The medical technology (“medtech”) innovation process is marked by several key stages. The journey typically begins with ideation, the phase at which inspiration strikes and ideas are generated. From there, the process moves into development, a stage that demands significant R&D effort to bring ideas out of the conceptual realm and into reality. The testing phase follows, during which clinical data is gathered to validate the efficacy and safety of the innovation. The final phase — commercialization — is not necessarily the end of the work but a continuation of it, as new challenges and opportunities inevitably arise.
Successful medtech development requires close coordination among R&D, clinical, and intellectual property (IP) teams, each of which brings unique and valuable perspectives to the product life cycle. A holistic approach that integrates those perspectives provides a sturdy foundation for medtech innovators to bring safe, effective, and successful advancements to market.
The Q&A below is adapted from a panel discussion on medtech innovation co-hosted by Fish & Richardson P.C. and DeviceAlliance. Panelists included Ed Kim, M.D., Physician-in-Chief, City of Hope Hospital Orange County; John Knudson, Director of R&D, Johnson & Johnson MedTech; and Michael Hamlin and Crystal Culhane, Ph.D., principals, Fish & Richardson. The panel was moderated by Tyler Train, principal, Fish & Richardson.
Ideation
Mr. Train: At the ideation phase, how do you decide which idea-generating projects to prioritize?
Mr. Knudson: For established medtech organizations operating in well-defined markets, the ideation process often centers on enhancing device efficacy, integrating new technologies, and making incremental improvements to existing products. Decisions typically are guided by the need to meet evolving customer demands and drive greater efficiency or effectiveness within their current product lines. Startups, on the other hand, tend to focus on pioneering entirely new markets. Their priorities often shift toward generating compelling clinical data to attract investor support and validate disruptive ideas.
Mr. Train: How can R&D teams work with clinical partners during these early stages to fill critical healthcare needs?
Dr. Kim: Inventors often become fixated on a particular pathway, product, or service, only to find that their preferred alternative fails to land with clinicians, patients, and consumer groups. Bringing in objective clinicians can help to avoid tunnel vision by evaluating new ideas through the lens of practicing medical professionals. In many instances, a company’s initial product at the ideation phase is not the one that proves to be most viable, but, rather, a secondary or even tertiary version of it. Keeping options open by conferring with medical professionals who understand real-world clinical settings can help R&D teams increase their chances of creating a successful product.
Mr. Train: Once an inventor has an idea, what are some things to keep in mind to position themselves well for a later patent filing?
Mr. Hamlin: Tunnel vision can also have negative impacts on a company’s IP rights. When preparing for a future patent filing, teams should consider documenting not only their primary solution but also alternative approaches that they considered during the innovation process. If a patent is drafted too narrowly and covers only a specific implementation of the invention, it becomes easier for future competitors to design around it. By capturing a range of viable alternatives in early patent filings, companies can secure stronger, more defensible IP that will better protect their innovation as it moves toward commercialization.
Development
Mr. Train: Once you have an idea worth pursuing, what steps do you take to transition to R&D?
Mr. Knudson: Once the R&D team develops an idea worth pursuing, the next step is to develop a clinical strategy, a manufacturing strategy, and a regulatory strategy. On the clinical side, companies should consider the need to obtain clinical evidence to demonstrate safety and efficacy. On the manufacturing side, consider scale; will the company need to manufacture 100,000 or 1 million units per year? On the regulatory side, will the device be subject to premarket approval or will it fall under the 510(K) pathway? Each of these considerations will dictate what the manufacturing process will look like. Throughout the development phase, companies should continue to test assumptions, iterate on designs, and seek feedback from customers. “Scope creep” is an ever-present R&D risk; while some improvements are always necessary, there comes a point at which the R&D team must stop tinkering and consider the product acceptable for launch. However, companies must also resist the urge to cut corners. Seemingly minor problems during small-scale development can quickly become major challenges when production scales up.
Mr. Train: How can R&D teams meaningfully integrate physicians at the development phase?
Dr. Kim: An understanding of the daily realities of clinicians and patients can help inform product features at the development phase. For example, a device’s convenience factor can directly affect market adoption. Auto-injection devices, for instance, allow patients to bypass medical clinics once they obtain the initial prescription, making them much more convenient and reducing total healthcare costs. Even if a drug itself is highly effective, the method of its delivery — e.g. auto-injector vs. traditional syringe — can determine its success in the market. For many consumers, practicality is more compelling than perfection.
