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Success Starts Early: Tips for Building a Thriving Medtech Startup

A look at strategies that can help a startup reach success.

Scott Nelson

December 8, 2023

3 Min Read
Image Credit: cagkansayin via iStock/Getty Images

The medical device industry is not for the faint of heart; it’s one of fierce competition and intricate complexity. Nevertheless, certain strategies can position your startup on a path toward success.

As the co-founder and CEO of FastWave Medical and founder of Medsider, I’ve had the rare and enviable opportunity to interview some of the medical device industry’s most impactful leaders about the keys to building a robust startup.

 Delve into my top takeaways and arm your venture with wisdom from those who've walked the path before.

Robust quality management sets you up for success.

Will Martin, CEO of IRRAS, has spent decades in the medtech arena in various strategic roles at Boston Scientific, Access Closure, and Hotspur Technologies.

 He advocates for rigorous quality management as a cornerstone for future merger and acquisition (M&A) opportunities. A firm focus on audit readiness and comprehensive quality management systems can spell the difference between triumph and downfall.

Align interests to foster growth.

As the CEO of Alio, David Kuraguntla is making strides in kidney health innovation.

 Dave’s key strategy is aligning the interests of the "4Ps" - patient, physician, product, and provider. By delivering value to every key stakeholder and fostering a united team, you set the tone for success and prevent any party from feeling undervalued.

Secure funding that fuels your vision.

With more than 30 years in the medtech industry, ICHOR Vascular Co-Founder and CEO Tim Blair has practically done it all, from sales and marketing to strategy and development. Today, Tim is leading ICHOR on its quest to treat thrombus in the peripheral vascular system using an endovascular technique, which is significantly less invasive than traditional methods.

 Tim advocates for maintaining a minimum investment threshold when making deals with investors so that you attract more sophisticated parties instead of small players. This approach reduces administrative burden and attracts high-net-worth individuals who can provide significant capital.

Tackle big issues early on. 

Steve Dimmer is the former CEO of CurvaFix and has logged decades in the medical device arena, in startups, and at large multinationals. He led CurvaFix through their recent round of financing as their team works to treat high-impact trauma and fragility fractures of the pelvis using the minimally invasive CurvaFix IM Implant, rather than conventional screws and plates.

 Steve’s strategy is to go for the Achilles’ heel early before investing too much time and resources in a product. It’s crucial to make sure that the problem you’re solving has a large enough market to justify the investment and effort. Grappling with these issues early saves time down the line, limits back and forth with regulatory bodies like FDA, and helps your startup stand out in a crowded market.

Forge your own path to regulatory clearance.

Ohad Arazi is the CEO of Clarius, a company producing accurate, easy-to-use, and affordable ultrasound tools. Ohad brings an impressive technology background to the table, working with the Israeli military and industry leaders like McKesson, Telus, and Zebra Medical.

 He encourages entrepreneurs to carve out their path, even when it’s not completely clear. By demonstrating the clinical value of your product, you will eventually navigate the regulatory landscape successfully.

Key lessons from successful medtech startup leaders.

In summary, here are my key takeaways from these proven medical device entrepreneurs:

  • Put the user first: Center your product development around user experience. Understand its must-have features from a functional, clinical, and financial perspective.

  • Embrace difficult feedback: As a CEO in medtech, facing rejection is part of the journey. Don’t be offended or take criticism personally. Instead, transform feedback into growth lessons.

  • Initiate FDA engagements early on: Prioritize your regulatory strategy from the very beginning and keep the communication flowing with FDA. Doing so significantly improves your ability to manage your budget and timeline, as well as mitigate risk.

About the Author(s)

Scott Nelson

Scott Nelson is the co-founder and CEO of FastWave Medical, a medical device startup developing intravascular lithotripsy systems for cardiovascular disease. He’s also the Founder of Medsider, where he interviews founders and CEOs of promising, early-stage medical device and health technology companies. Scott has over 15 years of medtech and healthtech experience and is also a co-founder of Crossfire Medical and Managing Director of Big Sky Biomedical.

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