The MedTech Podcast (Karandeep Singh Badwal)

Alexandria DeVito Founder and CEO of Poplin is a functional nutritionist who specialises in fertility and preconception health, prior to founding Poplin, she worked as a management consultant in the finance industry before making the jump into healthcare

In this episode, we delve into the single most important thing someone can do to enhance fertility and increase their likelihood of having healthy children, the meaning of the term Preconception expert alongside what their roles are, the process of writing a book from start to finish and the common misconception of fertility rapidly declining in women after the age of 35.

Timestamps:

[00:03:15] Biological Markers for Pregnancy Success

[00:06:28] Optimizing health before conception for fertility

[00:13:10] Proactive approach in preconception

[00:15:39] Impacts of Chronic Stress on fertility and pregnancy

[00:20:34] Process of Book writing

[00:22:59] Writing a Book Vs Entrepreneurship

[00:25:47] Importance of Continuous Learning

Get in touch with Alexandria DeVito - https://www.linkedin.com/in/alexandria-devito-3381553/ https://getpoplin.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Jeremy discovered his passion for science and business at an early age hence his decision to pursue a bachelor's degree from Dartmouth College then an MBA in Healthcare Management from The Wharton School. Over the years he has held various roles with McKinsey, Purdue Pharma, Johnson & Johnson and Quotient Limited, a diagnostics company where he served as President and worked at for over 10 years prior to joining Senzo Health in October 2021

On this episode he covers the exciting innovations he is working on within his relatively new role as the CEO of Senzo Health, such as a new patented platform for biomarker testing known as the Mobile Analyzer Platform not only for COVID testing but also for various other conditions and diseases related to cardiology, hormones and different types of cancers, The latest developments within medical diagnostics, integration with software and what the future of testing will be like, By what method the decision process works within a company to find unmet needs, diversifying a business and dealing with the level of uncertainty new ideas come with during their implementation, How the technologies used within COVID-19 Lateral Flow Tests can be repurposed for other infectious diseases as the pandemic becomes less prevalent and his passion for working on and collecting cars, travelling and playing sports

Get in touch with Jeremy Stackawitz - https://www.linkedin.com/in/jeremystackawitz/ or visit his company website https://www.senzo.com/

In this episode, Josep discusses how hypertension can remain undiagnosed for years, potentially decades and why this is the case, how, unlike some other diseases that can just be treated once and forgotten about, this is one that you have to monitor for the rest of your life, the somewhat lack of regulatory hurdles he faced bringing his product to market compared to other types of devices and what he learned from over 15 years research on the disease.

Get in touch with Josep Solà - https://aktiia.com/ or https://www.linkedin.com/in/josepsola/

Get in touch with Karandeep Badwal - https://aktiia.com/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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For the past 20 years, Erez had led various R&D projects in the healthcare and aerospace industries. He is a well-known 3D medical imaging expert, and most recently led the development of the Itero Element Intraoral Scanner, the leading 3D dental scanner in the world. He holds a BSc & MSc in Electrical Engineering, specializing in AI, a BA in Mathematics, and an MBA, all from Technion Israel Institute of technology and Tel Aviv University and has published several patents in the field of 3D cameras in medical applications.

On this episode, he discusses the low success rate of spinal surgeries, the complexity of such procedures and how the spine should be seen as a combination of many organs rather than as just one. His background as an engineer, his time as an R&D Manager at Invisalign helping to develop their 3D Camera and the set up in Infrastructure in Israel for start-ups hence why it is deemed Start-Up Nation, the common mistakes start-ups make and the importance of learning sales an entrepreneur together with being able to sell your vision, dreams, company and team

Get in touch with Erez Lampert - https://www.linkedin.com/in/erez-lampert/or https://www.path-keeper.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

Amy went through the exact same challenges as many women do during infertility and leveraged her expertise to develop an approachable remedy. She discovered that for herself and others, the crucial element in achieving pregnancy was surprisingly uncomplicated: comprehending the roles of hormones, their distinct functions, and ways to maintain equilibrium. This knowledge completely changed Amy’s approach to fertility - ultimately resulting in the birth of her second child.

On this episode she discusses the lack of education around healthy conceiving in the school systems, the misconceptions around ovulation in the current healthcare system, revealing the surprising ways that traditional off-the-shelf fertility tests fall short in truly testing ovulation. She also explains how traditional fertility tests available over-the-counter do not accurately measure ovulation. Additionally, she highlights the inadequate coverage for fertility treatments in health insurance plans and a discussion on the regulatory journey her device that was initially exempt from pre-market clearance by the FDA but eventually had to undergo a 510k process after contact with the FDA.

Get in touch with Amy Beckley - https://www.linkedin.com/in/amybeckley/ or https://proovtest.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Dr Mark Kestner is the Chief Innovation Officer of MediGuru, a software platform for enabling Telemedicine solutions

Mark started his career within biomedical engineering eventually going on to apply for medical school at the University of Michigan, USA. Upon the completion of his degree instead of beginning his practise of medicine within Michigan, he decided to conduct his fourth year of residency at the US Army which led to him moving to West Germany. Mark worked through various different roles throughout his career and eventually began private practise as a trauma critical care surgeon but had quickly come to the realisation that a change was needed in the healthcare system which began his journey towards telemedicine solutions. In this episode he discusses the current status of Telemedicine and the challenges in regards to its growth, how Mediguru differs from other telemedicine platforms presently on the market, his journey into healthcare, what he learnt from travelling and working around different states within the USA and his interest of first edition modern fiction books.

Get in touch with Dr Mark Kestner - https://www.linkedin.com/in/markkestnermd/ 

Find out more about Mediguru - https://www.mediguru.com/

View his recent publications - https://disruptmagazine.com/this-medical-platform-is-helping-minority-communities/ & https://exeleonmagazine.com/mark-kestner-benchmarks-in-telemedicine/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Gray has over 20 years of experience in the healthcare industry, a large portion of which was at St Jude Medical now Abbott, a company of which I also worked at in early in my regulatory career. During his professional life, he held several commercial leadership positions. Most recently Gray, held the position of Chief Commercial Officer at Carecubes, a company created to provide a temporary and scalable negative pressure isolation technology solution based upon original joint request from the Defense Advanced Research Projects Agency (DARPA) and Centers for Disease Control and Prevention (CDC). He holds a Bachelor of Business Administration degree with a Major in Marketing from Stephen F. Austin State University in Texas and a certificate in Leadership in Excellence and Development (LEAD) Program from the University of Texas at Austin.

On this episode he discusses how the idea of PURE EP came to fruition, the prevalence of Atrial fibrillation in the U.S making it one of the most deadliest diseases and how they are trying at BioSig to help detect this condition earlier, the concept of physician reimbursement including its importance in the sales of medical devices, the greatest challengers the industry faces today including how to overcome them and how he started his career from a clinical associate to modern day as CCO of BioSig.

Get in touch with Gray Fleminghttps://www.linkedin.com/in/gray-fleming-5882a7b/ or visit his company website https://www.biosig.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Dr Hugh Harvey is the Managing Director of Hardian Health a digital health consultancy specialising in Clinical, Regulatory, Health Economics and Investment. Hugh has been working in the medical space for over 13 years previously specialising within Radiology and is now more focused on AI and Machine Learning Medical Devices. In this episode he shares with us the future of AI seperating hype from reality, the challenges AI companies face when trying to gain market access and his journey from Radiology to AI & Digital Health alongside his advice for young people looking to enter the industry.

Get in touch with Hugh - https://www.linkedin.com/in/dr-hugh-harvey-58a470112/ or https://hardianhealth.com/

Get in touch with me - https://www.linkedin.com/in/karandeepbadwal/

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Kevin developed an interest in Machine Learning in 2014, which combined with his decades of experience in ultrasound, he noticed a need in the industry for Ultrasound of which was portable, affordable and able to provide optimal results. He started his career within this sector as a sales rep for ATL Ultrasound which is considered to be one of the pioneers in the industry and a University of Washington spin off.

On this episode he covers the misunderstandings of Artificial Intelligence and Machine Learning, his developments for the future consisting of AI disrupting the industry with new business models, the need for devices to become smaller, more powerful and less expensive, the three common denominators in healthcare that have the most impact which include: Time, Quality and Variation, cases where algorithms are proving to outperform physicians such as in the case of Mammography and why the location of Seattle, Washington is a well-known hub for Ultrasound technology.

Get in touch with Kevin Goodwin https://www.linkedin.com/in/kevin-m-goodwin-2bb82a86/ or visit his company website https://echonous.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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In this captivating bonus episode, we embark on an exploration of our individual backgrounds and the fascinating paths that led us to our present achievements. Join us as we discuss the exciting possibilities of in-person podcast recordings, delve into the current regulatory landscape and delve into Rodney's thrilling globe-trotting adventures.

