Those in the business of therapeutic or diagnostic devices know how quickly things can change, so let's take a quick look at a few stories that appeared in Medical Device Daily in August 2009. After all, two years are less than the average time needed to get a patent through the U.S. Patent and Trademark Office, which is another story.
Aug. 12, 2009: Schultz out at CDRH; Shuren to serve as interim director
On Aug. 11, 2009, the Internet was abuzz with reports that Dan Schultz, MD, had stepped down from his post as director of FDA's Center for Devices and Radiological Health “by mutual agreement.”
One thing that surely damaged Schultz was the flap over the Menaflex 510(k), but it could not have helped that Schultz was appointed by interim FDA commissioner Les Crawford, MD. Crawford resigned his job at FDA in 2005 after it was revealed that he'd failed to disclose stocks he had in companies regulated by FDA.
Shuren ditched the “interim” part of his title in January 2010, and it's safe to say the world of device regulation in the U.S. hasn't been the same since. Schultz is now with the consultancy Greenleaf Health (Washington) and is routinely seen at med-tech related events, including the unveiling of the IOM report on the 510(k) program.
Aug. 14, 2009: Once bankrupt SeraCare now a profitable company
SeraCare (Milford, Massachusetts) took in no less than eight warning letters between 1998 and 2002 largely due to operations at its blood banks, but the company's president/CEO, Sue Vogt told Medical Device Daily in August 2009 that the firm was confident it would turn a profit despite problems with the Securities and Exchange Commission the previous year, along with a de-listing of its shares.
SeraCare, which also makes diagnostics, is still in business, but it seems the company won't be operating independently much longer. An Aug. 1 statement indicates the firm's directors had “initiated a process to explore and evaluate potential strategic alternatives … which may include a sale or other transaction.”
Three days later, a story at outsourcing-pharma.com reported that SeraCare had disclosed a revenue loss of 15% in the company's third quarter 2011 report, but the story also indicated that Vogt is about to part ways with the company.
Aug. 18: Danaher gets $77M equity stake in Align plus $13M cash
Danaher (Washington) has a lot of subsidiaries to go with its deep pockets, but its acquisition of Align Technologies (Santa Clara, California) in August 2009 came about in an unusual manner.
A subsidiary of Danaher, Ormco (Orange, California), brought a suit against Align for patent infringement related to the latter's Invisalign orthodontic device. The settlement entailed Align paying $13 million in cash and $77 million in stock to settle the suit.
The move seemed to help Align as its shares rose about 16% the day after the story broke, and Align is also named in an Aug. 24 brief – that's Aug. 24 this year – at the website for Zack's Investment and Research as having the best relative performance in the healthcare supplies industry.
Danaher is still going strong, but perhaps a bit low on cash after agreeing to buy out Beckman Coulter (Brea, California) for $6.8 billion earlier this year. Beckman came with a regulatory problem as an Aug. 9 warning letter demonstrated, but that's a small headache for such a large acquisition.