|Before and after: Top image depicts an old-fashioned IV alignment and securement device, while the bottom image shows a new IV-securement method that Edison Nation Medical helped bring to life.|
MDDI: What types of red tape stand in the way of inventors of medical devices, preventing them from bringing their products to market?
Grajewski: Several factors inhibit individual inventors—doctors, nurses, or other medical professionals—from bringing their ideas to the market. The first is lack of access to a steady supply of capital. The second is lack of knowledge about how to build a business and a corporate infrastructure, from finances and operations to sales. The third is their own personal risk appetite and their unwillingness to take out a second mortgage to further the idea that comes into their mind. The fourth is their lack of access to the healthcare supply chain. Added to these factors is the clinical advocacy issue of being able to prove that a product is innovative, saves lives, or increases efficiencies in the healthcare system. Finally, there’s the red tape of being a first-time or small-company entrepreneur in getting ideas or products into the healthcare system. Certainly, when inventors are unproven, don’t have a track record, and are capital constrained, they are at a disadvantage as compared with larger companies that have a much longer track record, a much more established infrastructure, and much more capital.
MDDI: What are some of the new pathways enabling designers of medical devices to begin the commercialization process?
Grajewski: A number of new and innovative pathways have come into existence over the last several years to help inventors in the medical device industry to bring their products to the market—from crowdsourcing to crowdfunding to open innovation. However, all of these avenues have their pluses and minuses. At Edison Nation Medical, we focus on using open innovation. We do this by having an online portal at which medical inventors can sign up for a free membership and then submit their ideas. We treat these ideas confidentially and review them from the perspectives of medical efficacy, intellectual property, and commercialization potential. For an inventor’s ideas to pass our hurdles, we invest the necessary money, time, and effort to develop the ideas further and generate prototypes. We file intellectual property around them and work to commercialize them via product licensing to leading medical device companies.
This is an innovative model because it enables individual inventors to pursue an idea without having to quit a job and start a new company, without having to raise significant amounts of capital, without having incredible amounts of access to the healthcare supply chain and ecosystem. All they need is an idea, and we take care of the rest if the idea has merit.
MDDI: What is the review process for new medical device applications on the road to commercialization?
Grajewski: Many steps must be taken to get a medical device idea fully vetted, reviewed, and commercialized. The first step is to understand the intellectual property around the idea and the ability to file patents that will protect the idea. The second is to understand the clinical efficacy of the device and to determine whether it improves care or increases efficiencies in the healthcare ecosystem. The third is to understand the FDA regulatory pathway to determine whether the innovation is safe. Thus, compared with other industries, the innovation pathway in the medical device sphere is quite long, arduous, and unique. To navigate this pathway as a first-time individual inventor, it’s necessary to have a trusted partner that knows the ropes.
MDDI: What are the basic trends in the commercialization process? How will these trends impact future commercialization efforts?
Grajewski: Major trends in the healthcare field center on cost reduction, infection prevention, and remote patient monitoring. These trends, in turn, are having a significant impact on the types of products that are being successfully commercialized. For the first time, the healthcare sphere is adopting a patient-centered focus. These ideas and trends are getting the greatest amount of traction in the industry, both in terms of the investing community and the medical device community as they try to push new ideas forward.
MDDI: What types of relations have you had with university research departments?
Grajewski: We have a good relationship with university transfer offices, viewing ourselves as a complementary service not only to the individual inventor that visits our website but also to the university itself. Universities that sit on a treasure trove of intellectual property have historically been in a position to incentivize patent ideas and assist their faculty and graduate student brethren in helping to protect those ideas. However, from a bandwidth and capital perspective, many universities have traditionally found it difficult to commercialize these ideas.
Because of our deep relations with corporate R&D departments, innovation labs, and company leaders, we have built relationships with more than 100 universities and their transfer offices. We supplement their own internal commercialization efforts by being an additional resource to get their ideas commercialized. For example, we have worked with almost every university that has been a part of the Association of University Technology Managers. Small to large universities work hand in hand with this association to review their intellectual property and then submit their ideas to our searches around a variety of healthcare categories.
Bob Michaels is senior technical editor at UBM Canon.