President Obama campaigned on the idea of change, addressing everything from foreign policy to healthcare. Change proposed by the federal government for healthcare often targets the way the FDA operates. Already making several signifcant decisions that will impact the medical device industry, Obama has shown he intends to make good on his promise of change. This was the topic industry leaders addressed for this month's Perspectives.
What changes do you see coming to the FDA and/or the industry as a result of President Obama's policies and do you expect the impact to be overall positive or negative?

President, Quinley & Associates

Under the Obama administration, we can expect an FDA that is much tougher on safety enforcement against medical device companies. Compensating—or overcompensating—for a perceived regulatory torpor under the Bush administration, the election changeover brought renewed focus on FDA staffing, claims of politics skewing regulatory decisions, and concerns about the FDA's fitness to safeguard public health.

President Obama may act on such concerns by spurring a new zeitgeist of "activism" and having the Agency ratchet up enforcement against medical device firms. Further, an Obama-appointed FDA Commissioner may reverse prior FDA support for Federal preemption as a bar to state product liability lawsuits, re-opening the way for more litigation against devices that passed rigorous PMA muster. These actions will increase tort, liability, and insurance costs for device firms. They may also result in more recalls, product seizures, warning letters, and regulatory sanctions.

Few of these outcomes will be welcomed by medical device firms. They may, however, garner applause from consumer groups, certain segments of the physician community, and all segments of the personal injury plaintiffs' bar.

Senior Subject Matter Expert, QPharma

On January 23rd of this year, President Obama reversed the "Mexico City policy." This policy, instituted by Ronald Regan, expressly forbade U.S. foreign aid to fund abortions and contraceptives, or to develop and disseminate information on birth control and family planning.

This may appear to be pandering to his Democratic party base. But a less cynical perspective is that Obama is prepared to take on the challenge of putting U.S. healthcare policy back into the sole realm of science.

If President Obama is serious about permanently changing women's health policy, he must change entrenched thinking that executive agencies like FDA and EPA serve to promote Administration agendas. Bill Clinton restored funding to women's health initiatives within the U.S. but did little to change underlying theory about the executive branch's role in dictating health policy worldwide. Now Obama must contend with Mrs. Clinton, who as Senator publicly took on top FDA officials over the Plan B contraceptive, and who must surely be reminding Obama of the dangers of letting politics determine health policy.

Therefore, one expectation is that Mr. Obama, through HHS Secretary Kathleen Sebelius, will revise the role of Scientific Advisory Boards from making non-binding product approval recommendations to political appointees, to that of actually approving applications on behalf of FDA. This would no doubt be condemned by special interest groups whose power to affect health care product approvals has been curtailed, but welcomed by industry and public health advocates.
Director of Engineering, Astrodyne

President Obama's budget blueprint to put the U.S. on the path to universal healthcare will create a positive development for medical device manufacturers, increasing the demand for medically approved power supplies. The increase of people becoming insured will require significant improvements in how our current healthcare system operates—reducing manual labor and increasing dependency on advanced technologies to reduce errors, time, and cost, and increasing the speed and accuracy of treating patients. Home healthcare and outpatient treatment is another opportunity for medical device manufacturers to provide alternative measures for people who want to save money by treating themselves at home by purchasing self-monitoring systems for common diseases like diabetes.

An area of concern may stem from more stringent government regulations which tend to lead to longer design cycles. This may delay manufacturers from recovering from the economic downturn faster than hoped. Adding to the delay is an order issued by President Obama's administration to conduct a policy review on all regulations issued by the federal agencies under the Bush administration which had not gone into effect. These conditions favor those companies with a larger horizon of the marketplace.
VP R&D, Sparta Systems

With the promise of a myriad of new policy initiatives that will directly impact the medical device manufacturing industry, it is clear that President Obama's administration will bring big changes to the FDA. More attention is now being focused on how to improve the quality and compliance standards the agency currently places on device manufacturers, and the new administration's arrival signals that stricter regulations are on the horizon.

As the new President begins reviewing current policy to make way for stronger FDA-imposed safety standards, device manufacturers will see a renewed focus on the quality of the products they produce. In anticipation of the forthcoming stringent policies, device manufacturers will need to take a fresh look at their internal quality practices, including complaint handling, CAPA management, supply quality management, and internal audits. Make no mistake, change is coming to the device industry and with it will come a revamped focus on quality that will ultimately result in higher-quality manufactured products and improved patient care.
President, Ocean Optics Inc.

Fostering investment in technology innovation through intervention from our government, rather than through regulation, has always had a far-reaching positive effect on our economy. In many regards, innovation is the foundation of our national competitiveness. Our analytical instrumentation business in particular can benefit from robust funding for programs such as the Small Business Innovation Research Program, which encourages the sort of entrepreneurial action that can lift the U.S. economy out of recession; and by initiatives at the National Institutes of Health and at national laboratories, which can have a similarly salutary effect.

Investment in technology for the public good often comes at a price—whether in more regulation or, conversely, less oversight. A balance needs to be struck and that's often difficult since you can't please everyone. However, we're hopeful that in the long term such investment will create new jobs, opportunities, and industries that we couldn't imagine today, while providing lasting economic growth. A simple thing such as significant prizes for technology breakthroughs could change the course of things. Look what the X-PRIZE did for aviation. Can you imagine if a similar prize was suggested for early, non-invasive detection of disease? It could save the taxpayers 100 times the value of the prize in just a few short years. We're excited about the future and wish more people took on the challenge with the same enthusiasm.