Get in touch with Rodney Moses - https://www.linkedin.com/in/rodmoses/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Kirk Huntsman, CEO of Vivos Therapeutics, a pioneer in the treatment of obstructive sleep apnea. With decades of experience in the dental and medtech space, Kirk has led Vivos to secure multiple FDA clearances including the first ever for treating moderate to severe pediatric sleep apnea using an oral appliance

In this episode, we uncover why sleep apnea is a silent global epidemic, why it's so underdiagnosed and how Vivos is transforming the way we approach treatment, shifting from CPAP-based management to true rehabilitation. Kirk also shares how Vivos is achieving life-changing results in less than a year, and why even mild, untreated sleep apnea can lead to serious downstream health issues like hypertension, depression and cognitive decline. We also discuss societal misperceptions, global prevalence and exciting innovations that could one day lead to a cure

Timestamps:

[00:00:27] What Is Obstructive Sleep Apnea and Why It’s Dangerous

[00:03:07] Why Sleep Apnea Remains Widely Undiagnosed

[00:06:49] Changing the Narrative Around Snoring and Awareness

[00:08:49] FDA Breakthroughs: Treating Children and Adults Differently

[00:13:13] CPAP vs Vivos: Why Patients Need a Third Option

[00:17:26] From Dentistry to MedTech: The Journey to Founding Vivos

[00:26:07] The Future of Sleep Medicine and Ending Apnea Permanently

Get in touch with Kirk - https://www.linkedin.com/in/kirkhuntsman

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Peter Brady is a MedTech specialist with over 30 years experience in the field and is the founder of UOVO Technologies, a medical devices & digital health consultancy. On this episode he shares with us what the main challenges are that digital health companies face, the differences in regulation accross the world and his journey into this sector alongside what the future of Digital Health and AI will look like.

Get in touch with Peter - https://www.linkedin.com/in/peter-brady-2b824913/ or https://www.uovo-technologies.com/

Get in touch with me - https://www.linkedin.com/in/karandeepbadwal/

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Omar is a marketing leader who is passionate about Healthcare, Sales and Learning. He developed his marketing strategies originally within surgical robotics and through his own entrepreneurial ventures creating consumer products within men's fashion. Outside of his work he is an avid reader sharing his knowledge of books through his YouTube channel and Podcast, on todays episode he discusses the future of MedTech, how he got into the sector and why he continues to help people into the sector.  

Get in touch with Omar – https://www.linkedin.com/in/okhateeb/

https://www.youtube.com/channel/UCt1NrFetvobTwMB8ClcCBig

https://anchor.fm/mindloom/

https://www.instagram.com/omar.m.khateeb/

https://www.facebook.com/OmarMKhateeb/

Get in touch with me - https://www.linkedin.com/in/karandeepbadwal/

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Giovanni Lauricella is a connector of MedTech professionals to insights, people, and startup capital. He has travelled to over 43 different countries and is currently based in the USA working at the Mullings Group within global MedTech talent acquisition. On this episode he shares his journey, the evolution of technology within the industry, the move towards predictive rather than reactive treatment and the differences in growth within other countries.

Get in touch with Giovanni - https://www.linkedin.com/in/giovannilauricella/ or https://mistermedtech.com/

Looking for your next MedTech role? get in touch with the Mullings Group team - https://mullingsgroup.com/

Get in touch with me - https://www.linkedin.com/in/karandeepbadwal/

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Lucien Blondel is a surgical robotics expert and the co-founder of Quantum Surgical, a company specialising within surgical robotics for the treatment of liver cancer. Lucien has been working in this sector for over 20 years and in this episode, he shares with us what surgical robotics is, its many applications, its integration with artificial intelligence together with the challenges he faced co-founding his own surgical robotics company alongside what he has learned traveling around Asia in his free time.

Get in touch with Lucien - https://www.linkedin.com/in/lucienblondel/ or https://quantumsurgical.com/

Get in touch with me - https://www.linkedin.com/in/karandeepbadwal/

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Rick Rowan started his career as a real estate entrepreneur in Syndey, Australia. Since then he went on to form his own company NuroKor Bioelectronics in London, UK which focuses on wearable personal medical devices with further applications for Animal Health and Femtech. In this episode he discusses the development of Artificial Intelligence, the common misconceptions in bioelectronics, current opportunities in the market, advice for new businesses and his ambitions for the companies future.

Get in touch with Rick Rowan - https://www.linkedin.com/in/rick-rowan/ or https://nurokor.co.uk/ or https://www.nurokor.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical  

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Prior to Medable Sans at the helm of Accenture's Global Life Sciences Research, assumed the pivotal role of orchestrating visionary market-shaping strategies and spearheading program execution in therapeutics, digital health, and scientific innovation. With over two decades in the industry, Sans's expertise graced the corridors of more than 30 companies, launching an impressive lineup of 10 groundbreaking products. Her guidance extended even further, advising digital health venture funds and masterfully managing a top 20 pharmaceutical portfolio.

In this episode, she delves deep into the pervasive issue of gender bias in clinical trials unveiling the startling truth about how these trials predominantly focus on Males with little Ethnic Diversity, leading to medicines that may not be optimized for everyone. How in the late 1970s women of childbearing age were excluded from medical research, regardless of their intention or ability to have children, how despite women comprising over half the population, a mere 1% of healthcare research and development is invested in addressing their specific conditions and how both the FDA and EMA have undergone a transformative shift in their perception of digital tools.

Get in touch with Sans Thakur - https://www.linkedin.com/in/sanskritithakur/, https://www.medable.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Yoshinaga Kazutaka is a medical doctor based in Japan and founder of Melp, an online medical questionnaire application. Yoshinaga graduated from medical school in 2014 and it was during his studies he began researching brain development which led to the idea of his latest startup for developing an ear-EEG based platform. In this episode he discusses how he got into medical entrepreneurship, the current demands within the Japanese medical market with a significant elderly population, differences in regulation in Japan and his ambitions for his future ventures.

Get in touch with Yoshinaga Kazutaka - https://www.linkedin.com/in/kazu098/ or https://monshin.melp.life/en/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Mark Goddard, Vice President of Clinical Services at InfoBionic.Ai, a leading authority in cardiac remote monitoring. A registered nurse with over 20 years of experience in clinical electrophysiology, Mark has pioneered service lines across ambulatory ECG, cardiac event monitoring, mobile telemetry and heart failure management in hundreds of institutions. He’s also a certified Clinical Cardiac Device Specialist with deep knowledge of subcutaneous monitoring and AI-assisted diagnostics

In this episode, we explore how AI and real-time ECG data are revolutionising arrhythmia detection, heart failure prediction and patient engagement especially for high-risk groups like those with A-Fib. Mark shares practical insights from the front lines of cardiac care, how to tell genuine innovation from AI hype and why the future of diagnostics may lie beyond traditional heart monitoring. We also cover clinical implementation challenges, device design for older populations and the fine line between wellness tracking and medical-grade care

Timestamps:

[00:00:27] AI-Powered ECG: From Novelty to Necessity

[00:03:28] How Clinicians Are Separating Hype from Reality

[00:05:07] Why Near Real-Time Beats Traditional ECG Monitoring

[00:08:49] A-Fib and the Global Data Gap

[00:11:36] When Good Tech Goes Bad: Early Pacemaker Mistakes

[00:13:30] Hospitals, Homes and the Future of Cardiac Care

[00:19:59] AI vs Machine Learning: What’s the Real Difference?

Get in touch with Mark -

https://www.linkedin.com/in/mark-goddard-035ab427/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Ty for many years had a passion for art, design and engineering hence leading to the formation of Trig in 2008, having started his career as an Industrial Designer at Home Depot he decided to return to school to complete an MBA in Innovation Management and Marketing at North Carolina State University, where he got exposed to medical devices and realised that the issues faced during home development were similar to those within devices especially during the human ergonomics phase hence why he decided to serve the industry through his own company Trig.

On this episode he covers the development of blockchain plus its integration into healthcare, his career development to date and the need to develop yourself as an entrepreneur, the distribution of pharmaceutical and MedTech companies in the RTP area of North Carolina, his athletic past as a world-class kayaker and how he applied the skills and lessons he learnt during his athletic career to his work and his advice for students together with various different programs available for career development across higher education institutes within the USA.

He has a unique take on how early stage medical innovators can get funding. His company has developed a workshop that engages clinicians to identify problem areas in healthcare and build well-articulated need statements. He asserts that the structured processes for medical device development are not the same as the skills and techniques needed to generate a novel device idea at the beginning. Teams of clinicians and researchers are led through a 7-week hands-on curriculum where they work on their highest priority unmet needs in healthcare and learn how to prototype low-risk experiments. The second cohort of 4 teams presented their work on June 8th, 2022. To learn more about the Design-Inspired Team workshops, check out: https://www.designinspired.team/

To follow along on the results of the current cohort, please consider supporting their work through the novel grant funding mechanism, GitCoin: https://gitcoin.co/grants/5321/healthcare-innovation-is-broken-were-fixing-it

Get in touch with Ty Hagler https://www.linkedin.com/in/tyhagler/ or visit his company website https://www.trig.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Richard Houlihan is the founder of EirMed, a company specialising in EUDAMED training & support, he was part of the original team at the European Commission who managed, designed, and led the development of EUDAMED.

Richard has considerable knowledge when it comes to EUDAMED, the current European database on medical devices. He started his career in IT working as a programmer going into project management and had spent over 8 years working within the European Commission in Brussels, Belgium helping build the EUDAMED system. In this episode he discusses why the EUDAMED system was created, the issues the medical device industry currently faces, the challenges the new Medical Device Regulation and Brexit has brought into the EU and why companies are not currently allocating resources to learning about this new system.

