The medical market – hurdle or opportunity?

Mark Fletcher talks to Alun Wilcox, head of medical at design consultancy PDD, about what firms heading into medical should expect

The big question is, if the market is so big, and we are doing so well, then why are most OEM medical equipment manufacturers looking to extend their supplier base? Let us elaborate: one would like to think that they know most of the possible suppliers due to the limited number who have braved the path to medical accreditation, so this must mean there is a shortfall of those offering products for use in this market. Someone, somewhere is missing a trick. Getting into the market is deemed by many as a tortuous process, akin to the 12 labours of Hercules, but it is, in fact, easier than you may think, and for those wishing to bite the bullet the rewards could be immense. Innovation, traceability, market knowledge and the ability to take standards on the chin – if you mix them all up and add a large pinch of engineering know-how, you are almost ready for this market. It may sound a very generalistic viewpoint but it isn’t far from the truth. According to Alun Wilcox, head of medical at PDD, his company works to ISO 9001 which is a “great anchor” if you are working to the Medical Device Directive (MDD), a pan-European standard with a similar remit to that of the US FDA (Food and Drug Administration). Eureka asked him: “Would it be fair to say that ISO 9001accreditation is a major step towards coping with medical standards?” His answer was ‘yes’, as the design control procedures are already in place, but the caveat is that the MDD and the FDA ask for slightly different things, and there are certain specific requirements – but at least the right mindset is in place. Where they start to vary is in the classification of devices – you have to understand what classification you are working to. The standards for medical devices get tougher the nearer they get to the human body. Basically, as the risk of adverse results increases, so does the intensity of the standards. But, if you are a trade moulder and you only intend to make a casing for a dialysis machine, then chances are your path to the market is fairly easy – it’s just a case of getting yourself known. This leads on to another point – visibility. Wilcox told us that PDD is high on the list of many medical companies because it has actively got itself on to approved suppliers lists. In this respect, the medical market is just like any other. The only time people will come to you is if they know you. The good news is that once you’ve gone through a client’s quality audit you are well and truly in the frame. Knowing what the market wants is, according to Wilcox, another important factor. Innovation is high on the agenda of many medical device firms, but this has normally been in reaction to a market demand. Companies which know and follow the market can pre-empt what their customers are likely to need and wait in the wings until the call is made. But there is still room for innovation as a means of differentiation. In general, the medical market can change from a walk in the park to the Spanish Inquisition, the nearer you get to the patient. This must be taken on the chin if you want to crack this sector. It is fair to say that most Eureka readers will work for companies that will not have meet the most exacting standards – so what are you waiting for?