Mr. Train: What can companies do during the development stage to prepare to meet with an IP attorney?
Dr. Culhane: IP strategy typically becomes more complex as a project advances and the number of people aware of it grows. It is an IP best practice to share details about a product only on a need-to-know basis, as oversharing — especially with anyone outside the company — can compromise a company’s ability to obtain patent rights in its products. Also, a common IP myth during the product development phase is assuming that a company needs to have a “perfect” product before consulting an IP attorney. Instead, companies should keep meticulous records of tests conducted and data gathered and share them with attorneys via invention disclosure forms early on in the development process. A robust evidentiary record can help IP attorneys build a case for patent protection.
Mr. Hamlin: For companies seeking investment at the development stage, exercise caution when disclosing project details to potential investors. At a minimum, such companies should have a non-disclosure agreement (“NDA”) in place before sharing sensitive information. Keep in mind, however, that NDAs offer only contractual protection through breach of contract claims; if the receiving party discloses the information in violation of the NDA and files a patent application first, that can create prior art that jeopardizes the disclosing party’s own patent rights. An even better strategy is to pair an NDA with a pending provisional patent application, which establishes the filer’s priority to the invention.
Testing
Mr. Train: What are the types of testing approaches when developing a product for the market?
Mr. Knudson: At the testing stage, a company needs to develop an appropriate model to challenge its device and demonstrate to regulatory agencies that the device performs as intended. This process may involve experimenting with several different models to identify which one provides the most accurate and meaningful results for the specific invention. For example, if the innovation is a bladder device, consider testing it specifically on animal bladder tissue to ensure both safety and efficacy. Once the company develops a suitable testing model, the next step is process characterization. This involves both verification and validation testing, which can confirm that the device meets all design specifications and intended uses. These tests can help to ensure compliance with regulatory standards and provide the data to support the company’s claims about the device’s performance.
Dr. Kim: Real-world clinical testing can show how the device will function in practice. Key questions during clinical testing are whether the product will actually be widely used and why practitioners would choose it over existing alternatives. Physicians often must be convinced to learn a new product — including new dosing regimens or side effects — before integrating it into their practices, and a new product will gain traction only if it is demonstrably superior to prior solutions. Favorable results from head-to-head comparisons with existing products can persuade both physicians and the Food and Drug Administration that a device offers tangible improvements and is worthy of adoption.
Commercialization
Mr. Train: What steps do you take to commercialize a medical device?
Mr. Knudson: Once a product advances to the commercialization phase, the focus should shift to preparing for market launch. While awaiting regulatory approval, companies can begin scaling up their manufacturing to begin producing launch units. In parallel, companies can develop a marketing strategy, which can include engaging directly with potential customers, presenting at industry conferences, crafting a publication plan to raise awareness in scientific and medical communities, and other initiatives.
Mr. Train: If there’s a competitor in the market who you notice is infringing your patent, what do you do?
Mr. Hamlin: A reality of commercial success is that it brings the risk of litigation, both offensive and defensive. On the offensive side, options for addressing potential patent infringement by competitors may include sending a cease and desist (C&D) letter and/or initiating a patent infringement lawsuit. The optimal course of action depends a great deal on the competitor, their market share, and their growth trajectory.
Mr. Train: How do you respond if you receive a cease and desist letter from a competitor asserting infringement against your product?
Dr. Culhane: On the defensive side when receiving a C&D letter, it is important to work closely with counsel to determine the best path forward. One option for response is to send a letter acknowledging receipt and stating that there is a current investigation into the allegations. At this point, a company may also decide to obtain an opinion of counsel to assess validity and infringement issues for the asserted patent. Ultimately, these decisions — both offensive and defensive — should be made case-by-case based on strategic guidance from attorneys.
When to involve IP counsel
Mr. Train: What stage in the innovation process should IP strategy become central?
Dr. Culhane: IP strategy should always be a central component of the innovation process, but when determining the right time to file a patent application, consider the following factors:
- How confident are you that your ideas will prove valuable to the company?
- How close are you to a final design?
- What’s your development timeline?
- Are you operating in a hot space?
- Are you trying to fundraise?
While the answer to each of these questions is client- and invention-specific, regular counseling with an IP attorney can help determine when an invention is ripe for patent filing.
