it, but we are the poster children for Einstein’s definition of insanity.” Links: | |||||||
| 07 Nov 2019 | How To Avoid Major Common Mistakes During the 510(k) Process with Michael Drues | 00:25:32 | |||||
We’ve got a good one for you today. In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascular Sciences. As many of our listen may recall, Mike does consulting for medical device companies, the FDA, Health Canada and other regulatory bodies.
Today Jon and Mike talk about 510(k)s and some of the major mistakes some companies make when they get 510(k) clearance. Specifically, they talk about companies that get 510(k) clearance but don’t have design controls, risk management and don’t have a quality system.
And it’s chuck full of actionable advice and takeaways.
“70-75% of 510(k) and PMA submissions are rejected the first time.” -Mike Drues
The FDA’s mission is to make sure the products we bring to market are safe and effective. The 2 areas of 510(k) submissions that are getting the most scrutiny are the substantial equivalents argument and the risk mitigation strategy.
If you don’t have a rock solid argument and a bulletproof strategy you will probably be rejected. Early and frequent communication with the FDA is the key to success.
“Design controls are nothing more than a synonym for prudent engineering.” - Mike Drues
Today Mike and Jon talk about:
When a 510(k) isn’t necessary
Reasons for rejection of a 510(k)
“Lead don’t follow, tell don’t ask.”
Design controls
Multiple Predicate Strategy / Split Predicate Strategy
Risk Mitigation
Regulatory checks
Corrective Action/Preventative Action Plan
“Physicians can kill patients one at a time but an FDA reviewer can kill patients thousands at a time.” -Mike Drues
What can a company do if they’ve been approved for market but aren’t prepared? Conduct a gap analysis, figure out what you have, figure out what’s missing, fill in what’s missing and be upfront about it.
Ask for help if you need it. Go to the experts. There is so much more we can do to help before, rather than cleaning up problems later, but, “It’s never too late to do the right thing.” -Jon Speer | |||||||
| 07 Nov 2019 | Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions | 00:35:50 | |||||
The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draft guidance was issued last summer and the final guidance was issued in August. So what does Real-world Evidence mean for you and from a regulatory perspective?
Today we speak with Mike Drues, President of Vascular Sciences, about how real-world evidence can help you develop products that will improve and save lives.
Some of the highlights of the show include:
● Why medical device companies should care about real-world evidence and why it’s as important and more realistic than the “gold standard” of randomized clinical trials.
● Reasons that a clinical trial can be less informative than real-world evidence and how the FDA is beginning to change its thoughts on accepting real-world evidence.
● Thoughts on why the quality of the real-world data is important when it comes to getting FDA to accept it.
● The mechanism of going down the path of using real-world evidence in regulatory matters.
● How real-world evidence might be used even after a device or product is already on the market, either in lieu of a clinical trial or as a reason to use a smaller clinical trial.
● Thoughts on the future of credible real-world evidence.
● Examples of how real-world evidence can be used. | |||||||
| 07 Nov 2019 | Understanding The Differences Between Clearance vs Approval vs Granted | 00:31:56 | |||||
Are you confused by regulatory terminology? Clearance. Approval. Granted.
Do these terms matter or make a difference when it comes to medical devices and working with the FDA? Yes, they do!
Mike Drues of Vascular Sciences joins me to talk about the differences between clearance vs. approval vs. granted, which are the three most common ways medical devices are brought to market.
Some of the highlights of the show include:
● Clearance: When a 510(k) is cleared from the FDA. Approval: When a PMA is complete. Granted: When a De Novo is complete by the FDA.
● There are reasons to get angry when medical device companies use incorrect terminology. What other mistakes might they be making?
● Riegel v. Medtronic Case: U.S. Supreme Court held that the level of safety and effectiveness of a PMA medical device is higher than a 510(k).
● There are pros and cons to each pathway. Know all your options because 510(k) is not necessarily the best.
● Companies should not avoid PMAs as a convenient excuse because they think extra time, work, risk, and investment are involved. Instead, pursue them.
