Medical OEM Manufacturing:
Questions to Ask When Choosing a Contract Manufacturing Partner

For a medical OEM, outsourcing manufacturing is about more than finding capacity. Complex medical equipment can combine mechanical assemblies, electronics, embedded computing, power, cooling, software, cabling and extensive testing—all within a regulated manufacturing environment.

GMI Solutions has supported OEMs since 1983 and specializes in low-to-medium-volume, high-mix, application-critical products. Services span New Product Introduction (NPI), Design for Manufacturability (DfM), supply chain management, electromechanical assembly and integration, application-level testing, documentation, traceability, and lifecycle support.

Below are questions medical OEM engineering, operations, sourcing and quality teams commonly ask when evaluating an outsourced manufacturing partner.

What should I look for in a medical device contract manufacturer?

Look for a manufacturer whose capabilities match the complexity, volume and regulatory requirements of your product. Important considerations include quality systems, engineering support, supply chain management, inspection, process controls, testing, traceability, documentation and lifecycle support. For complex capital equipment, experience integrating mechanical, electrical, computing, power and other technologies can also be important.

GMI Solutions specializes in low-to-medium-volume, high-mix manufacturing for application-critical products. Its services extend from NPI and DfM through sourcing, assembly, integration, testing, traceability and lifecycle support.

What certifications should a medical device contract manufacturer have?

Certification requirements depend on the product and the manufacturer's role, but ISO 13485 is an important consideration for medical device manufacturing because it establishes quality-management-system requirements specific to medical devices. Depending on the product and markets served, FDA registration and support for UL, CE, ETL or China CCC requirements may also be relevant.

GMI Solutions' U.S. and China facilities are ISO 13485:2016 certified, its Mequon facility is FDA registered for finished medical device manufacturing, and GMI supports UL, CE, ETL and China CCC certification and audit requirements.

Can a contract manufacturer take a medical device from prototype to production?

Yes, although the depth of support varies considerably among manufacturers. A strong New Product Introduction (NPI) process should address the BOM, supply chain, manufacturability, documentation, quality requirements, testing and production readiness before volume manufacturing begins.

GMI Solutions uses a formal NPI process encompassing quote, prototype and production-transfer activities. Cross-functional engineering, sourcing, quality and program-management resources work together to identify issues early and establish a controlled transition into production.

What is New Product Introduction in medical device manufacturing?

New Product Introduction, or NPI, is the process used to convert a product design or prototype into a repeatable manufacturing process. It can include design and BOM reviews, sourcing, DfM, tooling, work instructions, test development, quality planning, prototypes, validation and the eventual transfer to regular production.

GMI Solutions maintains a dedicated NPI organization with launch engineering, project management and strategic sourcing resources. The team works across functions to move complex OEM products from development into controlled production.

When should I involve a contract manufacturer in a new medical device project?

Generally, involvement before the design is completely frozen provides more opportunity to identify manufacturing, sourcing and testing risks while changes are still practical. Early manufacturing input can reveal difficult tolerances, long-lead components, assembly problems, serviceability concerns and test requirements before they become expensive production issues.

GMI Solutions can engage during product development and uses DfM, sourcing and NPI resources to evaluate these issues. Early engagement allows GMI and the OEM to address manufacturing risk while preserving the OEM's control of its product design and intellectual property.

What is Design for Manufacturability, and why does it matter for a medical device?

Design for Manufacturability (DfM) evaluates whether a product can be manufactured efficiently, consistently and economically without compromising its intended function. Reviews can consider materials, tolerances, assembly sequence, component choices, potential failure points, tooling and manufacturing methods.

GMI Solutions applies DfM throughout product introduction and production. Its engineering capabilities also include Design for Assembly (DfA) and Design for Testing (DfT), providing OEMs with manufacturing-focused engineering support while they retain design authority.

Can I outsource a medical device that is already in production?

