FDA’s September Biocompatibility Update Should Be On MedTech Marketing’s Radar

FDA’s September 9 town hall on medical-device biocompatibility discussed updates to ISO 10993-1:2025 and risk-based approaches to evaluating device biocompatibility, including material-mediated pyrogenicity and systemic endpoints.

The update is not simply a regulatory affairs matter. It also matters to medtech marketing departments.

Changes in how a company evaluates and documents biological safety eventually affect product messaging, sales materials, and the claims teams are comfortable making in the market. Regulatory changes like these updates create a communication ripple effect.

The Technical Story Behind The Product Is Changing

FDA’s approach to biocompatibility is explicitly risk-based. The agency says its endpoint framework is not simply a testing checklist. Relevant endpoints should be addressed using existing data, additional testing, or a documented rationale explaining why additional assessment is unnecessary.

FDA also looks beyond an individual raw material. Its assessment considers devices that directly or indirectly contact the body and evaluates the potential for an unacceptable biological response. Factors can include the device materials, manufacturing, sterilization, anatomical location, and duration of contact.

The nuance here matters to marketing teams. A broad statement such as “made with biocompatible materials” may not accurately communicate the evidence supporting a finished device. The actual story could involve material characterization, endpoint-specific testing, and a documented risk assessment. Marketers do not need to become toxicologists, but they do need to understand what the evidence allows them to say.

Regulatory Documentation Eventually Becomes Marketing Source Material

FDA’s own Biocompatibility Assessment Resource Center shows how much documentation can sit behind a biological safety evaluation. The agency addresses test articles, comparisons with previously marketed devices, processing and sterilization changes, formulation changes, test parameters, acceptance criteria, results, and conclusions. Much of that information will never appear in a brochure. However, it can still shape your brochure content. The same underlying technical evidence may eventually support:

• Product Messaging & Claims

• Sales Presentations

• Distributor FAQs & Training

• Technical Articles & White Papers

• Website Content

• Objection-Handling Materials

• Customer Education

• Launch Materials

Often, this is where we see medtech companies run into trouble. Regulatory, engineering, and marketing may describe the same product differently because each team works from a different level of information. Instead, Strong medtech marketing requires a reliable path from technical evidence to market-facing language.

September 9 Was Not An Isolated FDA Conversation

FDA is continuing the discussion this month. On September 23, the agency will hold another town hall focused on chemical characterization testing and extraction approaches under ISO 10993-18, including common issues and examples. Taken together, these sessions reinforce something marketers should already be watching closely. The evidence behind medical-device products is becoming more structured, risk-based, and technically specific. Marketing has to keep pace.

Medtech Marketing Needs A Better Translation Layer

Regulatory and technical teams need to clearly and consistently establish what the data supports. Next, marketing determines how to communicate that information clearly to customers. Sales also receives language that works in actual conversations. Finally, distributors receive enough information to answer questions without improvising technical or regulatory claims. Everyone works from the same source of truth. Then a regulatory update will not leave marketing discovering six months later that the product's technical story has changed.

Regulatory Change Creates Marketing Work

FDA’s September 9 biocompatibility discussion is a useful reminder that medtech marketing does begin with evidence. As the underlying regulatory and technical story changes, companies need to decide what those changes mean for positioning, product claims, and sales conversations. Strong technical marketing helps drive this value home.

At Borrowed Pen, we help medical device companies turn complex product, scientific, and regulatory information into content that speaks to buyer needs. If a regulatory or technical change has created a pile of information your marketing team now has to translate, Borrowed Pen can help turn it into a clear, consistent story across the business. Learn how we can support you.