Medical device OEMs can benefit from working with EMS partners with the technology expertise to start up new manufacturing lines quickly, perform final testing, and ensure that products meet appropriate standards, says Kathryn Olson, business development director, BIT MedTech LLC (San Diego).
MPMN: What benefits do medical device OEMs derive from partnering with EMS providers?
Olson: EMS providers have extensive technology expertise, which significantly reduces OEMs’ project risk and time to market. Partnering with an EMS provider to develop and manufacture medical devices enables OEMs to focus on what they do best: intellectual property, clinical trials, regulatory submissions, and sales and marketing efforts. And while it can be challenging for large medical device OEMs to implement a new manufacturing line cost-effectively or ramp up manufacturing when a technology takes off, EMS providers have experience at taking on new projects. They can respond quickly to changes in manufacturing volumes and can often manufacture devices more cost-effectively than can OEMs.
MPMN: What systems, expertise, equipment, and skill sets should the medical device OEM expect of an EMS partner?
Olson: An OEM should partner with an EMS provider that has the appropriate certifications, quality systems, supply chain, and technology expertise for the product in question. When introducing a new product, the OEM should also consider a contract manufacturing company that maintains an engineering support staff. An experienced supplier’s engineering team can implement small changes to the design of a product or the manufacturing process, helping to reduce costs without erecting regulatory hurdles. It is also important for EMS providers to have experience performing final device testing, since testing can be technically challenging and the consequences significant if it is not performed correctly. Testing experience could include burn-in testing for electrosurgery devices or wet QC tests for IVD instruments.
MPMN: Are there changes to EMS requirements and regulations that medical device OEMs should be aware of?
Olson: Full-service EMS suppliers, which provide engineering as well as manufacturing of finished products, should be aware of the new IEC 60601-1 third-edition testing standard. After June 2012, EMS providers will be required to implement this standard in order to receive a CE mark and sell medical products in Europe. Although similar to the second edition, the new testing standard is risk-based, and the documentation required is significantly different from that stipulated in the earlier iteration. Upon bringing this change to the medical device OEM’s attention, the contract manufacturer should be able to help the OEM to understand the third-edition documentation and testing required to receive a CE mark. For laboratory instruments, IEC 61010-1 third edition will be required in 2013.
Full-service PCB manufacturing
Specializing in PCB surface-mount, through-hole, hybrid, box-build, test, and fulfillment services, Cirtronics Corp. provides a range of offerings, from individual PCBs to completely assembled and tested systems. Offering turnkey medical product manufacturing services, the ISO 9001:2008–certified PCB contract manufacturer operates a 175,000-sq-ft facility that provides complex product builds, low- to medium-volume production runs, high-mix assembly types, and quality assurance services. The full-service manufacturer also specializes in the fabrication of components for Class III medical products.
Electronic medical technology
A manufacturer of electronic medical technology uses radio-frequency energy, low-frequency ultrasound, high-frequency focused ultrasound, high-voltage x-ray, microwave, and cryogen to manufacture electronic medical systems that deliver these energy modalities. Employing electronic, electromechanical, user-interface, and software systems, Stellartech Research Corp. specializes in Class II and Class III medical instruments and ‘smart’ disposables. It makes finished, clinic-ready devices for atrial fibrillation ablation, esophageal ablation, vein ablation, and pain management. Its facility also houses a controlled environment for the manufacture of energy-delivery catheters, surgical tools, and other sterile devices. The company also provides fabrication, product assembly, final test, packaging, and postproduction support as part of its contract manufacturing services.
Stellartech Research Corp.
PCBs, wire harnesses, and box-build assemblies
Specializing in low- and medium-volume assembly projects with a moderate to high degree of complexity, an electronics service provider manufactures printed circuit boards, wire and cable harnesses, and box-build assemblies. Electronic Technologies International Inc. concentrates on design, layout, prototype, programming, testing, reengineering, and burn-in services. It also offers revisions, material selection, ball-grid arrays, x-rays, and RoHS-compliant components, relying on design for manufacturing and design for test practices.
Electronic Technologies International Inc.
Fort Atkinson, WI
Electronics design and manufacturing
Employing cell-based lean production techniques to optimize efficiency, a contract electronics manufacturer can assemble complex medical electronic devices in its ISO 13485:2003– and ISO 9001:2000–certified facility. Inovar Inc. supports medical device OEMs by providing design and layout, design validation, design for manufacturing, PCB assembly, and testing and test development services. It can also perform rapid prototyping of any PCB assembly. About 30% of the business is devoted to box-build services and system integration.
BIT MedTech LLC, a full-service outsourcing partner, provides turnkey design, development, and manufacturing of electromechanical instrumentation to the medical device industry. Focusing on finished goods manufacturing—including box builds—the FDA-registered and ISO 13485–certified company designs and manufactures Class I, II, and III medical devices. Its engineering capabilities cover all major medical device disciplines, including fluidics, thermodynamics, motion control, optics, photonics, and radio-frequency engineering.
BIT MedTech LLC
Published in MPMN, March 2012, Volume 28, No. 2
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