Engineering Trends: Medical Device Manufacturing

Engineering Trends Medical Device Manufacturing Kendall Christian, Aramark CTS/Floyd Medical Center Noah McNeely, Slingshot Product Development Angela Sinton, Medical Device Marketing Stacy Williams Shuker, Georgia Center of Innovation for Life Sciences Diane Lewis, Lewis Chemical Company

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EXPLORE OPPORTUNITIES. INNOVATE. LAUNCH. SUCCEED. Copyright © 2011, Slingshot Product Development Group, Inc. www.slingshotpdg.com

FDA: Challenge and Opportunity on the Critical Path to New Medical Products March 2004 http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html

Innovation or Stagnation? Challenge and Opportunity on the Critical Path to New Medical Products

Clear as Mud: Obtaining & Marketing Your 510(k) With Today’s FDA Presented by: Spectrum of Technology IV Symposium Digital and Engineering Technology Breakout Session October 14, 2011 Rome, Ga

Welcome to My World

It’s a strange and Topsy Turvy World The Company Me Tweedle Dee and Tweedle Dum CDRH Reviewers FDA Ombudsman FDA ‘s Office of Chief Counsel Company Regulatory Affairs Congress

The Company’s

An update on what is happening politically with FDA and Congress RECENT DEVELOPMENTS: The FDA and the 510(k) program are political footballs

The ReGen controversy

FDA’s report: “Review of the ReGen Menaflex®: Departures from Processes, Procedures, and Practices Leave the Basis for a Review Decision in Question” (September 24, 2009).

. … and FDA’s own employees go to Congress

. . . and to President Obama “ The purpose of this letter is to draw your attention to the frustration and outrage that FDA physicians and scientists, public advocacy groups, the press and the American people , have repeatedly expressed over the misdeed of FDA officials.” … “… sweeping measures are needed to end the systemic corruption and wrongdoing that permeates all levels of FDA and has plagued the Agency far too long.”

CDRH Director Dan Schultz Resigns Under Pressure . . .

“ Never let a crisis go to waste” ”

Commissioner Hamburg: “the device unit was ‘clearly troubled’ and it was immediately clear to her that big changes were in order.”

The problem with the Queen (FDA) is: she cheats

New FDA Administration requests Institute of Medicine (IOM) to review 510(k) Program

. September 25, 2009, Internal CDRH Memo, “Change is in the air for 510(k)” Establishes 10 Working Groups

Another FDA hearing February 9, 2010 on Using New Science in Clearances and Approvals

FDA’s February 18, 2010 hearing on the 510(k) program

. ReGen: another FDA Advisory Panel meeting

. Approval and Clearance timelines are increasing

. All of this is affecting sustainability for some firms

As a Result its Affecting Investment and Innovation

So What is Alice Doing About It?

What we’ve done in Minnesota

The Minnesota Medical Device Alliance (MMDA) presents its White Paper to Dr. Shuren at the FDA Town Hall in Minneapolis on May 18, 2010 Can be obtained at www.duvalfdalaw.com See “Resources: Client Alert—FDA Town Hall Meeting”

What the Future Holds?

. “ . . . advancing the public health by helping speed innovations . . .” “ . . . Responsible for protecting the public health. . .” Let’s start with the past

What really prevents FDA from making clearances?—an over-emphasis on safety, depriving patients of benefits .

UPDATE: CDRH chief Shuren blasts Stanford study on medical device regulations December 1, 2010 by MassDevice staff Center for Devices and Radiological Health director Dr. Jeffrey Shuren fires back at recent study from Stanford University on the costs associated with satisfying Food & Drug Administration rules during the 510(k) process. Center for Devices and Radiological Health director Dr. Jeffrey Shuren strongly refuted findings from a recently study that said more than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles. Shuren told MassDevice that a study by researchers at Stanford University titled "FDA Impact on U.S. Medical Technology Innovation," which said that millions of U.S. patients were being denied or delayed access to leading medical devices that are first (or exclusively) brought to market in other countries, was " highly flawed ." The Nov. 18th report was based on a survey of 204 public and venture-backed medical device companies out of a possible 1,023 companies in the domestic medical device industry, according to its authors. " That's well below the quality level of a good study ," Shuren said, pointing out that lower response rates would magnify the opinions of people unhappy with the process. He added that a sufficient response rate would have been 35 to 40 percent. "We want to have good data."

What’s Next?

Bipartisan Congressional Pressure Continues

Bipartisan Minnesota Congressional Pressure Continues

Bipartisan U.S. Senate Pressure Continues Signatories: Amy Klobuchar (D-MN), Al Franken (D-MN), Scott Brown (R-MA), John Kerry (D-MA), Pat Roberts (R-KS), Ben Nelson (D-NE), Mike Johanns (R-NE), Kay Hagen (D-NC), John Cornyn (R-TX), Kay Bailey Hutchinson (R-TX), Olympia Snowe (R-ME), Evan Bayh (D-IN), Debbie Stabenow (D-MI), Bob Casey Jr. (D-PA), and John Barrasso (R-WY). Senators Feinstein and Boxer from California notably missing

“ Under Hamburg and Sharfstein, the agency has ‘become more aggressive in regulatory matters,’ the paper says , ‘issuing more warning letters to companies for manufacturing and marketing violations with less negotiation time . . .’”

FDA and Promotional Issues

510(k) General vs. Specific Use Specific Indications—on or off-label?

Examples of Ablation Products Boston Scientific – Cobra / Thermaline Atricure - Bipolar Microwave Afx - Lynx Boston Scientific – Cobra / Thermaline Bipolar Medtronic – Cardioblate Biopolar

August 15, 2007: FDA Warning Letter to Spineology

March 12, 2007: The Biliary Stent Meeting at FDA

14 Fairly Recent Drug Warning Letters FDA cites specific sponsored links “ The sponsored links cited in this letter are misleading because they make representations and/or suggestions about the efficacy of Cymbalta, Evista, and Gemzar, but fail to communicate any risk information associated with the use of these drugs. In addition, the sponsored links for Evista and Gemzar inadequately communicate the drugs’ indications.”

Beware of the Unholy Alliance Anti- kickback Off-label information False Claims Act

Social Media a BIG Issue Today

Social media use for FDA regulated products under fire by some . . .

Example of FDA Inspection leading to a claim of “adulterated” and “misbranded” product

Promotional Activities Getting More Attention—Targeting individuals and officers

What is Industry’s Responsibility?

Sometimes We Have to Fight Them

But Mostly We Work With Them as Best We Can

The END??? Things Just Get Curiouser and Curiouser...

QUESTIONS??? Not one... But you’re an idiot .... Are you kidding, I have tons!! Takes one to know one ....