If the year 2005 was anything, it was a period of transition for the med-tech arena. Or more precisely – and more wordily – it was a year when a variety of things were set to happen, or supposed to happen, and then didn't take place, but are now positioned to happen in 2006.

The biggest of these non-events was, of course, the proposed merger of cardiovascular powerhouse Guidant (Indianapolis) into even larger healthcare mega-power Johnson & Johnson (J&J; New Brunswick, New Jersey). That deal, originally rolled out in late 2004, was set to be, with a $24.5 billion price tag, the King Kong of mergers, one of the largest deals ever by J&J and certainly the largest amount ever paid for a company focused primarily on manufacturing medical devices.

It was scheduled to close before year-end 2005, but, like the great Kong, this monster-sized deal was beset with a variety of antagonists and pitfalls. In Guidant's case, however, the injuries were mostly self-inflicted – though with considerable prompting from The New York Times, which published throughout the second half of the year a series of stories on these problems in what some might characterize as a vendetta.

In May, the company began unveiling a series of recalls and announcements concerning problems with its implantable cardioverter defibrillators (ICDs), these announcements being followed by the inevitable series of lawsuits and investigations and, just as inevitably, the delay of the merger and – not so inevitably – a higher offer by Boston Scientific (Natick, Massachusetts).

While J&J and Guidant continue to talk and act like their courtship will be consummated, nothing will be known for sure until next year. This gorilla of a deal hasn't been brought down yet, but if it does fail, it will likely form the biggest story of 2006.

For patients, the most important event in the wake of Guidant's difficulties will be new guidelines concerning the reporting of problems concerning ICDs, pacemakers and other implantable devices, guidelines that should be followed carefully by those in the diagnostics sector.

Another of the major product non-events during 2005 also dealt with implanted devices: gel breast implants.

In the face of a 13-year FDA ban of these devices, both Mentor and Inamed (both Santa Barbara, California) went through the FDA panel process early in the year and then received "approvable" letters from the agency – Inamed's "approvable" reversing the "not approvable" recommendation vote by the panel. But neither company has yet to win the final go-ahead for marketing of these products.

Why the delays? Perhaps the pro forma need to fulfill final agency requirements. Or, like other current delays by the agency – the most high profile example being the apparent long-term "hold" on the morning-after pill – it may be political. In this case, the FDA could be trying to figure out how to overcome the objections of the many women's organizations that continue to say that these devices have not received the necessary long-term scrutiny and supportive data concerning the safety of these newly engineered devices.

But whatever the reason, everything points to final approvals of these devices in 2006, providing large new revenue streams for both companies – and another opportunity for diagnostics firms targeting the health problems these implants are said to create.

Other non-events, delays and false starts:

• Among a variety of negatives for the FDA this year was its continuing lack of top-level leadership. This too could be put by some under the category of self-inflicted embarrassment.

In July, Lester Crawford, MD, survived congressional interrogation to accept the post and then shortly after resigned, claiming too-advanced age (though he was only two months less elderly when accepting the position). Still to come – if it comes at all – is a thorough report on allegations that Crawford held stock in companies that the agency oversees and issued approvals for.

What we hope to see in 2006 is the appointment of an FDA chief who can withstand close scrutiny and then will be able deal with the contrary political, policy and scientific winds currently battering the agency.

• In healthcare's legal arena, perhaps the biggest surprise to many was Richard Scrushy's avoidance of jail time.

Indicted on nearly three dozen counts related to the multi-billion-dollar inflation of accounts at HealthSouth (Birmingham, Alabama), the rehabilitation giant that he founded, an Alabama jury found the company's founder and former CEO "not guilty" on all counts, those indictments including the first test of Sarbanes-Oxley legislation. However, Scrushy is far from off the legal hook, since he now faces over the next two years a variety of other actions that seek to disgorge from him millions of dollars, challenges that will be weighed by legal standards considerably less friendly than an Alabama jury.

Also expected from the government over the next several months are additional suits that will serve to test the mettle of the thorough accounting accountability of top executives intended by Sarbanes-Oxley.

• On the broad technological front in 2005 was the continued inability to develop a national electronic health record (EHR) – sometimes called an EMR, for electronic medical record – a comprehensive electronic system for storing and making portable from one caregiver to another the important health data of each of us, a system that would serve to reduce the wasteful paper chase that now encumbers the U.S. health system.

As in many years before, 2005 featured a variety of organizational announcements concerning the need for an EHR, the adoption of standards that supposedly would enable it and sporadic funding of efforts to bring it about – and no real progress toward that system's realization.

While we would like to think that the industry is positioned to achieve such a goal in 2006, we must confess considerable doubt. The problem? Probably too many industry players that currently have a stake in maintaining their individual pieces of this highly fragmented pie and no single person or entity with the will and the power to bring these pieces together.