Get in touch with Richard Houlihan - https://www.linkedin.com/in/richard-houlihan/ or https://eudamed.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Dr. Kenneth Monaghan, University Lecturer at Atlantic Technological University, a world-leading expert in stroke rehabilitation, digital health and neuroplasticity research. With over 32 years of clinical, academic and research experience, Kenneth is revolutionising stroke recovery by making cutting-edge therapies accessible from home

As a lecturer in health science and director of the Neuroplasticity Research Group at Atlantic Technological University, Kenneth has pioneered groundbreaking rehabilitation solutions that challenge traditional recovery models. He shares insights on why home-based rehab can be more effective than hospital treatment, how digital health is transforming stroke recovery and the science behind innovative therapies like mirror therapy and sensory substitution. We also discuss his role in securing over $2 million in research funding, his patented rehabilitation devices and the mission behind his book Lights, Mirrors, Action

Timestamps:

[00:00:27] The Silent Killer: Biggest Risk Factors for Stroke

[00:02:30] Home-Based Rehab: Why It Works Better Than You Think

[00:05:41] Overcoming Fear: Getting Patients to Engage in Therapy

[00:08:02] How Testosterone Boosts Stroke Recovery

[00:11:35] Digital Health & Remote Monitoring in Stroke Rehab

[00:17:37] Mirror Therapy: A Stroke Recovery Game-Changer

[00:25:51] Sensory Substitution: Using Vibration and Sound to Retrain the Brain

Get in touch with Kenneth Monaghan- https://www.linkedin.com/in/kenneth-monaghan-msc-phd-miscp-75b746103/

https://www.lightsmirrorsaction.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Bob Roda President and CEO of Hemosonics, the creators of the Quantra Hemostasis Analyzer, a diagnostic platform that provides a comprehensive blood analysis detailing hemostasis in the operating room in less than 15 minutes. Bob joined HemoSonics in February 2020 as the company’s President and CEO, bringing more than 25 years of global experience developing and commercializing innovative diagnostic and medical device products and services

In this episode, we explore his transition from economics to medtech, highlighting the urgent global need for blood donations and the causes behind the current blood shortages. We also examine the significant effects of COVID-19 on blood supply, the biological process of bleeding and its implications for military trauma care.

Timestamps:

[00:02:34] Blood crisis due to COVID, global issue.

[00:05:23] Blood product technology helps save lives.

[00:08:22] Technology for acute bleeding management, military applications.

[00:14:38] Body's response to injury and bleeding.

[00:21:35] Vetinary Applications

[00:24:58] Responsibility of leadership: be present, humble.

[00:27:56] Passion for healthcare can change lives.

Get in touch with Bob Roda - https://www.linkedin.com/in/bob-roda-8175b24/ https://hemosonics.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Joe Mullings is the founder of The Mullings Group, the worlds leading search firm in medical devices and TMGPulse, a MedTech news website. Joe has been in the industry for over 3 decades, his clients vary from multi-billion dollar companies to early-stage startups involved in various different technologies including but not limited to Surgical Robotics, Telehealth and AI. In this episode he shares with us what he has learned travelling the world, meeting with different MedTech companies through his television series on TrueFuture.TV, his predictions for the future and his advice for young people looking to enter the industry. 

Get in touch with Joe - https://www.linkedin.com/in/joemullings/ or https://mullingsgroup.com/ 

Watch his TV Series here - https://truefuture.tv/ 

Follow Joe on YouTube - https://www.youtube.com/c/JoeMullings293 

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ 

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical Subscribe to the Podcast

Keith Smith, President of Vonco Products, a leader in medical device packaging and contract manufacturing. Keith has spent years refining the science behind sterile packaging solutions, ensuring that medical products survive extreme conditions, from freezing temperatures to high-pressure airline transport

In this episode, we uncover why medical packaging is far more than just a box, it's a critical component in ensuring safety, sterility and regulatory compliance. Keith shares real-world failures where improper packaging led to catastrophic outcomes, the rigorous testing required to meet global standards and how manufacturers can avoid costly recalls. We also discuss the benefits and pitfalls of outsourcing medical device production, why some companies thrive with contract manufacturing while others struggle and Keith’s own entrepreneurial journey from acquiring Vonco to leading it into the medical device space

Timestamps:

[00:00:27] Why Medical Device Packaging is Critical for Patient Safety

[00:02:30] The Hidden Dangers of Poorly Designed Packaging

[00:05:46] Surviving Extreme Conditions: Cold, Heat & Pressure

[00:07:02] Global Packaging Regulations: Why Standards Vary by Region

[00:10:16] The Pros & Cons of Outsourcing Medical Device Manufacturing

[00:13:43] From Food Packaging to MedTech: The Evolution of Vonco

[00:20:54] Leadership & Entrepreneurship: Lessons from Running a Business

Get in touch with Keith Smith - https://www.linkedin.com/in/keith-smith-725508b/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Ivan has both strong science and business background, he holds a BSc and MSc in Physics and an MBA. Having worked for nearly 15 years within the industry, in leading medical companies and also as a consultant in the areas of regulatory, product and business development, he has broad experience with different types and classes of products, supporting a variety of organisation models and management, from start-ups to large corporations.

In this episode, we explore the challenges of staying abreast of constantly evolving regulations and guidance documents on a global scale. Ivan shares invaluable insights on successful networking and imparts valuable advice for aspiring entrepreneurs. Furthermore, we delve into his personal journey, uncovering how a sports injury compelled his shift from physics to medical devices, prompted by a misdiagnosis that persisted for more than 4 years.

Timestamps:

[00:01:01] Importance of networking early on in your career

[00:04:35] Keeping up with changes in regulations and guidelines

[00:18:38] Turning a negative into a positive

[00:22:05] Dealing with failure

[00:25:08] Explaining entrepreneurship to your peers

Get in touch with Ivan - https://www.linkedin.com/in/ivan-perez-chamorro-804b0b22/

https://www.medboard.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Steve Curran Senior Regulatory Consultant at Trinzo, a medical device and pharmaceutical consultancy firm. He has over 20 years experience in the medical device industry both as an engineer and leader developing medical devices but also as a Notified Body regulator ensuring that devices are compliant when they reach the market. He has a broad range of experience from general medical devices to orthopaedic and dental devices and combination devices incorporating drugs and biologics

In this episode, we explore why Ireland is becoming a growing sector in this industry, the parallels of working at a notified body to a consultancy, the concept of a virtual manufacturer, which market to enter first the UK, EU or USA and Steves advice for those looking to get into quality and regulatory roles.

Timestamps:

[00:03:08] Virtual Manufacturing

[00:07:08] Common Mistakes manufacturers make

[00:15:11] UK, EU v USA Markets

[00:17:48] Time constraints and interdepartmental cooperation challenges.

[00:24:25] Enforcing safety in the medical device industry.

Get in touch with Steve Curran - https://www.linkedin.com/in/vincentcafiso/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Mitch has an extensive background in the recruitment and staffing industry, prior to setting up his own firm, he worked a successful career for two nationally recognised search firms Spherion and Management Recruiters International. Mitch is also a content creator regularly posting videos online about recruitment alongside his tips for job seekers and hosts a weekly live show where he answers any questions about job seeking and the industry from the audience. He holds a bachelors degree in psychology and business from the University of Wisconsin-Madison.

On this episode, he discusses how to approach hiring managers and how he used such techniques to find a job in his early days, the high demand for Quality & Regulatory staff alongside whether this demand is here to stay after the EU MDR situation has calmed down, his advice for candidates currently on the market for medtech roles, the importance of building a network early on in your career, how he got into content creation and his younger days as part of a rock and roll band.

Get in touch with Mitch Robbins - https://www.linkedin.com/in/mitchrobbins/ or https://www.theanthonymichaelgroup.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Ladan has a wealth of knowledge in the Neurotech space and has been running his own podcast in this field for over 4 years, he studied Nanobiophysics in Germany whilst completing his Master thesis in India and has travelled to over 100 different countries around the world and now resides in Florida whilst he completes his PhD. In this episode he discusses the controversial side of neural implants, the challenges of funding for companies in this sector, the hottest areas of focus in this space, the lessons he learned as an avid traveller and his unusual but interesting hobbies.  

Get in touch with Ladan Jiracek - https://www.linkedin.com/in/ladan-jiracek-37273237/ or https://neuralimplantpodcast.com/ or https://travelwisdompodcast.com/  

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/  

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical  Subscribe to the Podcast

Adam is a Senior Recruitment Consultant based in Zurich, Switzerland working within the Medical Device Industry and In Vitro Diagnostics with a focus on Swiss SME´s and global companies. On this episode he explains why Switzerland is so popular with med tech companies, how the industry is changing, the impact of digitalization and what Swixit is all about.

Get in touch with Adam – https://www.linkedin.com/in/adam-hotovy/

Looking for a role in Switzerland or the EU? Get in touch with the EPM Team: https://www.epmscientific.ch/

Get in touch with me - https://www.linkedin.com/in/karandeepbadwal/

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Laura is a board certified family medicine physician who has wrapped up 14 years as an officer in the US Army, she started working in telemedicine in 2016 as a full time physician and became medical director of MDLIVE after which she become one of the Regional Medical Directors of hims and hers. Having now worked for dozens of virtual health companies across the industry and also consulting for early-stage telehealth startups in the US and UK. She has 49, soon to be 51, US state medical licenses and believes in empowering young businesses to meet and exceed their business vision. She has co-founded two telehealth companies and is now lobbying at the federal level to influence change that increases access to care and reduces disparities in telehealth.

On this episode she discusses what really puts doctors careers at risk, the reality of virtual care, her time working in the US army and how this helped developed her skills as an entrepreneur, what physicians should start doing to make the most of the digital health movement, her passion for business, what makes a successful entrepreneur, lack of cost transparency within US healthcare, the advice she has for women at the start of their career to overcome any obstacles they may face early on and what she would tell her younger self if she could go back in time.

