Bringing a medical device to market is a years-long process that costs tens of millions of dollars. To reduce time and expense, many medical device manufacturers outsource their essential parts and equipment, such as medical computers, to medical contract manufacturers, namely Original Equipment Manufacturers (OEM) and related Original Design Manufacturers (ODM).
How does one find the correct OEM? Today's article addresses this vital question, covering essential certifications they should have as well as any additional qualifications like meeting green computing standard goals.
OEM: What It Means and Why It's Important
Original Equipment Manufacturers, or OEMs, manufacture and sell products that other companies, like medical device manufacturers, sell under their branding. OEMs who design, manufacture, and sell products under their brand are also known as Original Design Manufacturers (ODM).
OEM sales may include parts of their products. For example, an MRI manufacturer may attach an OEM-built medical box PC to handle all the MRI's computing functions.
Why Medical Device Manufacturers Should Work Strictly with OEMs
A medical device is defined as any type of machine, instrument, equipment, device, or delivery system involved:
- In the prevention, diagnosis, or treatment of illness or disease.
- In the detection, measurement, restoration, correction, or modification of a body structure or function for some health purpose.
Because medical devices can directly affect a patient's health, they are highly regulated by governing bodies like the FDA to ensure their safety and efficacy. Medical device manufacturers should ensure they partner with true OEMs and ODMs experienced in these regulations, as they have the necessary expertise, personnel, production capabilities, equipment, and materials to build customized parts for medical devices. Off-the-shelf and resold brands won't meet many, if not all, of the following requirements.
60601-1 Certification
IEC 60601 is a worldwide standard ensuring that medical devices and equipment are safe for near-patient use. IEC 60601-1 means a medical device like an X-ray and equipment (e.g., a medical tablet) have been tested and certified not to shock the patient accidentally. Devices certified to meet IEC 60601-1-2 standards have been tested so as not to cause electromagnetic interference with nearby medical devices and equipment functions.
Medical device manufacturers can obtain the 60601-1 certificate of an outsourced part from its contracted OEM. Device manufacturers should request the full test report. They can then match the certificate's report reference number to the report number on the test report. This ensures that the OEM is the real deal rather than a rebrander whose lack of direct control over the part could jeopardize the device.
ISO: 13485 Certification
ISO 13485 provides a quality management system for medical device manufacturers to ensure their devices are safe, reliable, and effective. Virtually every aspect of medical device manufacturing is covered: design, development, production, inspection, testing, packaging, labeling, installation, servicing, repair, maintenance, disposal, and documentation. Many countries will simply not allow the sale of non-ISO 13485-certified medical devices in their markets.
Medical device manufacturers should partner with medical equipment OEMs certified to ISO 13485: 2016, as this shows a similar commitment to high-quality products and excellent service.
Other Qualifications
Beyond the above certifications, medical device manufacturers should query medical equipment OEMs for the following:
Product portfolio: True OEMs have complete control and ownership over their products, from the materials used to custom designs. Medical device manufacturers can use these to bring their devices faster to market and with less expense. For example, the OEM can shorten development by leveraging similar designs from other projects instead of creating a new one, an expensive and time-consuming process.
Another advantage is that many of these designs have already passed medical certifications, which increases their chances of being approved quickly by governing bodies.
Control over Bill of Material: A bill of material (BOM) lists everything that goes into a product or service: components, raw materials, how to construct, etc.
Changes in a BOM can delay or even halt governing agencies' approval of a medical device as they review those changes and their impacts on patients. Actual OEMs can significantly aid medical device manufacturers by revealing their products' BOM and, more importantly, guaranteeing it will remain the same during the approval process and the product's lifecycle (usually 5-7 years).
Selling to the public sector: Government agencies and departments like the Veterans Administration have unique medical device and equipment requirements. Examples range from smart card ID readers to ENERGY STAR compliance.
OEMs and ODMs that regularly deal with the public sector can offer their expertise to medical device manufacturers, especially if the OEM's headquarters is in that country.
Leveraging Cybernet's 30 Years of Experience as OEM/ODM
OEMs can significantly aid medical device manufacturers by reducing their devices' costs and speeding up their development. Device manufacturers should carefully vet OEMs before starting by making sure they're actual equipment manufacturers. That fact will make verifying other essential factors like certifications and design control more straightforward and trustworthy.
Contact the team at Cybernet Manufacturing if your medical device manufacturer is looking for an Original Equipment and Design Manufacturer. Our medical computers are medical-grade (60601-1 and 60601-1-2 certified), and our manufacturing processes and products have the latest ISO 13485 certification (2016). Our team members will happily discuss our numerous certifications as well as our nearly 30 years of experience in the design, manufacture, and testing of all-in-one computers, box PCs, and tablets in the healthcare, industrial/manufacturing, and enterprise markets.
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