CHALLENGE

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A small medical device manufacturer was developing a polymer mouthpiece for a Class IIa inhaler. The mouthpiece would come into contact with patients, and while the device type was already well established, the team needed to understand how their choice of polymer could affect the biocompatibility plan.

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They had shortlisted several materials but were unsure what each option might mean for testing, documentation and regulatory expectations. With limited in-house regulatory resource, they wanted clear guidance before committing to laboratory work.

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The goal was to avoid unnecessary testing, while still building a plan that reflected the contact type, duration of use, intended patient population and relevant regulatory requirements.

 

SOLUTION

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Hands on Research carried out a focused Biocompatibility Test Planning review.

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We reviewed the proposed polymers, device configuration, patient-contact profile, supplier information and evidence from comparable materials already used in the market. Using ISO 10993-1:2025, we assessed what existing evidence could reasonably support and where further testing might still be needed.

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This helped the manufacturer take a risk-based approach to biocompatibility, rather than defaulting to a broad testing programme. For a mid-risk, lower-classification device using well-documented materials with a history of market use, we identified where existing data could help reduce additional testing, including the need for animal studies.

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We then set out a practical testing route that was proportionate, ethical and aligned with regulatory expectations.

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RESULT

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The manufacturer gained a clear biocompatibility strategy before starting laboratory testing.

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The review helped the team compare polymer options, avoid unnecessary studies and prepare a concise rationale for discussions with test laboratories, suppliers and internal stakeholders. It also gave them a clearer view of the remaining evidence gaps and how to address them.

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By taking an evidence-led approach, the manufacturer was able to move forward with a proportionate biocompatibility package that supported regulatory compliance, controlled costs and kept patient safety at the centre of the decision-making process.

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