Medical Device Link.

Proposed revisions to the clinical research policy of the Centers for Medicare and Medicaid Services (CMS; Baltimore) have elicited a strong reaction across the medical industry. While some industry members question CMS’s authority to issue such revisions, others are cautiously evaluating the implications of a new self-certification process for clinical trials.

In claiming that the proposed policy exceeds CMS’s authority, the Medical Device Manufacturers Association (MDMA; Washington, DC) has called on the agency to withdraw the proposed revisions. Mark Leahey, MDMA executive director, said, “CMS has long recognized that its authority to issue national coverage decisions requires that these policies apply to specific items and services. This proposed decision would address coverage of an extraordinarily broad range of items and services . . . and any effort to revise coverage for such a vast assortment of items and services would exceed the scope of a national coverage decision and must be pursued through rulemaking.” [More]

Bausch & Lomb Marks Medtech’s Latest Move into the Private Sector

Gunderson

Thomas Gunderson, a managing director and senior medtech analyst with Piper Jaffray & Co. (Minneapolis), says the idea of more medtech companies going private is intriguing. “There’s an excess of private equity funds and a paucity of good opportunities,” he says. “Medical technology is increasingly recognized as one of those sector opportunities.”

Gunderson says there are a number of incentives for companies going private. “By going private, many medtech companies could realize significant cost savings while having a far greater ability to focus on long-term goals and objectives—rather than worrying about the next quarterly report,” he says. Gunderson estimates that many companies could realize savings of 20–30% by going private. [More]

 Medical Product Centers Planned for New York City, Cleveland 

Organizations in Cleveland and New York City have emerged with separate yet similar plans to construct massive exhibition and conference complexes targeted specifically at the medical manufacturing industry. Both projects—which have yet to break ground—call for hundreds of thousands of square feet to be dedicated to permanent medical device and equipment showcases, as well as space for medical education activities.

Although both projects have been in planning stages for years—and are still several years out from their anticipated completions—they’ve each received their fair share of attention in recent weeks due to the achievement of significant milestones. Parties on both sides, although acknowledging that the significant size of the medical product market provides room for competition, tout their respective locations as being key to their anticipated success. [More]

IP Watch: Medtronic to Acquire Biophan MRI Safety Technology

Weiner