Can You Keep A Secret? The Trade Secret Tightrope In FDA-Regulated MedTech

• Published date: 12 November 2025
• Subject Matter: Intellectual Property, Patent, Trade Secrets
• Law Firm: Mintz
• Author: Mr William Meunier, Carolina E.K. S've and Benjamin Zegarelli

Trade secrets are a critical tool for protecting medical technology innovations. To that end, a robust trade secret management program is essential for safeguarding these valuable assets. To be effective in today's legal environment, this program must also comply with the Defend Trade Secrets Act (DTSA) which provides a federal legal framework for pursuing remedies against misappropriation, but only if the company can prove it took reasonable measures to maintain the secrecy of the information. Therefore, a successful strategy for protecting MedTech innovations requires both a proactive internal management program and compliance with the federal law requirements. But the need to maintain the confidentiality of these valuable secrets is increasingly at odds with the competing requirement to disclose information for FDA approval. This article explores this growing tension and offers practical strategies for navigating the FDA submission process without compromising proprietary information.

Why MedTech Companies Are Rethinking IP Protection

Although the industry once frequently viewed trade secrets as an afterthought to patent protection, forward-thinking medical devices companies now recognize that trade secret protection plays an equally important role in protecting their proprietary methods, designs, software algorithms, and manufacturing processes. Indeed, certain MedTech innovations - such as those involving AI-enabled software and connected devices - are often difficult to protect through patents and may be better safeguarded under well-defined trade secret policies.

But unless great care is taken, the need for FDA approval may put these secrets and policies at risk. For most class II or III MedTech devices, once a product milestone is reached and a company begins preparing for market launch, FDA authorization becomes a necessary but resource-intensive hurdle. This approval process can be a trade secret minefield because the FDA requires a vast amount of information to be disclosed in submissions to demonstrate safety and effectiveness, almost all of which is proprietary and critical for the applicant's business. Submissions are also a repository of sensitive information containing details like component specifications, unique materials, mechanical configurations, sterilization techniques, manufacturing parameters, testing protocols, control algorithms, source code, software architecture, and raw datasets.

And although the FDA is charged with maintaining confidentiality of submission information, there are, in reality, many potential risks. Sensitive proprietary details - including algorithms, data codes, source code...