Today, I am beginning a series of articles that will explore some of the important relationships involved in each phase of developing a medical device.
Before everyone jumps on me for having the wrong number of product development phases, or the incorrect names for the phases, or for associating activities (and their corresponding relationships) with the improper phases, remember: We all know there are different ways to craft a product development process. Development phases provide for periodic formal design reviews and ensure acceptable outcomes for current tasks before committing additional resources (people and money) to the next phase of the project. I have seen as few as four development phases work successfully, and I have seen product development processes with 10 phases.
For this series, I will be using a five-phase product development model: concept, design, verification, validation/manufacturing transfer, and release/sustaining. This article will focus on key relationships during the concept (or conceptual) development phase. For larger medical device companies, many of these relationships will exist within the organization, while start-ups likely will need to partner with third-party experts or consultants for assistance. Regardless of the medical device company’s size, keep in mind, it’s not just WHAT you know, it’s WHO you know.
Attorneys are well-paid for the services they provide, and if you’ve ever had to defend yourself or your company from patent infringement, you understand why. Connecting with a good intellectual property (IP) attorney is one of the first important relationships established during development of a new medical device. You don’t want to spend time and money developing a new device, only to have someone copy your device and pilfer part of your market share immediately after your product launch.
This is an area where it can be costly to be frugal. I worked with a start-up that was using a patent attorney who was very affordable, but it proved to be a costly choice. The patent attorney was not deeply experienced, and was somewhat timid with the company’s IP filings. The company’s progress was impeded as it waited for patents to be issued. After about 12 months of delay, the company made the decision to hire a larger law firm, with deep IP experience, and the new attorney was able to secure multiple patents in a short amount of time.
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