Get in touch with Laura Purdy https://www.linkedin.com/in/laura-purdy-md/ or visit her company website https://mdintegrations.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Chuck grew up as a cattle farmer eventually getting into engineering working on various aerospace and military projects, he then got involved in gaming as a animator, producer and developer with one company he worked at being EA Sports working on the popular games at the time of Madden NFL 2000 and NCAA football 99. He eventually went on found PRSONAS in 2013 which was acquired by nuMedia in 2019 and still remains CEO of the company to date.

On this episode, he discusses the differences between digital humans and digital personalities, how such technologies can be used in healthcare, how around 1% of the US population uses American sign language and how his technology at PRSONAS helps improve communication with those people, current oppositions to this technology including how some fear it may result in job losses, where to learn more about digital personalities and his love for musical instruments and aviation.

Get in touch with Chuck Rinker - https://www.linkedin.com/in/chuckrinker/  or https://www.prsonas.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Lishan has over twenty experience as a heart surgeon but his entrepreneurial and professional success was not an easy road, he fled political violence in Ethiopia as a teenager but despite this went onto study both physics and medicine at Harvard University. He serves as Board Chairman of The Boston ECG Project Charitable Foundation Inc., a non-profit corporation whose purpose is to save the lives of children and adolescents by preventing sudden cardiac death and identifying underlying cardiac abnormalities and conditions

On this episode he discusses how he took his company public in 2016 including the process and reasons why a company may consider going public, the steps entrepreneurs can take to spot opportunities or create solutions for current problems, what he learnt about the heart during his years as a surgeon of which may not be common knowledge, the causes of oesophageal cancer together with EsoCheck a device he brought to market which aims to detect pre-cancer and oesophageal cancer, a deadly cancer with an 80% mortality rate at 5 years and his philanthropic projects.

Get in touch with Lishan Aklog - https://www.linkedin.com/in/laklog/ or visit his company website https://pavmed.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Mark McDonough CEO of ChromaCode, an innovator in molecular genomics providing easy to implement, cost-effective workflows within Oncology and Genomics. Mark has over 25 years of experience helping build high growth HealthCare organizations. He most recently was the CEO of Pierian (now Velsera) which he led to a successful sale to Summa Equity, a private equity firm, in 2022. Prior to Pierian, he led CombiMatrix for five years, culminating in a sale to Invitae in 2017. Over his career, Mark has held various executive and commercial positions, and even once served as a US Naval Officer.

In this episode, we delve into Marks experience in the healthcare space and his thoughts on the future of healthcare with HDPCR technology, we discuss his experiences of growing and selling multiple businesses alongside the many lessons he learned along the way, he shares his advise in terms of what he looks for in potential board member and advisory roles alongside the reasons of why you may not want to consider such positions and his reasons for continuing to work within the healthcare sector

Timestamps:

[00:00:15] Delivering high-impact testing faster and cheaper

[00:04:08] Lesser known facts of Lung cancer.

[00:09:38] Developing targeted markers for lung cancer.

[00:16:12] Add value to your tech team

[00:20:52] Importance of Authenticity to success.

Get in touch with Mark McDonough - https://www.linkedin.com/in/mark-mcdonough-b1055216/

https://www.chromacode.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Vlado left school early to begin work across various industries from gardening, property development and Healthtech. His different work experiences and an interaction with a sports physiologist eventually led to him co-founding Advanced Human Imaging (formerly MyFiziq Limited) in 2014. He now has over 30 years of experience in assisting businesses with strategy, structure and entry to capital markets.

On this episode he discusses how he first developed the idea and progressed the technology into Advanced Human Imaging, the process of bringing an idea to reality, the importance of execution and believing in yourself, trends in healthcare technology within Australia, how his company helps doctors to treat more patients in less time by providing vital information such as body composition, heart rate, blood pressure and respiration rate all of which can be used by doctors to determine if any and the extent of treatment needed. He also discusses the true cost of entrepreneurship and how it can impact every part of your life together with the advice he offers for those looking to embark on a similar journey to his.

Get in touch with Vlado Bosanac https://www.linkedin.com/in/vladobosanac/ or visit his company website https://www.ahi.tech/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

In this episode, Pietro discusses the concerns about the impact on physicians' workload with the increase in technology within healthcare, the key milestones in the development of AI in medicine, the concept of personalized medicine and the most promising areas of research at the intersection of AI and medicine.

Get in touch with Pietro Arina - https://www.linkedin.com/in/dr-pietro-arina-64293213b/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Mariusz Mąsior CEO of Consonance, a medical device development company providing multiple services from prototyping to manufacturing. He has a very strong academic background, he is an Author and co-author of numerous publications in reputable scientific journals and a visiting Scholar at Stanford University and Nagoya Institute of Technology.

In this episode, we discuss the implications of the AI Act including how it is not application-specific by not taking into account the risks and applications of AI therefore making it difficult for new companies, the unique challenges of investing in MedTech startups in respect to product and ethical considerations and how ResearchGate and Web of Science can be used as effective networking tools.

Timestamps:

[00:00:02] AI, machine learning, regulation issues

[00:06:46] AI: Magical, not dangerous and its application

[00:14:07] Networking for startups: Be social, talk, attend events.

[00:20:06] Network to find experts: Six words

[00:27:48] Exploring new things fearlessly

Get in touch with Mariusz Mąsior - https://www.linkedin.com/in/mariuszmasior/

https://consonance.tech/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Karen has a diverse range of experiences under her belt. From working for large corporations in manufacturing and marketing to running her own successful consulting firm. she's also a passionate advocate for changes in healthcare, using technology to make a real difference in the lives of patients.

Get ready to unravel the secrets of your body's "wires" as we dive into the fascinating world of nerves in this episode. From muscle movement to breathing and beyond, nerves are responsible for multiple functions that keep us going. But what happens when nerve damage goes undiagnosed? We'll explore the outcomes for patients and the need for education for both patients and physicians in this space. Plus, we'll take a closer look at the regulatory pathway for biological products and give you the inside scoop on the healthcare scene in sunny Florida.

Get in touch with Karen Zaderej- https://www.linkedin.com/in/karen-zaderej-56342318/ or https://axogeninc.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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This groundbreaking technology empowered paralyzed individuals to navigate their world with newfound freedom. Building on this success, James embarked on his latest venture, Vistim Labs, aiming to solve a significant barrier in neurodegeneration with timely diagnosis.

In this episode, we delve into the fascinating connection between stress, gene expression and the subconscious mind. We explore how stress can impact our DNA and the role our brain plays in regulating stress levels whilst uncovering the intriguing interplay between conscious and subconscious thoughts and how negative imagery may trigger subconscious responses with potential implications for our health.

Get in touch with James Hamet - https://www.linkedin.com/in/jchamet/

https://vistimlabs.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Sundeep serves regulators and industry professionals alike, he frequently contributes to industry & government collaborated conferences as a speaker and panelist. A prominent guest lecturer in various MBA and Pharmacy educational institutions in India.

He is a lead auditor for medical devices and has expertise in ISO 13485, EU MDR, IVDR, CE Certification, CER, PMS, USFDA, 510(K), ISO 14971, MDSAP. He has delivered multiple global webinars for medical devices, diagnostics and life science companies. He is currently associated with Datt Mediproducts, India as a General Manager - Compliance & Regulatory Affairs, in addition to being an active member of a Technical Group (Software as Medical Device) at Global Harmonization Working Party.

On this episode he discusses how India is the fourth largest medical device market in Asia worth approx. $12 billion in 2022, its dominance in consumables and disposables, the process for exporting and importing medical devices from India, the regulatory frameworks of the region, the challenges of the EU MDR and IVDR in both the EU & UK, how to keep up to date with the everchanging regulatory environment, what makes the area of Bangalore a hotspot for MedTech and the similarities in regulation around the world.

Get in touch with Sundeep Agarwal https://www.linkedin.com/in/sundeep-agarwal-5680342a/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Having studied Biomedical Engineering at the University of Texas San Antonio Meri had quickly realised how much of an interdisciplinary field it is combining biology and engineering principles hence had decided to co-found The BME Life which is a community of Biomedical engineers where professionals and students share resources such as career concepts, industry news and the different opportunities available to help current and future biomedical engineers navigate their career.

Meri started her career within engineering working with a medical devices start-up specialising in medical treatments for orthopaedic surgeries and now works as a regulatory affairs consultant for a medical devices consultancy. On this episode she discusses the various different industries Biomedical Engineers can consider outside of medical such as Aerospace or Automotive, unconventional methods she has used to find roles throughout her career, how to find out what the various different career choices you can have with your education, which areas within the USA are most appealing for Biomedical Engineers, why she created The BME Life and her plans for future content.

Get in touch with Mertixell Martinez - https://www.linkedin.com/in/meritxell-martinez-478353158/ or follow her on YouTube: https://www.youtube.com/c/TheBMELife or Instagram: https://www.instagram.com/thebmelife/ 

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Christa Natoli Executive Director at Center for Telehealth and Ehealth Law has extensive policy experience and knowledge in the areas of physician and nurse licensure, Internet prescribing, e-consultations, Medicaid reimbursement, mHealth and international telemedicine. She has led research efforts on these topics and is a published author and noted lecturer and speaker

In this episode, we dive into the world of telehealth technology discussing its origins, challenges, and potential benefits. We also explore the role of AI in reducing clinician workload alongside the misconceptions around this type of technology and discuss the future of global healthcare

Timestamps:

[00:02:38] Telehealth defined as point-in-time care

[00:05:11] Accessibility for all in digital health

[00:07:48] Regulations on AI and medical devices

[00:20:27] Early AI adoption in healthcare: IBM Watson

[00:26:16] Inaccuracy of online information

Get in touch with Christa Natoli - https://www.linkedin.com/in/christa-natoli/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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David is a seasoned expert in the industry with a wealth of over 25 years' experience. He has an impressive track record of crafting and delivering compelling international regulatory presentations, submissions and reports to the most demanding of audiences - the competent authorities and certification bodies around the world. His background includes not only an illustrious career in academia where he was once a professor, but also a stint as a Director at Abbott Medical Devices where he led clinical and regulatory operations, a company I also spent a portion of my career with.

