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Beyond Clinical Data

Beyond Clinical Data

A medtech deep dive into different paths to market

Federica Montrone
July 24, 2024

As some of our most avid readers may remember, in one of our recent issues we deep-dived into First in Human (FIH) studies, a hallmark of MedTech companies.

As stated at the end of that issue, FIH is just a milestone that falls within the very early stages of developing a new medical device. If clinical data has to be collected, then FIH is just the beginning.

The graph below nicely wraps up all the steps between the early development and marketing of a medical device. FIH is just one of the initial steps along with collecting pre-clinical evidence through in vitro, in vivo and bench tests.

Source: Greenlight Guru

Is Clinical Data mandatory for everyone?

Despite FIH being an exciting milestone in bringing a medical device to market, not every device needs to go through it and it’s still possible to bring value to the market with an innovative solution without clinical data.

The unique pathway your device will follow strongly depends on the intended application and which innovative elements the technology per se is bringing to the device.

According to the risk, each device is categorised: Class I for low-risk devices, Class II for medium-risk devices and Class III for high-risk ones. While for Class III gathering clinical data is mandatory, that does not always apply to Class I and II.

In fact, achieving clearance for a Class I device only requires to undergo general controls, while a Class II device might need special controls and in some cases collect clinical data too.

The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market.

The key is to ensure safety and effectiveness.

For example, within Class II, a very common route is the 510(k) regulatory path. This path is used to demonstrate that a medical device is substantially equivalent to an already existing device such that safety and effectiveness are ensured through comparison. 99% of Class II devices are cleared through this route.

Why does this matter to you?

The majority of medical devices fall into Class I or Class II (respectively 47% and 43% of all medical devices) with 95 % of Class I being exempt from regulatory processes.

Class III covers the remainder 10% of medical devices with the obligation to follow the demanding PMA (Pre-Market Approval process) which strictly requires a strong collection of Clinical Data.

Only in very rare cases, clinical data is required for a 510(k) submission which means that only a small number of medical devices have to go through all the stages of regulatory approval and clinical development.

Of course, companies tend to choose the less cumbersome path which means less time and fewer investments to reach the market. Consider that the average time to get an answer from a 510(k) submission is 150 days while it’s around 399 days for PMA (Class III) devices.

Depending on the stage you are in within the development cycle of a new medical device, things change a lot in terms of timeframes and effort. The higher the risk the more the milestones to be reached to get approval and bring the product on the market.

If you’re working in a medtech company, knowing the intended use and the market will certainly help you better understand the potential timelines ahead of your journey.

If you enjoyed this issue, share it with someone who works in medtech!

This week's top scientific reads

A roadmap for affordable genetic medicines (Nature)
LAB-Bench: Measuring Capabilities of Language Models for Biology Research (ArXiv)
Impact of structural variants in hematopoietic stem cells (Nature)
Ultrasounds can improve mindfulness (Frontiers in Human Neuroscience)
Robot radiotherapy for the treatment of eye diseases (The Lancet)

Latest European funding rounds in health & bio

Vanrix raised €4.1M for its regenerative medicine technology that focuses on articular cartilage regeneration 🇨🇭
Onego Bio raised €14M to develop & commercialize animal-free egg protein 🇫🇮
Bioniq closed a €13.8M Series B for its platform that provides personalised supplement recommendations based on blood test data 🇬🇧