Medical devices must perform safely and consistently throughout their intended use. Risk management therefore needs to begin during development rather than being treated as a final-stage compliance exercise.
Early decisions about materials and manufacturing can affect the finished device. For adhesive-based products, this can include attachment performance, skin compatibility and behaviour throughout the intended wear period.
Identifying foreseeable risks early gives development teams more opportunity to investigate alternatives and introduce appropriate controls before a design becomes established.
Overview of ISO 14971
ISO 14971:2019 provides an internationally recognised framework for managing risks associated with medical devices throughout their lifecycle.
The standard requires manufacturers to establish a risk-management process that identifies hazards, estimates associated risks and determines appropriate controls. Residual risk must then be evaluated, with production and post-production information feeding back into the process.
Risk management should remain linked to product development. Manufacturers need to consider the intended use of the device and reasonably foreseeable misuse, alongside characteristics that could affect safety.
Risk acceptability criteria should also be established so that identified risks can be assessed consistently.
ISO/TR 24971:2020 provides guidance on applying ISO 14971:2019.
For manufacturers operating in the US, ISO 14971:2019 is also relevant within the FDA regulatory framework. The FDA recognises ISO 14971:2019 as a consensus standard, while the FDA’s Quality Management System Regulation (QMSR), effective from February 2026, incorporates ISO 13485:2016 into its quality-system requirements.
Identifying Material & Adhesive-Related Risks Early
Risk identification should begin while materials and device constructions are still being evaluated. This gives development teams greater flexibility to investigate alternatives before a construction progresses towards validation.
Material-Related Risks
Material selection can introduce risks that depend on the device and its intended use. Areas for consideration include:
- Biocompatibility and skin contact
- Chemical compatibility
- Sterilisation compatibility
- Ageing and shelf-life behaviour
- Interactions between materials
- Variability between suppliers or material grades
A material that performs well in isolation may behave differently once incorporated into a complete construction. Surrounding layers and the manufacturing process can influence its final performance.
Material assessment should therefore reflect the construction in which the material will actually be used.
Adhesive-Related Risks
Adhesives can introduce additional performance considerations where they are responsible for attaching a component or maintaining contact with the skin.
Potential concerns include insufficient adhesion or excessive adhesion. Performance may also change when the device is exposed to conditions such as moisture, temperature or movement.
For some applications, edge lift or partial detachment may create a risk and the significance of these factors depends on the device, its intended use and contact duration.
Testing can provide objective evidence about adhesive performance. Depending on the application, this could include peel, shear or tack testing. Ageing and environmental conditioning may also be appropriate where these conditions could affect performance.
The most important factor is that standardised adhesive data should be considered alongside the actual device construction rather than in isolation.
Manufacturing Considerations
Material selection also needs to account for manufacturing consistency. A construction may meet an initial performance requirement while creating challenges during converting or scale-up.
BDK can provide material and manufacturing insight during development, helping customers assess compatibility and adhesive performance before moving towards larger-scale production.
Risk Evaluation & Risk Control
Identifying a hazard is only the starting point. Manufacturers must evaluate the associated risk against their defined acceptability criteria and determine whether further controls are required.
Under ISO 14971, manufacturers analyse risk based on the probability of occurrence of harm and the severity of that harm. This risk is then evaluated the resulting risk against defined acceptability criteria. For material and adhesive-related risks, mitigation could involve selecting an alternative adhesive construction or adjusting factors such as coat weight or contact area.
Substrate compatibility may also need to be assessed and testing under representative conditions can provide evidence about how the finished construction performs. Where sterilisation or ageing could affect performance, these conditions may need to form part of the assessment.
Manufacturing controls can help maintain important characteristics once production begins. Any control introduced during development should also be assessed for unintended effects. For example, increasing adhesive strength could reduce the potential for lift while making removal more difficult.
Verification of Risk Controls
Objective evidence should demonstrate that risk controls perform as intended. The appropriate verification approach will depend on the device and the risk being assessed.
Testing the final or representative construction can provide more relevant evidence than relying solely on the specification of an individual adhesive material. BDK can manufacture prototypes and representative constructions to support this work.
Lifecycle Risk Management
Risk management continues after design verification and product launch. ISO 14971 requires production and post-production information to remain part of the process.
New information can change the understanding of an existing risk which may arise from manufacturing experience or user feedback. Supplier changes can also require assessment if they affect a material or manufacturing process.
Changes to the intended use or reasonably foreseeable use of a device may affect the existing risk assessment too.
Where residual risks remain, manufacturers must evaluate them against defined acceptability criteria and, where applicable, consider the overall benefit-risk profile of the device.
Supplier & Material Change Management
Material and manufacturing changes require careful control. Two materials may have similar technical specifications but behave differently within an established device construction.
Potential changes include:
- Raw material formulation changes
- Supplier manufacturing changes
- Material discontinuation
- Alternative material grades
- Converting process changes
- New manufacturing equipment
A replacement material should therefore be assessed within the finished construction before implementation. This is particularly important where the original material has already been validated.
Supplier management can support this process as consistent specifications help manufacturers monitor important material characteristics. Appropriate change notification arrangements can also provide information needed to determine whether further assessment is required.
ISO 13485:2016 provides the quality-management framework incorporated into the FDA’s QMSR. It includes requirements relevant to controlling changes within the quality-management system.
Where a material change could affect biological safety, manufacturers may also need to consider the applicable biological evaluation requirements. ISO 10993-1:2025 addresses biological evaluation within a risk-management process and is recognised by the FDA as a consensus standard.
BDK can support customers through controlled manufacturing processes and material traceability. Clear technical communication around material or process changes can also help customers understand what has changed within an established supply arrangement.
Building Risk Management into Medical Device Development
Risk management should remain connected to medical device development throughout the product lifecycle.
Considering risk during material selection gives development teams greater opportunity to identify potential issues while changes can still be assessed. This can reduce the likelihood of discovering material or construction problems later in development.
For adhesive-based medical devices, the choice of materials and manufacturing approach can therefore form part of the wider risk-management process.
BDK provides medical device converting and manufacturing support for customers developing adhesive-based products. Its experience can provide practical insight into material selection and manufacturing feasibility while supporting the wider risk-management activities led by the customer’s own teams.
Contact us today to discuss your project requirements.
