Medical Devices Today

Medical Device and In Vitro Diagnostics/Research Deal Statistics Quarterly, Q3 2011

Article preview from IN VIVO - December, 2011

Medical device companies raised a total of $906 million in Q3, while in vitro diagnostic/research developers took in $72 million. The top M&As in each segment were private buyouts of public companies: Kinetic Concepts for $6.3 billion and Immucor for $1.9 billion.

Device Industry Expects Quicker Path To Market In Exchange For Doubling Of User Fees

Article preview from "The Gray Sheet"-  February 6, 2012

The tentative agreement of $595 million in user fees over five years is more than companies had wanted to spend. But industry negotiators insist it is a good deal, tied to performance goals and process improvements they say will ensure greater speed and predictability in reaching the U.S. market.

Owning the Disease: A New Business Model For Medical Technology Companies

Article preview from IN VIVO - December, 2011

The convergence of expanded access, lower reimbursement rates, higher velocity of innovation, diminished pools of venture capital, the advent of personalized care and a growing demand for improved patient outcomes has created ripples that already are altering the economics and operating dynamics of health care. To survive the coming storm, biomedical companies must build new models of innovation that are anchored in consumer-centric disease solutions rather than the traditional R&D department approaches.

CDRH In 2012: More Pilots, Guidances And Regs

Article preview from "The Gray Sheet"- January 30, 2012

The device center plans to finalize all the 510(k) program guidances it issued last year, among a boatload of 2012 priorities. Many of this year's top goals spring from the 510(k) and “science in regulatory decision making” reform programs that commanded attention in 2011.

DFINE Seeks Meaning Outside Of Spine

Article preview from IN VIVO - December, 2011

Privately held DFINE Inc., a supplier of tools for treating vertebral compression fractures in the spine, is trying to reposition itself from being a spine company to an “interventionalist company” that provides tools necessary to interventional radiologists, neuroradiologists, and oncologists.

510(k) Guidance Footnote May Signal Greater FDA Oversight Of Preclinical Testing

Article preview from "The Gray Sheet"- January 23, 2012

Device industry experts say a seemingly minor footnote to the recent 510(k) program draft guidance could create a new requirement for nonclinical studies.

Solta Medical: In Aesthetics, A New Device Model For An Evolving Market

Article preview from IN VIVO - December, 2011

Solta Medical was formed by the merger of two aesthetic device start-ups targeting the same customer with complementary technologies: Thermage in skin tightening and Reliant in skin resurfacing. Solta Medical’s product and marketing strategy has made it more immune in the economic downturn than its peers in aesthetic energy devices. What’s helped it most these past few years is its reliance on high margin disposables, rather than capital equipment, for the majority of its revenues.

FDA, Industry Haggle Over Price For New User Fee Deal

Article preview from "The Gray Sheet"- January 17, 2012

As of last month, FDA and industry were several hundred million dollars apart, according to recently released negotiation meeting minutes. And insiders suggest the two are still haggling over the total amount companies will need to shell out in the five-year user fee reauthorization.

Sober NASS Reflects Challenges Facing Spine Industry

Article preview from IN VIVO - November, 2011

This years’ gathering of the North American Spine Society (NASS) carried a muted tone that befits a stagnant or shrinking industry. Surgeons in NASS’ leadership spoke to the minimal growth in their own reimbursements and their concerns over how changes in the health care sector will impact the specialty going forward.

Changing The Paradigm: 510(k) Draft Guidance May Raise New Questions

Article preview from "The Gray Sheet"- January 9, 2012

New concepts such as “primary predicates” and “reference devices” may be more confusing than clarifying, former FDA staffers say.