Study Finds Top-Ranked Hospitals Typically Run by Physicians

  Study finds top-ranked hospitals typically run by physicians indings published in Social Science and Medicine report that the top-performing hospitals are typically led by physicians rather than non-physician managers. The conclusions run counter to modern trends in the western world that place generally trained managers — rather than those with medical degrees — at the helm of hospitals. [...]

Medical-Device Venture Capitalists Go to Washington

Medical-Device Venture Capitalists Go To Washington (WSJ Blog) Health care-focused venture capitalists have long been telling anyone on Capitol Hill who will listen that problems at the Food and Drug Administration are stifling innovation and deal flow, as they say the agency is inconsistent and vague on the rules for approving new medical technologies.

FDA Device Chief, Jeff Shuren, Is in Complete Denial Regarding the Effects of the Agency on Innovation

FDA device chief Shuren: Recession played a role in pushing medical device industry to EU (MassDevice) The “Device Gap” between EU and US is heating up Jeff Shuren testified at a House Oversight & Government Reform Subcommittee on Health Care’s “Pathway to FDA Medical Device Approval: Is there a Better Way?” Shuren believes that the recession [...]

The 6 Biggest Concerns of Physicians in the Wake of Healthcare Reform (By Dr. Stephen Hochschuler)

Dr. Stephen Hochschuler: 6 Points on Healthcare Spending for Spine and Orthopedics (Beckers) Stephen Hochschuler, MD, co-founder of Texas Back Institute and former president of the Spine Arthroplasty Society. 1. Lowering the high cost of implants and devices. 2. Disarray of the FDA. 3. Managing healthcare entitlement programs. 4. Patient control over healthcare spending. 5. [...]

An Emotional Patient Shares Her Horror Story With Senate Panel About Her Depuy ASR Metal-on-Metal Hip

DePuy hip recall: Patient shares horror story with Senate panel (MassDevice) Katie Korgaokar captures the attention of a Senate panel examining medical device safety on Capitol Hill with her story of a faulty ASR hip implant made by DePuy Orthopaedics Inc., accusing the surgeon who implanted the device of receiving more than $600,000 in consulting [...]

The Feds Are Expanding Their Investigation Into Medtronic’S Off-Label Use of Infuse

Medtronic Bone-Growth Product Scrutinized (NY Times) Feds Widening Infuse Inquiry (OTW) The New York Times reported that the U.S. Justice Department (DOJ) criminal investigation into Medtronic’s off-label marketing of Infuse was “apparently widening.” Medtronic received the first subpoena from the DOJ looking into off-label use of InFuse in October 2006.

Canadian Patients Wait Time for Total Joint Surgery Has Been Reduced

Canada’s Surgery Wait-Time Down (OTW) By 2010, 84% of Canadian patients were receiving hip replacements within wait time benchmarks of 182 days.

Medical Device Tax: AdvaMed Asks IRS to Define “manufacturer”

Medical device tax: AdvaMed asks IRS to define “manufacturer” (MassDevice) Indiana Senator leading the charge to repeal the new 2.3% Medical Device tax Orthopedic device industry rattled by proposed tax    

6 Ways Evidence-Based Medicine Impacts Orthopedics

6 Ways Evidence-Based Medicine Impacts Orthopedic and Spine Surgery (Beckers) Reprint from Becker’s Orthopedic and Spine Review – March 22, 2011 ================================================= The recent focus on evidence based medicine throughout the medical field has prompted both challenges and opportunities in orthopedics. “I think there will be much more scrutiny in the future of the value [...]

14 Reasons Commodity Implants Yield Big Savings

14 Reasons Commodity Implants Yield Big Savings for Orthopedics and Spine (Beckers) Reprint from Becker’s Orthopedic and Spine Review – March 16, 2011 ================================================= Richard A. Kube, MD, CEO of Prairie Spine & Pain Institute in Peoria, Ill., explains how commodity implants, which are simpler and less expensive than premium implants, can yield big savings [...]

Indiana Senator Leading the Charge to Repeal the New 2.3% Medical Device Tax

Senator Coats Holds Orthopedics Roundtable In Winona Lake (Times-Union) Under the health care law passed in 2010, orthopedic device makers will get hit with a 2.3 percent excise tax. Senator Dan Coats (Indiana) is the co-sponsor of the “The Medical Device Access and Innovation Protection Act” that would immediately repeal the tax.

FDA Public Workshop on June 2011 in Dallas, “The Future of Medical Products Regulation: Ensuring Safety and Integrity in a Global Market”

FDA will hold a 2-day public workshop, “The Future of Medical Products Regulation: Ensuring Safety and Integrity in a Global Market,” Dallas, TX, June 20-21, 2011. (FDA)    

The FDA Backlash Reaches a U.S. House Subcommittee

Medical device industry tees off (MassDevice) The medical device industry’s public relations campaign to push the regulatory agenda its way hit another level today, with industry advocates testifying before a U.S. House subcommittee, studies taking aim at the Food & Drug Administration and even an op-ed from a pair of friendly legislators.

Report: Patient Safety Is Not Compromised With Faster EU Regulatory Process

AdvaMed-Sponsored Report Says Safety Not Improved By Longer Approval Process (WSJ) A new report prepared by the Boston Consulting Group shows that a slower regulatory process in the U.S. doesn’t improve the safety of patients here compared to Europe. Findings show that the number of products pulled due to “significant health risks” is about the same in [...]

The FDA Is Forcing Medical Device Companies to Focus on OUS Markets

Medical Device Makers Shun United States (NYTimes) Medical device industry executives and investors are complaining vociferously these days that the industry’s competitive edge in the US and overseas is being jeopardized by a heightened regulatory scrutiny. In 2010, the F.D.A.  granted 19 premarket approvals, down from 48 in 2000.

FDA to Approve Innovative Medical Devices in Half the Time

 FDA to Approve Innovative Medical Devices in Half the Time (MedScape) FDA Launches Medical Device Innovation Initiative (FDA) FDA Introduces Medical Device Innovation Initiative (HealthPointCapital) The FDA proposes the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced that the first submission will be a brain-controlled, upper-extremity prosthetic that will serve [...]

Experts See 6 Challenges for Medical Device Industry Post-Reform

Orthopedic and Spine Device Industry Post-Reform: 6 Challenges (Beckers) Consolidation within the medical device industry. Changes in the FDA 510(k) clearance process. Reimbursement for orthopedic and spine procedures. Lowering the cost of healthcare. Connecting with orthopedic surgeons. Device marketing and communication with customers.

FDA Announces 510(k) Changes

FDA Announces 510(k) Changes (HealthPointCapital) FDA to improve most common review path for medical devices (FDA) 510(K) AND SCIENCE REPORT RECOMMENDATIONS:   SUMMARY AND OVERVIEW OF COMMENTS AND NEXT STEPS (FDA) FDA will implement 25 actions during 2011 to improve the 510(k) review process for medical devices.  Key actions include: Streamlining the “de novo” review [...]

Bill Hawkins Predicts “Mild pain” After the FDA’S 510(k) Overhaul

Medtronic’s Hawkins: 510(k) changes to be ‘neutral to slightly negative’ (MedCityNews) Outgoing Medtronic (NYSE:MDT) Chief Executive Bill Hawkins is predicting only mild pain when the federal government unveils changes to the 510(k) rules governing approval for most medical devices.

Jeffrey Shuren Talks About the New 510(k) Process

Shuren Innovation Update (OTW) Shaky Industry Confidence Recommendation Roadmap Political Cover Remarks: MassMEDIC FDA Update Conference, December 1, 2010 (FDA)

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May 18, 2012

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