Medical Devices Today

Value Proposition Is Key to New Product Success in a Cost-Conscious Medtech Market

Article preview reprinted from Medtech Insight - August/September 2009

The need for a positive economic argument when introducing a new medtech product is more critical than ever. Management teams are well aware of the need to demonstrate compelling economic data, but can a product still be successful without an economic benefit in the increasingly cost-conscious health care marketplace? Overcoming negative economics means identifying a combination of positive attributes that can overcome the economic barrier, and this thought process should be conducted well before significant R&D funds are invested. Read more...

Abbott Unit, Hospira Device Power Cords Probed By FDA For Defects

• Abbott Unit, Hospira Device Power Cords Probed By FDA For Defects
• Terumo Seeks To Be Major Presence In U.S. Diagnostics Market
• Wright Medical To Move Europe Distribution From France To Amsterdam
• Cook Group Founder Urges Different Approach To Health-Care Reform
• GE Settles Patent Suit With SonoSite For $21 Million In Royalties
• CareFusion Begins Shipping Ventilators For CDC National H1N1 Stockpile
• St. Jude, Medtronic, Zimmer, Others Find Bipartisan Support In Bunching
• Baxter Gets FDA Warning Letter Over Good Manufacturing Practices
• Medtronic ‘Consultant’ Cleared By Panel Of Faking Bone-Growth Data
• Boston Sci Reports Disappointments With Stents, Heart-Rhythm Devices
• Abbott, Advanced Medical, Alcon, Others Get Laser Warning From FDA
• J&J Unit Ends Agreement With Palomar For Cosmetic Devices
• C.R. Bard, Covidien Sued In W. Virginia Over Implanted Devices

 

Facility Registration, Import Problems Keep CDRH Compliance Office Busy

Full article reprinted from "The Gray Sheet" - October 19, 2009

CDRH Compliance Director Tim Ulatowski gave an update last week on activities at his office, including import safety efforts and a notable warning letter push. Read more...

Firms Not Making Progress In Improving Recall Notifications, FDA Says

Full article reprinted from "The Gray Sheet" - October 19, 2009

More than four years after it was revealed that Guidant failed to properly warn patients and physicians about potentially fatal product malfunctions, an FDA official says the overall quality of manufacturer recall notifications has not improved. Read more...

CDRH Acting Director Jeffrey Shuren Vies For Permanent Spot

Full article reprinted from "The Gray Sheet" - October 19, 2009

Acting device center director Jeffrey Shuren is vying to head the center permanently. He announced his candidacy to agency staff last week, according to Principal Deputy FDA Commissioner Joshua Sharfstein. Read more...

Colorectal Cancer: Meeting the Challenge

Article preview reprinted from Medtech Insight - August/September 2009

Medtech Insight -- Early detection of colorectal cancer can dramatically improve an individual's chances for avoiding this deadly disease, and screening colonoscopy is the gold standard for CRC prevention. One detractor, however, is patient avoidance due to perceived discomfort of the bowel preparation process and the colonoscopy itself. Mitigation of these concerns has prompted companies to look for less invasive or even noninvasive screening solutions that have the same sensitivity as diagnostic colonoscopy. These emerging technologies range from advanced endoscopic devices to new methods of in vivo tissue characterization. Read more...

Device VCs Keep Eye on Capital Commitments

Article preview reprinted from Start Up - September/October 2009

Medical device investors have a newfound appreciation for keeping a lid on their capital commitments. Read more...

Medical Device and In Vitro Diagnostics/Research Deal Statistics Quarterly, Q2 2009

Article preview reprinted from IN VIVO -  September/October, 2009 

Highlights from the Q2 2009 review of medical device and in vitro diagnostics/research dealmaking: Financings by medical device companies jumped an impressive 62% over Q1 to $847 million--primarily from private VC rounds that contributed over 90% of the total deal volume with 52 early- and late-stage transactions--indicating a possible rebound in fundraising. Medical device M&As, on the other hand, proved to be a disappointment with only ten deals raising $794 million, most of which was Covidien's $470 million cash purchase of Vnus Medical. Although there were no big mergers, some device firms instead turned to the strategic alliance as a way to gain inexpensive products and technologies. On the in vitro diagnostics/research side, financing activity captured over three times the previous quarter's dollars through 12 deals totaling $302 million, however, almost 80% of that amount was from Beckman Coulter's $239 million FOPO. VC rounds only averaged $6 million apiece, with early- and late-stage rounds together bringing in $43 million. M&A in this industry segment was almost non-existent with only two transactions adding up to $358 million, a mere third of Q1 M&A deal volume. Read more...

FDA Panel To Review Zimmer PMA For Dynesys Spine Stabilization System

Full article reprinted from "The Gray Sheet" - October 12, 2009

Zimmer will argue for PMA approval of its Dynesys dynamic spinal stabilization device Nov. 4 in front of FDA's Orthopaedic and Rehabilitation Devices panel.

FDA Orders 12 Firms To Collect Data On Dynamic Spine Stabilization Devices

Full article reprinted from "The Gray Sheet" - October 05, 2009

FDA is ordering 12 spine device manufacturers to begin collecting post-market data on how well their devices fare in doing what they are 510(k)-cleared to do: support spinal fusion procedures.