Frequently Asked Questions

FAQs

Frequently Asked Questions

Find the answers to some of our clients’ most common questions. If you have a question that is not covered below, don’t hesitate to ask — we’re happy to share our views and insights on any issue related to Medical Devices: production, design, quality, cost and regulatory compliance.

Sterling Industries is a leading medical device contract manufacturer with manufacturing facilities in the USA and Canada. We provide end-to-end solutions that help our clients — whether Fortune 50 companies, late-stage startups or ‘scale-ups’ — manufacture, assemble, package and deliver their medical devices at scale.

A medical device contract manufacturer is a company contracted to manufacture — on behalf of an Original Equipment Manufacturer (OEM) — complete medical devices, or components and sub-assemblies. Sterling Industries is a contract manufacturer that focuses on the production of complete medical devices, including assembly, packaging and labelling. We also fabricate key components or sub-assemblies for our clients.

OEM, or Original Equipment Manufacturer, refers to companies that manufacture and assemble complete medical devices to exact client specifications, ensuring these products are finished and ready-to-ship. Medical Device OEMs focus specifically on manufacturing within the strict regulatory and quality frameworks that govern medical device production.

We specialize in optimizing our clients’ proprietary designs for cost-efficient mass production. Sterling Industries’ Design Transfer process (see below) meticulously captures every nuance of our clients’ original designs. Then, our Design-for-Manufacturing (DFM) engineers  (see below) offer manufacturing and assembly optimizations that can improve quality, ensure repeatability, or reduce costs when manufacturing their medical devices at scale. We collaborate with our clients at every step.

At Sterling Industries, we take a structured approach to managing medical device manufacturing projects, emphasizing Design Transfer, pricing, and Product Lifecycle Management. This method is designed to to increase efficiency and reduce costs, while enhancing transparency, communication and project oversight. It is a repeatable process for designing any manufacturing solution our clients require, regardless of the product category or underlying technologies.

We have a clear onboarding process that includes a meticulous design transfer process to ensure we capture every detail of our clients’ designs. We also have structured manufacturing and assembly proposals to ensure our clients have complete clarity regarding project expenses and timelines. Lastly, we take a “stage gate” approach to project development, ensuring both parties have aligned and approved on product development, process development, and quality/validation plans before approving production runs.

Everything is documented and measured in our Quality Management System, and once production has begun, we follow a Continuous Improvement philosophy, seeking opportunities to improve repeatability and cost-efficiencies.

Sterling currently operates 4 medical device manufacturing facilities in the USA and Canada, covering 150,000 square feet (14,000 square meters). We have flexible, comprehensive manufacturing facilities in both the United States (Kalamazoo, Michigan) and Canada (three location in the Greater Toronto Area).
Learn more at our Facilities page

There are numerous reasons:

  1. Supply chain security: COVID & geopolitical uncertainty underline just how fragile global supply chains are. By manufacturing your medical devices in North America, at the heart of the world’s largest consumer and healthcare markets, transport and shipping lead times are significantly decreased, both inbound and outbound, minimizing exposure to global risks.
  2. Regulatory standards: North America has the most stringent standards and regulations for medical devices in the world. At Sterling Industries, our robust Quality and Regulatory practices are part of our core identity. 
  3. Innovation: North America remains at the forefront of global innovation, hosting the world’s top universities, research institutions, and technologies, giving us the ability to remain ahead of the curve and innovative in the medical device sector.
  4. Skilled labor force: as a center for advanced medical device manufacturing and innovation, North America has nurtured a highly skilled labor force with a track record of quality and compliance.

Sterling Industries has a wide range of advanced medical device manufacturing and assembly capabilities, including:

  • ISO Class 7 (10,000) Clean Rooms,
  • Electronics assembly and testing,
  • advanced injection molding & low-pressure molding (also available in Class 7 Clean Rooms),
  • DFA: Design for Assembly and Design for Automation,
  • CNC machining,
  • laser tube forming & processing
  • Metal finishing,
  • electronics integration,
  • robotic, laser, and ultrasonic welding,
  • Serialization and Lot Control,
  • automated/robotic high-speed assembly,
  • as well as labelling and packaging.

You can find a list of our full capabilities on our manufacturing capabilities page.

Sterling Industries is ISO 13485:2016 registered, C-TPAT and 21 CFR Part 820 compliant. All our facilities are FDA Registered and Health Canada Registered and maintains state-of-the-art Quality Management Systems.

Yes. All Sterling Industries facilities are FDA Registered and its Canadian facilities are also Health Canada Registered in addition.

DFM stands for Design For Manufacturing, and refers to design refinements that improve the ease, speed, quality, repeatability and/or cost-effectiveness of manufacturing medical devices at scale. Thoughtful DFM decisions can meaningfully impact the profitability and reliability of products. Related terms include DFA (Design For Assembly) or DFMA (Design For Manufacturing and Assembly).

Design Transfer is the process of readying a fully designed and validated medical device for manufacturing production. Every design feature, function and objective is specified; manufacturing processes are then designed and validated to ensure repeatable production that meets all quality and regulatory standards. Design Transfer can refer to either new products or existing products where production will be transferred to a new facility or organization.

There are a few key steps in any Medical Device contract manufacturing & assembly project, assuming the client has a validated design and has secured all regulatory approvals:

  1. Design Transfer: the client communicates all specifications of their design. The contract manufacturer may also provide design & prototyping services to help finalize the product, or Design for Manufacturing (DFM) expertise to optimize for mass production.
  2. Secure the supply chain: ensure a stable supply of inputs is available to support production.
  3. Design & validate production processes: the contract manufacturer designs and validates the assembly line and labor processes, as well as quality monitoring standards.
  4. Quality Management System: all processes and quality standards are documented and entered into an ISO certified Quality Management System.
  5. Production: with all preparation, testing and validation complete, the first production run begins. 

Sterling has medical device manufacturing facilities in both the United States and Canada, allowing us to take advantage of numerous free trade & tariff agreements and avoid quotas. Strategic configuration of a product’s supply chain, manufacturing and assembly can provide our US-, Canadian- and Internationally-based clients easy, tariff-free access to key markets. Our U.S. headquarters are proudly located in Kalamazoo, Michigan, a medtech hub for manufacturing and innovation.

About us
 

Process & Design

Process & Design
 

Sterling Industries Medical Device Manufacturing & Assembly

Manufacturing
& Assembly

Sterling Industries Quality & Certification

Quality
 

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

CEO

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.