Scaling Your Medical Device Production

Scaling Your Medical Device Production

Benefits of Partnering with a Medical Device Contract Manufacturer

David Van Slingerland

David Van Slingerland

CEO, Sterling Industries

Reprinted from BioMatters magazine

Benefits of Partnering with a Medical Device Contract Manufacturer

Whether you work for a large Medical Device OEM or a fast-growing device startup, scaling production marks a new phase in your product’s journey. You’ve already identified the opportunity, designed the solution, validated demand, iterated prototypes… perhaps you’ve received FDA approvals and sold some units into the market. Now it’s time to grow a profitable business by delivering a quality medical device, over-and-over again, without compromise.

Historically, many device makers assumed they needed to become a high-volume manufacturer, building out a facility and production line, hiring the expertise required, securing inputs and managing the supply chain, handling packaging and logistics. Even for a large OEM with established products, building a new production line is a daunting and capital-intensive task. For fast-growing medical device ‘scale-ups,’ it can be paralyzing. It’s no wonder that partnering with an experienced Medical Device Contract Manufacturer is becoming an increasingly popular path to success.

Do What You're Best At

Robotic WelderWhat is at the heart of your business’ success? For most growing medtech companies, it’s product innovation, marketing and sales… not managing a complex, compliant manufacturing operation. Growing the business is your organization’s primary focus; for an experienced Contract Manufacturer, it’s efficiently managing the thousands of details and disciplines required to consistently produce medical devices that meet stringent industry regulations.

In today’s competitive labor markets, one of the biggest advantages of working with an established, Medical Device Contract Manufacturer: they tend to attract and retain the industry’s top talent, by offering them a steady supply of cutting-edge, innovative medical device projects to work on.

Design for Manufacturing

Design-for-Manufacturing-DFMAs the demand for your medical device grows, so does the chance to boost profits while simultaneously enhancing quality, reliability, and repeatability, if you are able to avoid costly supply chain issues. Top-tier Medical Device Contract Manufacturers with Design for Manufacturing (DFM) and supply chain expertise can have a massive impact on the product’s business case.

The Supply Chain Challenge

When new medical device scale-ups attempt to scale their own manufacturing in-house, one of the most common and surprising challenges faced is managing the supply chain. The seemingly straightforward task of obtaining inputs and components can quickly become a major risk to both the business and staff when faced with unexpected shortages or price increases. Securing reliable sources, managing price fluctuations, and having effective contingency plans require both meticulous planning and maintaining strong relationships with a wide range of suppliers. This is where long-established Contract Manufacturers have an advantage: because they produce a broad range of products, they typically have strong relationships with a wide range of reliable suppliers.

Technology and Facilities

Medical-Device-Cleanroom-2For medtech ‘scale-ups’ and OEMs, the most obvious advantage of partnering with a Contract Manufacturer is the lower capital requirements. The idea of constructing a suitable facility – especially when demand growth and profitability are still unclear – typically involves significant capital investment and betting on uncertain projections. By contrast, a good Contract Manufacturer will typically own much of the advanced technology required for producing your medical devices; and any capability they don’t have in-house, they can often obtain through trusted subcontractors.

Certification, Compliance and Quality

Lastly, in this highly regulated and scrutinized industry, it’s crucial for medtech companies to safeguard their reputation. Clients of top-tier Medical Device Contract Manufacturers benefit from using their FDA-registered facilities, ISO certification, and robust quality control systems – all respected industry standards that are expensive and resource-intensive to maintain.

FOR ANY TEAM TASKED WITH SCALING PRODUCTION OF A MEDICAL DEVICE – whether from a well-established OEM or a fast-growing scale-up – in-house manufacturing presents a capital-intensive and resource-consuming challenge that can pose significant risk to the business. Device makers are increasingly turning to medtech-exclusive contract manufacturers – like Sterling Industries – that have a track record of helping medical device makers increase quality and profitability, while reducing risk.

If you’re looking for a partner to help manage production and free up resources for business growth, don’t hesitate to reach out to learn more about how Sterling Industries can help your medical device succeed in the marketplace.

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