The Importance of Medical Device IP Protection

Preserve Potential and Reduce Risk

For investigators and researchers with an idea for a novel medical device, the importance of protecting that idea—the intellectual property (IP)—is paramount. In fact, it’s one of the first considerations that translational researchers must address. IP protection is a crucial aspect of business strategy from the initial concept and early R&D because any gaps in protection will equal a gap in valuation. To attract investors, strategics, and partners, researchers must show that they have a well-rounded IP portfolio, creating potential to monetize on their innovation while also withstanding competitive challenges.

For insight into strategic IP protection for medical devices, we spoke with Carolina Säve, Of Counsel at Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Defensive IP

To protect your IP portfolio, two strategic approaches are critical. Early on, you want to think about a defensive strategy.

Patents

A defensive strategy includes covering core innovations with patents as soon as possible because the US has a first-inventor-to-file patent system (replacing the previous first-to-invent system under the America Invents Act of 2011), meaning whoever files first establishes priority—regardless of who conceived the idea first.

A comprehensive provisional patent application is cost-efficient and locks in that priority date, which establishes your rights. Carolina says, “It's a good idea to draft not only broad claims that have a lot of flexibility and could cover incremental changes, but also more narrow claims that cover the core embodiment of your idea: what is special about your device versus a competitor.” Then, during the 12 months of patent pending status before you must convert the provisional application into a formal patent application, you can make changes to your application and your final claims. Later, you might expand your protection to cover, for example, design iterations or manufacturing processes.

You should also be aware that granted patents are not permanently secure. Competitors can challenge them through inter partes review (IPR) or other post-grant proceedings at the US Patent and Trademark Office (USPTO), which is a growing risk in the competitive medtech space. Building a portfolio with multiple overlapping patents, rather than relying on a single core patent, makes your IP position significantly harder to dismantle.

Trade Secrets

Trade secrets also come into play when developing your provisional application, although translational researchers often overlook them or decide to deal with them later. After that first year from your filing date, however, your patent application becomes public, so you want to avoid disclosing key information that you can instead treat as a trade secret under the Defend Trade Secrets Act. Carolina advises, “Failure to secure your rights to trade secrets is a big risk. Also, robust trade secret protocols are just as important to investors as your patents.”

Companies should categorize their trade secrets and create a program of trade secret protocols to manage them as soon as possible. Researchers often overlook what might be a trade secret. To categorize your trade secrets, it helps to first determine what is core invention that you need to patent. Any information that could be reverse engineered if made public should probably be a trade secret.

Your trade secret protocols should include:

• Physical security measures, such as restricted access to a certain manufacturing floor.
• Requirements for what employees can and can’t take in and out of the building and secure areas, such as lab notebooks and laptops.
• Confidentiality agreements.
• Digital security measures, including password protection, forbidding the use of thumb drives, and preventing employees from downloading sensitive information or emailing to a personal account.
• Communication program
  • Restrict internal access to sensitive information on a need-to-know basis across departments.
  • Establish clear protocols for external communications—defining who is authorized to discuss your program, under what circumstances, and when IP counsel must be consulted, including at events and conferences.
• Onboarding and termination procedures.
• Software code, often a key aspect of medical devices today (embedded software, cloud-based platforms, etc.)
• Training materials, including videos and augmented or virtual reality experiences
• Marketing materials
• Think about IP protection early and talk to experts.
• Identify core innovation(s) and file a provisional application ASAP.
• Implement a program of trade secret protection protocols, including employee training, as soon as possible.
• Establish channels of communication within your company and ensure that protected information is kept confidential.
• Conduct an FTO search and develop a market positioning strategy.
• Protect your branding and materials with trademarks and copyrights.
• Keep development milestones aligned with your IP strategy; they should move together towards eventual commercialization.

Communication issues are often overlooked, but a lack of protocols in this area poses a significant risk. Carolina has seen problems arise from conversations in a trade show booth. You can lose the opportunity for an acquisition, licensing deal, joint collaboration, or other partnership, as well as control of any unprotected IP. Carolina observes, “Marketing is often under pressure to promote the product’s key features but isn’t in the communications loop when it comes to IP protection. Something goes public through marketing materials or trade show conversations and it’s suddenly no longer a novel feature.”

Onboarding and termination procedures are another area of potential risk. Carolina says, “I once saw a company where employees were in charge of wiping their own computers when they left, which was pretty incredible. Luckily, nothing bad happened, but it was a definite risk. Your onboarding and termination procedures must be strict.” In medtech, people often change jobs and can take information with impunity if you aren’t careful.

All these steps are important because if you have no trade secret protocols and the worst happens, you will have no recourse. Once you’ve created your trade secrets protocols, you need to train and retrain employees. These internal processes and procedures demonstrate that you’ve taken measures to protect trade secrets and give you recourse if needed. Carolina says, “We strongly emphasize putting as much emphasis on the trade secrets as the patents. In general, a trade secret program is relatively easy to implement early on, but I’ve often seen companies put it to the side. If you wait, it becomes more challenging and you’re placing the company at increasing risk.”