Yes. Existing products are frequently transferred from an internal factory or another contract manufacturer. A well-managed transfer should capture not just drawings and a BOM, but also work instructions, quality criteria, test requirements, known field issues, supplier information and the practical manufacturing knowledge accumulated over time.

GMI Solutions supports manufacturing transfers as well as new-product launches. Its process can incorporate the existing BOM and supply chain while applying DfM, testing and process-development expertise where improvements are appropriate.

Can a contract manufacturer build an entire medical device instead of just parts?

Yes. Some manufacturing partners can assume responsibility for complete system integration rather than providing only individual parts or subassemblies. This can include mechanical structures, wiring, embedded computing, power, cooling, electronics, displays and final testing.

GMI Solutions provides subassembly through full-system integration services. Its experience includes integrated medical carts, imaging and oncology systems, embedded computing, power systems and other complex electromechanical equipment.

What production volumes are best suited to a medical device contract manufacturer?

That depends heavily on the manufacturer's business model. Some factories are optimized around very high-volume repetitive production, while others specialize in lower-volume products with greater complexity and product variation. Complex medical capital equipment often benefits from a manufacturer configured for high-mix, low-to-medium-volume production.

That is GMI Solutions' primary manufacturing focus. Documented GMI programs range from complex products produced in the tens annually to assemblies produced in the tens of thousands per SKU.

How does incoming inspection work in medical device manufacturing?

Incoming inspection verifies that purchased components meet defined requirements before they are released for production. Depending on the component, this can include identity, revision, dimensions, cosmetic requirements, documentation or product-specific testing. Components that do not meet requirements should be controlled so they cannot inadvertently enter production.

At GMI Solutions, incoming materials are inspected against established criteria before release to inventory, and nonconforming material can be physically segregated. OEM-specific lessons learned and critical characteristics can also be incorporated into incoming inspection requirements.

Can incoming inspection criteria be customized for my product?

Yes. Incoming inspection is most effective when it reflects the actual risks associated with the product rather than applying the same generic inspection to every component. Known supplier issues, critical dimensions, revisions and other characteristics can become part of the inspection plan.

GMI Solutions works with OEMs to establish product-specific incoming inspection criteria. Requirements can include dimensions, revisions and other critical characteristics identified through specifications or previous manufacturing experience.

How are manufacturing processes controlled for complex medical devices?

Controlled manufacturing normally combines revision-controlled work instructions, defined inspection points, trained personnel, calibrated equipment, testing and production records. For complex equipment, controls should extend throughout the manufacturing sequence rather than relying only on final inspection.

GMI Solutions uses electronic manufacturing process controls that guide and document production activities, including assembly, inspections and testing. Product-specific requirements can be linked to parts and individual manufacturing steps throughout the process.

How do you prevent the wrong component revision from getting into a medical device?

Revision control starts with purchasing and receiving and continues through inventory, kitting, assembly and change management. Parts need clear identification, while drawings, BOMs and work instructions need formal revision control.

GMI Solutions tracks applicable part numbers, revisions, lots and serial numbers through its systems and controls engineering changes through a formal ECO process. That helps maintain alignment between approved product documentation and what reaches the manufacturing floor.

Can individual medical devices be traced back to the components used to build them?

Yes, where product and regulatory requirements call for it. Traceability can connect finished serial numbers with component lots, revisions, test results and manufacturing records. This becomes particularly valuable when investigating a field failure or determining the scope of a component-related issue.

GMI Solutions maintains lot and serial traceability as applicable, with manufacturing and test information incorporated into Device History Records for medical products.

What is a Device History Record in medical device manufacturing?

A Device History Record (DHR) provides documentation showing the production history of a medical device or production lot according to applicable requirements. Depending on the product, the manufacturing record can include assembly information, lot and serial traceability, inspections and test results.

GMI Solutions maintains DHRs for applicable medical products. Its electronic manufacturing environment can maintain traceability of lot numbers, serialization, product expiration information and test results.

