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WAVING A MAGIC WAND

LAUNCHED ON 18 SEPTEMBER 2003, IQA'S NEWEST SPECIAL INTEREST GROUP, THE MEDICAL DEVICES QUALITY GROUP (MDQG), IS A JOINT VENTURE BETWEEN IQA AND THE BIO- MEDICAL DIVISION OF THE ASQ. MDQG CHAIR EXPLAINS WHY HE NEEDED TO GET INVOLVED

'The medical device industry has been seen for too long as the Cinderella of healthcare... all this is set to change.'

If I were to explain why I wanted to get involved in the MDQG I could express some of my deeply held beliefs, such as the fact that medical devices are the driving force in healthcare development. Billions of pounds are thrown at drug discovery but 'another aspirin', a universally appropriate drug that markedly improves the quality of life, seems more elusive by the year.

I could also say that the integration of QMS into regulations makes the medical device unique in being regulated by law to a special 'voluntary' standard. Or finally, that the quality professional is faced with specific moral and ethical challenges in the medical device industry because the work is all about saving lives in an arena where every benefit has an associated risk and every delay in introducing a new product could be a life lost.

A Wise Man Once Said

True as they are, my reasons for getting involved with the group are more personal. After 25 years in the medical device industry, the last ten or so abroad, I returned to the UK to find the absence of a support network of other professionals in the business. As an expatriate working in Asia, I had learnt to treasure contacts with others in the business community, and was delighted when I moved to the US to find existing networks. The valuable lesson I learned can be summed up by the quotation: 'Any fool can learn from his mistakes, but a wise man learns from the mistakes of others'.

MDQG is about training, learning, professionalism and all those good things you expect of a SIG, but more than that, it is about a community of professionals. It is about creating opportunities to meet and learn from others who have faced the issues that are now challenging you.

Cinderella Complex

The medical device industry has been seen for too long as the Cinderella of healthcare. A low public profile, a lack of investment in new products and a reliance on old 'tried and tested' technologies have led the industry to be seen as unglamorous compared with the ostentatious and large pharmaceutical companies and the 'sexy' biotechs. All this is set to change.

Ask Joe Bloggs what a medical device is and you still probably get a blank stare, but talk to him about his most recent hospital treatment and he might say any of the following:

'they gave me this monitor to wear for a day and when I took it back the doctor could tell me exactly what was wrong'
'I thought I would be in hospital for a week or more, but they did one of these new key-hole surgeries and I was at home that evening and driving again within the week'
'the GP realised at once this could be connected with that "little turn" I had five years ago' (because he could search for records on his computer quicker and more efficiently than he ever could with paper notes)

It is only a small step to raise the public awareness that all these advances in healthcare are only possible because of a dynamic medical device industry - and this is an important part of MDQG's mission.

Lack of Investment

Investors are starting to see pharmaceutical and biotech companies as 'lottery investments' which offer the promise of a mammoth payout, but when averaged over all the expensive failures, provide a poor return on investment. Conversely, the medical device is a safe investment offering above average returns on most investments and for a lucky few a large, if not mammoth, payout.

We may enjoy playing the lottery and justify a couple of pounds a week for the thrill, but when it comes to our life savings we prefer a conventional investment with a better chance giving a return. Think what medical devices we could see with just some of the development billions currently gambled on the lottery of the pharmabiotech industry.

The type of medical device in development has changed dramatically over the last few years. The innovators are no longer the big multinational corporations but the start-up companies, university and health service spin-outs. They have the flexibility to embrace new technologies and a degree of enthusiasm about its potential that is just a dream for most multinationals. Working in small teams on new technology, we need the support of a professional community.

Quality Philosophies

The changes in the device industry challenge some of the fundamental regulatory tenets and outdated quality philosophies enshrined in regulations. To exploit exciting new device developments the industry needs to smash through the traditional barriers of different drug, device and biotechnology regulation and force the regulators to accept the latest quality philosophies, rather than basing their regulations on the batch based philosophies of the 1950s and 1960s.

Increasingly, advances are coming through combination products: drug- and biologic- coated devices, and devices changing the viability of a drug or biologic through targeted effective delivery and monitoring.

Drugs and devices have the same intended actions, only their method of action (pharmacological or not) is different. So why not regulate them in the same manner, apply the same, latest quality philosophies to both? Biologies only differ in their source material - so why not regulate these in the same manner?

MDQG works with the other IQA SIGs (PQG, healthcare, and integrated management) to develop approaches to 'health-products' and adopt the best quality philosophies for these.

The Federal Law QMS

Device regulation began in the US with a quality system enshrined in federal regulations. The law is generally always behind the times because it does not change until there is a political imperative and consensus to change it. European regulators realised this and opted to use standards, because these are easier to change and generally more up-to-date.

If we are to drive healthcare forward, it is necessary to use the latest and best quality philosophies to match the technologies and manufacturing methods of today, and in this regulated environment that means it is necessary to change the conservatism of governmental bureaucracies.

We are entering a decade of revolution in the medical device industry, the regulatory affairs profession and the first decade in which the quality standard for device industry deviates considerably from ISO 9001.

There are big issues to discuss and the profession needs to take a lead. Those involved with MDQG and other SIGs will make these things happen, without the inherent bias of government or industry. There is also a duty to the public to ensure safe, effective, reliable devices to extend life expectancies and improve quality of life.

If you would like to find out more about MDQG please contact Neil Armstrong on e: mdqg@iqa.org

Neil Armstrong (CEng MIEE MBIRA RAC MIQA) is managing director of MeddiQuest Ltd, a UK-based regulatory affairs management company. He has over 25 years' experience in the medical device industry in leading companies such as Smiths Group, Teleflex Inc and the Automation Partnership. His various roles have included engineer, manufacturing manager, technical manager, quality manager and regulatory affairs manager.

Source: The Quality Professional, Institute of Quality Assurance, London; May-June 2004