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Articles from 2007 In October

The Perils of Integration

After the firm announced it is cutting its 2007 sales and profit forecasts, Wall Street analysts downgraded its stock, and the price promptly fell by 29%, the largest one-day drop in company history. The main problem appears to be a failure to properly integrate Laserscope's sales force into American Medical Systems. If your sales force isn't functional, you're simply not going to get the revenues and profits you want. This should be a lesson to all firms that are considering an acquisition that might be biting off more than it can chew.

What to Do About Results of Failed Trials?

There is little incentive for a company to keep following up on products that it never marketed. This is a serious issue. Unfortunately, the Times appears to be using it as an excuse to bash industry again. This slant is apparent from the headline on. The author, Barry Meier, never considers that public disclosure and patient follow-up are two separate issues. The debate is over whether the results of trials for failed products need to be publicly disclosed. That is irrelevant to the more important question of whether patients from such trials should continue to be monitored. They should, regardless of whatever regulatory disclosures have taken place. It is up to device companies to make sure this happens -- and they have not always done a good job of doing that. The disclosure issue is minor by comparison, and little more than an excuse to continue to bash industry.

Bausch & Lomb Buyout Completed

B&L is still feeling the fallout from a May 2006 contact-lens-solution recall, and it has been named as a defendant in about 550 product-liability lawsuits. At least the firm won't be pressured by Wall Street analysts and shareholders as it tries to work through the problems.

MRI Identifies Severity of Brain Injury

MD&DI Names Medical Manufacturers of the Year

Integra, which makes regenerative-medicine and neurosurgical products, and Intuitive, which makes robotic-assisted surgery systems, were honored for developing extraordinarily innovative technologies and building successful businesses around them.

Firm with First NanoDevice Gets Acquired

Angstrom will become a subsidiary of PST, and part of its orthobiologics division. Angstrom's NanOss uses nanotechnology to enable products that are highly osteoconductive and can remodel over time into human bone. NanOss, like human bone, is made of hydroxyapatite crystals. By controlling the material at the nanocrystalline level the resulting compound can have the strength of established polymer surgical implants.

Covidien, U. Missouri Collaborate on Hernia-Surgery Research

Propylene is preferred because it is linked to low occurrences of infection and other complications, but it does not remain stable once implanted. So researchers at the university's Biodesign and Innovation Program will study why the mesh changes size, shape, and even color once implanted, and how to prevent that. Changes associated with other materials will also be investigated.

AdvaMed Speaks Out on "Comparative Effectiveness" Policy

The full list of principles can be found here. At a press teleconference this afternoon, AdvaMed President Stephen Ubl said the organization has three key points: 1. Comparative effectiveness data can have value, but individual judgements for individual decisions must remain. 2. Any decision-making process that incorporates comparative effectiveness data should focus on clinical effectiveness instead of cost effectiveness. Otherwise, patients might have to undergo treatments that are cost effective but clinically inferior. 3. All stakeholders -- industry, doctors, patients, payors -- need to have input into these policies.

CMS Not Likely to Restrict Coverage of Drug-Eluting Stents

But judging from comments by Marcel Salive, director of medical and surgical services in the agency's coverage and analysis group, that's probably not going to happen. Of course, not a whole lot of study of off-label patients has been done. In a few years, when more data is available, we'll see if the agency changes its mind.

Deal Synthesizes Diagnostics and Disease Management

If this plays out as Inverness expects, it will be interesting to see if others go down this path.