Medical Device Daily Executive Editor

End of the year – a year in which not all that much happened in med-tech that couldn’t have been predicted. No surprises of the particularly surprising sort.

Deals activity was strong, companies – both large and small – reorganized and retrenched to deal with the changing circumstances of customer demand and governmental policy/regulation.

The two companies that had courted Guidant in 2006, Boston Scientific and Johnson & Johnson, both found the going in med-tech somewhat more challenging than they probably thought it would be, and so they are doing significant retrenching as a result.

J&J’s recent foray beyond consumer healthcare products into device arenas may produce some hesitation about moving further into clinical med-tech, at least during the rest of this decade. Or it may judge forge ahead in this arena. (Take your choice of these two options, since we find our predictions always iffy, especially given the current haziness of our crystal ball).

While J&J looks like it is making restructuring changes in a way that will provide continued strong investor support, Boston Scientific, on the other hand, still has some major hills to climb to win back slipping investor confidence – or see the slope of its share price get even more slippery.

For Boston Sci, the key will be a twosome of solutions: the company’s ability to tighten up and batten down a downsized operation in quick-time; and its ability to throw off the FDA’s embargo on new product approvals. (Did its investors get rather concerned about the nearly weekly news the company was making via analyst reports – and perhaps headlines in MDD? [OK, maybe the latter not so much]?)

As usual in this sector, product recalls peppered the ’07 calendar, early and late. The biggest of these came at the end of the year, with the recall of the pacemaker leads made by Medtronic.

In terms of med-tech history, this was a continuation of issues raised in 2006 concerning the risks of implanted electronic cardiovascular devices and will, we hope, improve safety (or, on the other hand, result in a closer scrutiny of the sector, more frequent patient reports of adverse events, and a much more realistic assessment of what the risks might actually be [darn that crystal ball haze]).

Speaking of electronic systems, where is the electronic health record that we keep being told is so essential to improving the efficiencies of healthcare? While a certain amount of “certification” is going on, this technology so far seems to be moving forward as a product without real demand.

Our guess is that if you stopped 50 people on the street and asked them what they thought of the electronic health record system, all 50 would ask what you were talking about.

And then you’d probably have to interview another 50 to find one or two who actually had heard of the idea – after which they would then probably express a variety of concerns about keeping their data away from prying eyes (read, government).

(If some U.S. officials are trying to figure out how to get everyone to sign up for a [hypothetical] universal insurance plan, they are really going to have trouble getting people to participate in a governmental EHR.)

But getting back to implantable devices.

Debate continued concerning the safety of drug-eluting stents, but this debate may subside a bit in 2008 with the roll-out of second-generation DES devices and what appears to be reduced risk.

Based on positive recommendations by the FDA’s circulatory systems panel, two of the 2.0 devices are likely to be approved for marketing in the U.S. – and the marketing battle will then be on, the entrenched first-generation devices getting elbowed aside by the new devices ... . Or do the first-generation devices experience a significant drop in prices to maintain their hold on the hearts – and pocket books – of physicians? (Sorry, a bit catty there.)

As usual in 2007, conferences were held, scientific presentations were given, and the difficulty of understanding presenters continued as a problem – partly, perhaps, resulting from some hearing loss on our part but mostly because of the increasing number of presenters who speak English as a second language.

Clearly, this continues to indicate the withering of scientific and technological education in this country and, conversely, the emphasis on such education by other countries or international immigrants who seek out the best of scientific training that we still offer.

This is not expressing a prejudicial bias against international scientists. Those difficult accents simply may be indicating that as U.S. science education withers, med-tech is becoming robust all around the globe and creating broader markets and, hopefully, a healthier world. But at the current rate, the U.S. may have to get used to the idea that it may not be the leading med-tech country on the globe 10 to 15 years from now.

No doubt about it, 2008 has to be more interesting – an easy bet since healthcare is likely to be a major “decider” in the year’s presidential election in the U.S.

If voters are concerned about the need for broader insurance coverage and the need to rein in the non-coverage policies of private insurers, this could push some independent votes toward the Democratic aspirant – all of the nominees on that side of the aisle offering plans in that direction.

But if there is a greater concern that the Democratic noise on this issue is pushing the country toward a dreaded universal system run by the government – and thinking it will reduce the quality of healthcare that the now-insured have — these independent voters will look more kindly on a GOP candidate, none of whom having put healthcare in the top five of their “must-dos,” either in their first-100 days ... or ever.

If the year 2007 brought us anything of value, it may have served to indicate what the most important path for med-tech might become in the next decade, or, most certainly, the rest of this century.

If the last 25 years have been the period of enormous innovation in the cardiovascular device sector – from pacemakers to stents – the next decade (or, most certainly, the rest of the century), will be devices – both man-made and biologically engineered — to deal with neurological diseases and trauma.

This has been shown in 2007 in three ways:

Most spectacularly, the Iraq/Afghanistan conflicts which have produced concussion and head trauma as the “signature” injury of current war fighters.

Most historically, year 2007 marking the sign-up for Medicare by the first Baby Boomers, and thus the Boomers heading tsunami-like our way, with the follow-on wave of stroke, dementia and Alzheimer’s disease. The effects of these diseases impact whole families, not just individuals, and must be dealt with, even more aggressively than the development of new cardio therapies.

And finally the advances made this year in the use of the newest computer and robotic technologies that address neurological deficits. With improved patient-friendliness and lower prices, these systems are on the verge of becoming widely available.

Finally, though we don’t have high hopes for large med-tech surprises in 2008, we think it will be a year that continues the push toward the most amazing decade of all for med-tech in the 21st century – years 2011 to 2020.

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