Choosing a medical device contractor is one of the most important decisions a medical device start-up can make.

In today’s 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.

This article features StarFish employee recommendations on choosing a medical device contractor that fits you like a glove (medical grade nitrile, of course).

Technical capabilities and expertise

Consider how the contractor’s skill set and experience overlap with your own. If you’re looking to build a very innovative device, then you should probably go to a company that has a skill set and secret sauce around innovation versus one that’s more implementation oriented that can bang something out quickly. Pathfinder whitepaper or checklist are great resources for help exploring and understanding some of the requirements of your medical device.

Don’t assume a medical device contractor knows who you are. Be self-aware of your team strengths, what you’re good at, what you understand and have experience in, and what you don’t. Be clear about what you need, how it relates to your business strategy and what your strengths and weaknesses are.

Select a contractor that has expertise in many different aspects of your project. Development teams work well if they have strong communication links and strong connections with each other. There is benefit in having a contractor that can work on all steps of the process such as engineering, regulatory, industrial design and so on efficiently.

When you’re trying to develop a unique device, it may not be obvious where the challenges are and the depth of experience needs to be. A company that has a broad portfolio of successes that seem to overlap seems like a pretty great place to start. A medical device contractor who has created similar devices to the one you’re creating can give some comfort that your project is likely in their wheelhouse.

Track Record and References

When selecting a contractor, expertise and experience in the medical device industry are important because they directly impact the success and quality of your product. A proven track record in designing and developing similar medical devices helps ensures they possess the necessary skills and knowledge to handle your project effectively.

Avoid “Tell me all the specs and we’ll go and do it”. Instead, look for a contractor that really understands the clinical needs and the people that will benefit from the device (both the patient population and the clinicians).

It starts with the sort of questions that they’re asking, if they really want to engage in your intent, those questions will include “why are we doing this?”, or “Tell me more about the clinical need”. Those are good clues that they are thinking bigger picture.

Flexibility in Cost and Contractual Considerations like IP Protection

Figure out if the contractor’s value proposition is aligned with yours. Is their core mandate to build a manufacturing pipeline? Or do they focus on a fee for service model where everything they do is yours?

Once a good contractor digs in and starts designing, they learn stuff and spot opportunities. You want a contractor/partner to be interested and look for those opportunities. They will try to align development with timeframes, funding, and all the things that are important to making development decisions. You can tell they are trying to understand what you’re asking for beyond an RFP.

It is very valuable for your contractor to really appreciate what you are trying to do and not be super transactional. They should be inclined to say yes and then build upon the mandate you give them rather than just do it and not think too deeply about what might not be as optimized or as thought through as it could be.

Look for someone who wants to help you with the whole journey and not just solve your immediate problems or your initial spec. They should carry your project from A to B to C along different parts of the program and meet your needs for unforeseen, but inevitable funding or technology restricted segments of the journey.

If you chop a problem and then disperse it amongst a whole bunch of third parties, you’re going to impose speed bumps and breaks in communication. Things will go a little slower, less efficiently. There will be less opportunities for big, big breakthroughs and innovation which are multi-disciplinary and cross-functional in nature.

Robust Regulatory and Quality Management Process and Controls

If you have a huge regulatory hurdle, then go with a company that’s skilled in developing a regulatory strategy. Or, if your regulatory strategy is well understood, but you think the project is going to require a huge technical lift, or your core technology is obscure, then find somebody with innovative core technology that you can leverage.

Look for contractors who have processes in place to address your unique regulatory needs as they ramp up through the development process. They can efficiently scale up as you move through the phases of development so that you end up with everything you need.

Cultural Fit

Make sure the contractor’s culture matches what you’d expect for someone who is going to go into the weeds for you, work on your problems and define a lot of your products. These journeys often take years. Make sure you mesh initially, and the contractor is just as excited as you are about where you want to go.

You should get a feel for what your contractors care about, their value structure and how much they care about you. It’s great when you are like your contractor, you enjoy engaging with them and they’re jazzed about your project. You can tell when your device is something they really want to work on. It’s not just about income to pay their bills.

Speaking of bills, before you begin your medical device contractor search, you should understand how much time and money it will likely cost to develop your medical device. The How Much Does it Cost to Develop a Medical Device? white paper includes costs for a ‘No Design’ Product, compares the cost to develop a device to the total amount of commercializing a device, reviews an industry survey for the total raised funds for medical devices, and examine an study focused on Point of Care Diagnostic Devices.

Finding a medical device development partner that enables collaboration and innovation is not that difficult if you follow our recommendations above. Or, reach out and contact us for a free consultation.