Regulatory Issues

The point of FDA submission is another critical time to think about your defensive IP strategy, because even though the FDA has a duty to protect confidential business information, it's not a guarantee. You’re required to submit detailed technical information, but you want to limit it to what is absolutely necessary to satisfy regulatory requirements. You also want to properly designate everything that's a trade secret within your submission, whether that is marking it off as confidential within the text or putting it all at the end if that's possible. If a competitor submits a Freedom of Information Act (FOIA) request for the submission materials, the FDA will know that they need to redact it. You’re required to include a public submission summary which will not have redactions, so make sure to exclude any trade secrets.

Offensive Strategy

A robust defensive strategy lays the foundation — but protection alone is not enough. To maximize the value of your IP and establish your position in the market, you must pair it with an equally deliberate offensive approach.

Freedom to Operate Search

First, you need to evaluate the market by conducting a Freedom to Operate (FTO) search. Researchers often find the FTO a difficult cost to bear up front, but it’s important to do it early because it’ll help you to see what’s going on in the space. You can discover what already exists, so that you don’t drain your resources on something that's directly infringing. And you can identify gaps where your device might fit and discern what filings you can do that cover key competitive features.

You’re aware of any big competitors, but you might find solo inventors or other start-ups, which can present an opportunity. You could uncover a potential collaborator, or an inventor whose patent you can acquire. The FTO is important because you can’t be sure of what’s out there. Carolina advises, “You might think that your idea is so novel, nobody’s doing it. But just because no one is visibly doing it yet doesn’t mean there is no risk of infringing someone's patent.”

Market Positioning

You can use your IP to increase your offering’s attractiveness to potential investors, strategics, and partners. Making certain moves related to the market can help you get more traction.

Carolina says, “When we do an assessment of a patent portfolio, we look at how to optimize it to put it in a strategic position, whether the company seeks licensing opportunities, enforcement of existing protection, or a pure acquisition. We can go in and file new claims or tweak existing claims. We're able to craft claims that might come close to a competitor or something that's relevant in the scoped market. We look at the market trends and find gaps. Where does this product fit in? Is there a particular type of procedure or a type of customer that may not currently be using this? Why? How can we fit into that gap? Then we consider if we can massage the claims to be in that space.”

Licensing

Licensing is another powerful tool in an offensive IP strategy. Rather than commercializing a device directly, researchers can license their patents to established companies in exchange for royalties or upfront fees—generating revenue while leveraging a partner's manufacturing and distribution capabilities. For early-stage translational researchers, licensing can also serve as a bridge strategy, providing income and validation while full commercialization is still in development.

Trademarks and Copyrights

Trademarks and copyrights are also important in an offensive strategy. Trademarks play a key role in medtech because your stakeholders will refer to devices by their names, not necessarily the company name. That market recognition is important; Carolina observes, “The name of a device gets used so much more often than one thinks as you are trying to get on the market.” And even if you’re pre-launch, you’re going to conferences, presenting to investors, and putting together marketing material. You build name recognition by having a clear, usable trademark that you've protected early.

Copyrights can apply to a range of items:

A Strategic Approach

Translational researchers looking to develop their idea into a viable product, and build a company around it, must take a strategic approach to IP protection. Keys to remember:

Case Study

To learn more about IP protection for medical devices, we talked to Robert Chisena, Co-Founder and CTO of AVS Pulse, a Boston-area medtech startup developing an intravascular lithotripsy system to help patients with calcified arterial disease restore blood flow.

Robert says, “You definitely want expert help with IP. The first seminal patent is key because it establishes your priority date and covers what will be the broadest topic for your product.”

Robert invested significant time in searching for and reviewing as many patents as he could find. Many seemed to pose a problem for his invention but after close examination, they proved to be different. He points out, “Studying the space is important, so that you know where the white space is. When you’re about to start a technology company, you better know everything that’s out there at the moment and where your place is going to be.” He jokes, “Patents are an extreme level of work without knowing if you did a good job until years later. It’s the total opposite of instant gratification!”

Robert and his co-founder, Dr. Hitinder Gurm, were based at the University of Michigan and worked with the office of tech transfer, which is where they filed the first patent. Eventually, they licensed that patent from the university.

The company, now located in the Boston area, also implemented a trade secret program. Robert observes, “Not letting anybody into the space that doesn't belong is relatively easy. Physical material and electronic material retention is a little more difficult. You have to make sure the appropriate security measures are in place so that people don't take thumb drives or other material.”

Robert adds, “We've done a good job trademarking the AVS logo and the AVS Pulse name. All these things are important to creating a brand and making sure that people recognize your logo.”

Today, AVS Pulse’s innovative intravascular lithotripsy system for calcified arterial disease is being developed, giving healthcare providers a new tool to help patients restore blood flow.

Close Gaps in Protection to Ensure Value

Without taking steps to protect your IP, there's really no value to your device. A well-rounded strategic approach that includes multiple layers of IP protection will be attractive to investors, strategics, and partners—laying the groundwork for the next critical steps in your translational development journey.

About Carolina Säve

Carolina is a registered patent attorney at Mintz whose practice centers on protecting client innovations across mechanical, electrical, and computer science arts, including AI — serving clients in technology, life sciences, medical devices, and automotive industries. She brings particular depth as a former in-house IP director at a Massachusetts medical robotics company, where she built and managed a US and international patent portfolio spanning surgical robotics, surgical instruments, network communications, and AI-related technologies. Her work spans patent preparation and prosecution, portfolio strategy, freedom to operate analysis, licensing, and diligence, with notable expertise in automotive innovations including autonomous vehicles, battery systems, and driver-assist technologies.