Bioinformatics in mission success FDA-CDRH

1. Bioinformatics in mission success FDA-CDRH Brian Fitzgerald Brian.fitzgerald@fda.hhs.gov (301) 796-2579 Bioinformatics technology forum

2. 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. Traditional engineering practice } • Train • Monitor Professional discipline • Review • Use the “currently acknowledged state of the art”. • Standards • Regulation

4. 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. 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. 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. 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!