On this episode he delves into the intricacies of quality, clinical and regulatory, breaking down what they mean and how they interact with each other, particularly in regards to language, he then takes the audience on a journey through his entrepreneurial career, sharing the inspiring story of how he got started and the process of writing a book. He also shares insights on what investors look for when evaluating companies during their pitch and how he made the transition from a background in pharmaceuticals to medtech. For students who are unsure about which field to pursue, David offers valuable advice and explains why Silicon Valley is such a thriving hub for business and emphasizing the importance of always having a hunger for learning, and how this drive for knowledge can greatly benefit one's career growth.

Get in touch with David Rutledge- https://www.linkedin.com/in/david-rutledge-9291609/ or www.GlobalStrategicSolutions.com

Get his book here: https://amzn.to/3HL7oKD

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Weronika Michaluk Digital Health Principal and SaMD Lead at HTD, a company specialising in the planning, designing and development of custom healthcare software. Weronika is an experienced professional with a diverse background in the fields of biomedical engineering, international business and public health. Her career began as a Biomedical Engineer, where she contributed to the development of various biomedical devices, including a wireless ECG system, then she worked in South Korea in the Neuroscience Department and after that, she focused on digital health solutions and consulting in the medical device space.

In this episode, we delve into the world of software medical devices, explore the agile and waterfall approaches in software development and their application to regulated medical devices. We discover the crucial role of software in medical devices, uncover how some companies unintentionally market unregulated medical products and learn how to stay updated with the ever-evolving regulations.

Timestamps:

[00:00:10] What makes a software a Medical Device

[00:05:57] Complexity of regulating software

[00:11:52] Agile individuals and interactions over processes

[00:17:30] Software medical device: engineering, research, business and coding

[00:23:00] How to keep up with regulations

Get in touch with Weronika Michaluk - https://www.linkedin.com/in/weronika-michaluk-mba-43811698/

https://htdhealth.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

Mike Pogose is a Senior Quality & Regulatory Consultant at Hardian Health, a digital health consultancy specialising in Clinical, Regulatory, Health Economics and Investment. Mike has been in the MedTech industry for several years initially starting as an engineer in industrial metrology and mechatronics. In this episode he discusses how software medical devices are regulated around the world, the unique challenges a SaMD product faces in comparison to traditional devices, his advice for software companies and his journey starting as a software and systems engineer, eventually transitioning into MedTech.

Get in touch with Mike Pogose - https://www.linkedin.com/in/michaelpogose/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical 

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Arun began his career in clinical development and commercial roles of increasing responsibility at BristolMyers Squibb and Covance has over 20 years of hands-on healthcare business executive experience with an emphasis on corporate and business development, strategy and finance.

In this episode, we delve into the paramount importance of prioritising patients amid physician shortages in the US healthcare system, the cutting-edge approach of targeting regulatory T cells to combat neurodegenerative diseases effectively, the pivotal role of biomarkers in diagnosing these conditions together with the potential of combining them with physician tests, cognitive assessments and advanced scans for a truly ideal approach alongside how the intricacies of the human body remain a profound challenge and that there is still an abundance of knowledge to unravel and discover.

Timestamps:

[00:00:00] Excellent healthcare: Patient-centered excellence.

[00:06:09] Treating neurodegenerative diseases with Tregs.

[00:11:45] Bringing therapies to patients faster.

[00:18:00] Forming a company to fight neurodegenerative diseases.

[00:24:39] Evolution of Coya: Follow Your Calluses.

Get in touch with Arun Swaminathan - https://www.linkedin.com/in/arun-swaminathan-a8571b3/

https://coyatherapeutics.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Dima had a unique vision of tech-enabled human evolution with a strong belief that electronic implants will have the biggest potential to make a positive impact on the world. Since forming Esper Bionics he has successfully built a human-like FDA-registered self-learning mind-controlled robotic hand known as Esper Hand. He is a serial entrepreneur and holds a Medical Degree from Bogomolets National Medical University and Degree within Dermatology from Shupyk National Medical Academy of Postgraduate Education

On this episode he covers the current issues within Bionics, why he chose to go into entrepreneurship over the traditional route of a medical doctor, the challenges of the reimbursement system within the EU in comparison to the USA for medical devices, how his location of New York is a great hub to synchronise with many different people from different cultures and backgrounds, the other applications for his technology such as gaming and industrial robotics in addition to his interests in classic games such as Warcraft 3 and Civilization 3

Get in touch with Dima Gazda -  https://www.linkedin.com/in/dimagazda/ or visit his company website https://esperbionics.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Eric Horesnyi CEO of Matrix Requirements, a leading platform in design and quality control for Software Medical Devices. Eric started his career in finance in tech having co-founded Radianz a financial data exchange and Streamdata.io for real-time API. However during the pandemic of 2020 after organising a hackathon for his company at the time, he realised a lot of skills and knowledge he had built in these industries could be beneficial in digital health hence his transition to healthcare in 2022.

In this episode, we delve into the intriguing parallels among finance, tech and healthcare. Discover the contrasting approaches of agile and waterfall methods in software development for medical devices. Learn expert strategies for fostering seamless collaboration between departments, navigating the common challenges faced by developers and quality teams. Gain insights into the significance of advisory board positions, exploring reasons to embrace or reconsider them and share our firsthand encounters and effective tips for maximising the value of industry conferences.

Timestamps:

[00:08:16] Developers and FDA Compliance.

[00:13:41] Traceability requires multiple dimensions.

[00:15:53] Reality of Medical Device regulatory timelines

[00:19:04] Preparation for Industry Conferences

[00:22:21] Effective networking

[00:25:34] Helping others, finding passion and gaining skills

Get in touch with Eric Horesnyi - https://www.linkedin.com/in/horesnyi

https://matrixreq.com/?utm_source=podcast&utm_medium=referral&utm_campaign=2023-06-themedtechpodcast-all-all

Get in touch with Karandeep - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Phil discusses the potential of machine learning and artificial intelligence to advance healthcare and shares his vision for the future of movement health and Sparta Science's role in it. He also provides valuable insights for aspiring entrepreneurs looking to break into the industry and discusses notable collaborations his company has had with other healthcare organizations. Finally, Phil shares ongoing research and development projects at Sparta Science and how they may impact the future of healthcare. Tune in for a fascinating conversation with a thought leader in movement health and technology.

Thank you for listening to Episode 45 of the MedTech Podcast, if you have not already done so please subscribe, if you wish to learn more about Phil you can connect with him on LinkedIn or visit his company website, the links of which are provided in the description. If there are any particular topics or guests you would like me to have on the show in the future, feel free to reach out.

Get in touch with Phil Wagner - https://spartascience.com/ or https://www.linkedin.com/in/drphilwagner/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Bijan's career began in aerospace back in 1985, where he played a crucial role in ensuring safety within NASA and overseeing space systems. However, it was a fateful encounter at a risk management conference in 1991 that sparked his interest in the field of medical devices. When someone sought his advice on this topic, it paved the way for his transition into the realm of medical devices. Since then, Bijan has become a respected figure, sharing his knowledge and expertise through lectures at numerous universities. He has also provided valuable guidance to multiple medical companies on the intricacies of risk management. As a testament to his deep understanding of the subject, he has authored two comprehensive books on risk management.

In this episode, he delves into the intriguing world of risk management, drawing parallels between aerospace and medical devices. With years of experience as an advisor, he unveils the common misconceptions surrounding this crucial topic. He sheds light on his earlier days when risk management lacked standardized frameworks and how he navigated through that landscape. Above all, Bijan shares his unwavering passion for transforming uncommon knowledge into something accessible and widespread.

Get in touch with Bijan Elahi - https://www.linkedin.com/in/bijanelahi/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

Katie Cooney, founder of Leap Compliance an expert in quality culture, training and compliance. With extensive experience in MedTech, including roles at Boston Scientific and leading training initiatives globally, Katie is on a mission to ensure that quality is woven into every aspect of organizational culture

In this episode, Katie discusses her journey into MedTech and how she transitioned to entrepreneurship with Leap Compliance. We delve into effective training strategies, the importance of leadership in fostering a quality-first mindset and real-world examples of what happens when quality is neglected. Katie also provides actionable advice on building and maintaining a robust quality culture that stands the test of time

Timestamps:

[00:00:27] The Role of Leadership in Quality Culture

[00:02:30] Creating a Mock Production Environment for Training

[00:05:22] Building Psychological Safety in Teams

[00:07:33] Reducing Over-Assignment in Training Curriculums

[00:12:09] Enhancing Training with Contextual E-Learning

[00:15:33] The Impact of Neglecting Quality: Case Studies

[00:18:10] From Retail to MedTech: Katie’s Journey

Get in touch with Katie Cooney - https://www.linkedin.com/in/katie-cooney-08ab7061/

https://www.leapcompliance.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Pablo is a technical expert with a focus on medical devices and checkpoint security industries, he has a pHD in physics from University of New Brunswick and was the product introduction lead for 6 products currently in the market from concept to commercialization. He is the Founder & CEO of ORS and One Resonance, the President of Turbospec, and has been the VP of Engineering at Quasar Federal Systems, CTO at Progression Inc., VP of Development at T2 Biosystems (trading TTOO), and Senior Manager and Product Introduction Lead at GE and Quantum Magnetics. He is also the author of 10 patents, 2 book chapters, and more than 40 scientific articles.

