BRUSSELS, Belgium — Like a great gathering of the tribes, Eucomed (Brussels) brought together its stakeholders on the second day of its first-ever MedTech Forum as a show of strength and solidarity for an emerging agenda of activism on the European scene.

Sixteen national associations set up camp in an exhibition area while the big chiefs from the largest medical device manufacturers held forth in panel sessions.

The centerpiece for the discussion were findings from a specially commissioned survey by McKinsey & Co. (London) and report leader Martin Dewhurst offered a review of key trends and challenges for the industry that packed the plenary session.

While the study sounds low-powered at 80 respondents, the participation was high-level with 50 being CEOs of European operations for multinationals and the remainder being heads of regional operations.

The report showed executives upbeat and aligned in agreement on many key points regarding business prospects.

Demand for existing products will continue to increase according to 93% of those surveyed.

The statement that there are "pockets of attractive growth opportunities" in developed markets of Europe won 86% agreement.

Untapped opportunities include the shift in care settings for patients and the wild variations in clinical practice across Europe, such as the fact Germany has 80% more hip replacements than Italy while there is no clinical reason for this variation.

European executives also share a conviction that there are significant unmet needs for medical devices in their developed markets that will drive innovation.

Over 90% of respondents said there were "exciting drivers for growth in the emerging markets of Eastern Europe, the Middle East and Africa."

McKinsey's Dewhurst said that despite the enthusiasm among med-tech executives for emerging opportunities in China, India and Brazil, the region defined as Europe, the Middle East and Africa "represents the biggest market block and will remain so over the next 20 years."

The challenges faced by the industry identified why the survey came as no surprise as it is aligned with the Eucomed agenda for which the trade association has been building industry support to confront.

Top issues identified for Europe were regulation, reimbursement requirements, and tendering processes.

Over 80% of the executives share the belief that generic pose a credible threat to their business, and several affirmed a prediction by Dewhurst that between 30% to 40% of their current product portfolios are venerable to commoditization.

Turbulence ahead in the 'Healthcare Century'

In his presentation of trends for what he termed "The Healthcare Century," Dewhurst showed that the spending in the sector, which has outstripped gross domestic product (GDP) by 2% every year for the past 50 years shows no signs of slowing and a train wreck is coming.

"If the growth was slowed by half to just 1% each year above GDP, which no government has been able to do," he said, healthcare spending in the United States will grow to 40% of GDP.

The aging of the population in Europe means that maintaining the current benefit levels for citizens will require in 2030 a 140% increase in taxes in Italy, 90% in Germany and 70% in France.

"A turbulent period is coming for the industry with a risk of misplaced or disruptive healthcare reforms" where governments desperately slash services and cut prices in an effort to cope with the runaway trends.

"There is a huge imperative for everyone, and importantly for industry, to become engaged in the solutions to these problems of access, quality, productivity and affordability in order to shape the future," he said.

What a difference a day makes

A panelist on the first day of the MedTech Forum, Sabine LeCrenier, the head of the unit responsible for medical device regulation with the European Commission's (EC) Directorate General (DG) Enterprises and Industries made a repeat appearance on the second day, taking to the podium for a presentation on the European Union's Agenda for Medical Devices.

Everyone seemed to be holding their breath as she worked through praises for the industry's role in the European economy, like waiting for someone to complete the phrase, "What a nice person, but ..."

What came next left industry regulatory experts surprised, somewhat pleased and, as always, cautious.

"It was not what she said that was important, but what she did not say," said Hauke Schik, Quality and Regulation Manager with Philips Healthcare (Eindehoven).

"We did not hear anything about the European Medications Agency (EMEA), and that was a surprise," he said, referring to the EC's proposal this summer to recast the Medical Device Directives by grouping medical device regulatory authority under the aegis of that agency.

"It was very surprising," agreed Dario Pirovano, director for medical device legislation at Eucomed, who wryly suggested Madame LeCrenier was being diplomatic.

"Having seen the reaction of industry to this proposal, and especially the very mention of EMEA as the authority, she may have been reluctant to mention it again in a closed room full of industry executives," he said.

A second surprise was an overt statement that the New Approach regulatory method used in Europe since 1993, where industry is responsible to police itself across several broad categories of devices, will remain in place.

Instead the commission seems to have shifted its position toward carving out the emerging category of bio- devices that have raised concerns over what she called "gaps and loopholes" in regulations.

Pirovano parsed the commission's position for Medical Device Daily saying, "She did not refer expressly to innovative devices as being part of the technologies they are concerned need a higher scrutiny. She said some category of devices may need this scrutiny but that 'most' medical devices will remain under the New Approach. She did not say 'all' so this needs to be clarified."

"The real bombshell in her presentation was to hear that last week the commission created a group to study reimbursement and pricing of medical devices across Europe," he said.

"My first reaction was quite positive," he said, adding that since lunch he had become cautious, waiting to hear more specifics, "yet it is very encouraging they are going to address this topic."

Shrik said it is clear the commission "has understood the message about reimbursement issues in Europe, that there can not be innovative medical systems without a means to pay for it, so this is good."