Hear from medical device experts at Resonant Link and Cirtec Medical as they share actionable strategies to get your next-generation or novel implantable medical device to market faster. Topics covered include:
1. Common mistakes to avoid
2. Tips to accelerate design and development without sacrificing quality
3. Regulatory considerations
4. Lessons learned from working with the leading medical device companies
Hit play below to listen to the webinar now or continue reading for the webinar highlights.
It's Important to Design Devices for Manufacturability
One of the biggest pitfalls to avoid when bringing a new or next generation medical device to market is having to undergo costly redesigns because something about the device's design doesn't work. Reworks could be needed because of several reasons, from failed trials to going over budget on the per unit cost to make the device, or the COGS (cost of goods sold). Many of the factors driving reworks can be avoided with diligent planning and attention upfront to designing the medical device for manufacturing and production. Designing for Manufacturing or Designing for Manufacturing and Assembly (DFM or DFMA) entails optimizing the product's design for its manufacturing and assembly process, merging the design requirements of the product with its production methods to ensure that not only will the design meet the performance requirements of the medical device, but that it can be build on time, on budget, and with as little risk as possible.
Companies should identify a cost target upfront for how much each device should cost to make, and consider cost as a parameter and trade-off when making design decisions. The highest value of a medical device is on the day it launches, and after that, the ASP or weighted average price of that device will only erode from there. So designing for manufacturability should also ensure long-term profitability of devices by taking into account accessibility of different components as well as the cost to produce them.
Semi-Custom Offers Significant Benefits vs. Custom Medical Device Design
Using off-the-shelf components can significantly reduce costs for medical device companies. Custom medical devices can cost between $15-$20 Million whereas medical devices using an off-the-shelf design and components, such as off-the-shelf packaging, ASICs, and wireless charging, can cost just 10% of the total cost of a custom medical device, or $2-$2.5 Million. A great option for companies who are making a novel or next generation medical device with some custom functionality is to look for off-the-shelf functionality that can be slightly modified, for a semi-customized device design.
It Pays to Assess Feasibility Upfront
Both Cirtec Medical and Resonant Link offer accelerated design and development, and that starts with what's known as Phase 0 or assessing the feasibility of a device. During a feasibility study, different parameters are modeled to reflect desired inputs, from performance inputs to materials used such as titanium for biocompatibility. The outcome of a study is a set of specifications for the device to meet performance, manufacturing, and cost criteria. The study answers questions like "what form factor is possible for my device?" and "how fast can I recharge my device's battery?". Assessing feasibility upfront is a critical step to designing and developing high performing medical devices as it surfaces trade-offs and potential issues, like tissue heating or size constraints, upfront when decisions can be made to mitigate them without having to go through a full redesign and rework of a medical device. One example of the importance of assessing a device's feasibility upfront is that the form factor of an implantable medical device is driven by the size of its battery. It's critical to figure out your device's power management strategy upfront because if you don't, you might have to redesign the device to ensure it has the right amount of power at the right time.
Resonant Link offers a 6-week feasibility analysis and design process called an Opportunity Study, through which medical device companies can understand and define the best wireless power system design for their device. Learn more about the Opportunity Study.
Summary
For all of the insights from panelists Will Pitkin, Chris Polek, and Grayson Zulauf, watch the full webinar. Contact us with questions about your medical device.
