© Guidant 2004
Medical Device versus Drug
Similarities and Differences
Jeng Mah, David Breiter
Guidant Corporation
FDA Industry WorkshopSeptember 16, 2005
2 © Guidant 2004
Workshop 2005
Device vs. Drug - physical
Device Drug
3 © Guidant 2004
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Device vs. Drug - functional
Device Actions
• Mechanical
• Physical
• Dynamic
• Adaptive
• User dependent
Device Effects
• Local
• Direct/immediate
• Measurable
• Reversible
Drug Actions
• Chemical
• Physiological
• Fixed
• Not adaptive
• Simple
Drug Effects
• Systemic
• Indirect/deferred
• Difficult to measure
• irreversible
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Device vs. Drug - statistical
Device Studies
• May perform multiple adaptive functions (bundled features)
• Extensive & informative bench and acute tests
• Non-blinded, non-placebo pivotal studies
• Automation & decision making
• Subject specific optimal programming
• User interface/skill affects/determines out-comes
• Real time data collection generates lots of data
Drug Studies
• One drug one desired effect (usually), or deal with drug interactions
• Phase I, II studies serve different purposes
• Active control, blinded pivotal studies
• Subjects receive identi-cal, fixed treatments
• Data collection focuses on final, pragmatic outcomes
5 © Guidant 2004
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Device vs. Drug - statistical
Device Studies
• Difficult to administer
• FDA requirement: single pivotal trial
• Reliability and quality control issues
Drug Studies
• Easy to administer
• FDA requirement: two pivotal trials
• Reliability and quality control issues are less prominent
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Totest an ‘intelligent’ device with a new feature: the new feature include one programmable parameter; physician needs to find the optimal setting of each patient based on the responses of an acute test. This parameter can be modified anytime.
Questions: how do we model a true ‘device effect’ adjusted for the physician, parameter, and patient? What is the ‘treatment’ we are interested in? Feature? Parameter? Programmability? Utility? What is the experimental unit? When do we need to do new studies?
An Example
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