Medical device design for manufacturability is more important than ever. The success of a launch can not only affect speed-to-market, but it also affects patients on the other side. Are your complex electro-mechanical devices causing inefficiency and costing more money to manufacture? Or is communication and product lifecycle management causing delays in manufacturing? That’s what a Nortech client was experiencing when they first brought their unique medical device to the table.
Our client, a well-known surgical and medical device company, came to us with a product development issue. They needed our help taking a custom-made Bluetooth console and multiple probe models from a two-piece board assembly to a one-piece board, making it much more efficient to build. The challenge was maintaining the same level of functionality that identified and removed cancer in the body while trying to minimize assembly parts. They also needed help increasing manufacturing efficiency and increasing manufacturing yield.
The multiple probe models work together with the console to identify concentrations of the drug in the patient’s body. This probe detects concentrations of the drug which can indicate cancerous tissues. Those tissues are then removed and biopsied to see if treatment is necessary.
Medical Device Design for Manufacturability
The single-piece design is highly complex due to the sophisticated board layout. Additionally, the concentrated location criticality of components and susceptibility to electromagnetic interference noise [EMI] added to the complexity. Throughout the design process, the teams tested to overcome this issue. Working together the design engineers and the in-house manufacturing engineers and operators were able to consider all aspects of medical device design for manufacturability.
For our clients, this made working with Nortech unique because manufacturers are not typically as accessible during the design phase. The teams produced several prototypes before the final product design was proven and accepted. Both manufacturing and production shared feedback early in the design phase, ensuring the end product would meet the customer’s needs.
Nortech’s engineers expressed how important it was to partner with the client’s design and development team. “We need everyone’s input to make it successful.” They continued, “It’s not us and them, we’re a team.” Communication and creating deep trust were key in developing a real team that could accomplish this project. As a result, the close-working relationship with this client allowed the team to do outstanding things with the design and build of this device.
Nortech’s Milaca facility has deep experience with higher level assemblies and integrated complex electro-mechanical devices. Our team was well-prepared to meet the client’s needs with attention to qualified materials and processes as well as regulatory requirements.
Total product lifecycle management and history, plus a flexible and robust quality management system and client input in each stage has made this design successful. Our client received the regulatory/agency approval necessary and in 2023, started marketing the newly redesigned product to medical providers worldwide.
Learn how we can help you improve medical device design for manufacturability. Contact us now!