Can a contract manufacturer maintain Device Master Records and manufacturing documentation?

Yes, when that responsibility is included within the manufacturing relationship. Effective document management is especially important for products with long lifecycles because drawings, specifications, procedures and revisions can evolve over many years.

GMI Solutions maintains DMR documentation for applicable products along with specifications, procedures, drawings and quality records. It also provides product traceability and records-retention services.

How should nonconforming material be controlled in medical device manufacturing?

Nonconforming material should be clearly identified and controlled to prevent unintended use. A mature quality system should also provide defined processes for disposition, investigation, root-cause analysis and corrective action when appropriate.

GMI Solutions maintains documented nonconformance and CAPA processes, including identification, segregation and disposition of nonconforming material. Its quality system also supports root-cause analysis and use of 8D methodology.

How are engineering changes controlled after a medical device goes into production?

Changes should be formally documented, evaluated and approved before implementation. That process may involve drawings, BOMs, work instructions, components, suppliers, testing and inventory to ensure the change is introduced in a controlled manner.

GMI Solutions uses a formal ECO process aligned with its ISO 13485 quality system. Changes are documented, reviewed and tracked through its PLM/ERP environment, with OEM approval incorporated as required.

What kind of testing should be performed on a complex medical device?

Testing should reflect how the product is intended to operate and the risks associated with its application. Depending on the device, that can include in-process testing, functional testing, system integration, electrical safety, calibration, software or firmware verification, burn-in and final acceptance testing.

GMI Solutions provides product-specific, application-level testing and can integrate tests at multiple stages of manufacturing. Its capabilities include functional, integration, electrical safety, calibration-related and final acceptance testing.

Can a contract manufacturer develop a custom production test fixture?

Yes. A product may have been thoroughly evaluated during development without having a practical production test method. Converting engineering requirements into repeatable production testing can require custom fixtures, software, procedures and validation.

GMI Solutions designs and develops custom test fixtures and test protocols. Its engineers have also collaborated with OEM R&D teams to develop production testing when a completed test solution did not yet exist.

Should a medical device be tested during assembly or only at final inspection?

It can be beneficial to test at appropriate stages throughout assembly. In-process testing can identify a problem before additional components and labor are added, while final functional testing verifies performance of the completed product.

GMI Solutions can incorporate inspection, testing and calibration activities within the manufacturing sequence as well as at final acceptance. The test strategy is developed around the requirements and critical characteristics of the individual product.

Can a contract manufacturer perform electrical safety testing on medical equipment?

Some can. Capabilities should be evaluated against the specific electrical and regulatory requirements of the product. Relevant tests can include hi-pot, ground continuity and leakage-current testing.

GMI Solutions has documented capabilities for hi-pot, ground continuity, leakage current and other applicable electrical safety testing. It also supports high-voltage applications and external certification processes where required.

Can a contract manufacturer manage my entire supply chain?

Yes. Full supply chain management can include sourcing, purchasing, supplier management, inventory, logistics and delivery. Whether that is preferable to maintaining sourcing internally depends on the OEM's strategy and the complexity of the product.

GMI Solutions provides end-to-end supply chain management and can source through its qualified suppliers, use an OEM's existing Approved Vendor List, or combine both approaches.

Do I have to change suppliers when I outsource manufacturing?

Not necessarily. Keeping qualified incumbent suppliers can preserve tooling, qualifications, continuity and institutional knowledge. In other cases, additional suppliers may offer cost, lead-time or risk advantages.

GMI Solutions can incorporate customer-designated suppliers, GMI-vetted suppliers or a combination. This allows an OEM to preserve valuable supplier relationships while giving GMI an opportunity to evaluate the broader supply chain.

How can a medical OEM reduce single-source component risk?