On this episode he covers why fatty liver is called the silent disease, his method for point of care diagnosis at Livivos by introducing accuracy of MRI but at the price and ease of use of ultrasound, the overlooked concept of preventive medicine for liver health, regions of the world where the disease is more prominent, the key skills and knowledge he looks for when hiring, how he came up with the idea for his company and the reality of running a small business together with the sacrifices he had to make.

Get in touch with Pablo J Prado - https://www.linkedin.com/in/pablojprado/or visit his company website - http://livivos.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Jason brings a wealth of experience in strategic operations planning and technical projects management from his rigorous technical background. He began his career as a technical engineer working for Adecco at SC Johnson in 2009, where he developed comprehensive maintenance plans to support manufacturing processes at scale. His philanthropic work with the Juvenile Diabetes Research Foundation sparked an interest in biotech, leading him to co-found Biostem Technologies in 2014. Jason holds a bachelor’s in mechanical engineering technology and a minor in Mathematics from the Milwaukee School of Engineering

Andrew is a veteran and manufacturing operations expert with over eight years of experience working in FDA-regulated pharmaceutical and tissue processing firms, prior to his biopharmaceutical career, he served as an aviation mechanic and flight captain in the United States Marine Corps. He co-founded Biostem Technologies in 2014 and played a pivotal role in the development of the company ensuring compliance with FDA and state pharmacy board guidelines. Andrew studied at Florida Gulf Coast University and has completed Landmark Courses to hone advanced leadership skills

On this episode, they discuss what a complex wound is, what causes it to form and how this condition can be debilitating for patients, how the nutrients from perinatal tissue can be used as a solution for healing advanced wounds, their unique process method know as BioRetain® and how it differs from existing methods on the market and how their technology has been used within sports injuries such as trauma wounds with UFC fighters.

Get in touch with Jason Matuszewski - https://www.linkedin.com/in/jason-matuszewski-034163b4/

Get in touch with Andrew VanVurst - https://www.linkedin.com/in/andrew-vanvurst-ctbs-a69807b2/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Raghu Bala Founder of Clinitraq, a company specialising in Smart Radiation Dosimeters that reduces the time for measuring cumulative radiation from 60 days to 60 secs. Raghu possesses an MBA in Finance from the Wharton School (University of Pennsylvania), an MS in Computer Science from Rensselaer Polytechnic Institute and a BA/BS in Math and Computer Science from the State University of New York at Buffalo. He is the Head Managing Instructor for MIT courses in AI, Decentralized Finance and Blockchain on the 2U platform. He is also an Adjunct Professor at VIT (India) and an ex-adjunct Lecturer at Columbia University.

In this episode, we explore the lack of education surrounding the pernicious consequences of radiation exposure, discover the hidden hazards healthcare workers face, oblivious to their exposure levels due to measurement inadequacies, delve into his transition from the tech industry to MedTech and the motivations behind it, uncover his strategies for funding multiple companies he nurtured and eventually sold, alongside diverse capital-raising methods and gain valuable insights from his candid revelations about the mistakes he encountered as a serial entrepreneur

Timestamps:

[00:02:32] Antiquated methods of radiation diagnostics

[00:05:41] Radiation health risks overlooked, ignored

[00:12:14] Misconceptions about radiation risks

[00:18:01] Underestimated risks

[00:23:20] Medical tech advances: Embracing tech for better care

Get in touch with Raghu Bala - https://www.linkedin.com/in/raghubala/

https://clinitraq.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Dr Qasim Ali Butt is the founder of Your Kidneys Your Health, an Interventional Nephrologist, Health Content Creator and a Scientific Advisor to Healthcare startups.

Qasim is an expert when it comes to Kidney Health, having worked for many years within both clinical and interventional nephrology. For the past four years he has been running his own YouTube channel “Your Kidneys Your Health” in addition to creating content on Facebook, LinkedIn and Instagram with the aim to educate people on Kidney Health in addition to various different health tips and innovations within the health care industry.

In this episode he discusses the concept of value-based medicine, developments within AI and Machine Learning and the impact this will have on the physician patient relationship, his advice for medical students and the various opportunities that have arisen as a result of his content creation.

Get in touch with Dr Qasim Ali Butt - https://www.linkedin.com/in/qasimbuttmd/or follow him on YouTube and Instagram: https://www.youtube.com/c/YourKidneysYourHealthwithDrQasimButtMD/ & https://www.instagram.com/qasimbuttmd/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Praveen Kumar, Director and Heard of Clinical Sciences at nference, a physician, clinical pharmacologist and an advocate for real-world data in drug development and medical devices. Praveen is passionate about leveraging AI, machine learning and data-driven insights to optimize clinical trials, reduce development costs and improve patient outcomes

In this episode, we explore the critical role of real-world data in shaping the future of medicine, how it differs from traditional clinical trials and why it’s increasingly being used for regulatory approvals. Praveen shares real-world case studies of drugs and devices that have successfully used real-world data, the challenges in global regulatory acceptance and how AI is transforming patient recruitment and trial efficiency

Timestamps:

[00:00:27] What is Real-World Data?

[00:02:30] The Key Differences Between Clinical Trials and Real-World Data

[00:06:46] How Real-World Data is Used for Drug Approvals

[00:08:28] Cutting Drug Development Costs with AI

[00:15:33] The Growing Role of Drug-Device Combinations

[00:21:53] Emerging Trends in AI and Real-World Evidence

[00:25:38] Challenges in Global Regulatory Acceptance

Get in touch with Praveen Kumar - https://www.linkedin.com/in/praveen-kumar-m-33a6bab3/

https://nference.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Navid is a seasoned entrepreneur in the artificial intelligence space, he is a sought-after panelist, judge, speaker and moderator on the topics of venture capital and entrepreneurship at forums such as CyberHive and MIT Forum. He holds a Bachelor’s degree from UC San Diego in political science, economics and eastern history and an MBA in finance from the University of San Diego

On this episode, he discusses his definition of Artificial Intelligence alongside the misconceptions people often have about it, the mistakes he made when founding his first few companies together with the advice he has for young entrepreneurs, the higher prevalence of undetected heart disease in women and how CureMetrix can help with this, the popularity of tech in San Diego along with the different boards and positions he holds outside of work and the concept of KRRAI plus how it differs from Machine Learning

Get in touch with Navid Alipour - https://www.linkedin.com/in/navid-alipour-a295777/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Stephen is a UK and European patent attorney and founder of The Intellectual Property Works. In the last 25 years he has worked with some incredible businesses, including writing the patent applications for the Speedo swimsuit that helped Michael Phelps to his record breaking 8 gold medal haul at the Beijing Olympics. Stephen is recognised by ‘IAM Strategy 300’ as one of the world's leading IP strategists and is now focused on working with ambitious medtech start-ups and SME’s to protect their innovations using IP strategies aligned with their business goals, helping them to succeed so they can make a positive impact in the world.

Get in touch with Stephen – https://www.linkedin.com/in/stephenjcarter/

https://linktr.ee/theipstrategist

Get in touch with me - https://www.linkedin.com/in/karandeepbadwal/

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Dr Adam Power Co-Founder and CMO of Front Line Medical Technologies is a leader in innovative medical devices for trauma and emergency care who is committed to lowering the barriers to bleeding control and resuscitation, having previously worked as a vascular surgeon he quickly realised that there needed to be a better way for haemorrhage control so went on to co-found Front Line Medical Technologies in 2017.

In this episode, we delve into the fascinating world of trauma care and the groundbreaking innovations in haemorrhage control, Dr. Powers journey from general surgery to vascular surgery, the importance of preventive medicine alongside the role of new technologies in healthcare and the effect of the pandemic on global healthcare systems.

Timestamps:

[00:02:38] Quick haemorrhage control techniques.

[00:07:00] Gearing up for European CE Mark

[00:09:30] From Physician to entrepreneur in med tech.

[00:12:51] Shortage of physicians, focus on prevention.

[00:15:39] Impact of pandemic on healthcare

[00:18:49] Uses for telehealth

[00:22:21] Barriers in telehealth

Get in touch with Dr Adam Power - https://www.linkedin.com/in/adamhpower/ https://frontlinemedtech.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Carlo Odicino CEO and Founder at One TEAM Partners has over 24 years of experience working with therapeutic, medical device and diagnostic companies and is an expert in guiding CEOs and their leadership teams through the challenges that come with bringing a new innovation to market while achieving exceptional results.

In this episode, we explore why certain life science company CEOs struggle to grow their company despite working long hours, the key aspects in scaling a company alongside building a suitable team, what makes the location of Orange County a hub for life sciences and Carlo managed to get into consulting very early on his career

Timestamps:

[00:06:43] Learning from mentors and embracing vulnerability

[00:10:23] Key to great relationships

[00:17:14] Supporting life sciences companies with growth

[00:23:15] Convince CEOs to work smarter, not harder.

