1. Center for Devices and Radiological Health U. S. Department of Health and Human Services Bioinformatics technology forum Bioinformatics in mission success FDA-CDRH Brian Fitzgerald Brian.fitzgerald@fda.hhs.gov (301) 796-2579

2. Center for Devices and Radiological Health Regulatory Mission  Safe and effective medical devices  Effective is mostly a clinical decision  Does it do what it says it will (evidence based)  Is it really a “pulse oximeter” (or something else too)  Safe is an engineering approximation  Never 100% safe or else too expensive  Is ‘safe enough’ actually ‘good enough’  So how to;  Establish that its good enough  Communicate to the regulator that its good enough

3. Center for Devices and Radiological Health Traditional engineering practice  Train  MonitorProfessional discipline  Review  Use the “currently acknowledged state of the art”.  Standards  Regulation }

4. Center for Devices and Radiological Health Modern reality  Development costs are very high  Single exemplar cost  Expertise necessary not easily available  Complexity is astonishing  Analysing the software for defects  Flaws may not correspond to failures  Margins for safety?  Latent flaws?

5. Center for Devices and Radiological Health New engineering practice  Predictive Modeling  Derive the risks (safety, costs, manufacturing methods, materials, etc)  Usage simulation  Look and feel, coexistence, training, maintenance  Model based development  Avoids building in defects, formally derives the system properties  Model as a surrogate  May remove clutter, and allow visibility, may provide a baseline.

6. Center for Devices and Radiological Health Examples of bio-informatic modeling currently in use  Safe leakage current limits  Previously very little science involved  Modeled on a whole body simulation  Same with  Safe temperature (contact, infusion, etc)  Radiation transport in whole body  Materials degradation  Stent flexing  Elution of substances from implants and food containers

7. Center for Devices and Radiological Health What do they have in common?  It may not be safe, practical or ethical, for regulators to always use clinical methods to determine the acknowledged state of the art. Maybe these are new clinical methods!