Companies introducing new sensor-driven technologies to the biosensor market must make careful and strategic decisions at the design stage if their products are to compete with existing players. In the excitement of burgeoning product ideas, it's easy to forget the need for component compatibility, but this is an important consideration that has a significant impact on market viability.
Selecting components for sensor-driven medical devices is difficult. They must not only be compatible with each other, but also fit into demanding environments (particularly wearables and implantable products) and assembly processes for scalable manufacturing.
Because contract development and manufacturing organizations (CDMOs) understand how incompatible components can derail production, force recalls, threaten profitability, and even put lives at risk. , we regularly consider component compatibility during the design phase. These pitfalls can be avoided with a design-for-manufacturing (DFM) approach.
The following discussion details four component selection considerations that companies should address during the design phase to reduce cost, reduce risk, and accelerate timelines for sensor-driven medical devices.
1. Lifetime monitoring in design and manufacturing
Obsolescence is a major concern for biosensor and microelectronic device manufacturing. Unlike consumer electronics, which are considered to be characterized by planned obsolescence, medical devices must operate reliably for many years in demanding environments. When even one component on a bill of materials reaches end of life (EOL), the entire supply chain can be disrupted.
Consider a real-world scenario where a component has reached the end of its life and is no longer usable.
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Without components, production stops and OEMs are unable to meet market demand.
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Patients may lack access to biosensor devices that could improve and potentially save lives.
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OEMs may even go out of business if they cannot find substitutes or substitutes.
OEMs must proactively plan for sustainability, understanding that some components will inevitably be discontinued and need to be replaced.
Proper monitoring and early notification of EOL components is critical to avoid catastrophic supply chain disruptions that can delay product timelines by months. For example, integrated circuits (ICs) have a six-month verification cycle and three-month regulatory activities, requiring a nine-month lead time. Once replacement components are identified, prototypes must be built, necessary tests performed, validation units constructed and revalidated, and regulatory issues addressed before the supply chain is disrupted.
If no alternative options are available, the device must be redesigned to achieve the same functionality. For example, printed circuit board assemblies (PCBAs) may require redesign due to obsolete package sizes. The original Gullwing may have been a 12-legged component, but its package size is EOL, and its replacement is a 12-pin ball grid array package that doesn't fit into a PCB or flex pad layout. The new components do not fit into the board form factor, so the board layout must be redesigned to accommodate the new package size. This is a time-consuming process that extends the timeline.
All this emphasizes the need not only to plan for development in the face of obsolescence, but also to address unavoidable costs. EOL monitoring is critical and OEMs must be prepared to act immediately once their EOL alert is issued. The recommended steps are:
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Inform your customers and make them aware of potential disruptions to your supply chain.
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Create a plan to address EOL components (including redesign).
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Identify EOL timeline and availability of EOL components during distribution
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Determine the quantity that should be procured beyond the current safety stock quantity, allowing EOL components to continue to be used for as long as needed.
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Negotiate with original manufacturer whether to continue production
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Evaluate replacement components to use if an EOL component becomes unavailable
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Revalidate with replacement components
It's important to choose a manufacturing partner that not only has formal monitoring processes in place, but also processes to alert and manage EOL. Without good partners and management processes, startups and small businesses are at risk because they don't have the same purchasing power as larger manufacturers. Simply subscribing to EOL alerts is not enough. The partner must have an organizational solution for managing obsolescence and a plan in advance for when components reach their EOL. This also applies to any materials used in the manufacture of sensor-driven medical devices.
2. Biocompatibility and environmental conditions
Biocompatibility is important because sensor-driven medical devices must continue to function for years without experiencing failures that require premature removal or, in some cases, can cause life-threatening situations. Critical to performance and safety. Therefore, components and materials for implantable and wearable devices should:
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Safe for subcutaneous application
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Compliant with ISO 10993 biocompatibility standards
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Corrosion resistance to prevent side effects when exposed to tissue, blood, and other body fluids
Ultimately, it is the designer's responsibility to ensure that the device is biocompatible, but some CDMOs offer consulting or testing services to assist in selecting compatible components and materials. I am.
