Medical-device technology has advanced at a rapid rate as innovators have brought together mechanical and electronic componentry, along with advanced bioengineered materials, into elegant tools for providing focused, functional medical solutions. Bringing such innovations to market can be delayed by the regulatory issues associated with getting new medical equipment approved. The development and approval process can take more than ten years in some instances, demanding a strong IP strategy with longevity and room for growth. Moreover, such exit timeframes can scare off investors who may be looking for quicker returns. Furthermore, device lifecycles may prove inadequate for recouping investments.
The areas of diagnostics and imaging, as well as a wide range of non-invasive techniques, have shown an uptick in the pace of innovation. Adoption of new technology is still hampered by resistance to changes in work-flow behavior by medical practitioners and hospital staff. However, caregivers are receptive to breakthrough solutions when the economics of total cost of ownership (TCO) make sense (the areas of neurology and cardiology tend to be early adopters, while orthopedics lags behind in adoption, for example). These are significant challenges to overcome. Intellectual property firms are not always attuned to the subtle nuances that can prove to be critical in the long run.
Moreover, regulatory-approval protocols differ according to jurisdiction. In the U.S., clinical trials require both testing for safety and efficacy, while in Europe, the requirement is only for safety testing. This has caused many inventors to focus on a “Europe-first” strategy. Entrepreneurs rely on the strength of their intellectual property as a key asset to secure funding throughout these various stages. With the requirements for receiving a grant or allowance for a patent being much more stringent in the EPO than in the USPTO, a combination of expert skill sets are needed to properly capture the technical features and monetization schemes (via the claims) in a patent application during the patent-drafting process, while steering clear of potential infringement issues and litigation liability.
FlashPoint IP, a leader among intellectual property firms, factors these wide-ranging aspects into the process of securing patent protection, whether in performing a patent search of the prior art, engaging in patent drafting of applications, selecting how and where to file, or prosecuting your claims to an invention to help you maximize value in an extensive array of practice areas. Having Ph.D. degrees and industrial experience, our patent attorneys are adept at synthesizing the many facets needed to create a winning formula for your IP. Contact us to discuss your options regarding IP strategy and positioning, and how best to secure your rights.