Don’t underestimate regulations and safety

Now head of a specialist medical design consultancy consortium, DeviceGroup, Jon Plumb talks to Dean Palmer about the key issues facing suppliers that are looking to leap into the medical devices sector UK manufacturing firms need to address lots of issues before taking the plunge into the medical sector,” explains Jon Plumb, director of a new, specialist medical design consultancy consortium, DeviceGroup. “First, they have to be aware of the regulatory management issues affecting the product they wish to market, so developing a regulations strategy is key. Second, they need to consider the product’s validation and verification approvals, safety-critical and design traceability issues. These are often overlooked,” he adds. As far as regulations are concerned – whether they be FDA (US Food and Drug Administration) or European CE Marking approvals, Plumb says that firms need to be aware of the classification of their device. Medical products are classified into three areas: class one are invasive (such as a pacemaker or bio-implant), class two are non-invasive, and class three contains products that are to be delivered as drugs to the patient’s body. “This is not a two week process,” warns Plumb. “It is the critical path on any medical design project and can take as long as 12 to 18 months to complete. You can have the best idea and design in the world, but without approvals you won’t sell it.” He adds: “It’s a bit like ISO9000 approvals, but even more stringent. You need to document everything like you would in ISO audits, but on top of that you need to document design reviews, product requirements definition, sign-offs from the relevant individuals, all the way through the product development process. At each decision review along the way, you also need to be asking [and documenting] ‘Are we on track, on target and are we doing everything we should be doing?’” Then, according to Plumb, you’ve got to think about planning, design, control and validation methodologies for building intrinsic safety into the final product and ensuring it passes clinical trials. Plumb’s credentials are impressive. He worked as a design engineer for Baxters Healthcare for 10 years on some very high profile medical design projects, including state-of-the-art volumetric infusion pump technology. In 1999, he moved on to work for a design consultancy firm in Suffolk, where he worked on drug delivery systems design projects. This is where he met his current colleagues. Plumb’s current venture, DeviceGroup, was set up in February, and is a consortium of three specialist medical consultancy firms. The first, Innovate3, specialises in helping companies with their mechanical product designs, engineering development and helping them take their product to market in the most cost-effective way. The second firm, MeddiQuest, specialises in regulatory affairs management. This involves helping companies with new healthcare products develop the appropriate regulations strategy, gain the necessary EU and US regulations and to advise and assess the likely risks of launching the product. As Plumb explains: “Regulatory approvals can be run concurrently with the development process. Frequently, firms don’t consider regulatory issues until the product development is complete. They may have to re-develop the product because key documentation was not produced or systems were not formalised. The ideal scenario is if firms review and implement adjustments as the product takes shape.” The third part of the DeviceGroup is DC Allen Engineering. This part of the trio looks after any medical software- or hardware-related issues. For example, some firms require translation of concepts into reality using schematic capture, printed circuit board layout, embedded systems and EMC testing. “The real differentiator,” continues Plumb, “is that we have the essential knowledge and skills under one roof that firms are looking for. In the past, they have had to go to separate specialist consultants for help.”