Emily Newton, Editor-in-Chief, Revolutionized06.13.23
The medical device market is booming. Renewed attention on personal health and new opportunities emerging in the wearable tech space have led to rising demand, but this comes at the cost of heavier competition. Manufacturers must optimize biomedical device design to stand out and maximize profits.
Ensuring product quality is essential in any industry, but medical devices face higher standards than most. Design flaws can impact people’s health and lead to hefty regulatory fines, not just lower sales. Given this pressure, here are seven design tips to ensure high manufacturing quality for biomedical devices.
Start with Subchapter H of CFR Title 21, which outlines general requirements for medical devices under the FDA and HHS. However, remember you may fall under additional regulations depending on your location and the devices you’re making. You don’t need to know every law by heart, but you should understand the standards your designs must meet.
Considering these regulations from the beginning will minimize rework in the future. As a result, you’ll streamline the compliance process and bring new products to market faster.
Review your organization’s current manufacturing equipment and workflows. Can you reuse any production lines with minimal adjustment? Can you design your product to use the same types of equipment? Reusing machines and workflows wherever possible will help minimize production costs and shorten lead times, leading to faster ROIs.
The same goes for materials and components. If possible, design devices to use materials and parts you already order for other products to minimize supply chain complexity and enable bulk ordering.
Human error is the most critical factor to consider in this step. These mistakes account for over 80% of process deviations in medical manufacturing facilities, posing significant threats to material efficiency, profits, and regulatory compliance. However, you can prevent many by designing products to use less error-prone processes.
Consider using automated processes to create or assemble your device’s components. Review designs to ensure they’re easy to understand in a production setting. The easier it is to manufacture your product within acceptable parameters, the less waste it will create once it goes into production.
Counterfeit components, stock shortages, delays, and other supply chain issues are common and significantly impact your device’s development and production schedule. You can minimize these disruptions by staying in close contact and collaborating with upstream supply chain partners.
Communicate with suppliers to understand component and material availability levels. Review past supply chain trends to grasp shipment times and price fluctuations. These insights can reveal which design choices will produce a more cost-efficient and supply chain-resilient device.
Ensuring sensitive components stay unaffected by EMI is the most critical step. However, you should also consider cost and resiliency factors. Silver is the most conductive metal available, making it ideal for EMI shielding, but it’s prone to corrosion, so it may not be a good choice for applications like pacemakers. Platinum offers more corrosion resistance and less interference with other materials, but copper may be a cheaper alternative.
You can boost EMI shielding’s effectiveness through component placement, too. Face EM wave-emitting parts away from other sensitive circuitry if possible to minimize interference from the beginning. If size isn’t a pressing concern, you can place sensitive electronics farther apart.
Record why you’ve chosen to use a specific material, component, or process. If you discover you need to change part of your design, document what you changed, when, and why. This documentation can help explain choices to stakeholders, inform future adjustments, find the root cause of any issues that arise, and provide more transparency for regulators.
Keep in mind that manually recording everything may significantly impact your productivity. You can address that by using automated data entry and record-keeping software.
Digital twins use AI to replicate real-world environments and simulate various changes, helping discover better designs or manufacturing processes. These technologies can lead to a 58% reduction in the time it takes to reconfigure a production workflow, making any necessary process changes far more efficient.
Similarly, you can use AI-enabled design software to suggest optimized designs. AI can highlight where some designs may introduce issues in practice, or offer changes to reduce material consumption or boost performance. With these tools to help, following the previous six steps is far easier.
Making the most of device design means considering a huge range of factors. If you can incorporate this broader approach into your workflows, you can create effective, cost-efficient, and safe devices in minimal time to remain competitive.
Emily Newton is the Editor-in-Chief of Revolutionized. She’s always excited to learn how the latest industry trends will improve the world. She has over five years of experience covering stories in the science and tech sectors.
Ensuring product quality is essential in any industry, but medical devices face higher standards than most. Design flaws can impact people’s health and lead to hefty regulatory fines, not just lower sales. Given this pressure, here are seven design tips to ensure high manufacturing quality for biomedical devices.
1. Review Regulatory Standards Before Designing
Regulatory compliance is the most critical part of biomedical device design. Before you create anything, refamiliarize yourself with applicable laws and regulations to keep in mind throughout the design process.Start with Subchapter H of CFR Title 21, which outlines general requirements for medical devices under the FDA and HHS. However, remember you may fall under additional regulations depending on your location and the devices you’re making. You don’t need to know every law by heart, but you should understand the standards your designs must meet.
