By Dan Aicher, CEO of EmbedTek, LLC
Medical device designs are complex – from the technological advancements that created them and interconnects between different functional facets, to their enclosures and regulatory requirements. When you add scalable manufacturing to the mix, medical device OEMs are faced with a complex burden to manage. Third party partners experienced in medical product design, supply chain, manufacturing, and regulatory can help OEMs streamline design without sacrificing integrity.
Consolidating multiple elements of a design into one single product can provide significant benefits to OEMs in ergonomics, regulatory, cost, and quality. Device consolidation improves the supply chain and, most importantly, the customer experience.
Ergonomics go beyond the look and feel of a device and can improve the customer experience in the field. Enhancements can be made across the board, from the device itself to how it is transported. In the case for one medical device manufacturer, the only way they could originally create the audio and video capture system they needed was to utilize three separate devices connected to a computer on a desk. The devices and the cables connecting them created clutter, consumed space, and each connection was a potential failure point. The OEM enlisted EmbedTek to consolidate the three devices into one. Here’s how we did it.
Another medical equipment manufacturer had a different ergonomic issue. They were looking to develop a compact, portable version of their popular image-guided surgery equipment. The feat would require the elimination of multiple external components, while still meeting challenging technical, regulatory, and ergonomic requirements. Requirements included the use of proprietary control and power systems as well as being portable, durable, and medically rated. The enhanced version also needed to have the same high-performance computing as the larger, original version. This included high-resolution 3D graphics, field generation, instrument tracking, and surgical interface. Here’s how we did it.
EmbedTek engineers leveraged proven best practices and experience with embedded computing and integrated touchscreens in surgical applications as building blocks for the design of this elegant solution. The resulting product exceeded the original goals of the program, was completed on time, and has expanded the available market of the product.
Working with a supply chain expert in a device consolidation means less vendors to work with, better lifecycle management of each component, and, often times, a reduced cost of production. When the audio/visual imaging manufacturer consolidated multiple audio/visual devices into one, they were able to streamline their own manufacturing process and gain a competitive edge in the market. They also experienced a 25% cost reduction, improved revision control, and long-term availability.
When EmbedTek engineers designed the consolidated audio/visual device, they leveraged existing supply partners of COTS components, enabling competitive costs, consistent availability, and revision control. The custom components represent less than $100 and can be applied to other embedded computers without modification. This allows the solution to participate in new computing developments and software releases. An added bonus is the single SKU that makes it easier for buyers to manage.
For the portable image-guided surgery device, EmbedTek’s FDA registration as a Contract Manufacturer of Medical Devices and our ISO 13485 certification meant the customer could follow its normal supply chain and minimize the risk of bringing the new device to market.
Better Quality Experience
Consolidation to one SKU drastically reduces points of failure and interconnects, resulting in fewer issues in the field. The audio/visual imaging system features a custom enclosure designed by EmbedTek with supportive branding. Consolidating the system from three-plus devices into a single device eliminated multiple layers of cable interconnects improving reliability substantially and eliminating most of the prior installation and commissioning process/requirement.
Similarly, the design of the portable image-guided surgery device incorporates what had been several external devices and a custom power supply into a single device. This resulted in a substantial reduction of the number of discrete parts and power supplies, resulting in a better in-field quality experience.
Reducing the number of devices, the complexity of the solution and the number of suppliers involved streamlines the regulatory management burden and reduces the risk of a regulatory related disruption to product fulfillment.
EmbedTek partners with medical device manufacturers to achieve their desired design improvements while optimizing the supply chain to make it appropriate for a medical device. We have a long track record of meeting “nice to have” features and stretch goals while staying ahead of schedule. Quality, cost, supply chain, ergonomics, and product consolidation can provide a huge win to medical device OEMs. Connect with EmbedTek to explore the possibilities: https://www.embedtek.net/medical-devices/.
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