FDA Roadmap to Innovation

The FDA recently published a roadmap with the goal of promoting innovative new technology in healthcare.  This is excellent news for patients, providers, and manufacturers alike.  Biomedical Innovation has been one of the driving factors behind improved patient outcomes, lower lengths of stay, and longer lifespans over the years.  It has also been responsible for a large market.

To enhance their support in driving new innovation, the FDA published the following steps to help promote new products:

  • Rebuilding the FDA’s small business outreach services
  • Building the infrastructure to drive and support personalized medicine
  • Creating a rapid drug development pathway for important targeted therapies
  • Harnessing the potential of data mining and information sharing
  • Improving consistency and clarity in the medical device review process
  • Understanding emerging technologies
  • Training the next generation of innovators
  • Improving FDA regulations

Along with improving patient care, one thing to consider is how big of an impact this will make on the economy. In 2010 the Medical Technology Industry shipped more than $136 billion in products, with as much as 50% going to the surgical arena. Still, private financing of emerging medical technology companies dropped from $2.86 billion in 2009 to $1.86 billion in 2010, with the largest investments going to cardiology and orthopedics.

Two of the above steps should make a direct impact on this. The first is the FDA’s efforts to develop tools to promote data mining of clinical trial data.  This alone should speed the development of new products.  The other is development of a virtual patient.  Providing digital images of diseases and computer models of the human anatomy will assist researchers and help reduce the cost, time, and risk to patients when developing a new medical device. It sounds like a good time to be in the industry. I welcome your comments on this fascinating topic.

James Laskaris, EE, BME
James Laskaris, EE, BME, Clinical Analyst — Mr. James Laskaris is a senior emerging technology analyst at MD Buyline and has been with the company since 1994. With over 30 years of experience in the healthcare field, Mr. Laskaris is the primary analyst of high-end OR technology. He also covers issues related to the legislative and reimbursement effect on healthcare and authors a bimonthly “Issues that Matter” publication. Mr. Laskaris received his biomedical engineering degree from Southern Illinois University. His work has been published in hfm Magazine, Radiology Manager and Healthcare Purchasing News.