Considering these regulations from the beginning will minimize rework in the future. As a result, you’ll streamline the compliance process and bring new products to market faster.
2. Design for Efficiency
Biomedical device design typically focuses on functionality, which—although important—isn’t the only factor to consider. It takes a long time and a series of expensive trials to release new products in this industry, so you should also design with production efficiency in mind.Review your organization’s current manufacturing equipment and workflows. Can you reuse any production lines with minimal adjustment? Can you design your product to use the same types of equipment? Reusing machines and workflows wherever possible will help minimize production costs and shorten lead times, leading to faster ROIs.
The same goes for materials and components. If possible, design devices to use materials and parts you already order for other products to minimize supply chain complexity and enable bulk ordering.
3. Consider Manufacturability
Similarly, consider how easy it would be to manufacture the product while meeting a high-quality standard. If a device’s design enables high functionality but has a complex manufacturing process with significant room for error, it may not be as profitable as it initially seems.Human error is the most critical factor to consider in this step. These mistakes account for over 80% of process deviations in medical manufacturing facilities, posing significant threats to material efficiency, profits, and regulatory compliance. However, you can prevent many by designing products to use less error-prone processes.
Consider using automated processes to create or assemble your device’s components. Review designs to ensure they’re easy to understand in a production setting. The easier it is to manufacture your product within acceptable parameters, the less waste it will create once it goes into production.
4. Work Closely with Supply Chain Partners
As these last two tips highlight, no step in medical device manufacturing happens in isolation. Improvements in one phase lead to advantages in the next—the same applies to errors and inefficiencies. Biomedical device design must keep this in mind and the supply chain is another crucial outside factor to consider.Counterfeit components, stock shortages, delays, and other supply chain issues are common and significantly impact your device’s development and production schedule. You can minimize these disruptions by staying in close contact and collaborating with upstream supply chain partners.
Communicate with suppliers to understand component and material availability levels. Review past supply chain trends to grasp shipment times and price fluctuations. These insights can reveal which design choices will produce a more cost-efficient and supply chain-resilient device.
5. Look at Different EMI Shielding Options
One specific design factor that deserves special attention is electromagnetic interference (EMI) shielding. Newer medical devices tend to be more susceptible to EMI, so choosing the right shielding method and material is crucial to their functionality.Ensuring sensitive components stay unaffected by EMI is the most critical step. However, you should also consider cost and resiliency factors. Silver is the most conductive metal available, making it ideal for EMI shielding, but it’s prone to corrosion, so it may not be a good choice for applications like pacemakers. Platinum offers more corrosion resistance and less interference with other materials, but copper may be a cheaper alternative.
You can boost EMI shielding’s effectiveness through component placement, too. Face EM wave-emitting parts away from other sensitive circuitry if possible to minimize interference from the beginning. If size isn’t a pressing concern, you can place sensitive electronics farther apart.
6. Document Everything
As you design and redesign your device, be sure to keep thorough records. The more documentation you have on the design process and its influencing factors, the easier regulatory compliance and any necessary adjustments will be.Record why you’ve chosen to use a specific material, component, or process. If you discover you need to change part of your design, document what you changed, when, and why. This documentation can help explain choices to stakeholders, inform future adjustments, find the root cause of any issues that arise, and provide more transparency for regulators.
Keep in mind that manually recording everything may significantly impact your productivity. You can address that by using automated data entry and record-keeping software.
7. Use Technology to Help
Biomedical device design is complicated—especially when factoring in these quality assurance steps. You can make the process easier by embracing technologies like cloud computing and artificial intelligence (AI).Digital twins use AI to replicate real-world environments and simulate various changes, helping discover better designs or manufacturing processes. These technologies can lead to a 58% reduction in the time it takes to reconfigure a production workflow, making any necessary process changes far more efficient.
Similarly, you can use AI-enabled design software to suggest optimized designs. AI can highlight where some designs may introduce issues in practice, or offer changes to reduce material consumption or boost performance. With these tools to help, following the previous six steps is far easier.
Biomedical Device Design Must Account for Many Factors
Safety, production efficiency, regulatory compliance, and profitability all begin with biomedical device design. By optimizing this stage, you can enable a smoother process throughout the development and production lifecycle.Making the most of device design means considering a huge range of factors. If you can incorporate this broader approach into your workflows, you can create effective, cost-efficient, and safe devices in minimal time to remain competitive.
Emily Newton is the Editor-in-Chief of Revolutionized. She’s always excited to learn how the latest industry trends will improve the world. She has over five years of experience covering stories in the science and tech sectors.