By Dan Aicher, CEO of EmbedTek, LLC
Medical device designs are complex – from the technological advancements that created them and the interconnections between the various functional facets, to their packages and regulatory requirements. When you add scalable manufacturing to the mix, medical device OEMs face a complex load to manage. Third-party partners experienced in medical product design, supply chain, manufacturing, and regulation can help OEMs streamline design without sacrificing integrity.
Consolidating multiple elements of a design into a single product can provide significant advantages to OEMs in terms of ergonomics, regulations, cost and quality. Device consolidation improves the supply chain and, most importantly, the customer experience.
Ergonomics
Ergonomics goes beyond the appearance of a device and can improve the customer experience in the field. Improvements can be made at all levels, from the device itself to the way it is transported. In the case of a medical device manufacturer, the only way they could originally create the audio and video capture system they needed was to use three separate devices connected to a computer on a desk. Devices and the cables connecting them created clutter, consumed space, and every connection was a potential point of failure. The OEM called on EmbedTek to consolidate the three devices into one. Here’s how we did it.
Another medical device manufacturer had a different ergonomic problem. They were looking to develop a compact, portable version of their popular image-guided surgery equipment. The exploit would require the elimination of several external components, while meeting difficult technical, regulatory and ergonomic requirements. Requirements included the use of proprietary control and power systems, as well as portability, durability, and medical rating. The upgraded version was also to feature the same high-performance computing as the larger original version. This included high-resolution 3D graphics, field generation, instrument tracking, and a surgical interface. Here’s how we did it.
EmbedTek engineers leveraged proven best practices and experience in embedded computing and touch screen displays in surgical applications as the building blocks for the design of this elegant solution. The resulting product exceeded the original program goals, was completed on time, and expanded the available market for the product.
Supply chain
Working with a supply chain expert in a device consolidation means fewer suppliers to work with, better lifecycle management of each component, and often a lower cost of production. When the AV manufacturer consolidated multiple AV devices into one, it was able to streamline its own manufacturing process and gain a competitive edge in the market. They also benefited from a 25% cost reduction, better revision control and long-term availability.
When EmbedTek engineers designed the consolidated audio/visual device, they leveraged existing COTS component vendor partners, enabling competitive costs, consistent availability, and revision control. Custom components are under $100 and can be applied to other in-vehicle computers without modification. This allows the solution to participate in new IT developments and new software releases. An added bonus is the unique SKU which 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 allowed the customer to follow their normal supply chain and minimize the risk of marketing the new device.
A higher quality experience
Consolidation into a single SKU dramatically reduces points of failure and interconnections, reducing issues in the field. The AV Imaging System includes a custom EmbedTek-designed enclosure with supporting branding. System consolidation of more than three devices into a single device eliminated multiple layers of cable interconnections, greatly improving reliability and eliminating most pre-installation and commissioning processes/requirements.
Likewise, the design of the portable image-guided surgery device integrates what were previously multiple external devices and a custom power supply into a single device. This resulted in a substantial reduction in the number of discrete parts and power supplies, resulting in a better quality experience in the field.
Regulatory
Reducing the number of devices, solution complexity, and number of vendors involved streamlines the regulatory management burden and reduces the risk of regulatory disruption in product fulfillment.
EmbedTek partners with medical device manufacturers to achieve desired design improvements while optimizing the supply chain to make it suitable for a medical device. We have a long track record of delivering “nice to have” features and challenging goals while staying ahead of schedule. Quality, cost, supply chain, ergonomics and product consolidation can be a huge win for medical device OEMs. Log in to EmbedTek to explore the possibilities: https://www.embedtek.net/medical-devices/.
Content sponsored by EmbedTek
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