Bringing a medical device from concept to market requires teams to balance performance, usability, manufacturability and commercial viability with a complex set of regulatory requirements.
Compliance must be considered within decision-making throughout the process. From material selection and supplier qualification to testing and change control, all of these factors can influence the evidence required later.
For product development teams, the challenge is to identify potential issues early enough to avoid unnecessary redesign or other delays. While regulatory compliance is supported by specialist teams, understanding where challenges can emerge can help engineering and manufacturing teams make more informed decisions through development.
Common Compliance Pitfalls to Avoid
Often, compliance challenges develop through a series of smaller decisions made during product development. Common examples include:
- Selecting materials primarily around performance or cost
- Incomplete documentation
- Insufficient verification and validation planning
- Weak supplier oversight
- Poorly controlled changes
Poor change control is another compliance pitfall to be aware of, such as:
- Supplier changes
- Adhesive formulation changes
- Substrate changes
- Manufacturing process changes
- Notification/change-control procedures
- Reassessment of verification/validation following a change
It’s vital to stay up to date with any changes during the process, not just to take the product timeline into account, but to ensure all compliance checks and changes have been actioned. At BDK, we are fully aware and in control of any changes from development through to production.
Although adhesives may represent a relatively small part of the overall device construction, their properties can affect factors including wear duration, device performance, skin contact and manufacturing consistency. Therefore, material and adhesive decisions should be considered within the wider requirements of the device rather than treated as isolated component choices.
Leaving Regulatory Considerations Too Late
One potential pitfall is making these decisions before the relevant regulatory requirements have been fully considered.
Additional evidence may be required during verification or a material change after testing may create a need for further validation during the development process. If changes are required after a design has been largely finalised, teams may face additional development work which causes documentation amendments and delays.
Regulatory considerations should be incorporated into development planning from an early stage and with appropriate collaboration with the relevant teams. Frameworks, such as ISO 13485 for quality management and ISO 14971 for medical device risk management, can provide important guidance for the development and control of medical devices.
Early cross-functional collaboration helps teams to understand the parameters within which they can innovate, create and develop new solutions.
Inadequate Material Characterisation & Evaluation
A material that performs well individually will not necessarily deliver the same results once incorporated into a finished medical device; particularly, adhesive components.
Adhesive performance can depend on interactions with carrier materials, device substrates, sensors, patient skin, environmental and manufacturing conditions. Sterilisation and the intended clinical use environment may also need to be considered depending on the device.
For skin-contact applications, biological evaluation considerations can introduce another important consideration. ISO 10993-1, for example, provides a framework for biological evaluation within a risk management process. The key is to evaluate materials in the context in which they will actually be used.
Teams should also be cautious about substitutions as two materials may appear comparable on a specification sheet, but changing an adhesive, carrier or other component can affect the finished construction. It may also create additional verification or validation requirements.
This is where involving an experienced adhesive converting and manufacturing partner early on can add value. BDK can work with medical device manufacturers to consider material compatibility and manufacturing feasibility before production begins.
Poor Documentation
It is vital for teams to provide appropriate evidence supporting the development process and it is recommended to maintain this information throughout development rather than trying to recover it retrospectively. Documentation gaps can become particularly problematic when teams attempt to reconstruct information late in development.
For example, if an adhesive has been chosen for a particular application, appropriate documentation relating to its specification, supply and use within the device is required.
Depending on the applicable regulatory framework and device, documentation may include areas such as technical documentation, design records, risk management records and traceability between design requirements and verification activities.
Plus, working with suppliers and manufacturing partners that can provide relevant material specifications, certificates of conformity, traceability information and manufacturing records can support the device manufacturer’s wider requirements.
Underestimating Testing Requirements
Successful initial testing can create confidence in a new device construction, but it does not necessarily demonstrate how that construction will perform throughout its intended lifecycle.
Depending on the device and application, verification and validation activities may need to consider factors such as mechanical performance, ageing, environmental conditioning, packaging, shelf life and manufacturing process.
Adhesive components can introduce their own performance considerations. Testing may examine characteristics such as:
- Peel adhesion
- Tack
- Shear performance
- Wear duration
- Performance following ageing
- Environmental exposure
Recognised test methods can provide useful frameworks for particular adhesive properties e.g. ASTM D3330 for peel adhesion, ASTM D3654 for shear adhesion, ASTM D6195 for loop tack.
Testing should reflect the requirements of the finished application though. Real-world performance can involve combinations of movement, temperature, moisture, skin contact and extended wear that are difficult to understand through a single test.
Supplier Misalignment
The right material is only valuable if it can be supplied and manufactured with the consistency a medical device requires. Therefore, supplier selection is another important consideration during development.
Cost will naturally form part of procurement decisions, but evaluating suppliers primarily on price can overlook factors that become important later. Teams may also need to consider:
- Material and manufacturing traceability
- Supply consistency
- Technical documentation
- Change notification processes
- Manufacturing capability
- Capacity for future scale-up
A supplier change or undocumented material variation can have consequences beyond procurement; this may affect device performance and long-term lifecycle management.
For adhesive components, a specialist converting partner can help bridge the transition between material selection, prototypes and scalable manufacture. BDK works with medical device manufacturers to transform adhesive materials into repeatable, manufacturable components and constructions.
Building Compliance Considerations Into Product Development
Avoiding compliance-related setbacks may not remove risk or uncertainty from medical device development entirely, however it means making decisions with an understanding of how they may affect later stages.
For adhesives in particular, an early decision that appears small can have implications much further down the development line.
Contact BDK’s technical team to arrange a consultation about your specific medical device manufacturing requirements. Our expertise in medical device contract manufacturing enables us to support customers from development through to commercial production.
