The MedTech Podcast

Dr. ⁠Basant Bajpai⁠ CEO of ⁠Compliance MedQRA⁠, a UAE-based consulting company specializing in Quality Assurance, Regulatory Affairs, AI governance and compliance for medical devices, SaMD, AI/ML health technologies and digital health solutions. He holds a PhD in Neuroscience focused on brain monitoring and neurotechnology and has more than 12 years of international experience supporting MedTech and digital health companies across Europe, the Middle East and the United States.
He explains why regulatory and quality is still one of the most misunderstood functions in MedTech and why so many innovators treat it as a documentation exercise until it becomes an expensive problem at the worst possible moment. We get into the question every founder asks, how long will this take and what will it cost and why there is genuinely no straight answer without first building a proper regulatory strategy.
We also tackle the growing trend of companies choosing the US over EU MDR simply because it looks faster. Basant makes the case that regulatory approval alone does not guarantee commercial entry, why reimbursement codes should shape your market choice more than approval timelines and why he now finds EU MDR more convenient than many people expect. He also shares a contrarian view on device classification and why staying in the lowest risk class is not always the smart play.
Finally, we explore the GCC regulatory landscape, which Basant argues is not less regulated but differently regulated, with data compliance requirements he found tougher than GDPR or HIPAA. He closes with a clear message on AI in healthcare and why he does not believe regulators will ever allow a clinician to be replaced.
Timestamps
[00:01:23] From Biomedical Engineering to a First Audit That Changed Everything
[00:03:33] Why Everyone Thinks Regulatory Is Just a Documentation Department
[00:06:07] How Long Will It Take and What Will It Cost: The Impossible Question
[00:09:35] EU MDR vs FDA: Why Reimbursement Should Drive the Decision
[00:12:19] Regulatory Approval Does Not Guarantee Commercial Success
[00:14:36] Why Staying in the Lowest Risk Class Can Backfire
[00:16:00] The GCC: Not Less Regulated, Just Differently Regulated
[00:18:24] Why Data Compliance in the Gulf Is Tougher Than GDPR
[00:23:30] Who Should Not Pursue a Career in Quality and Regulatory
[00:29:17] Final Advice: AI Will Transform Healthcare but Not Replace Clinicians

Connect with Basant - https://www.linkedin.com/in/basant-bajpai-phd-63565961
Learn more about Complaince MedQRA - https://www.compliancemedqra.net/
Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠
Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠
Medical device training courses delivered by Karandeep through Bywater - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.bywater.co.uk/

Isaac Stoner, CEO of MindImmune Therapeutics, a drug discovery company pioneering a new class of medicines for Alzheimer's disease and other neurodegenerative conditions.
Isaac has built his career moving between the founder seat and the investor seat. He was the founding CEO of Octagon Therapeutics, the first team member at liquid biopsy company Firefly BioWorks and has evaluated life science companies for investment at Slater Technology Fund, PureTech Health, KdT and Action Potential Venture Capital. At MindImmune Therapeutics, he is chasing one of the boldest ideas in neuroscience: that Alzheimer's may in fact be an autoimmune disease that presents in the brain.
In this episode Isaac explains why the amyloid hypothesis that has dominated Alzheimer's research for 30 years has run its course, and why MindImmune is taking an immunology-first approach built on brain tissue donated by Alzheimer's patients. He breaks down the three biggest risk factors for the disease, how he pitched a 30 million dollar Series A on a condition where 99.9% of drugs have failed and what it would mean to develop a therapy bigger than the GLP-1 weight loss drugs.
We also get into the founder-to-investor-to-founder journey, why a brilliant scientific founder is often the wrong person to sit in the CEO seat and the hard truths every aspiring biotech founder needs to hear before striking out on their own.
Timestamps
[00:02:50] Why a Career Investor Keeps Getting Pulled Back Into Building
[00:05:25] Shutting Down Octagon Therapeutics and the Chip It Left Behind
[00:07:10] Why MindImmune Treats Alzheimer's as an Autoimmune Disease
[00:08:20] Why 30 Years of the Amyloid Hypothesis Has Run Its Course
[00:10:05] The Three Biggest Risk Factors for Alzheimer's and What You Can Do
[00:12:15] How He Raised a $30 Million Series A on the Hardest Disease in Medicine
[00:15:30] Why 99.9% of Alzheimer's Drugs Fail and What Makes This Different
[00:18:35] Why a Brilliant Scientific Founder Is Often the Wrong CEO
[00:22:20] Where MindImmune Goes Next: AMD, ALS and Beyond
[00:28:00] Final Advice: Get Into Biotech for the Right Reasons

