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MedTech approvals: From conception to delivery

With various hoops to jump through, the approvals process in the MedTech sector can be challenging.

Medical technology (MedTech) is one of the most exciting and fast-moving sectors for innovation in the manufacturing market today. Developments in the sector are proving their worth both behind the scenes and in direct contact with patients. From sample prep systems to heart failure monitoring equipment, the technology behind such devices is constantly evolving to deliver streamlined medical processes that make the experience for patients easier.

Whilst the content is exciting, as with any technology, there are a myriad of hoops through which both the device and developer must jump. In a field where malfunction can mean serious damage to people’s health, MedTech is rightfully subject to extensive and rigorous testing.

An Original Equipment Manufacturer (OEM) is responsible for guiding its MedTech designs through this process and, therefore, needs to be fully aware of the stages involved. OEMs should also be informed of the problems that can occur and take every measure to ensure that these dangers are carefully controlled.

“All products have to go through two stages of evaluation: pre-compliance testing and then compliance testing.”

Pete Smith

An effective preventative measure that many OEMs take is to partner with a design to manufacture company that is able to provide electronic engineering and manufacturing services (E2MS). These types of organisation are usually able to offer years of experience in every aspect of the process, from the initial design to the finished product, and help those less experienced to confidently and effectively navigate the testing process.

The approvals testing process

All products have to go through two stages of evaluation: pre-compliance testing and then compliance testing.

Pre-compliance testing can be an in-depth review of the product’s design at the component level to make sure it complies with key criteria, a functional testing on an early prototype, or both. Both forms of testing ensure that critical parts are correct and key elements of performance act as expected, and identify the ways that the device will be tested for compliance later on.

The aim is to fully inform the design and engineering teams in advance of a final build. Engineers will naturally want to know how the product will perform at the earliest stage possible - ideally before completing a full design. This process lowers the risk to the project’s success before final testing takes place by informing the final design and clarifying the changes needed to pass formal compliance testing.

Once pre-compliance testing is complete, formal compliance testing is performed on an official design: an alpha build. The design needs to pass this stage in order to be certified to the appropriate standard and enter the market.

As OEMs and their E2MS partner progress through these stages, they are likely to come up against a number of common obstacles that they should be aware of, and prepare for, well in advance.

The components

In any device, there is the problem of logistics: how do you integrate all of the electronics inside an enclosure? Cables, power supplies, screens, CPUs and so on, all have to be coordinated in a secure, functional and efficient way, in order to hit the prerequisite standards for device classification.

This process can be further complicated by the need to include certain components, or certain types of components, in order to qualify for a desired classification. The E2MS partner is often expected to provide manufacturing innovation as much as expertise - they need to create devices that provide a unique service, which often means breaking the mould in terms of design.

There is also the issue of timing. OEMs will have strict deadlines to hit in order to successfully deliver the end product onto the market. To prepare for this, both the OEM and any E2MS partner will need to conduct an intensive review of their supply chain. Can they source all the components needed from an individual supplier? Is a change of components going to require contact with a new organisation? Are alternative components being procured beforehand, or is testing being coordinated to dictate intermittent purchases?

These logistics can make or break the delivery of a product. An E2MS will be able to offer exceptional support on the options available to an OEM in terms of developing and procuring the components they need to make their design a reality. An OEM can expect expert support from its partner, which should have the expertise to help them source unique electronic components or even develop their own.

An E2MS partner will also have specialist teams on hand to collaborate on product development from the design process through testing and onto the build. By considering the manufacturing stage while the product is still being designed, the E2MS provides insight to the OEMs to avoid the use of elements that may prove problematic in the long term.

The tests

Once an OEM is aware of the general standards, a device needs to reach in order to achieve proper certification, they need to clarify how these standards are interpreted. Not all test houses and compliance authorities view them in the same way: an OEM that switches between testers may be unpleasantly surprised to find that an acceptable design to one authority could fail in the eyes of another.

Depending on the field, some devices are going to require more compliance tests for a wider range of certifications than others. MedTech devices, for example, are always going to be required to meet standards for electrical safety and EMC/EMI compliance. Today, most medical devices are mandated to comply with risk management and usability standards. Some may even require biocompatibility certification. The full range of certifications available to MedTech devices can be rather intimidating even for an experienced OEM.

As such, it’s crucial for an OEM - or its partner - to establish a concrete basis for judgement with the test house. OEMs need to be fully aware of the certifications that the devices will need to meet and then reach out to the relevant authorities to identify exactly what that certification will require. Design files should be shared prior to direct meetings where the tester can give feedback on initial ideas, providing crucial direction on how a device should be developed.

Below: In a sector where a malfunction can bring serious harm to people’s health, MedTech is subject to extensive and rigorous testing

Again, an E2MS partner can provide invaluable support here. It can take on virtually all compliance testing for devices, allowing an OEM to ‘divide and conquer’ as it chooses in terms of bringing a product to the necessary standard. The extent of this partnership is down to the customer, who will ultimately have to bear full responsibility for the final product.

The extent to which MedTech needs to be tested requires extensive forethought from its designers and manufacturers to make sure that a high-quality device can be delivered on time. The pre-compliance and compliance testing phases make high demands of any OEM, and the logistical planning required is substantial.

By employing a careful, methodical approach – and the expert advice of an experienced E2MS partner– an OEM is capable of delivering valuable devices to market efficiently, but which, in turn, will have a real impact.

Author details:

Peter Smith is Director of Engineering Solutions for EMEA at Plexus

Pete Smith

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