It was in September 1984, as a fresh languages graduate, that I first crossed the threshold of 18-20 Hill Rise, one of the original offices of PJB Publications in Richmond, close to the river, where Clinica resided in its early years.

“Clinica reporter for French and Italian markets” was my first title, and I had no idea that I had fortuitously fallen into a dynamic industry that was to captivate my interest over at least a quarter of a century, and who knows how much longer?

Nor did I know that I was entering this sector at a truly critical time when the whole European medical device regulatory system was about to be created.

It turned out that I was in the privileged position to be following its course from the beginning - when there was a patchwork of safety requirements ranging from no regulation at all in some European countries at the same time as the regulation of differing arrays of products in others - to the current day where we have a comprehensive set of requirements Europe-wide.

Whatever criticisms may now be levelled at the regulation of EU medtech, we should occasionally stop and remember to put them in the context of the massive progress that has been made.

Indeed, careful reflection now about achievements over the past quarter of a century is vital as we tackle revolutionary thinking about medtech regulations, driven by the European Commission’s proposals surrounding the recast of the medical device directives and rethinking associated with new technological demands.

We should not forget that changes over the last 25 years have transformed what was effectively a regulatory safety time bomb in the 1980s, ripe for a medtech equivalent of the thalidomide scandal, to a stage where there are now comprehensive, near-uniform requirements for the entire, and now much expanded, European Economic Area, not only the European Union.

Moreover the structure of responsibility, involving the European Commission, national regulatory agencies, notified bodies, manufacturers and others, has proved to be woven tightly enough to ensure that even those less well resourced countries and those that have joined the European Union more recently, have been brought up to speed and included in the single market in a manner that has continued to guarantee a high level of safety for patients.

There is no denying that there is room for improvement and that technological changes are creating new challenges, but equally this rate of technological growth has only been made possible through the acceptance of, and the determination to keep self-regulating a non-prescriptive regulatory system. It is this that has granted the medtech sector the freedom to develop new products at a rate far beyond anything possible in the more dogmatically regulated pharmaceutical sector.

Clinica: The current line-up, 2009

Tina Tan Peter Rixon Elizabeth Cairns Bernard Murphy Amanda Maxwell Madeleine Armstrong Joseph Harvey Salina Christmas Phil Solomon Ali Asaadi Paul Pancham Ashley Yeo

ABOUT US

And most importantly, we now have not only European, but also an increasingly global co-operation over medical device incident reporting, a vital tool in ensuring patient safety.

The improvements have been massive and are largely understood and appreciated by industry and regulators alike.

However, there is no denying that technological change, including new concepts made possible through IT, through better understanding of human genomics, biomaterials and other related sciences, as well as the advent of relatively new disciplines such as nanotechnology, theranostics, advanced therapy medicinal products, and drug/device combination products, are stretching regulatory agency capacity to extremes.

Few member states have the resources to manage the entire gambit of products that make up the medtech sector and the areas on its borderline, especially as they continue to chase a fast moving and rapidly morphing target.

It is the better resourced countries, such as the UK, France and Germany, but others too, particularly Ireland, for example, in specific areas of expertise, that are helping to carry the rest of Europe along. The regular communication and co-operation of the authorities together, usually under the auspices of the European Commission, and a team spirit, and a willingness to take responsibility when necessary, make the current system work.

It really does seem to be working well, despite the mass of unanticipated technological challenges, and the phrase often quoted now in the context of proposals for regulatory change are: “Don’t throw the baby out with the bath water”.

But where is technology taking us? Is this sector now at a pivotal crossroads where regulators must actively consider new routes, alien to the current system, to anticipate and be one step ahead of future needs still difficult to grasp?

Would the sector be foolish to overly meddle with a system which has managed to encompass so far within its scope ground-breaking changes in technology unimagined 25 years ago? Or would it be negligent to imagine that we can remain with a system created in an entirely different technological environment?

In my view, what is vital is that the risk benefit balance that currently provides the backdrop to regulation in this sector, does not become skewed and that regulation stricter than what is considered necessary now does not effectively result in more deaths due to products being unnecessarily held back from the market.

These are the tough questions we now face. They are going to heavily absorb regulators for at least the next 18 months at a guess, as the European Commission struggles with the questions of how to shape the regulatory future in the context of the recast. We need to look forward, but looking back is valuable too.

What has been created so far in a quarter of a century has served patients and industry alike well. The products that are now available to treat patients, often in an increasingly less invasive way, have transformed patient care and quality of life. The industry is riding relatively high – in my personal experience it enjoys a greater level of trust than that of the more regulated medicinal product sector.

Loyal fan club

So how much longer will I be writing about medtech regulations? Not even I can answer that question. But the subject of EU regulations continues to fascinate me, and clearly to challenge and absorb the attention of this sector.

There is no doubt that there is a demand for the type of information that Clinica produces. The shrewd individual that set up Clinica within the newsletter business that had begun with the Scrip pharmaceutical newsletter Scrip in 1976, Dr Philip Brown, turned the £2,000 he paid for Scrip into a business worth £150m by December 2003, which he sold to the Informa business and publishing group.

