How to Mitigate Risk in a Medtech Startup


In this playbook, we'll lay out the importance of effective risk management, especially during the early stages, and share some strategies for overcoming unexpected hurdles along the way.

Key Lessons From This Playbook

  • Tackle technical risks first: Early prototyping and iteration helps ensure product-market fit and stakeholder confidence.
  • Embrace failures as growth opportunities: When you adopt the right framework, your mistakes won’t be catastrophic. Instead, fail forward and view mistakes as stepping stones towards progress.
  • Prioritize safety and efficacy early on: You should prove your device’s safety and efficacy before anything else. Small, targeted clinical trials can help verify product performance and prevent you from building on loose soil.
  • Leverage scientific breakthroughs: Utilize unique research inflection points as a means to demonstrate unmet needs versus merely responding to known gaps in the market.

Prototype and Iterate as Quickly as You Can

Osman Khawar, a board-certified nephrologist, now CEO of Diality, is an ardent proponent of reducing technical risks as early as possible. For him, early prototyping and continuous product iteration inspire confidence in investors and end users. 

He also accentuates the need for building relationships with key stakeholders to preclude future complications and ensure every iterative step takes your product closer to both regulatory and end-user requirements.

Fail Forward Efficiently and Rapidly

Lloyd Mencinger, currently leading Aqua Medical, is an experienced CEO with an impressive track record in medical device business development and commercialization, and he stands as a strong proponent of the lean startup approach. 

For Lloyd, strategic resource allocation and swift prototype development are keys to success. He champions a mindset of capital efficiency and rapid iteration, urging entrepreneurs to "fail forward" and use their experiences as stepping stones towards improvement and growth. 

The ultimate goal, according to Lloyd, is to minimize the initial errors that could potentially lead to catastrophic outcomes if they occur later down the line.

Follow Your Fear

Sam Mazin, CTO and the inventor of RefleXion Medical’s core technology, asserts the significance of tackling the most substantial risks first, a principle he fondly calls "follow your fear." 

Rather than focusing on the easy tasks, Sam’s advice is to address threats early on rather than focusing on lower risks and kicking the can down the road. By prioritizing “deal breaker questions,” you avoid just ticking tasks off your list, forcing you to overcome more significant barriers and risk factors with each decision. This is a crucial strategy to validate the core viability of your technology. 

Sam prompts medtech startup leaders not to be afraid of challenging assumptions and tackling the biggest hurdles from the get-go. This approach will best position your company for sustained success in a high-stakes industry.

Ensure Safety and Efficacy From the Outset

Carol Burns, CEO of Cagent Vascular, is a serial entrepreneur in the cardiovascular device space, and she believes that any medical product's trust hinges on safety and efficacy right from the start. She advises starting with small, targeted clinical trials to verify the device's performance and potential for clinical adoption. 

Carol recommends focused pilot studies to showcase a device's potential. Her method is straightforward: start with bench and animal testing to prove a device is safe and effective, then transition to in-human work in order to build trust with your key stakeholders—investors, providers, patients, and payers.

Leverage Breakthroughs to Demonstrate Unmet Needs

Last but not least, innovation itself can also be used as a tool to reduce risks, and that entails leveraging scientific breakthroughs. A great example of this ideology is Dr. Meesha Dogan, co-founder of Cardio Diagnostics and a leader in the epigenetic space. 

Rather than focusing solely on solving existing market needs, her strategy utilizes innovative technology — which is synonymous with rigorous lab work and in-depth research. Dr. Dogan also emphasizes the importance of validation when developing on the backs of technological breakthroughs, especially through a reputable external partner, to ensure the product's reliability under varying conditions.

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