FDA’s Critical Path to New Medical Product Development

Opportunities from the Center for Devicesand Radiological HealthLarry Kessler, Sc.D., DirectorOffice of Science and Engineering Laboratories, CDRH

Outline Devices are different and varied Our vision and the critical path Device “opportunities” Directions for the future

Evaluative tools: The techniques & methodologies needed to evaluate the safety, efficacy & quality of medical products as they move down the path

Examples of some of these medical devices…

Test Strips

Infu

sion

pu

mp

Patient Examination Table

Heart Valve

Contact Lens

Hip Implant

Pacemaker

Biopsy Device

Blood Pressure Cuff

Stethoscope

CDRH’s Vision

Ensuring the H ealth of the

Public Throughout the Total ProductL ife Cycle --

I t's Everybody's B usiness

Underlying Assumptions:•Covering products from concept to obsolescence•Connected global public health community •Stakeholders are our partners•Science fuels the regulatory engine•Meeting all statutory responsibilities•Meeting our own standards for quality

Areas that FDA’s Critical Path Can Impact

Imaging and the ROC curve

Digital mammography Initial studies ignored reader variability True clinical trials too big Multiple-reader multiple-case ROC

analysis developed by FDA (and others) Studies became accessible Products on the market!

Imaging of Peripheral Vasculature

Drug eluting stents proven for coronary Will standard imaging of lower

extremities provide adequate data? Requires independent study to establish

data and methods for later trials

Ablative Therapies

Ablative therapies for atrial fibrillation AF – commonly diagnosed Problem in demonstrating true patient

benefit Requires large patient series Requires agreement on endpoints and

data analysis from co-sponsored study

Cataractous Crystalline Lens

Intraocular lens (IOLs) Successful but has limits Single focal length unlike human lens

Critical path issues: assessment of – Optical quality Material properties Biocompatibility

Genomic and proteomic devices

Microarray expression discovery phase For multiple expression profile an

algorithm is needed for interpretation Current algorithms are “learning” FDA products require reliability and

consistency No standards yet for these algorithms

Future Directions

Identify key problems in devices Prioritize scientific efforts Pursue collaborations

Within FDA With NIH (e.g., NIBIB, NCI) With industry