Medical device products nearing the end of their lifecycle pose unique challenges to original equipment manufacturers (OEMs). Products with still-proven value to end-users and patients can be vulnerable to market forces. An upcoming patent expiration, in particular, can result in loss of market share for OEMs because of increased competition from competitors looking to replicate a successful design at a lower price point.

But a looming patent expiration can also be an opportunity for OEMs to re-evaluate and enhance their product offerings and market value. Our company has been involved in projects where a patent expiration was the impetus for a product redesign that met continued market success. In one case, we were able to re-engineer a device on behalf of an OEM to accomplish the same functional result but at a significantly lower price. The result was a major win for this customer—a device that looked, felt, and functioned like the original at a fraction of the cost.

Medical device companies are often met with challenges in their drive to cost-effectively design devices that respond to market dynamics or solve unmet medical needs for patients. It’s critical to have a contract manufacturing partner that can successfully counsel and support OEMs when a device requires a redesign or design alteration.

In the example above, our company was tasked with re-engineering a wound closure device coming off patent in order to block future competition by cutting the price point in half. A 50 percent cost reduction is a lofty goal, so the approach required a product revision, including a redesign of internal components, resulting in an updated suture closure device at a reduced and realistic price point.

Using a Design For Manufacturability (DFM) process, we first performed a financial analysis and cost breakdown to determine what costs were involved in the manufacturing and assembly process, focusing on the internal components and how these could be addressed with alternative manufacturing solutions. Our cost model helped us identify where the major cost drivers were and how these might be reduced through less expensive manufacturing operations. We also worked closely with the customer to understand how a product must function and what properties are essential in order for it to be optimally functional for the end-user.

The DFM process resulted in the following changes:

• Converting machined end-effectors to a metal injection molding process (MIM). This alone would have reduced cost significantly, but the fact that we were able to achieve the required sharpness right out of the mold eliminated a costly secondary sharpening operation.
• Adapting a Swiss Screw machine component to a laser-cut and plastic overmolded part, significantly reducing cost.
• Replacing a welding process that had joined two metallic components with plastic overmolding, reducing cost significantly while also retaining the properties and strength needed for a wound closure device.

Designing a product to look and perform equivalently to its predecessor without sacrificing integrity and functionality can be challenging. Surgeons are accustomed to an instrument performing a certain way for a specific procedure. An updated design needs to be able to accomplish the same function, fit, and form as its predecessor, allowing the surgeon to flawlessly perform each procedure.

This instrument was rebuilt with functional equivalency in addition to delivering a substantial reduction in cost. The result was well-received by the customer and surgeons. The customer ultimately gained market share with the re-engineered device and preempted a reduction of market share over the long term.

Medical device contract manufacturers must help customers overcome the many obstacles they face in delivering high-quality, functional, and efficient products—often while driving down cost. Our DFM approach entailed close collaboration with the customer to understand device functionality to improve processes while maintaining performance and cost efficiencies, enabling these customers to deliver new and improved medical technology solutions in an increasingly competitive marketplace.

When companies strive to save costs, value can be misunderstood. It isn’t always about the lowest price. Instead, it means producing the most cost-effective and efficient product that will be profitable while meeting customer and FDA requirements. Successful partnerships between contract manufacturers and medical device companies will help ensure that quality and value in product development and production are fully realized.

From： MDDI