Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

Venture Capitalists Lobbying Congress Heavily to Reign in FDA

Venture capitalists are spending significantly on efforts to lobby the US Congress to ease FDA regulatory requirements for medical device manufacturers, to considerable effect.

According to a New York Times report, venture capital funds allocating to medical device and technology manufacturers have provided more than $3.3 million in political donations to lawmakers and political action committees over the past five years; 20% of those donations were made to politicians and groups explicitly advocating less regulatory authority for the FDA in terms of medical device reviews.One lobbying group, the National Venture Capital Association, spent $350,000 last year on medical device and health care efforts, and expects that figure to increase to $450,000 for 2011.

Now that the FDA’s Medical Device User Fee law is up for renewal in Congress, medical device industry and venture capital lobbying efforts appear to be paying off. No less than 10 bills have been introduced by House Republicans since early October, along with a bipartisan Senate bill, all aiming to speed up the FDA’s medical device review process. Industry efforts to repeal a looming sales tax on medical device manufacturers mandated by the Affordable Care Act have also gained support among lawmakers from states such as Massachusetts and Minnesota with sizeable medical device sectors.

Although the merits of their arguments have been questioned by various medical experts, industry and VC advocates have so far effectively steered the conversation in Congress.

Markets: USATags: 510(k), 510k, FDA, medical device, new york times, venture capital

Author: Stewart EisenhartDate: October 26, 2011

New Study: US Med Tech Industry Losing VC Funding

Venture capital firms are investing less in US medical device and pharmaceutical companies in favor of European and Asian firms, and expect that trend to continue unless the US Food and Drug Administration reforms its regulatory processes.

A new study by the Medical Innovation & Competitiveness Coalition (MedIC), a branch of the National Venture Capital Association, surveyed 156 venture capitalists investing a combined $10 billion in the health care sector over the past three years. Nearly 40% of respondents reported decreasing their health care investments between 2008 and 2011, and nearly 40% of firms also plan to further reduce allocations to life sciences companies over the next three years.

Furthermore, 42% of respondents indicated plans to reduce investments in medical device firms; increased allocations to the health care information technology sector as well as to health care services outside the purview of the FDA are planned instead. US medical device and drug manufacturers focused on conditions such as cardiovascular disease, diabetes and cancer are expected to see significant decreases in venture capital support.

A strong majority of respondents (61%) cited FDA regulatory challenges as the key factor behind their investment decisions; concerns about reimbursement (38%) and financial market conditions (35%) also factored heavily, according to survey results.

While 58% of respondents currently invest only in US life sciences companies, 31% of venture capitalists plan to decrease US investments in the next three years; 36% of respondents plan to increase their European investments, and 44% plan to increase allocations to Asian firms. On a related note, respondents anticipate that more and more US-based medical technology manufacturers will seek regulatory approval and commercialization of their products first in other markets.

To reverse these trajectories, venture capitalists recommend that the FDA to improve predictability and speed of its regulatory decisions—familiar suggestions that the agency itself claims to be pursuing in earnest. But what degree of predictability and efficiency would suffice in order to reverse the flow of medical device venture capital out of the US market?

Markets: USA, WorldwideTags: FDA, MedIC, medical device, venture capital

Author: Stewart EisenhartDate: October 7, 2011

VC Group Lobbies for Reforms to US Medical Device Review Process

The Medical Device Venture Council, an informal group of venture capitalist firms focused on life sciences investing, has undertaken efforts to convince US lawmakers and Obama Administration officials that the Food and Drug Administration’s medical device review process needs to be reformed.

The Wall Street Journal’s Venture Capital Dispatch blog reports that the group has recently met with the White House’s Council of Economic Advisers as well as Senate committees to argue that the FDA’s current device review process has slowed commercialization of innovative products in the US as well as discouraged increasing numbers of investors from providing much-needed capital to manufacturers.

Improving those alleged trends, the group contends, entails setting up more efficient, transparent and predictable medical device clearance and approval processes—an argument very much in line with that made by industry trade groups also making the rounds and getting attention on Capitol Hill. The group cited reforms implemented for the US patent process as good precedents on which FDA reforms should be built.

According to Mike Carusi, a council member and partner at Advanced Technology Partners interviewed by Venture Capital Distpatch, the group’s discussions with government officials focused on deal flow as well as declining numbers of medical device start-up activity in the US relative to Europe.

Carusi emphasized, however, that pressing for a more efficient and predicable review process should not equate to lowering quality and safety standards. Instead, he argues that regulators should more consistently apply standards already in place.

Markets: USATags: FDA, medical device, medical device venture council, venture capital

Author: Stewart EisenhartDate: June 9, 2011