Compliance Corner

Tim Mohn

Tim Mohn is an industry principal in Sparta Systems’ product management group. In this role, Tim is responsible for helping both Sparta and Sparta’s clients track and understand changes in the regulatory environment and trends in the life sciences industry. He previously served as worldwide quality systems manager at Ortho-Clinical Diagnostics, a division of Johnson & Johnson. At OCD, Tim championed eMDR and SAP integration activities, owned the CAPA process and supported multiple FDA inspections at OCD's locations. Prior to J&J, he worked at Pfizer Consumer Healthcare and Wyeth Pharmaceuticals. Tim holds a B.S. in Biology and a Masters in Manufacturing Management from Penn State.

Regulatory compliance vs. innovation: Does it have to be either-or?

There's nothing you can do about looming changes to the 510(k) program. But you can take the time to make sure your internal processes are up to snuff.

Arne Carlson, the former governor of Minnesota, recently contributed an opinion column to the Minneapolis Star-Tribune, voicing concerns about increased Food & Drug Administration regulation of the medical device industry stifling innovation. The column came as Dr. Jeffrey Shuren, director of the FDA's Center for Devices & Radiological Health, prepared to visit the state — one of the country's biggest medical device hubs — for a town hall meeting to discuss CDRH's 2010 Strategic Imperatives and hear feedback from industry officials.

07/05/2010 - 09:00

Tim Mohn

Have you hugged an auditor today?

Enterprise quality and compliance management software solutions can provide the consistency your company's audit system needs.

In the life sciences industry, many companies have a heightened sensitivity to risk due to increased regulatory scrutiny and/or product quality issues. As a result, the concern around compliance has renewed many organizations' focus on audit programs, which are being re-calibrated as a tool to identify the most vulnerable parts of the business.

06/01/2010 - 15:11

Tim Mohn

Chance-takers are accident-makers

Improving medical device safety from pre-review to post-market.

It pays to remember an old adage: "Better to be safe than sorry." Indeed, many medical device manufacturers are re-evaluating their quality systems as a result of the Food & Drug Administration's recent review of pre-market notifications and a FY 2011 budget request for additional funds to address product safety. Device makers should heed this advice and take the necessary steps to pro-actively — rather than reactively — address compliance issues.

03/11/2010 - 16:34

Karin Gregory

Karin Gregory, an attorney who's spent more than 30 years in healthcare, is a founding partner at Furman Gregory LLC. Gregory specializes in life science companies and research institutes, advising medical device and other high-tech firms on regulatory issues, including FDA and FTC issues of advertising and promotion of medical products, licensing, collaboration agreements, issues of confidentiality, genetic testing in medicine and invention protection, venture capital and strategic corporate partnering along with other related business transactional matters.

Mixed tidings for 2010

Healthcare reform promises to present a mixed bag of goodies for medical device makers this year.

There is a bit of holiday cheer going into 2010, as the Senate delayed the implementation of a healthcare reform tax on medical device makers to 2013. This amendment also provides an exemption to the small startups and companies with yearly revenues of less than $100 million. But those with revenues above that mark will see their tax burdens increase. This is perhaps a boost to the early-stage startups that are looking to raise funds to commercialize their products. The climate is difficult enough to find investors willing to fund an early-stage, pre-commercialization company.

01/04/2010 - 16:58

Karin Gregory

What's a woman to do?

Mammography shouldn't be the only medical procedure under the microscope when it comes to slowing the growth of healthcare costs.

What's a woman to do? The latest health care reform is coming in the form of a report from an independent body of clinical specialists who have determined that mammography screening starting at 40 years old has lead to false positives, increased costs and other "risks" that are best handled by changing the time and number of mammograms mandated for women. According to the American College of Radiology, since regular mammography went into widespread use in 1990, the mortality rate from breast cancer has declined by 30 percent.

11/30/2009 - 11:45

Karin Gregory

Federal appeals court decision upholds fines for TMJ Implants and its founder

The U.S. Court of Appeals for the 10th Circuit's decision in a case involving TMJ Implants Inc. and founder Robert Christensen might signal an increased readiness by the Food & Drug Administration to levy fines against medical device makers — however inadvertent their mis-steps.

In TMJ Implants v. United States Department of Health and Human Services, the U.S. Court of Appeals for the 10th Circuit upheld the Food & Drug Administration's imposition of $170,000 in civil money penalties against TMJ Implants and its president, Robert Christensen.

11/23/2009 - 12:33

Karin Gregory

Voluntary recalls are still the best way to protect consumers

As the Institute of Medicine reviews the Food & Drug Administration's 510(k) medical device approval process, it's worth taking a step back to assess the best way to keep faulty or ineffective devices off the market: Voluntary recalls.

The Food & Drug Administration is asking the Institute of Medicine for a $1.3 million review of the 510(k) process. Is this a good or a bad way to review this agency’s work product?

10/19/2009 - 13:19

Karin Gregory

Here we go again

It's time for another round of reform mania in Washington. But will legislators find real solutions to the problems facing healthcare, or will it be business-as-usual inside the Beltway?

Here we go again, taxing and spending, but now the theme is healthcare reform. We see this trend every eight to 10 years, so it's really more of a cycle. It usually comes in lock-step with more regulation, because there are more funds to pay for the increased regulation. This "reform" is not shaping up to be all that different from the last attempt. If the Senate has its way, more fees and taxes will result to cover the $900 billion working price tag.

09/18/2009 - 10:53

Karin Gregory

Wanted: Common sense reforms at FDA

Medical device makers are focused on bringing good, safe products to market. There are better ways to police the industry than the proposals in the Medical Device Safety Act of 2009.

We watch to see the outcome of the hearings and discussions from the Congressional activities that have stemmed from the U.S. Supreme Court’s February 2008 decision in Riegel v. Medtronic Inc. Congress is rushing to enact the Medical Device Safety Act of 2009 to reverse the preemption bar for those injured by medical devices that have been approved for use via the pre-market approval process of the Food & Drug Administration.

09/01/2009 - 11:27

Karin Gregory

Fasten your seatbelts

FDA's new focus on more stringent enforcement could mean a roller coaster ride for medical device manufacturers.

Newly confirmed FDA commissioner Dr. Margaret Hamburg indicated In a recent speech ways that the agency will step up enforcement activities.

So put on your seatbelts. We're going to see just how much the new mantra of "transparency" will help or further hinder the commercialization of medical products.

Hamburg announced several initiatives during her talk, including post-inspection deadlines of 15 working days for FDA to outline its issues for industry before a warning letter will be sent and limiting warning letter reviews to "significant legal issues."

08/18/2009 - 11:42

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