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FDA Industry Workshop
September 16, 2005
Medical Device versus
Drug
Similarities and Differences
Jeng Mah, David Breiter
Guidant Corporation
© Guidant 2004
Workshop 2005
Device vs. Drug - physical
Device
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Drug
© Guidant 2004
Workshop 2005
Device vs. Drug - functional
Device Actions
• Mechanical
• Chemical
• Physical
• Physiological
• Dynamic
• Fixed
• Adaptive
• Not adaptive
• User dependent
• Simple
Device Effects
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Drug Actions
Drug Effects
• Local
• Systemic
• Direct/immediate
• Indirect/deferred
• Measurable
• Difficult to measure
• Reversible
• irreversible
© Guidant 2004
Workshop 2005
Device vs. Drug - statistical
Device Studies
• May perform multiple
adaptive functions
(bundled features)
• Extensive & informative
bench and acute tests
• Non-blinded, nonplacebo pivotal studies
• One drug one desired
effect (usually), or deal
with drug interactions
• Phase I, II studies serve
different purposes
• Active control, blinded
pivotal studies
• Automation & decision
making
• Subject specific optimal
programming
• User interface/skill
affects/determines outcomes
• Subjects receive identical, fixed treatments
• Real time data collection
generates lots of data
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Drug Studies
• Data collection focuses
on final, pragmatic
outcomes
© Guidant 2004
Workshop 2005
Device vs. Drug - statistical
Device Studies
5
Drug Studies
• Difficult to administer
• Easy to administer
• FDA requirement: single
pivotal trial
• Reliability and quality
control issues
• FDA requirement: two
pivotal trials
• Reliability and quality
control issues are less
prominent
© Guidant 2004
Workshop 2005
An Example
To test 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?
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© Guidant 2004