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.

Dale Morgan, Director of Global Quality at Sterling Industries

Dale Morgan

Director of Global Quality

Dale is our Director of Global Quality. He brings a career’s worth of experience and leadership in Medical Devices, with deep expertise in quality management systems, regulatory submissions, quality engineering, and more.  Dale has worked with both established medical device OEMs and start-ups, as well as product certification and audit organizations. A licensed professional biomedical engineer, Dale is also certified as an ISO 13485 auditor/MDSAP.

Tim Doyle | Quality Manager, U.S. Operations

Tim Doyle

Quality Manager, U.S. Operations

As Quality Manager of our U.S. Operations, Tim brings over 30 years of experience in computer-aided surgical devices, electromechanical devices, metal fabrication and assembly processes, including clean room assembly and packaging for sterilization. He has extensive international experience, partnering on quality and supplier development projects. Tim holds the ASQ CQE designation. He also proudly served 7 years in the United States Air Force.

Patrick Tam | Quality Manager, Canadian Operations

Patrick Tam

Quality Manager, Canadian Operations​

Patrick serves as Sterling’s Quality Manager, bringing over 20 years of Quality Systems Management experience in the Medical Device and Pharma industries. He leads our Quality Management proactive, bringing a tactical and strategic focus to ensure consistent, repeatable quality for our clients. Prior to joining Sterling, Patrick served as Quality System Manager at Integra LifeSciences where he was responsible for maintaining Quality in their Canadian operations.

Jeff Kiel | Manager, Engineered Solutions

Jeff Kiel

Manager, Engineered Solutions

Jeff serves as Manager of our Engineered Solutions. He works closely with clients to evolve and refine their Medical Device designs — sometimes from the idea stage — through to a fully-optimized, scaleable, ready-to-ship product. He uses his engineering and technical expertise to design our production processes. Prior to joining Sterling, Jeff worked with Toyota in their Prototype Weld Group.

Libni Cano is our Toronto operations’ Regulatory and Quality Manager, responsible for quality and regulatory.

Libni Cano

Regulatory and Quality Systems Manager​

Libni serves as Regulatory and Quality Manager for Sterling’s Canadian sites, responsible for both quality and regulatory compliance. She has over 14 years of experience in medical device quality management systems, with expertise in FDA and Health Canada regulations as well as electronic QMS implementation. Libni is a BSI-certified Lead Auditor for ISO 13485:2016.; she is also ASQ certified with CQE and CMQ designations, and holds a BSc in Industrial and Systems Engineering.

Ronitt is our Director of Business Development with 25 years of experience, and is responsible for Sterling Industries' global business development.

Ronitt Katz

Director of Business Development

Ronitt serves as Sterling’s Director of Business Development, bringing 25 years of experience. She has an extensive background in the tech industry, having worked for IBM, TIBCO and several software companies, from startups to industry leaders. Within the Medtech space, She has vast experience in partnering with Fortune 100 organizations, early stage startups, and everything in between.

Jojo Wang is our Engineering Manager, responsible for leading our Sterling Engineering Team.

Jojo Wang

Engineering Manager

As Engineering Manager, Jojo is responsible for leading the Engineering Team. She brings a wealth of experience in Project Management, Lean Manufacturing, and Product Development, and expertise in designing manufacturing solutions and driving business improvements. Prior to joining Sterling, Jojo served as a process engineering leader for Boston Scientific, focused on electrophysiology solutions. She holds a BSc in Mechatronic Engineering & Automation, and a Masters in Engineering Management.

Lilian So is the Director of Finance here at Sterling Industries.

Lilian Soo

Director of Finance

Lilian is the Director of Finance at Sterling. She is a seasoned professional with over 15 years of progressive experience in Finance, and a talented CPA/CGA who unites operations with finance continuously improving company performance. She has extensive experience with fast paced environment, driving innovations and process improvements to help drive positive changes and optimize profitability.

John Pleskina is the Director of Global Operations for all our facilities, responsible for manufacturing operations.

John Pleskina

Director of Global Operations

John is the Director of Global Operations for Sterling, responsible for manufacturing operations. John has over 25 years manufacturing experience in a variety of leadership roles, most recently as VP of Manufacturing at Southmedic Inc.  Previously, John was Director of Operations for Scapa Healthcare where he was responsible for the effective operation of sites in Canada, the U.S. and the U.K.  A graduate of the University of Waterloo, John served over 14 years with the Royal Canadian Navy.

David Van Slingerland, CEO of Sterling Industries

David Van Slingerland


David assumed the role of CEO in 2007 and has led Sterling Industries through transformative growth. He brings over 30 years of executive experience, with deep expertise in change management and growing organizations through innovative technology and human capital. At Sterling, he has introduced an agile manufacturing model, built an industry-savvy leadership team, and is responsible for driving customer-focused end-to-end solutions. Prior to Sterling Industries, David held a variety of executive positions with Manulife Financial and Shoppers Drug Mart.