The first step is identifying single-source and long-lead exposure before it becomes a shortage. Depending on the component, mitigation may involve alternate-source qualification, inventory strategies, long-term agreements or redesign.

GMI Solutions includes strategic sourcing in its NPI process and evaluates component availability, lead times, shortages and single-source exposure. Potential mitigation strategies can then be developed with the OEM early in the program.

How do you manage obsolete components in a medical device with a long lifecycle?

Long-life equipment often outlives individual electronic components. Good lifecycle management therefore includes monitoring component availability, responding to end-of-life notices, evaluating replacements and considering last-time buys when appropriate.

GMI Solutions provides obsolescence and lifecycle-management support, including component monitoring, end-of-life notifications, replacement qualification and last-time-buy strategies.

Can a contract manufacturer manage a medical product with a very large bill of materials?

Yes, provided it has appropriate systems for multilevel BOM management, sourcing, inventory, revision control, traceability and testing. BOM complexity is not just about part count; dependencies among components, subassemblies and revisions create much of the manufacturing challenge.

GMI Solutions manages complex multilevel BOMs. One documented medical imaging and treatment cabinet contained more than 1,200 items and combined mechanical assemblies, electronics, cables, custom PCBs and extensive testing.

Can a contract manufacturer integrate embedded computers into medical equipment?

Yes, but integration can involve more than installing a commercial computer. Long-life medical equipment may require controlled hardware configurations, BIOS settings, software images, component lifecycle management and system-level functional testing.

GMI Solutions has more than 30 years of documented embedded-computing experience, including customized computing platforms, BIOS configuration, software imaging, integration and component lifecycle management.

What should I look for in a manufacturer of medical or surgical carts?

Medical and surgical carts can combine structural metalwork, power distribution, patient isolation, embedded computing, displays, cabling, cooling and application-specific hardware. A manufacturer should therefore be evaluated on complete system integration—not just its ability to fabricate an enclosure.

GMI Solutions has experience manufacturing integrated medical and surgical cart platforms, including complex robotic systems. Its capabilities span computing, power systems, displays, cabling, mechanical integration, testing and complete turnkey assembly.

Can medical equipment be manufactured in both the United States and China?

Yes, when the manufacturing partner has appropriate facilities, quality systems, documentation and transfer controls. A dual-region strategy can provide sourcing, logistics, market-access and business-continuity options.

GMI Solutions operates manufacturing facilities in Mequon, Wisconsin, and Shanghai, China. Its Shanghai operation has been wholly owned since 2005, and both locations support high-mix, low-to-medium-volume production under GMI's quality systems.

How can a medical OEM manufacture products for the Chinese market?

Manufacturing and selling electromechanical products in China can involve local sourcing, logistics and China Compulsory Certification requirements, depending on the product. Using a manufacturing partner experienced in both North American and Chinese production can simplify those considerations.

GMI Solutions has a wholly owned Shanghai manufacturing facility, while both its U.S. and China operations are CCC certified. GMI can therefore support manufacturing and supply-chain strategies for OEMs serving China and other global markets.

Can a contract manufacturer help reshore or transfer an existing medical product?

Yes. Manufacturing transfers can include relocation from an internal factory, another supplier or another country. A successful transfer should capture the existing product knowledge while validating BOMs, sourcing, work instructions, quality controls, testing and manufacturing readiness.

GMI Solutions provides onshoring, reshoring, offshoring and manufacturing-transfer support. Its NPI, DfM, sourcing and engineering processes can be applied to established products before they transition into regular production.

Can a contract manufacturer support a medical device after production has launched?

Yes. Medical capital equipment can remain in production and in the field for many years, making sustaining engineering, component management, revision control, service and records retention important parts of the manufacturing relationship.

GMI Solutions supports products beyond launch with sustaining engineering, supply chain management, change control, obsolescence management, records retention, repair and out-of-warranty services.

Can a contract manufacturer repair or refurbish medical equipment already in the field?

