You and your team have made the decision to outsource the development of your medical device. Now, how to pick the best development partner?  Finding the right development partner can be a daunting task, even in the best of times.

In our current distributed workforce environment, finding a medical device development partner that will enable collaboration and innovation without actually physically being together is possible if you know what questions to ask. Let’s explore a few of the questions you and your team should consider to guide you in the best direction.

1. What is your end game? This may be another way of asking; what problem are we trying to solve?

Is your ultimate goal to develop your medical device all the way through to commercialization or do you want a mature prototype to sell the technology?  Or maybe you just have a technical challenge and need to gain confidence in the device or application before you invest more $ into your business.

Understanding the answer to this question can help narrow your search to a partner that has broad experience in developing medical devices from ideation to manufacturing, or to one that has a deep understanding and experience around the technology area in question.

2. Can you define or articulate the gap areas in your current device development? Having a solid assessment of the status of your device provides a clearer roadmap of what is needed to commercialize it. For help in understanding some of the requirements of a medical device, Pathfinder whitepaper or checklist are great references. Once you have defined your problem statement and have a better understanding of the gap between your medical device today and a commercial launch, the path to matching your product development requirements to an ideal partner becomes more clear.
3. Does your device need innovation or a deeper exploration into user experience? You may just need fresh eyes to generate new ideas, or an experienced team to meet critical business milestones that can’t be accomplished with your current resources. When you are looking for early stage innovation, a consultancy with a broad, multi-disciplinary team often makes sense.  A medium sized consultancy that knows your domain and market will often be exposed to many different projects and technologies.  Their collective experience provides a wider reference library to draw upon for your device.

New (innovation) happens at the intersection of different/diverse things.  One of my colleagues ran the R&D side of a Bay area consumer electronics firm that would often pair up individuals and teams with specialists from very different disciplines (i.e. electrical engineers with soft goods designers etc.).  The results were often unusual, but out of the box and compelling.

People who work on the same type of problems day after day often get burnt out and have a hard time innovating (thinking outside the box).  If you truly want innovation from a development partner, then you need to tolerate a certain level of uncertainty with the early stages of development, even some chaos.

Innovation cannot and should not be constrained to standard work practices.  If you are looking for innovation, and the company you are considering boasts of how they are ‘lean’, then turn in the other direction and run!

4. Are there high risk technical challenges that need to be resolved? Making sure you identify and resolve these issues early can save thousands or millions of dollars in the long run. If you have a specific/narrow/technology task you need performed, a smaller group/team/consultant who has deep domain knowledge may be the right fit. Deep domain knowledge is sometimes hard to find in a generalist consultancy.
5. Are you outsourcing because you don’t have the right resources or enough resources internally to develop your device? You are a small start-up so it makes perfect sense to find a partner that can augment your current resources to help you get to market or the next milestone quicker.
6. What do you truly value in a development partner? If you have never worked with a development partner, you may not know the answer to this question.  Here’s what I know after 15 years of working with development teams and clients. There is no one right answer, but two top answers:
   • The experience of the team. Partner with a team that has expertise in a similar device, area of focus, and understands some of the challenges. This provides confidence in the approach and outcome.
   • The relationship between the teams. Quite often a medical device that is going to go the full journey from conception to launch is going to take multiple years.  You will likely be working with the same core team throughout this journey and there will be highs and lows along the way.  Having a development partner and team that will challenge assumptions, collaborate, and innovate to create the best medical device will enhance your company value, which is the ultimate goal.

7. What questions should I ask to determine if a development company would be a good match? Here are a few questions, but not an exhaustive list, that might help you determine the right team/company to outsource.
   • Can I meet/talk to the team that is likely going to work on my development project?
   • How are the teams organized in the product development company and do they line up with my team?
   • Agree and confirm on the deliverables for the first stage of engagement.
   • Have you developed this type of device or system before, and can you give relevant examples?
   • How do the teams interact with each other?
   • One question clients ALWAYS ask is how much will this development cost? Since I know you are going to ask this question, here is a really great reference article to read first.

8. Is your development project a 2^nd generation device that requires some incremental design improvements but not large technology challenges? If yes, then a good/solid contract manufacturer with well defined business, transfer and manufacturing processes may be the right choice.

9. Are you looking for a good manufacturer with little to no design requirements? If yes, then prior experience in your market is important.  Also you need to find a manufacturer with appropriate business and manufacturing processes in place that align with your required volumes.