Navigating the Minefield: IP Considerations and Risks in AI Medical Device Creation

The siren song of AI promises to revolutionize medical technology – conjuring images of wheelchairs commanded telepathically and instantaneous diagnosis via smartphone. But during product development, the harsh realities of IP protection emerge. It is risky not to tend to IP considerations in product development activities. Recent studies reveal 62% of medtech engineering leaders cite difficulty navigating third-party patents and IP rights associated with AI/analytics capabilities (CSC, 2021). And the risks compound from there:

Unwitting Infringement Landmines

With over 6,000 global AI health patent families held by companies like IBM, infringement allegations loom large over product launch. Freedom-to-operate searches during design phases mitigate risk.

Open Source & Data Quandaries

While open source AI frameworks expedite development, integrating modules under licenses like GPL introduces complex ripple effects regarding proprietary extensions. Similarly, utilizing third-party data sets highlights ownership uncertainty.

Regulatory Unknowns

Governing AI/ML medical devices, regulators still rely on traditional frameworks like FDA’s Quality System Regulation. As requirements evolve, so must parallel IP preparations accounting for pivotal clinical trial or transparency needs.

For medical device makers traversing this precarious landscape, IP consultants well-versed in AI can illuminate safe passages:

Leveraging landscape analyses of key patent holders, GPS analysts and consultants help clients assess infringement dangers or licensing options for necessary IP. By illuminating open source framework and data set ripple effects early on, we preemptively de-risk downstream impacts. And via ongoing regulatory insights, companies can ensure that product planning integrates both existing and forthcoming guidelines.

With AI promising to reshape the healthcare horizon, new questions now emerge – what hidden obstacles obscure your organization’s path ahead? Perhaps the prudent first step is simply opening your eyes to the challenges already lying ahead.

This article is the third in a 4-part blog series focused on the intellectual property impacts of AI in medical devices. To start the series at the beginning, click here.

Next up in our series, we look at Medtech IP Strategy Creation, particularly as it pertains to the industry impact of AI.