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Many companies seek to engage a product design partner to supplement and enhance internal teams developing medical technology products. It is a strategy that can be used to rapidly scale up the product development (PD) team and to bring in capabilities where internal teams may not have expertise in a necessary technology. While there are many factors in selecting a PD partner that are not unique to medical technology products, there are a few unique factors that need to be considered.

Here are a few tips for selecting the best partner for your product design project:

1. The right experience and expertise: It can be helpful to find a partner with a breadth of experience and expertise. Even though your need may be in a specific narrow niche, it can be helpful to engage with a PD partner with additional areas of expertise. Anyone involved in PD over a long period knows that the road to success rarely follows a straight line. Your need may initially be in one area, however, as a project progresses, you might find you have needs for other areas of expertise. It is vastly more efficient and easier to manage if your PD partner has the adjacent skills you might need over the course of development.

2. Be open to one with different experience: There can be value in engaging a PD partner that is not specifically working in your area of medical expertise. Almost any problem can be broken down into a matter of applying physics. For example, the medtech product under consideration could be one involving a respiratory device. Those with experience in pneumatics and airflow more broadly may have the technical knowledge needed with your company providing the domain expertise in biology and specific medical factors around the device. A good engineer with expertise in the necessary fundamental technology can readily pick up the nuances of a particular domain. However, an engineer who has worked in a particular domain but who lacks a sound background and experience in basic physics cannot readily pickup this knowledge. Bringing in a team with adjacent, relevant experience can also be helpful in bringing new ideas and perspectives to the project. The last thing most good PD managers want to do is stifle the innovation that comes from those with diverse thoughts and experiences. As a PD manager, you want creative tension and the challenging of pre-conceived notions. This is an important step in the process of being innovative and novel — and can lead to new intellectual property positions.

3. Experience in medtech regulatory processes: It is helpful to find a PD partner that has worked in medtech before within the constraints of an FDA certified Quality Management Systems (QMS). A design partner who has worked on a variety of medical devices will have exposure to a variety of regulatory approaches and QMS. This experience helps them adapt to various approaches and are potentially able to anticipate needs or suggest alternative approaches. It is important to select a design partner who has seen the product development process through the 510(k) or IDE approval. This experience will indicate an understanding of the level of risk management rigor needed. However, engineers who have worked in other highly regulated industries understand the types of process controls and documentation required to create a certified product. Many engineers who came from companies in aerospace and military contracting have worked under similar systems. Likewise, engineers who came from a company with an ISO certification may also have experience in working under a managed QMS. The nuances of an FDA certification process can readily be transferred to a team whose members came from other similar regulated industries. Essentially, a design partner does not really need to have a specific certification to be a good partner for your company. As the company owns the product, so too must they own the QMS. It is important that your PD partner can work with your QMS. When submitting to FDA for approval, they are going to ask you about your QMS system and data management. They are not approving your supplier.

4. Has a deep bench: This is a basic need for anyone considering engaging a PD partner. The question is, how deep is the bench of the partner being considered? Do they have just one engineer with the expertise you need? What happens if that engineer is already engaged on another client project? You want to know if there is a viable number two (or three or more) to ensure your project gets assigned to individuals with the right skills. Also make sure that the bench includes enough senior staff to ensure you are getting the benefit of an experienced professional and not an entry level engineer. If the project is large, you need to know if the bench is deep enough so that the development schedule is not hobbled by an insufficiently sized team.

5. Does not claim IP rights: This sounds very basic but make sure that your PD partner signs over all intellectual property rights for your product development work. It is surprising to see that some firms are loath to give up the rights to intellectual property coming out of the client’s PD project (at least not give up the rights without a specific consideration). Also make sure that the PD partner is turning over all the documentation and collateral material from the project. It is best not to assume anything. Make sure your expectations are well documented in the contracts.

6. Watch for intellectual property risks: It can be helpful if you can find a partner with unique experience in the domain of your specific product. However, one needs to be careful in how they gained their experience in the product category. Did they gain their knowledge from team members working in a former company? Does the PD partner work with a company that could be perceived as a competitor? In either case, you will need to be assured that cross pollination of intellectual property from another company doesn’t bleed into your project. Likewise, you will need assurance that your intellectual property does not get transferred, intentionally or unintentionally, to another company, especially if they may be a competitor. An NDA is a good start, but it can be difficult, in the heat of development, to ensure that information does not get unintentionally transferred to the wrong place.

7. Do reference checking:This is even more important than when hiring a staff member that will be bound to your company rules and intellectual property protection policies. Take a look at the client list of your potential PD partner. Are there any companies on their website where you would like to reference check? Prepare your list of questions and make the calls. Try to extract more than one-word answers and get to the anecdotes about the client’s engagement with the potential PD partner. You are looking for casual tidbits that can reaffirm your expectations or provide clues to red flags from past engagements. With a few nuances, finding and selecting a PD partner for medtech product development is similar to selecting a partner for any engagement. Keep in mind the differentiators as you are evaluating prospective partners. Keep flexible in viewing the new and different thinking that may come from selecting the right partner. And take advantage of the way a solid PD partner can help accelerate the development of your medical technology product.

   Article source: MDDI