Are you considering patent protection for your software as a medical device? Should you keep your secret sauce via the trade secret route? Perform due diligence to stay ahead of the competition. In this episode of the Global Medical Device Podcast, Jon Speer talks to Kevin Buckley and Neil Thompson from Torrey Pines Law Group. Their biotech-focused legal firm specializes in artificial intelligence (AI) applied to medical devices. Together, they discuss intellectual property (IP) with software as a medical device (SaMD) and AI and machine learning (ML) powered technologies. Some highlights of this episode include: • Patent or not? From a patent perspective, it’s easier to understand protecting software from an IP perspective by considering the problem to be solved. • Perform a patent search using third-party vendors to determine if competitors have claimed inventions and infringement information. • Due diligence of competitive intelligence should address licensing, acquisition, investments, and freedom to operate that enhances research and development. • Interest in adapting AI, machine learning (ML), and SaMD is increasing as clients develop technologies from scratch (De Novo) for better ways to help people. • When deciding whether to seek patent protection on technology, consider international patent laws and follow the Alice: Two-step Rule for patent eligibility. • The pros and cons of choosing the patent protection over trade secret route include whether clients need limited or unlimited duration to enforce patent rights. • AI-enabled inventions, such as X-ray imaging, is software that utilizes and combines new/existing devices as systems using ML, algorithms, and datasets. • Regulatory pathways for medical devices include 510(k) and De Novo. Predicate devices may be required and potential improvements may be patentable.