Connect with Isaac - ⁠https://www.linkedin.com/in/isaacstoner/⁠
Learn more about MindImmune Therapeutics - ⁠https://www.mindimmune.com/⁠
Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠
Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠
Medical device training courses delivered by Karandeep through Bywater - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.bywater.co.uk/

Isaac Stoner, CEO of MindImmune Therapeutics, a drug discovery company pioneering a new class of medicines for Alzheimer's disease and other neurodegenerative conditions.
Isaac has built his career moving between the founder seat and the investor seat. He was the founding CEO of Octagon Therapeutics, the first team member at liquid biopsy company Firefly BioWorks and has evaluated life science companies for investment at Slater Technology Fund, PureTech Health, KdT and Action Potential Venture Capital. At MindImmune Therapeutics, he is chasing one of the boldest ideas in neuroscience: that Alzheimer's may in fact be an autoimmune disease that presents in the brain.
In this episode Isaac explains why the amyloid hypothesis that has dominated Alzheimer's research for 30 years has run its course, and why MindImmune is taking an immunology-first approach built on brain tissue donated by Alzheimer's patients. He breaks down the three biggest risk factors for the disease, how he pitched a 30 million dollar Series A on a condition where 99.9% of drugs have failed and what it would mean to develop a therapy bigger than the GLP-1 weight loss drugs.
We also get into the founder-to-investor-to-founder journey, why a brilliant scientific founder is often the wrong person to sit in the CEO seat and the hard truths every aspiring biotech founder needs to hear before striking out on their own.
Timestamps
[00:02:50] Why a Career Investor Keeps Getting Pulled Back Into Building
[00:05:25] Shutting Down Octagon Therapeutics and the Chip It Left Behind
[00:07:10] Why MindImmune Treats Alzheimer's as an Autoimmune Disease
[00:08:20] Why 30 Years of the Amyloid Hypothesis Has Run Its Course
[00:10:05] The Three Biggest Risk Factors for Alzheimer's and What You Can Do
[00:12:15] How He Raised a $30 Million Series A on the Hardest Disease in Medicine
[00:15:30] Why 99.9% of Alzheimer's Drugs Fail and What Makes This Different
[00:18:35] Why a Brilliant Scientific Founder Is Often the Wrong CEO
[00:22:20] Where MindImmune Goes Next: AMD, ALS and Beyond
[00:28:00] Final Advice: Get Into Biotech for the Right Reasons

Connect with Isaac - https://www.linkedin.com/in/isaacstoner/
Learn more about MindImmune Therapeutics - https://www.mindimmune.com/
Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠
Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠⁠⁠
Medical device training courses delivered by Karandeep through Bywater - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.bywater.co.uk/

