In our continuing series surrounding the recent hsDNA podcast with Global VP/GM Design, Development, and Human Factors Tor Alden, “5 Traps Startups Need to Watch Out for When Engaging with a Product Design Firm,” we’re expanding on them one by one for deeper understanding.


Previously in “Trap 1: Planning & Understanding the Medical Product Development Process,” we discussed the importance of taking the time to do the due diligence in design partner selection, creating a standardized RFQ/RFP, understanding the importance of a phased methodology, the regulatory pathway, compliance with DHF/QMS, and the importance of building your IP landscape. To read more about it click here.


Trap 2 focuses on Building & Scaling the Right Team. Taking a medical device from concept to market is a long & complex process and requires many disciplines. However, the easiest path to ensure your startup has the best foot forward is to build the proper foundation early.


“Key to this foundation,” Tor points out, “is having the right management team.”


Understanding that most medical product startup founders come from either a medical or technical background, they need to gauge their knowledge in startup ventures and if they have the time to lead the startup.


The key for founders is recognizing their strengths and abilities and supplementing them with team members who complement them and fill in the gaps.



  • CEO – “The Ring Master” Runs the day-to-day, understands funding, has an excellent investor network, leads, motivates, and creates the vision for the rest of the team.
  • Advisory Board- Strong Key Opinion Leader “KOL” network, past startup experience, and a member you can rely on as a “devil’s advocate” to discuss issues and pivots.
  • Technical Lead – Strong technical, prototyping, and manufacturing knowledge, able to communicate with the development team.
  • Marketing – Medical Marketing is different from other markets. Understanding of the FDA, reimbursement strategies, and confirming end-user needs. Past product launches and a balance of strategic thinking, budget and marketing analysis skills, and the ability to execute tactically.
  • Regulatory/QA – The ability to navigate the complex regulatory landscape surrounding medical device startups and 21 CFR 820, ISO 13485 standards. The ability to conduct audits and manage design history files and FDA submissions is critical. You can outsource this, but the Team will eventually need to bring it internally as you take it to production.


High failure rates for medical device startups are usually attributable to breakdowns in the team’s ability to mitigate unforeseen challenges such as funding, pivots, or technical issues.


Unfortunately, managing the multiple complexities surrounding medical device processes and development is frequently the crack in the foundation for many startup failures.


For medical device development, developing, prototyping, and testing the product to confirm regulatory compliance (FDA waterfall) and staying true to the user needs requirements (URS) can add significant challenges to unprepared startups.


To manage this added complexity, medical device startups looking to fill the gaps in their teams can turn to product design firms for expertise, guidance, and assistance. There are multiple design and development firms available. Therefore, it is essential to take the time to do the due diligence in selecting your design partner. Selecting a design firm is partially determined by how many pieces you need to complete the puzzle and how culture fits.


For example, a full-service medical product development firm’s capabilities span the breadth of initial product strategy to manufacturing, making the firm a collaborative team member and partner, complementing its clients’ capabilities throughout the entire medical product development process.


To conclude Trap 2,  “When I work with a new Startup, I view it as an exciting new adventure, almost as a marriage,” Tor explains. “No matter what firm is selected, everything goes well at the beginning (honeymoon). You have a fully funded budget, clear direction, and little to no conflicts. Teams with clear communications, trust in one another, and a solid partnership can avoid the ‘7-year itch’ scenario. This is where the right Team on all sides comes into play. Every startup will experience growing pains, pivots, and budget constraints, but the right Team will have to be able to discuss openly, work through conflicts, and make the necessary tradeoffs.”


Click here for Trap 3: Underestimating Monetary Resources