Too many variables....one out come wanted

The UK medical devices market is among four of the biggest EU markets and is growing at a phenomenal rate - around 7% with a 2005 market estimated to be worth £2.49bn. As such, there is a very good case for businesses to enter this market in search of high margins and high growth. There is, however, a flipside.

Products must be fit for some of the toughest regulatory approval processes there. Add to this the NHS which is constantly looking to save money and you get a conflict with the norm that medical device R&D projects are often extremely lengthy and costly. The result is an interesting design challenge for the team charged with developing a new medical device and it can be a very daunting task when one looks at the design infrastructure that is required to enter this market.

In the case of medical electronics, software can be an interesting minefield for the developer. With risk assessment being one of the major goals for a medical product and a simple ride through the approval process being very useful, the approach (and what functions are carried out by each) to hardware design and software can have probably the biggest impact on the simplicity of the design. The category of risk for a device can generally be increased or decreased by a wise choice of hardware interlock, measurements, alarm detection etc. Interwoven into all of this is the need to meet the regulatory approval, mostly ISO 60601, and also the needs of UL and FDA for the US markets.

As manufacturing is becoming too expensive to carry out in the UK, developers are looking to other locations to cater for their production and assembly requirements. Decisions like these carry design implications, in terms of where the device will be made and what manufacturing techniques will be used.

Obsolescence is a major challenge for medical devices. Ten to twenty years may be completely realistic in the conservative medical world for the life of a product. However if you choose cutting edge components for your product, will they still be available then? Probably not.

In the medical world there are many issues with placement of components, restraining wiring and isolation, to ensure patient safety. These are however the specifics, the detail of the challenge for the developer of an electronic medical device. In reality it is not these that will cause the headache for a designer, its catering for the multitude of product features the suitability for regulatory approvals and the simplicity of user interface.

With space at a premium in the operating theatre and A&E, medical customers are demanding smaller devices, that are either portable or small and easily stored. These mechanical specifications have a knock on effect on the electronics required to make them function.

There is also a calling from end users for more simple interfaces. For example; in the operating theatre most surgeons don't even want an on/off switch on the equipment, just in case it is pressed by mistake at a crucial moment.

If you contrast this with the engineer, who by nature is generally a perfectionist and wants to extract every last ounce of performance out of his or her equipment, you end up with the very traditionally styled equipment complete with knobs and dials. The result is a nightmare waiting to happen. In the increasingly litigious world we inhabit, this is a concern for both any company developing and the medical professional using it.

Unfortunately this outcome can quite easily occur when you take into consideration all the different parties that are involved in the development of a new medical device. Marketing has its role to play in increasing the challenge. Developers are tasked with creating designs that cater for marketing expectations including every feature possible as the enthusiastic marketing department identifies every possible upgrade path and competitors feature that needs to be incorporated into the end product.

As medical device companies place greater demand on their development teams, devices will not become any less complex. This is partly because of the number of people involved in developing a medical product and partly because of the increased medical possibilities that technology can provide. It is unlikely that the numbers of parties involved with the development of medical devices will decrease. This is being demonstrated with the increasing trend for collaboration within the medical industry. Whilst this can prove a management challenge, it can also be a positive, bringing with it the opportunity to learn from partners, to cross-pollinate ideas and give rise to the option for deploying the right people to undertake the tasks they possess the expert skills in, when they are needed. The key is open and clear communication and working with a partner that you can trust.

This article was first published in Electronics World magazine, December 2006

Mike Lloyd is the Managing Director of ML Electronics

Print This Page

MLE Creative Electronics

Too many variables....one out come wanted