● The safety and effectiveness of a medical device is never dependent on whether it is cleared, approved, or granted. So, set the bar high on its worthiness. | |||||||
| 30 Jan 2024 | #353: How Artificial Intelligence is Impacting the MedTech Industry | 00:45:58 | |||||
In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future of surgical robots, they delve into how these technologies are reshaping healthcare. The discussion also touches on the challenges and opportunities in validating and regulating AI within MedTech, highlighting real-world applications and predicting future trends. "Validation of AI tools in MedTech requires a staged adoption to build confidence due to the inherent uncertainty in AI outcomes." - Ashkon Rasooli
Key Takeaways: 1. Latest MedTech Trends:
2. Practical Tips for MedTech Enthusiasts:
3. Predictions for the Future:
References:
Sponsors: This episode is brought to you by Greenlight Guru, a comprehensive solution designed to streamline MedTech product development and ensure regulatory compliance. Discover how Greenlight Guru can accelerate your projects at www.greenlight.guru Share your thoughts and questions with us at podcast@greenlight.guru | |||||||
| 20 Jul 2023 | #328 FDA Guidance on Artificial Intelligence (AI) in Medical Devices | 00:50:44 | |||||
Description In April of 2023, FDA released a draft guidance entitled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning (AI/ML) - Enabled Device Software Functions." In today's episode, we speak with Mike Drues, PhD, President of Vascular Sciences, about artificial intelligence in medical devices, the history of this type of technology in the medical device field, and what this guidance means and doesn't mean. We hope you enjoy this episode of the Global Medical Device Podcast! Questions Asked
Quotes "I really try to stress what I call 'regulatory logic,' because if you understand the regulatory logic, really, all of this should be common sense." - Mike Drues Reference Links | |||||||
| 07 Nov 2019 | Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think) | 00:40:06 | |||||
When developing a new medical device, do you try to figure out the fastest and simplest way to get your product to market?
As a product developer, do you explore a regulatory path? Or, are you afraid that may kill your idea?
Mike Drues, president of Vascular Sciences, is with us today to do some premarket approval (PMA) myth busting and describes why a PMA path may not be as scary as you think.
Some of the highlights of the show include:
● PMAs are reserved for the highest risk devices (Class III and life-supporting).
● Utilize the patient-centered approach because assumptions are often made about risks and invasive vs. non-invasive devices.
● Can you use a predicate to show substantial equivalence for a PMA device? From a regulatory perspective, there is no concept of substantial equivalence.
● Use the MAUDE database and identify any precedence that has been set to gather knowledge about devices you are developing.
● You have a story to tell. Be able to explain your product, position, and why your product is good for the patient.
● All PMAs require clinical data. False! The vast majority of PMAs do require clinical data, but some PMAs do not require such data.
● What are the pros and cons of a PMA vs. a 510(k)? Most opt for a 510(k).
● Class III devices can do a PMA, or other options, including the Humanitarian Device Exemption (HDE) and Product Development Protocol (PDP). | |||||||
| 07 Nov 2019 | Tips to Help You Prepare for an FDA Inspection | 00:29:54 | |||||
On today’s episode, we’re introducing the newest addition to the greenlight.guru team, Jessica Lyons.
Jessica is a 2007 graduate of Rose-Hulman Institute of Technology and has worked in the medical device product development for nearly 10 years.
She worked in custom integration at Beckman Coulter, then worked on getting medical devices transferred to manufacturing at CRI, a medical device contract manufacture.
Jon and Jessica are discussing FDA inspections.
“It doesn’t matter your size, shape or how long you’ve been around. You’ll go through an FDA inspection.” – Jon Speer
No one looks forward to having the FDA come to inspect their facility, but you always need to be ready for it, as you might be subject to an inspection as frequently as every two years.
We want to put your mind at ease by giving you information on how to best prepare for FDA inspections, which can take a minimum of five to seven days.
“The FDA seems to find the one piece of information you wish they wouldn’t.” – Jessica Lyons
Some of the topics you’ll hear about it in today’s podcast include:
Jessica talks about her role at greenlight.guru, which is making sure the customers are successful, in whatever form that takes.
- Why FDA inspections are high-stress.
- How to prepare for an FDA inspection.
- What to expect during your inspection?
- Why the FDA nearly always finds potentially questionable items.
- How to react if you receive a 483 warning letter.
- What to do in order to resolve issues found during your inspection.
- What FDA data is available to the public.
Now if you liked today’s episode, then I know you’re going to find the free webinar we have coming up valuable. It’s titled, “How to Avoid and Respond to FDA 483’s and Warning Letters.”