[00:30:37] Simple hack to improve your morning

Get in touch with Carlo Odicino - https://www.linkedin.com/in/cjodicino/ or https://oneteampartners.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Christian Espinosa Founder and CEO of Blue Goat Cyber is a leading medical device cybersecurity expert, who started his career within the United States Air Force as a Computer Systems Officer and is now a serial entrepreneur, best-selling author, avid adventurer and Ironman triathlete.

In this episode, we delve into the vital necessity of safeguarding medical devices to avert potential harm or fatalities stemming from hacking. We cover the significance of initially designing devices with security in mind and advocating for ongoing monitoring throughout their lifespan. Furthermore, Christian offers valuable insights for companies on effectively integrating cybersecurity from the outset of development.

Timestamps:

[00:03:27] Securing wireless connections

[00:06:57] Threat modelling methods

[00:13:43] The need for continuous testing for medical device security

[00:19:47] How military discipline helped build a successful business.

[00:26:08] The importance of delegation

[00:28:47] Focusing on mono-tasking for productivity

Get in touch with Christian Espinosa - https://www.linkedin.com/in/christianespinosa/ https://bluegoatcyber.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with large Healthcare companies such as Johnson and Johnson, he decided to become an independent consultant eventually going on to create his own consulting firm Easy Medical Device GmbH and now delivers knowledge through his own videos, podcasts and online courses

Get in touch with Monir – Easymedicaldevice.com I https://www.linkedin.com/in/melazzouzi/

Get in touch with me - https://www.linkedin.com/in/karandeepbadwal/

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Bethany is a healthcare innovation and femtech attorney with almost a decade of experience working at multiple different law firms before founding FemInnovation.

In this episode, we delve into issues the Femtech industry faces in terms of growth and advancement. we discuss the lack of investment in women's health issues, the difficulties of advertising women's health products, the importance of involving an attorney early on in the process and recommended organisations for those looking to get involved in this space such as Femtech Lab and Impact 51.

Timestamps:

[00:00:00] Driving femtech growth: healthcare, menopause, breast/uterus health.

[00:04:36] Women's health neglected, femtech data traded for money.

[00:12:09] Women's health inequities in VCs

[00:17:54] Femtech: Mentoring, Advising and Collaborating

[00:23:54] Exploring FemTech: Don't be afraid.

Get in touch with Bethany Corbin - https://www.linkedin.com/in/bethanycorbin/, https://feminnovation.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Ahmed came up with the idea of Syntr during his studies at the University of California Irvine with his team initially bootstrapping the business to now finally having funding to successfully bring his product SyntrFuge onto the market, a device used for micro sizing of adipose tissue for body contouring. In this episode he discusses the sacrifices him and his team had to make to grow the business, the challenges he faced as a young entrepreneur, his advice for students looking to enter the field and what he learnt from his failures early on during his journey.

Get in touch with Ahmed Zobi - https://www.linkedin.com/in/ahmed-zobi-4b210855/ or https://www.syntrtechnologies.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical  

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Simon is a recruitment leader with a passion for technology, brand and innovation. With 17 years experience in Med Tech, he has learnt through economies of scale and deep analysis the key factors that lead to successful recruitment strategies. Passionate about results, relationships and technology that impacts the recruitment sector, on todays episode he discusses the future of how companies will go about onboarding talent and the ever growing concept of a hybrid workface.

Get in touch with Simon – https://www.linkedin.com/in/simoncurtisrec/

Get in touch with me - https://www.linkedin.com/in/karandeepbadwal/

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Nicola Thorn CEO and Founder of Tento+ a company that helps companies generate technical documentation that is audit-ready. Nicola is an expert in technical compliance for medical devices working across FDA, UKCA, and CE market approvals for digital health tech products and completed her PhD in Mathematics at the University of Reading, as well as founding Tento+, Nicola is CEO of AND Technology, an award-winning product development consultancy, she has worked in product development in electronics, software, machine learning and Tech 4 Good for over 10 years.

In this episode, we explore the application of generative AI tools in software development, examining their advantages for content creation and emphasizing the crucial need to verify their outputs. We also shed light on the entrepreneurial pursuits of individuals within the NHS, discussing the underlying reasons and the existing programs supporting this transition. Additionally, we delve into the risks associated with retroactively documenting design controls, providing insights into the potential pitfalls of such practices.

Timestamps:

[00:01:55] Design Controls in Retrospective

[00:12:26] Generative AI Tools

[00:15:53] Reality of Medical Device regulatory timelines

[00:20:26] NHS Clinical Entrepreneurship

[00:22:56] Reasons for getting into entrepreneurship

[00:25:38] The future of AI in Software

Get in touch with Nicola Thorn - https://www.linkedin.com/in/nicola-thorn-725131ab/

https://andtr.com/

https://tentoplus.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Adam is someone who I have been in contact with over the past few years sharing the occasional message, having spoken a few times we decided to record our conversation and share it with the medical device community

On this episode, he discusses how to go about dealing with suppliers from auditing to reviews, the common mistakes companies make with quality management systems and how to stay on top of ever-changing regulations as a consultant. He also talks about how he got started as an independent consultant and his experiences running his own business, including the upsides of being independent and how to nurture better relationships with clients.

Get in touch with Adam Isaacs Rae https://www.linkedin.com/in/adam-isaacs-rae/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Marcel, a scientist and serial entrepreneur, holds a PhD in Machine Learning in Healthcare from the University of Cambridge. He was named on the Forbes 30 under 30 list, won the Alexander Fleming Prize from the Gates Foundation for his contribution to global public health and the Prix Galien Award for the best medical technology with Cyted’s core product called Cytosponge™, a novel test for the early detection of cancer in the oesophagus.

On this episode, he discusses the pre-cancerous Barrett esophagus alongside the causes of this condition, the minimally invasive technique his company has developed for the detection of oesophageal cancer together with its comparison to the traditional methods of endoscopy, the process of acquiring funding for his startup, how acid reflux and heartburn could be early warning signs of the disease, his advice for founders and the importance of developing different types of teams at various stages of your business.

Get in touch with Marcel Gehrung - https://www.linkedin.com/in/marcel-gehrung/ or https://cyted.ai/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Kristen Mittal, Founder & CEO of Mittal Consulting a seasoned expert in regulatory affairs with over a decade of experience in the field. Kristen’s expertise spans across global regulatory challenges, innovative pathways and mentorship in quality and regulatory careers

In this episode, we dive into why regulatory affairs is a rewarding yet complex career path, explore innovative programs like the FDA’s Breakthrough Device Designation and Total Product Lifecycle Advisory Program, and discuss the importance of harmonizing global standards in medical device submissions. Kristen also shares insights into the evolving landscape of sectors like pediatric devices, FemTech and AI/ML in medical technology

Timestamps:

[00:00:20] Rewards of a Regulatory Career

[00:01:53] Key Qualifications for Regulatory Success

[00:08:21] EU vs. USA Regulatory Pathways

[00:10:30] Understanding Pre-Submission and 513G Processes

[00:14:09] Designing Clinical Studies for Global Approval

[00:21:49] Emerging Trends: Pediatric Devices and FemTech

[00:25:33] Breakthrough Devices and Total Product Lifecycle Advisory Program

Get in touch with Kristen Mittal - https://www.linkedin.com/in/kristenmittal/

https://www.mittalconsulting.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Eli is a serial inventor and two-time founder. He started his first company, Singular Sound, with his brother in 2013; they have since launched eight blockbuster products. In 2017 he and his team created the first device that automatically flosses all your teeth in only 10 seconds, Instafloss. After five years of research and development, Instafloss is ready to change the world pre-sold $2.5 million, has 41k people on the waitlist.

On this episode, Eli delves into the crucial topic of dental hygiene, specifically the importance of flossing, and uncovers why so many people still avoid this crucial habit despite its many benefits. He also explores the fascinating world of invention, including the process of sifting through ideas to determine which ones are worth pursuing, navigating investor relations, and the ins and outs of running a successful Kickstarter campaign. He then goes on to shares some surprising insights into the unexpected challenges of starting a business, and even gives us a glimpse into his thrilling hobby of wild camping.

Get in touch with Eli Packouz - https://www.linkedin.com/in/eli-packouz-390701149/ 

Visit his company website - https://instafloss.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

Vincent Cafiso Founder of Practical Compliance Results a quality and regulatory consulting practice.

In this episode, we explore our Vincents journey as an FDA inspector, revealing intriguing stories, we the importance of getting an early grasp of the regulatory process and what the FDA seeks in Medical Device Companies, extending to insights on securing FDA roles, founding a consulting firm and leveraging LinkedIn for networking

Timestamps:

[00:03:52] Working in the FDA

[00:07:37] Securing a role

[00:11:16] Importance of compliance

[00:15:26] Content-based networking

[00:25:12] Surgery and faulty blood pressure cuffs

[00:31:17] The Future of AI in Software

Get in touch with Vincent Cafiso - https://www.linkedin.com/in/vincentcafiso/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Eva van Rikxoort Founder and CEO of Thirona started her career as a scientist but transitioned as she wanted to create a business model to make AI centered around how to help a patient. She believes that AI is necessary in healthcare, unlike pharma, where she views AI as an option.

In this episode, we delve into the traditional methods of medical imaging and the benefits of using AI for better detection, why AI is proving to be popular in the radiology space, lesser-known causes for lung disease and her journey into entrepreneurship

Timestamps:

[00:02:41] AI in Medicine

[00:10:41] Lung cancer causes and advancements in AI

[00:13:43] Regulating AI in Medical Devices

[00:16:30] Early Detection for Rare Diseases

[00:19:34] Gathering Data and Clinical Trials

[00:21:39] CT screening for lung cancer, emphysema detection.