Yes, depending on the product and manufacturer's service capabilities. Connecting repair activities with manufacturing records can also help identify recurring problems and support root-cause investigation.

GMI Solutions provides repair and refurbishment capabilities, including out-of-warranty support. Its quality system can use DHR information, component traceability, root-cause analysis and CAPA processes when investigating applicable field failures.

How do I know whether outsourcing medical device manufacturing makes sense?

Outsourcing can make sense when manufacturing requires specialized engineering, quality, supply chain, labor, facilities, inspection or testing resources that are not core to the OEM's differentiation. The decision should consider total resources and risk—not simply compare an internal labor rate with a contract manufacturer's quoted price.

GMI Solutions provides vertically integrated manufacturing services spanning engineering support, NPI, sourcing, assembly, testing, quality, logistics and lifecycle management. For OEMs whose core value lies in areas such as product innovation, clinical application or software, GMI can take responsibility for more of the manufacturing infrastructure surrounding the physical product.

How can a contract manufacturer help reduce the cost of a medical device?

Cost improvement can come from several areas: DfM, assembly efficiency, supplier consolidation, alternate sourcing, part-count reduction, appropriate tolerances, improved test methods and reduced rework. The strongest opportunities are often found by evaluating the entire manufacturing process rather than simply negotiating component prices.

GMI Solutions combines DfM, supply chain management and manufacturing engineering to identify these opportunities throughout the product lifecycle. Its approach considers manufacturability and serviceability alongside quality and cost rather than treating cost reduction as a stand-alone purchasing exercise.

What happens if a component or product fails in the field?

A manufacturer should be able to establish what was built, which components were used, what tests were performed and whether other products may be affected. Traceability, DHR records, nonconformance processes and structured root-cause analysis make that investigation considerably more manageable.

GMI Solutions maintains lot and serial traceability and supports field-failure investigation through its nonconformance and CAPA processes. DHR records can be reviewed alongside component and test history to support root-cause analysis and corrective action.

What makes a good long-term manufacturing partner for a medical OEM?

A long-term partner needs more than manufacturing capacity. Medical OEMs should consider technical expertise, quality systems, communication, supply chain capabilities, disciplined change management, responsiveness and the ability to support the product as it changes over its lifecycle.

GMI Solutions has served OEMs for decades and structures its services around that lifecycle—from prototype and NPI through production, engineering changes, supply chain management, testing, repair and eventual obsolescence. The objective is to operate as an extension of the OEM's team while taking responsibility for the manufacturing challenges surrounding the product.

Looking for a manufacturing partner for a complex medical product?

If your product combines demanding quality requirements with electromechanical assembly, embedded computing, power, thermal management, complex sourcing or application-level testing, those requirements are worth evaluating together rather than as isolated manufacturing tasks.

GMI Solutions specializes in bringing those disciplines together for low-to-medium-volume, high-mix OEM products—from NPI and incoming inspection through controlled manufacturing, testing, traceability and lifecycle support.

Is GMI Solutions the Right Manufacturing Partner for Our Medical Product?

The strongest fit is typically an OEM with an application-critical product where manufacturing involves more than repeating a simple assembly operation. GMI focuses on high-mix, low-to-medium-volume products that can require electromechanical integration, embedded computing, power, thermal management, sophisticated supply chains, testing, documentation and traceability.

GMI's approach is to engage as a manufacturing partner across the product lifecycle—from NPI and DfM through incoming inspection, controlled manufacturing, application-level testing and long-term support. For an OEM, the potential benefit is a manufacturing organization that can take responsibility for more of the complexity surrounding the product while the OEM remains focused on its technology, customers and next generation of innovation.

Manufacturing What Matters

If you're evaluating the outsourcing of a medical device, subassembly, surgical cart, embedded computing platform or other complex electromechanical system, GMI Solutions can review the product, BOM, testing requirements and manufacturing objectives to determine where its capabilities fit.