By Bob Marshall, Chief Editor, Med Device Online
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.
Protect Your Assets
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.
Additionally, when communicating with your IP attorney, consider whether you will be filing a 510(k) for your device. Be sure to share and discuss the product claims that will be included in the submission, so they can be reviewed against the patent claims that will be made. This is important because a patent legally demonstrates how your device is unique or novel, while the 510(k) attempts to establish how your device is substantially equivalent to other currently marketed devices.
Find Your Way Through The FDA Maze
How many FDA hoops will you have to jump through? Hopefully, the answer is “as few as possible.” The ultimate answer will depend on your relationship with your regulatory strategist. In some cases, a device’s regulatory pathway is very clear. If a new device fits neatly into an existing classification and there are one or more predicate devices on the market, regulatory strategy can be rather simple. In many cases, though, it is not that simple, and you will be dependent on your regulatory strategist’s risk appetite.
The more accurately you can describe your device’s intended use, and the more clearly you can communicate claims that will be made, the better your chance to be in sync with your regulatory professional. Regulatory affairs is much more of an art than a science. It is important to establish a dialogue with your regulatory professional, and to understand whether they have developed an aggressive pathway or a conservative one. It also can be helpful to have your regulatory strategist develop some pathway options (if more than one regulatory pathway is feasible), so the project team and the organization can decide how much risk to take. One size often does not fit all.
Qualify The Demand For Your Device
Defining and understanding your patient population is key to developing the right device for the market. This is an area where medical or clinical professionals are necessary. Hopefully, your device addresses an unmet clinical need, but you need to confirm this with a medical thought leader. These professionals are intimately aware of the current standard of care and the idiosyncrasies involved in diagnostic or therapeutic application(s). Find someone whom you can trust, and discuss product concepts and features with them.
You also can have this professional evaluate early mock-ups or prototypes to shape your design input. Remember, you want medical and clinical professionals to become raving fans. You want them to write about this new device coming to market. You want them to go to conferences and talk about what you are developing. They can create the buzz that will provide for a strong launch at commercialization. Just be cautious that you are working with professionals who have good reputations in the area of medicine that your device will be addressing. Their reputation will reflect directly on your own reputation, for better or worse.
Think Like An Investor
All product development efforts require money, usually provided by some combination of your organization’s internal R&D budget and external funding from incubators, angel investors, or venture capitalists. You must empathize with the people providing the money; put yourself in their shoes. Whether it’s an internal project charter with a detailed budget or a business plan, you have a burden to communicate why your development effort is a good investment. The items above will be foundations of your plan.
If you were investing your own money, you would expect solid IP protection, a clear regulatory pathway, and thoughtfully qualified commercial demand for the product. Make sure that you have a compelling “pitch person” to secure investment. It’s not a sales pitch, and the individual or team asking for funding must be credible and confident. Know the backgrounds of those who will be asked to provide money and talk with them in advance, if possible, to learn what they will be looking for. I used to support an angel investment group and, after they would screen potential investments, their most common concern was that the company seeking investment was not asking for enough money. The group felt it displayed a lack of understanding what it really takes to complete a development effort. Never paint a rosy picture for potential investors. They are in a position to make investments because they are grounded in reality. A detailed business plan with associated risks and thoughtful contingencies will make you credible and fundable.