From Concept to Market: 7 Critical Questions for Your US Medical Device Development Partner

Key Takeaways: How to Evaluate a Medical Device Partner 

• Require End-to-End Integration: Choose a partner who handles design, engineering, regulatory affairs, quality, and manufacturing transfer in-house to minimize risk and delays.
• Verify FDA Expertise: Ensure the firm has a proven track record of 510(k), De Novo, and/or PMA submissions and an internal Quality Management System (QMS) compliant with 21 CFR 820 and ISO 13485.
• Demand Startup Agility: Look for a phased development approach (Phase 0, 1, 2, etc.) that validates feasibility before requiring full-scale capital commitment.
• Secure Your IP: Confirm contractually that you retain 100% ownership of all intellectual property developed during the project.
• Prioritize Manufacturability: Ensure Design for Manufacturability (DFM) is integrated from day one to prevent costly redesigns later on.

Turning a groundbreaking medical device concept into a market-ready product is a complex, expensive challenge loaded with regulatory hurdles.

For a startup founder, choosing the right development partner is arguably one of your most critical business decisions.

A great partner accelerates your timeline and de-risks investment, ensuring your device is built correctly from the beginning. Conversely, the wrong choice can drain resources with endless redesigns and communication breakdowns.

To help you evaluate your options, here are seven critical questions to ask potential medical device consulting firms.

1. Can you take my product from concept to market launch?

Avoid firms specializing in just one area, as managing disconnected vendors often leads to delays and integration gaps. Also avoid firms who give the impression they can do everything but are nothing more than a loose collection of independent contractors. Instead, look for a truly integrated, end-to-end partner capable of handling design, engineering, quality systems, regulatory affairs, IP strategy, and manufacturing transfer under one roof. This turnkey approach saves valuable time, ensuring the design team aligns with regulatory requirements from day one, preventing compliance issues down the road.

2. What is your specific experience with the US market and FDA regulations?

The FDA is the gatekeeper of the US market. You need a partner with a deep, proven track record who builds regulatory requirements directly into the design process. Ask them directly:

• How many 510(k), De Novo, and/or PMA submissions have you successfully submitted for similar devices?
• Is your internal Quality Management System (QMS) compliant with 21 CFR 820 and ISO 13485?
• Do you have in-house quality and regulatory staff managing my submission?

Startups require agility, not the rigid processes typical of large corporations. Look for a phased development approach that starts with a focused Phase 0 or 1 for feasibility and risk analysis. This allows you to quickly validate your concept and secure funding before committing to full-scale development.

4. Who will actually work on my project, and are they in-house?

Determine if the firm is a core team of experts or simply outsourcing work to contractors. You want a dedicated, in-house, multidisciplinary team where senior engineers, regulatory specialists, quality experts, and manufacturing gurus collaborate daily. This ensures seamless communication, faster problem-solving, and clear accountability for your project's success.

5. How do you integrate 'Design for Manufacturability' (DFM)?

Designing a functional prototype is vastly different from designing for mass production. A seasoned partner prioritizes DFM from the first sketch, considering supply chains, assembly processes, and material costs. Early DFM integration prevents the nightmare scenario of achieving FDA approval only to find your device requires a costly redesign to be manufactured at scale.

6. How is intellectual property (IP) handled?

For a startup, your IP is the main value driver for your business. It is imperative that you review all potential contracts with outsourced firms to clearly understand IP ownership, especially for IP that is developed during the term of your engagement. Make sure that you own 100% of the intellectual property developed for your project. Avoid any firm that seeks to retain ownership or license the IP back to you, unless you clearly understand what you are getting for it and how things will be handled if you need to exit the relationship. 

7. What happens after my product is launched?

FDA clearance is a milestone, not the finish line. A true long-term partner guides you through manufacturing transfer, helping vet manufacturers and providing post-market support as you scale. They should stick with you as you move from building one unit to one million.

Your Partner is One of Your Most Important Investments

Choosing the right partner is the foundation of your company's future. The right partner will not only help you get your first product to market, but they will also lay the groundwork for future products, as well as help you to hire and train future internal staff. You need an integrated team that shares your vision, understands startup culture, and has the in-house expertise to navigate the entire product lifecycle.

At Kapstone Medical, we built our firm decades ago to be this partner. We are a highly experienced, fully integrated, US-based team of quality driven senior engineers, serial designers, manufacturing gurus, regulatory experts and more; dedicated to helping startups turn innovative concepts into market-ready solutions. Our Kapstone Manufacturing business also provides supply chain management, design, development, manufacturing, assembly, packaging, sterilization, and labeling to further complement the Kapstone Medical services.

If these are the questions you're asking, we'd love to tell you our answers.