You can register for the webinar here: http://www.greenlight.guru/webinar/fda-483-warning-letter-response | |||||||
| 16 Mar 2022 | QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices | 00:48:59 | |||||
FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device industry and regulatory bodies? In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences and George Zack of Two Harbors Consulting about the changes unfolding and the pros and cons of harmonization between QSR and ISO 13485:2016—a standard not governed by FDA. Some of the highlights of this episode include:
Memorable quotes from this episode:“They are not going to adopt ISO or any other standards across the board. They’ll take sort of a piecemeal approach, and I think that makes sense.” Mike Drues “When was the last time that the design control guidance was updated since it was created in 1997? The answer is, never. That guidance has remained exactly the same.” Mike Drues “Good regulation is timeless.” George Zack “While it might not be a huge shift, I think it is a step in a direction of many steps toward some sort of global harmonization.” George Zack Links:ANSI/AAMI/ISO 13485:2016 Handbook NIST's "ABC's of Conformity Assessment" International Medical Device Regulators Forum (IMDRF) 21 CFR Part 820 - Quality System Regulation FDA - Design Control Guidance for Medical Device Manufacturers FDA - Case for Quality Program | |||||||
| 07 Jul 2023 | #326 CSA vs. CSV: Modern Validation for Modern MedTech | 01:08:10 | |||||
In this episode, Sandra Rodriguez, an analyst at Axendia, dives deep into the complexities of Computer Systems Validation (CSV) versus Computer Software Assurance (CSA) in the MedTech sector. She discusses the FDA's draft guidance from September 2022, the industry's response, and the practical applications of it all. The conversation also covers the evolution of software validation processes, the cost of system implementation, and the importance of critical thinking in Quality System Regulations. The impact of AI on Quality Assurance, the changing dynamics of the CSA Modern Validation, and the role of Software Assurance in the life sciences industry are also discussed. Some of the highlights of today’s show include:
Links:
Quotes: “Keep in mind if you talk software validation to anyone outside of life sciences, they're going to glaze over. Validation is not used. Software validation is not used outside of this industry.” “You could tell a lot about potential changes to a draft guidance based on the number of times you see certain things show up as a comment.” “Now look, if everything is high risk, then you didn't do a risk assessment, just like if everything's a high priority, you haven't prioritized anything.” | |||||||
| 14 Jan 2023 | Determining User Needs for Your Medical Device | 00:42:23 | |||||
What is a user need, and when should you start working on them? How can you figure out what the user truly needs – and by the way, do you know who the user is? These are some of the topics you’ll hear about in today’s episode. Jesseca Lyons joins the podcast today to share more information about user needs. Jesseca is a Mechanical Engineer who’s spent most of her career gathering and defining requirements for new product design and development in the medical device industry. During today’s conversation, you’ll learn more about how Jessica is thinking about challenges in getting to user needs, using Root Cause Analysis to get to true user needs, and determining who will be interacting with the medical device and which ones are users. Some of the highlights of this episode include:
Memorable quotes from Jesseca Lyons:“Most of the time, our user needs aren’t really doing a good job of telling us what the user is actually looking for; what problem we’re trying to solve.” “I always found it interesting that we were so willing to solve a problem before we really understood what the requirements were.” “Anyone who comes in contact with your medical device could be a user.” “Every fear is a legitimate fear.” “Your design inputs shouldn’t be so restrictive that there’s only one right answer.” Links: | |||||||
| 12 May 2021 | Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?) | 00:31:58 | |||||
Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles are one of the highest in demand in the medical device industry. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mitch Robbins, founder and managing director at The Anthony Michael Group. Listen as Mitch shares his unique insights and perspectives into why there's such a high demand right now for regulatory and quality roles and how you can find your next career opportunity with the help of a regulatory affairs recruitment solution for employers and candidates. Some highlights of this episode include:
Memorable quotes from Mitch Robbins:“When this pandemic started to happen, as rapidly as it did, in March, I, as the owner of our business, like everybody else was pretty freaked out because I saw things start to shut down and shut down more and more progressively.” “We had some searches going on that a couple had just finished up and a couple that were in the final stages went on hold—just pretty much overnight.” “We have just been non-stop with organizations that need our help to place regulatory and quality talent. So, I would say that the market is on fire and demand is...greater than it’s ever been.” “Be okay being uncomfortable—meaning, especially with hiring practices, so many organizations, never in their wildest dreams thought they would hire on a remote basis, let alone build a remote workforce.” | |||||||