Shai Policker, Co-Founder and Managing Partner at Edge Medical Ventures, a medtech venture studio and fund focused on developing and investing in medical devices that address unmet clinical needs. With a BSc in Electrical Engineering from the Technion, an MBA from Columbia Business School and over 25 years building medical device companies, Shai has founded or scaled 18 companies across cardiovascular care, surgery and respiratory health, filing more than 40 patents along the way.
In this episode, Shai cuts straight to something most investors won't say out loud: that even a great technology with strong clinical data can still fail. Not because the product is wrong but because the process takes too long and the funding runs out. He breaks down the fragmented decision-making landscape in healthcare, why physicians loving your product means almost nothing if the payer isn't on board and why reimbursement is the real gatekeeper that kills more companies than bad science ever will.
We also explore what makes Edge Medical Ventures different from a traditional VC fund. Shai explains how their venture studio model starts from validated unmet needs with a strategic partner already at the table and how their hands-on go-to-market support continues well past the R&D phase. A combination that helped one portfolio company go from zero to FDA approval with distribution agreements and paying customers on just $2.5 million. We also get into the Israeli startup mindset, the right way to think about IP and patents and how to know when a founder should step aside.
Timestamps
[00:00:17] What Pulled an Electrical Engineer Into MedTech 25 Years Ago
[00:01:48] What 18 Companies Taught Shai That One Never Could
[00:03:04] How to Know If the Problem Is Painful Enough to Build Around
[00:04:56] Why 80% of MedTech Startups Fail Even With Great Technology
[00:07:53] What a Venture Studio Actually Is and How It Differs From a VC Fund
[00:10:51] The $2.5 Million Company That Got FDA Approval and Started Selling
[00:13:54] Why Israeli Startups Move Faster Than Everyone Else
[00:17:28] How to Think About Patents Without Becoming Obsessed With Them
[00:23:44] Balancing Speed and Discipline Without Creating Expensive Mistakes
[00:26:20] Final Advice: What Shai Wishes Every MedTech Founder Knew

Connect with Shai - https://www.linkedin.com/in/shai-policker-b8760a3/
Learn more about Edge Medical Ventures - https://edgemed.vc/
Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠
Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠⁠
Medical device training courses delivered by Karandeep through Bywater - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.bywater.co.uk/

Cristiano Fontana, founder and CEO of Three Bridges, a Milan-based advisory firm helping early-stage MedTech companies navigate the full journey from innovation to market. With over 25 years in the industry starting in the family warehouse handling surgical drains and prostheses as a teenager, Cristiano has a perspective on this business that very few people can match.
In this episode, we kick things off with something a little different: a conversation about dressing well, the discipline behind it and why confidence is as much about how you present yourself as what you know. From there, we get into something both of us have strong opinions on. Cristiano breaks down why the conference ROI is so hard to measure, why ghosting has become an epidemic in the industry and why the real payoff from an event can take three years to materialise. He also delivers one of the most honest assessments you'll hear: that early-stage MedTech is just 3% of the industry and that the 97%, the commercial machine that actually drives revenue, is largely invisible to the innovation bubble.
We also explore what a better event model could look like, why trust beats value proposition every single time in a crowded advisory market and what innovators consistently get wrong when they think one conference pitch will change everything.
Timestamps
[00:00:33] Why Dressing Well Is a Form of Discipline, Not Vanity
[00:05:00] From the Family Warehouse to 25 Years in MedTech
[00:07:48] The 97% vs 3% Split That Nobody in Early Stage Wants to Hear
[00:08:37] What MedTech Conferences Are Getting Wrong
[00:09:35] The Ghosting Epidemic and What It Reveals About Human Nature
[00:10:14] Why Conference ROI Can Take Three Years to Show Up
[00:12:30] You Don't Sell on Value Proposition, You Sell on Trust
[00:13:17] The Uncomfortable Truth About So-Called Investors at Events
[00:20:42] What a Better, More Targeted Event Model Would Look Like
[00:30:41] Final Advice: Fill Your Gaps Fast and Stop Seeing Experts as a Cost

Connect with Cristiano - ⁠⁠⁠https://www.linkedin.com/in/cristiano-fontana-medtech-businessdevelopment/
Learn more about ThreeBridges - ⁠⁠⁠⁠https://www.threebridges.it/
Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠⁠⁠⁠
Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠
Medical device training courses delivered by Karandeep through Bywater - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.bywater.co.uk/