Environmental conditions are also an important consideration. Components and materials can behave differently at different temperatures, humidity levels, and altitudes, so consider where in the world your device will be used and ensure that its components will work reliably in those environments. It is important to do so.
The production environment affects cost and manufacturability and is therefore an important consideration when selecting materials. For example, adhesives that depend on moisture in atmospheric conditions to cure can have large process variations across seasons and locations. It cures differently in hot, humid conditions like summer or Costa Rica than it does in cool, dry conditions like winter or Minnesota. Depending on the component or material, manufacturing may require controlled storage conditions, a controlled environment, or a clean room to maintain an ideal production environment. If not properly addressed, this can lead to process variations, higher scrap costs, and potential failures in the field.
When selecting components and materials for medical products, perform due diligence to ensure that the manufacturer has properly evaluated and endorsed their product and intended use. This applies to all components within the device. Electronic assemblies include everything from PCB or flex manufacturing materials, adhesives, and encapsulants to SMT chip components, capacitors, resistors, and ICs.
3. Regulatory considerations
Prioritize regulatory considerations during the design phase to ensure components and materials comply with international regulations such as RoHS and REACH. While the onus is on the designer to meet regulatory requirements, we recommend working with a trusted partner with a proven and repeatable delivery process. When evaluating a potential supplier or manufacturing partner, be sure to check their ISO certification and perform due diligence, including an on-site audit.
Biocompatibility must be considered early in the component selection process. Look for materials that have already been vetted and verified for biocompatibility to reduce potential side effects, avoid costly redesign, and increase the likelihood of regulatory approval.
Other considerations include:
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Ensure components are not affected by conflict material concerns that can disrupt supply chains
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Ensure no animal tissues or latex materials are used (note that it may be difficult to obtain such information from the manufacturer)
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Consider the markets you serve, including geographic location and prohibited or restricted materials and substances
Obsolescence must also be anticipated as part of regulatory considerations. Once a component reaches its EOL, it may require design changes that require memos and new FDA submissions, a costly process that can delay production. Again, plan to address obsolescence first and choose components and materials accordingly.
4. Beware of counterfeit products
People may not realize that if manufacturers have extra components they can sell them to brokers for resale, but when dealing with the resale market there is always the risk of counterfeit components.
Counterfeit components are dangerous to patients and manufacturers for the following reasons:
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More likely to not receive appropriate testing
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Failure can cause patient inconvenience, injury, and even death.
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Expensive recalls can result in serious damage to the manufacturer's reputation
If you buy components from a broker, reduce your risk by having them analyze the components and verify their authenticity. If your broker doesn't offer testing services, send your parts to a reputable testing lab that does. We have specialized analytical labs that can perform X-rays, probes, functional tests, and other procedures to confirm authenticity.
A qualified manufacturing partner can help address component selection considerations and avoid pitfalls that can stall production, force recalls, threaten profitability, or put patient lives at risk. . When choosing a contract manufacturer or her CDMO partner, make sure that they are responsible for the manufacturing lifecycle of the device. It doesn't end just because they get the business. Choose a dedicated partner who prioritizes accountability and protects your customers with the ability to manufacture devices throughout their lifecycle.
Darren Gilmer is Senior Engineering Manager, Product Development, and Craig Sandbulte is Vice President, Corporate Quality Assurance and Regulatory Affairs. intricon. For 40 years, Intricon has improved and extended people's lives by developing and manufacturing sensor-driven micromedical devices.Intricon partners with medical device companies to provide unique microelectronics expertise — Including miniature molding to final assembly — Regulatory guidance, supply chain optimization, and scalable production specifically for the medical market. Intricon enables the world's smallest, smartest new next generation devices.
