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Key takeaways
- Many promising MedTech companies fail due to hidden barriers to clinical adoption, even with strong technology, funding, and product compliance.
- Clinical adoption is often addressed too late in the development process, leading to significant challenges in market penetration.
- Workflow friction within clinical environments and the high cost of forcing behavior change are major obstacles to successful medical technology integration.
- Effective MedTech solutions must satisfy diverse stakeholders, including clinicians, administrators, and economic decision-makers, to ensure viability.
- Cybersecurity, reimbursement, usability, and implementation are interconnected issues that cannot be treated as separate problems for medical devices.
- Founder blind spots and the "KOL trap" (relying too heavily on Key Opinion Leaders) can mislead product development and pilot study results.
- Addressing clinical workflow, economic viability, and cybersecurity early in the design process is crucial for successful medical device adoption.
Why do so many promising MedTech companies fail even when the technology is strong, the funding is there and the product is compliant?
In this episode of the Med Device Cyber Podcast, Christian Espinosa speaks with Amel Havkic, founder of EvoMed Consulting, about the hidden barriers that prevent medical technologies from achieving real clinical adoption.
Amel explains why clinical adoption is often treated too late, how workflow friction can derail an otherwise strong product and why the founder’s greatest strength can sometimes become the company’s biggest strategic blind spot.
The conversation also explores the KOL trap, the cost of forcing behavior change inside already overstretched clinical environments and why cybersecurity, reimbursement, usability and implementation cannot be treated as separate problems.
In This Episode
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01:08 Amel Havkic and VivoMed Consulting
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02:41 Why 75% of MedTech companies fail
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04:43 Clinical adoption, fundability and founder blind spots
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07:23 Why one solution must satisfy many stakeholders
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09:42 Economic viability and implementation friction
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12:37 The hidden cost of changing clinical behaviour
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15:43 The KOL trap and why pilots can mislead
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18:46 Alarm fatigue and real-world clinical environments
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20:46 Christian’s introduction to medical-device cybersecurity
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23:04 Why cybersecurity deficiencies derail submissions
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27:49 Building the right team around a MedTech founder
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32:38 Authenticity, intuition and choosing the right partners
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37:17 Why being human may become a superpower in the age of AI
Notable quotes
“Why is it that many very promising technologies that are very well-funded, that are compliant, that are solving a critical clinical problem, still fail to reach broad clinical adoption?”
“The number one reason for failure is neglecting clinical adoption. Not just delaying it, but sometimes outright neglecting it.”
“I like to talk about the concept of implementation friction, meaning the cost of forcing behavior change inside an already overstretched clinical environment.”
“Cybersecurity, reimbursement, usability, and implementation cannot be treated as separate problems. They are all one and the same problem.”
Frequently asked questions
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