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Compliance In Focus
Posted by Jacqui Lingler on Tue, May 7, 2013

Entrepreneurs-in-Residence Program - Take 2!

The Entrepreneurs-in-Residence Program (EIR), a program at the Center for Devices andEntrepreneurs in Residence Program  Take 2! Radiological Health (CDRH), brings entrepreneurs, innovators, and government employees to combine the principles of lean engineering in rapidly testing, validating and scaling new approaches to the development in areas that impact innovation with the goal of delivering transformational change. This change, specifically in the medical device arena of public heath, would provide patients in the U.S. to high-quality, safe, and effective devices quicker.

The close of April also brings the second EIR program to close, as it is a time-limited program that started in October of 2012 and closes in April 2013. The three areas that were addressed by the group in the past six months include the following:

  • Streamlining clinical trials
  • Streamlining FDA approval to reimbursement
  • Striking the right balance between pre- and post-market requirements

The team, which combines members from industry, on the strategic and tactical teams, and members of FDA, aimed to assess the current landscape, to identify problems and underlying drivers, and to develop potential solutions. IMARC will be on the look out for the EIR II report in the next couple of months. Check back for a blog summary of the six-month work group.

The goal of the EIR II group correlates with the CDRH’s 2013 Strategic Priorities, number 1 priority- accessibility to high-quality, safe, and effective medical devices of public health importance first in the world for patients in the U.S. The CDRH outline a September 30, 2013 goal for a finalized draft guidance identified in the plan of action to strengthen pre-market review is set, with contributions certainly being added by EIR II. Also, September 30, 2013, is set for a goal date in taking steps to reduce the time and cost associated with conducting clinical trials in the U.S. while maintaining patient safety. The strategy further notes that by June 30, 2013, the EIR will begin a pilot project focusing on reducing the time and cost of medical device clinical trials. So, although no official plans have been made for an EIR III, the CDRH strategic plan alludes to future projects.

Additional Strategic Priorities identified by CDRH for 2013:

  • The U.S. is the world’s leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product safety
  • U.S. post-market surveillance quickly identifies poorly performing devices, accurately characterizes real-world performance, and facilitates devices approval or clearance
  • Devices are legally marketed in the U.S. and remain safe, effective, and of high-quality
  • Consumers, patients, their caregivers, and providers have access to understandable science-based information about medical devices an use this information to make health care decisions
  • Strengthen our workforce and workplace

If an EIR III is established to meet the continuing goals of the CDRH in the remaining months of 2013, who would you suggest they invite to the world-class group of experts leading the charge to speedy approvals for devices to decrease the time from bench to bed? What items from the CDRH 2013 goals should EIR III focus on? Please share your thoughts here and don’t forget to check back for a summary of the EIR II report in the next few weeks.

Photo Credit: alternativeview1

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Topics: Center for Devices and Radiological Health, Entrepreneurs-in-Residence Program, Clinical Research

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