Disappointedly for my bank balance, I am not in the same league. But as of September 7, stories concerning EU regulatory issues accounted for 15 of the top 20 most read Clinica stories written since January 1, 2009. With such a loyal fan club and such interesting people to work amongst, I am happy to stay a while!

Clinica editors and a few memories

Over my 25 years, I have worked with nine different editors. To refresh your memories and to tell you theirs - some humorous, some sad, some factual - as well as give you an insight into where they are, all Clinica editors are listed in a chronological order below:

Ian Broadhurst – 1980-1983, the only editor before my time, known for launching Clinica and for wearing clogs in the office. Ian now works as an analyst at Fortis private Investment Managements, part of the BNP Parribas group.

Peter Charlish - 1983-1987 and 1990 -1993, now a Principal Analyst at Informa Healthcare, writing for and researching topics across the spectrum of newsletters that formerly belonged to PJB Publications when it was bought out by Informa Healthcare in December 2003. One of Peter’s most memorable events was having a ride in a police car in Munich after being involved in a car crash on the way back from visiting Dornier.

David Harnden – 1987-1990, now works as a freelance consultant and report writer specialising in Asian pharmaceutical markets and EU pharmaceutical legislation.

David particularly remembers a press conference at London’s Brown’s Hotel on support stockings. Since support stockings are rated 1-9, “some bright PR spark thought it a good idea to follow the meeting with a tasting of wines rating them on a 1-9 scale on the dryness-sweetness scale”. David overdid the wine tasting, lost his notes and information package and had little memory the day after of the substance of the meeting.

Jeanette Marchant – 1993 - July 1996 has her own healthcare communications business. During Jeanette’s early days in Clinica she attended Medica in Germany to get some idea about the products we were writing about. “I wandered round the exhibition seeking 'newsworthy' products and just stopped at stands to ask what was new. One of the first stands I stopped at had a 'device' that has probably been superseded by Viagra. Before I had fully realised what I was looking at I had already asked if they could explain the product - and I had to stand there for what seemed like eternity while I was given a very full description of how the thing worked!”

Helen Gavaghan – July 1996 - May 1997 has continued in the field of journalism but is about to leave that behind although she has not made decisions on her future yet. Her biggest challenge was how to reorganise Clinica editorially for the future.

Maureen Kenny – May 1997 – July 2000, now editor of the Informa Healthcare Regulatory Affairs Journals.

Phil Greenfield – covering for Maureen Kenny’s first maternity leave from September 1998-May 1999. Now Informa Healthcare Principal Analyst. One of his presiding memories was working with Liz Hicks, who sadly passed away in April 2006 after a long career with PJB Publications. She had focused on international news while writing for Clinica and was a great support to Phil during his time as editor.

Ashley Yeo – July 2000 to February 2009, now Informa Healthcare Principal Analyst, remembers the earlier years, when Clinica was still in Richmond, as the best time of his stint on Clinica.

Tina Tan – April 2009 to present, our current editor whose vision is to keep Clinica as the sharp end of news. Shortly after she took over, Clinica raised its profile nationally when Clinica’s Bernard Murphy was interviewed on Sky News television as the flu crisis was escalating. He had discovered there was a second strain of the flu virus, other than H1N1 that had claimed more victims in Mexico than H1N1, yet this was brushed off by the worldwide health authorities.

Swimming and window cleaning

And my funniest memory – well, it has to be attempting to pick up news as I swam in the Adriatic in Athens’ Vouliagmeni resort, alongside the EU’s best known regulators of the time, Norbert Anselmann of the Commission included, who were taking an early morning dip during a conference which marked the beginning of discussions surrounding the Global Medical Device Nomenclature.

However, there is no truth in the report that the window-cleaner that appeared at a medical device experts group meeting in Brussels about a decade ago, was Clinica in heavy disguise!

From pen and paper to online news delivery

Technological development in IT has not only revolutionised what Clinica writes about, it has transformed reporting. As a medtech journalist, the tools I now have for my job were science fiction a quarter of a century ago.

Back in 1984, an A4 note pad, a black pen and a red pen, a bottle of correcting fluid and a telephone were all the equipment we had, in addition to a small desk and chair. No computers, so no emails; just company reports and promotional releases which appeared from time to time in the post, and papers from various corners of the globe.

The arrival of the computers on our desks in 1986 – for typing only since email was still the stuff of science fiction at that time – was a fresh challenge. But armed with a qwertyuiop finger typing scheme, I found the dexterity of learning to play the piano paid off in a totally unexpected way.

The unprecedented rate of change has since made it possible to write articles at probably four times the speed, to source information within moments from all corners of the earth, and to facilitate the delivery of news in such a way that it can now be picked up by readers often moments after it has been signed off.

The immediacy of the delivery means that the tools are available to our readers in the agencies, companies, consultancies, notified bodies and beyond at the first possible opportunity for informed decision-making.

This in turn is a factor in accelerating the speed of reaction, enabling more and faster progress to be made; and this feeds new material for our articles.