Foundational Tips for Building a Thriving Medtech Startup

Playbook

In this playbook, explore our top takeaways to arm your venture with wisdom from those who have walked the path before.

Key Lessons From This Playbook

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

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 to marketing and strategy development. Today, Tim is leading ICHOR on its thrombectomy quest in the peripheral vascular system using an endovascular technique, which is significantly less invasive than traditional treatments. 

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

Tackle Big Issues Early On

CurvaFix CEO Steve Dimmer has logged decades in the medtech arena in startups and at large multinationals. Currently he is leading the charge in treating 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 on 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 in Regulatory Clearances

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

He encourages entrepreneurs to carve their own path, especially when there's no clear reimbursement pathway. By demonstrating the clinical value of your product, you can navigate the regulatory landscape successfully.

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