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    A roadmap for medical device innovation

    Dr. EinarssonIn this issue, respected authorities discuss several exciting developments and technologies that have the potential to change the way we practice medicine in the near future. These advances are based on medical device innovation, which is a very complicated and daunting process. I would venture to guess that during their career, most ob/gyns will have ideas for novel medical devices, but most have no idea what is involved in bringing products to market. It’s just like the line in Woody Allen’s film “Annie Hall” where an arbitrary person is overheard at a Hollywood party saying, “I have an idea and I am thinking about developing it into a concept.” I’ve learned a lot—including some important caveats I’d like to pass along—while actively taking several medical devices beyond the ideation stage.

    Many factors should be considered when evaluating the likely success of any project. First, how feasible is the venture? The issues at play here are clinical need, market size, strength of the intellectual property and the product’s technological feasibility. Let’s say you have an idea for new laparoscopic sterilization clip. There are a lot of sterilization procedures performed today, so at first glance, this product sounds like a good idea. However, the rise of salpingectomy instead of an occlusion could greatly affect your value proposition to industry.

    Attending a large medical conference such as the AAGL global congress is a great way to get a better sense for the clinical need for a medical device. It’s also a good venue at which to assess market size since your industry partners are all there and they will be eager to talk with you. Ask them about the annual US market size in dollars and units sold because that’s the first question you will hear from potential investors

    Another practical question is, what are the cost of goods (COGs) and ASP (asking sale price) of this device? Your device will have to be produced for a fraction of what the expected ASP will be.  If you have a great idea for a device that will cost $500 to make, but you can expect to sell it for $400, that idea is going nowhere fast.  Assuming you plan to sell your device to a multinational company, or have them value your device, it will have to be made for about 30% of the ASP. Your hospital should have information about ASP, but COGs are more complex and may require building an initial prototype, which I will discuss later. In today’s environment of cost containment, it is unlikely that your innovation will be successful in the market unless it offers cost savings over the existing technology.

    Next, keep in mind that if you have an idea that you want to protect, you shouldn’t talk about it, especially with your colleagues or industry representatives. That is considered public disclosure and all those entities have complete freedom to pursue your excellent idea. Our industry partners are especially clever at asking for your expert opinion on a particular clinical dilemma since they know that your free insight can be highly valuable in development of their next medical device. If you are affiliated with an academic institution, contact your intellectual property office and disclose your idea to them. They will then do a patent search to determine if your idea is novel. If you are in private practice, you may want to consider approaching a patent attorney to do a preliminary patent search for you. That may cost a few thousand dollars, depending on the extent of the search. You can also try to search yourself on Google patents. When you do, pay special attention to the claims section and the drawings because, as the saying goes, "a picture is worth a thousand words." By examining the pictures, you will better understand what the inventors are attempting to describe. The claims are even more important because they set boundaries around the invention that nobody can transgress once the patent is issued.

    If your idea is novel, a provisional patent application can be filed for as little as $200. The provisional patent application only covers the basic idea and often lacks details about the features of the device because it is often filed before the device has been developed. The provisional application only protects your idea for 12 months, although you can subsequently file a PCT (patent cooperation treaty, about $5,000) application which extends your coverage for another 18 months. However, once the PCT is filed, you cannot amend any of the claims and have to file a separate patent for any further innovations.

    That brings me to an important point. If you have no plan (funding, team, timeline) to develop the idea in the next 12 months, it may not be a good idea to file a provisional patent application. Let’s say you do file a provisional patent and then begin to discuss your idea with vendors, colleagues and industry. It would be very wise, at the same time, to actively develop your idea and enhance your understanding of how to improve it and make it work better. If you discuss your ideas with others, they will only be bound by what is in the patent and if they are better funded than you, they can pick up your idea and learn how to get around your patent before you get there. 

    When developing a new product, you need a team to be successful. Consider developing a relationship with an engineering team as well as seasoned medical device entrepreneurs. You will ultimately also need a regulatory expert and personal legal representation as well as a patent attorney. All that costs money. If you have an idea that is patentable, appears feasible to develop and sell and you have the resources to develop it, then file a provisional and get to work. If you are going to approach vendors, it is important to note that while a non-disclosure agreement (NDA) prevents the vendor from discussing your idea with others, it does not prevent the vendor from pursuing your idea independently. Therefore, file a provisional patent before discussing your brilliant idea with a vendor. 

    Do a Google search and you’ll find that many contract design and development vendors can build your prototype. Go ahead and contact a few of them and ask them for a quote while providing as little detail as possible. If a vendor is interested, you may be able to develop a partnership that could save money and give you access to the vendor’s business connections. The goal with your initial prototype is proof of concept and it need not look sleek and refined. Be sure to make a drawing with your ideas for the device and sign and date it, on paper and also digitally. Although the patent system is now “first to file,” it is important to document that you did, indeed, come up with your idea independently because I guarantee that some of your colleagues may think you may have “stolen their idea” when your device becomes publicly known.

    When you do establish a team, make sure that expectations for it are clear from the beginning. Do not divide the company up evenly because that is considered fair. The founders should have ownership based on their worth and contribution and that should be negotiated up front. Leave options in the company for future investors and shareholders and to incentivize the founders. Unfortunately, some startups suffer from non-contributing founders who do not actively contribute to moving the concept forward. Do not get too close to your idea, i.e. keep an open mind and listen to others on your team. Sometimes you will find that your brilliant idea was not that great after all and significant tweaking is required to make it work. Do not think that your idea will make you a millionaire overnight. Rather, think of developing a new medical device as a creative outlet and have fun with the experience. Make sure you pick your team carefully so that everyone has a defined role and, ideally, skin in the game. Finally, hope that your first idea is not your best idea. Medical device innovation is a slow process and you will make many mistakes along the way. Learning from your mistakes will increase the likelihood that you will eventually be successful.

    Jon I. Einarsson, MD, PhD, MPH
    Dr. Einarsson, Deputy Editor, is Associate Professor of Obstetrics ad Gynecology, Harvard Medical School, and Director, Division of ...

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