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Top Seven Things to Consider When Protecting and Patenting Medical Technology

6 min read
Authored by Matthew H. Grady , John S. Harmon, PhD

 Co-authored by: Matt Grady, Shareholder, Wolf Greenfield l John Harmon, Shareholder, Wolf Greenfield l Carol Burnton, Principal, FPA Patent Attorneys l Stuart Irvine, Principal, FPA Patent Attorneys

Innovation in medical technology—spanning devices, diagnostics, software, and AI—creates enormous value. But capturing and protecting that value requires a thoughtful, multi-layered intellectual property (IP) strategy. This is especially true when navigating how to protect medical technology IP across key global markets, including the United States and Australia, where legal frameworks can differ in important ways. Below are seven key considerations companies should keep in mind when building and enforcing IP around medical technologies.

1. Build a Layered, Not Singular, IP Strategy

There is no one-size-fits-all patent for medical technology. The most effective strategies resemble a “picket fence,” including multiple layers of protection covering different aspects of a product.

This can include:

  • Device and system claims

  • Methods of treatment

  • Drug compositions or dosing regimens

  • Software and AI functionality

  • Design protection (including GUIs and product appearance)

A holistic approach strengthens enforceability and makes it harder for competitors to design around your innovation.

2. Don’t Overlook Design Protection

Design patents (or design rights) are often underutilized in medtech, but can be highly effective, especially against knockoffs.

They can protect:

  • The visual appearance of devices

  • Graphical user interfaces (GUIs)

  • User experience elements

In some cases, design rights are faster and easier to enforce than utility patents, particularly when stopping copycat products entering the market.

3. Understand What Makes Diagnostics Patentable

Diagnostics are patentable—but not automatically.

The key challenge is avoiding claims that are considered:

  • Natural phenomena

  • Abstract ideas

  • Pure data observation without application

To strengthen patentability, claims should:

  • Include a concrete application (e.g., treatment steps) at least in dependent claims

  • Demonstrate a technical improvement, a novel system, and/or novel compositions that do not exist in nature

  • Go beyond merely identifying a biological correlation

  • Consider the importance of in vitro or ex vivo processes separately to any sample collection or in vivo treatment

In practice, tying diagnostics to actionable outcomes as well as new physical designs and/or compositions often improves success.

4. Treat Software and AI as Technical Innovations

AI is not treated as a special category of invention—it’s evaluated like software.

To be patentable, software-based innovations should:

  • Demonstrate a technical improvement (e.g., better accuracy, efficiency, or processing)

  • Go beyond applying known algorithms to new data

  • Show how the system improves underlying technology or functionality

  • Result in a concrete outcome for a system or process

Simply applying AI to a new medical use case is usually not enough without a technical contribution.

5. Align IP Strategy with Regulatory Strategy

One of the most overlooked risks in medtech is misalignment between patent filings and regulatory submissions.

Key considerations:

  • Ensure patent claims cover what will actually be approved

  • Coordinate timing to avoid premature disclosures

  • Plan for patent term extensions tied to regulatory delays

Failing to align IP and regulatory strategies can result in lost exclusivity—even if strong patents exist.

6. Plan for Global Differences Early

Patent laws vary significantly across jurisdictions, especially for:

  • Methods of medical treatment

  • Software and AI

  • Diagnostics

A strong strategy anticipates these differences by:

  • Including broad disclosure upfront

  • Drafting claims that can be adapted by jurisdiction

  • Maintaining flexibility for international filings

Planning globally from the outset avoids costly gaps later.

7. Draft with Enforcement in Mind

A patent is only as valuable as your ability to enforce it.

To improve enforceability:

  • Target claims to real-world actors (manufacturers, distributors, clinicians)

  • Avoid “split infringement” across multiple parties or jurisdictions

  • Include claims covering products, methods, and intermediate steps

Strategic claim drafting can make the difference between a strong asset and one that is difficult to assert.

Final Thought

Medical technology innovation is increasingly interdisciplinary, combining hardware, software, data, and therapeutics. That complexity demands an equally sophisticated IP strategy.

Companies that take a proactive, integrated approach—considering patentability, enforcement, global strategy, and regulatory alignment—are best positioned to protect their innovations and maximize long-term value.
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