[00:25:15] Bootstrapping a Start-Up

Get in touch with Eva van Rikxoort - https://www.linkedin.com/in/evavanrikxoort/ https://thirona.eu/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Ziv Yekutieli CEO of Mon4t a company that turns any standard smartphone into a sophisticated, personalized neurological medical testing device for remote and in-person testing the data of which can be used monitoring of neurological and psychiatric patients. He started his career as an electrical engineer, having experienced one of his teachers suffer from ALS, he began to study neurology alongside engineering eventually going on to study a PhD in Brain Science whilst in his engineering career eventually going to cofound Mon4t.

In this episode, we discuss his journey from studying medicine and engineering to connecting neurology and technology, the prevalence of neurological conditions affecting up to one in eight people, how the number of neurologists per capita is falling and his advice for aspiring entrepreneurs to know the box before thinking outside of it.

Timestamps:

[00:00:01] How Telehealth accelerates teleneurology treatment

[00:06:36] Telehealth advancing neurology and its complexity

[00:14:02] Neurology, engineering, technology: lifelong journey

[00:22:08] Know the box, identify beachhead, nurturing customers

[00:28:31] Exploring brain and starting a business

Get in touch with Ziv Yekutieli - https://www.linkedin.com/in/ziv-yekutieli/

https://mon4t.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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JoJo started her career within accounting and communications before going on to find her current niche of Neurotechnology and Bioelectronic Medicine, where she has helped establish strategic partnerships and build teams in this emerging field through her own company Platt & Associates and The Feinstein Institute. Over the years she has built a strong network of people in neuroscience, biology, engineering, data science, imaging and many more allowing her to become a thought leader within this space and recently go on to co-create a podcast, Skrapz, where she explores the stories of science and innovation of other leaders in the field.

On this episode she discusses the use of psychedelics for therapy and neural research, how she went from a career in accounting, communications, real estate and now in the Neurotech and Bioelectronics space, why she continues to be active on social media and the opportunities this has brought her way, what she has learn from interviewing thought leaders on her podcast, areas in the industry considered to be contentious, how pharmaceutical companies are responding to bioelectronic medicine and her joy for exploring new subjects and travel.

Get in touch with JoJo Platt - https://www.linkedin.com/in/jojoplatt/ or visit her company website http://theplattassociates.com/ and her podcast page https://skrapspodcast.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Having grew up in England, at a young age Caroline had quickly discovered her passion for organic chemistry hence pursued a PhD in this field at Imperial College London, followed by a career within research and drug development within various large pharmaceutical companies such as Merck and Bristol-Myers Squibb. With over 20 years successful experience in the field, she is now the CEO of Glympse Bio where she and her team are using their knowledge to help improve disease diagnosis, monitoring and treatment via the use of non-invasive technology.

On this episode she discusses why her location of Cambridge, Massachusetts is such a major hub for Biotech, how she grew her company during the global pandemic and still managed to secure series B funding during the height of it, her advice for students and those looking to start a business in this sector and her love for cooking different types of cuisine.

Get in touch with Caroline J. Loew - https://www.linkedin.com/in/carolineloew/ or visit her company website https://glympsebio.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Sam Libby President and Managing Director of TCB Capital Advisors is one of healthcare’s most impactful leaders, with a career devoted to revolutionising patient care through strategic investments, Sam has navigated over $20 billion in transactions across the life sciences and diagnostics sectors

In this episode, we delve into how healthcare companies raise capital alongside the traits he seeks in potential partners, how he went from investment banking to more of a focus on the medical sector, his introduction to the disparity within female health and his early career within martial arts

Timestamps:

[00:00:15] First exposure to colorectal cancer

[00:05:23] Importance of early detection and diagnosis

[00:09:47] Challenges in colorectal cancer treatment

[00:14:02] Working with EDP Biotech and its mission

[00:19:18] Innovations in cancer screening technology

[00:24:35] The role of data in advancing cancer diagnostics

[00:30:12] Future trends and goals in cancer research

Get in touch with Sam Libby - https://www.linkedin.com/in/shmuel-libby-b4530b48/

https://www.tcbcapitaladvisors.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Waqaas is a serial entrepreneur, a former investment advisor, an expert in corporate strategy, and an innovative technologist. Since forming Biotricity he has become deeply vested in the potential that connected technology, enhanced with artificial intelligence could bring to healthcare. He holds a Master’s in Computer Engineering from Rochester Institute of Technology and a Doctorate in Business Administration from Henley Business School, specialized in Transformative Innovations and Billion Dollar Markets.

On this episode he covers the gap in the market within digital health including the differences between passive and active monitoring, the innovations and problems he is working on solving at Biotricity, the process of forming, growing and maintaining a business within healthcare together with various hurdles he had to overcome in the early days, his advice for young student and graduates who are looking to get into Digital Health, the current status of AI as a support tool separating fact from fiction and what the future of it will be together with the limitations of the current regulatory requirements on the development of AI and Machine Learning and his passion for different types of cuisine and professional polo

Get in touch with Waqaas Al-Siddiq https://www.linkedin.com/in/dr-waqaas-al-siddiq-dba-5a0b682/ or visit his company website https://www.biotricity.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

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Estelle as a new mother, during her pregnancy, had experienced what many other women have to go through having to manage multiple appointments, measure her blood pressure multiple times a day and medication incompatibilities. She realised that these issues were not uncommon and although there existed many apps and tools, there was nothing available to help manage her own health during this time period. Having started her career in academia as a professor at The University of Western Australia and then transitioning to industry working at Illumina within Genomics, she used her knowledge to co-found Trellis Health to create lasting change and reframe the way pregnant mothers take control of their care.

On this episode she discusses how throughout the seventies up until the nineties, how women were excluded from clinical trials hence why the data has not always existed to create viable solutions for female health, the reality of genetics in terms of what is seen in movies separating fact from fiction, the emerging technologies we can look forward to seeing in terms of data science and genomics, her journey through pregnancy leading to the formation of Trellis Health, needs in female healthcare, what the gaps in the market currently are within Femtech and the empowering nature of remaining curious and the opportunities it can bring.

Get in touch with Estelle Giraud https://www.linkedin.com/in/estelle-giraud/ or visit her company website https://www.jointrellishealth.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical

Axel Strombergsson, Vice President, QuickVault at Veeva Systems a seasoned leader in medical device development and commercialization. With over 18 years of experience in R&D, operations and startup growth, Axel has a proven track record in navigating the complexities of regulatory pathways, venture capital, and global market strategies

In this episode, Axel shares his journey from mechanical engineering to becoming a driving force in medtech innovation. We discuss AI-powered diagnostic tools, the importance of proactive healthcare models, and the evolving role of startups in advancing medical technologies. Axel offers valuable advice on preparing for funding rounds, building impactful pitch decks, and addressing key investor concerns

Timestamps:

[00:00:24] MedTech Innovation Trends

[00:04:02] From Engineering to MedTech

[00:08:21] Proactive Healthcare Models

[00:10:30] Building Investor Confidence

[00:14:09] Navigating Global Markets

[00:21:49] The Role of Venture Capital

[00:25:33] Startup Growth Challenges

Get in touch with Axel Strombergsson - https://www.linkedin.com/in/axel-strombergsson/

https://www.veeva.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Ethan Drower Co-Founder and CEO at Cite Medical brings a unique blend of expertise to the table. His background as a trained software engineer, coupled with his partner's veteran experience in regulatory affairs and quality makes him an expert in the clinical space

In this episode, we discuss the impact of EU MDR on medical device manufacturers, the changes in clinical evidence requirements, the concept of state of the art alongside what this means in practice in addition to the need for adequately qualified reviewers and the challenges faced by smaller startups in finding the required expertise

Timestamps:

[00:02:36] Importance of literature review in research

[00:15:30] Continuous monitoring critical for device safety

[00:19:21] Regulatory and clinical synergy in business

[00:21:26] Clinical data and evaluation are crucial.

[00:24:56] Passionate about travel and cultural experiences.

[00:28:05] Sailor and motorcycle enthusiast, open to travel anywhere. Advice: improve regulatory skills, not fight against regulations.

Get in touch with Ethan Drower - https://www.linkedin.com/in/ethandrower/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Dr. Morgan Taylor, Chief Nursing Officer of Archer Review has redefined nursing education with her innovative teaching methods and empathy-driven approach, fostering confidence and competence among the next generation of nurses.

In this episode, we explore the gaps in nursing education exposed during the pandemic and how Dr. Taylor is addressing these challenges through groundbreaking solutions like virtual reality and AI-enhanced training. We discuss her global health experiences in Guatemala, her passion for pediatric care and how she leverages technology to bridge educational gaps. She also shares her insights on telehealth, the adolescent mental health crises during the pandemic and the shift toward proactive value-based care models

Timestamps:

[00:00:27] Gaps in Nursing Education During the Pandemic

[00:02:30] Global Challenges in Practical Nursing Training

[00:05:35] AI as a Tool in Nursing: Opportunities and Risks

[00:06:36] Unique Challenges in Paediatric Care

[00:08:55] Telehealth’s Role in Enhancing Accessibility

[00:13:13] Moving Toward Proactive, Value-Based Healthcare

[00:15:38] Burnout and New Career Paths for Nurses

Get in touch with Morgan Taylor- https://www.linkedin.com/in/morgan-clark-taylor/ https://www.archerreview.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

Subscribe to the Podcast