Medtech innovators understand the importance of navigating regulatory pathways on the route to market, but could the right IP strategy help them too?
Hosted by Withers & Rogers and delivered with the support of regulatory specialists from Educo Life Sciences, the Medical Device Regulatory Affairs Surgery provided medtech companies and entrepreneurs with more information about the importance of IP and regulatory alignment throughout the innovation process.
Regulatory pathways for medical devices in the UK and Europe are especially complex, and not without reason. When devices are directly linked to a person’s health, whether that involves monitoring their biological data, such as glucose sensors, or acting as a surgical implant, such as a joint replacement or stent, the implications of these technologies not working correctly can be life-threatening.
Regulatory pathways are designed to mitigate risks by appropriately categorising, testing, and monitoring medical devices throughout their development and lifecycle. This process is intended to provide assurance that applicable regulatory requirements relating to the safety and performance of a device have been addressed before it is placed on the market.
Patent and regulatory strategies serve different purposes, but decisions made in one area can have important implications for the other. Considering them together at an early stage can help medtech businesses make informed decisions as their technology develops.
Commercial protection is a key consideration for medtech innovators as new devices could be refinements of existing technologies, technologies designed for a particular patient group, or new approaches to monitoring, managing or treating a health condition. Patent protection should therefore be considered at an early stage, ideally before details of the invention are publicly disclosed. It is also important to consider how the timing and content of regulatory activities may interact with the patent strategy.
Patent protection can help innovators protect technical features of a medical device or its underlying technology while the product progresses through development and regulatory pathways. It can take anywhere from 18 months to several years for a medical device to complete the relevant conformity assessment and reach the market, depending on the category of the device. If clinical investigations are required, the development and regulatory timeline may be longer, particularly for more complex or higher-risk devices. Where patent protection is obtained, it can provide an important means of preventing competitors from exploiting technology covered by the patent, including while a product progresses towards market launch.
Adopting IP best practice at the outset can help innovators to attract the investment needed to bring their products to market, and it can also enable R&D-led collaborations. Bringing a new medical device to market typically involves manufacturers, clinical investigations, software developers, investors and other stakeholders, and so a strategic approach to IP protection can help to support collaboration and provide greater clarity around the ownership and use of relevant technology.
IP can also be particularly valuable where pharmaceutical and medical device technologies intersect. For example, an established drug, such as a GLP-1 medicine, might be administered using a new or improved medical device. Depending on the particular technical features of the device or its combination with a particular pharmaceutical, and whether the relevant requirements for patentability are met, aspects of the resulting technology may be capable of patent protection. This illustrates how patent strategy and regulatory strategy can be considered together when developing combination products.
The patent process can also help innovators identify the features that distinguish their technology from existing solutions, and consider which aspects of the innovation may warrant protection. Clearly defining the intended purpose of a device is equally important when developing the regulatory strategy, including when considering its classification and the claims that can appropriately be made for the product. In the UK, medical devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). Aligning patent and regulatory strategies at an early stage can help innovators identify potential issues and consider how decisions in one area may affect the other.
Navigating complex pathways to regulatory compliance and market access at the same time as securing robust commercial protection may seem like a lot for innovators to take on, but the two can intersect at important points during product development and commercialisation. Taking advice on both areas at an early stage can help innovators identify potential issues, make informed strategic decisions, and plan their route to market.
Georgia Mann
This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.
© Withers & Rogers LLP October 2026
