Challenges and Opportunities of evaluating medical devices

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Challenges and Opportunities of evaluating
medical devices

• Prof. Elio Borgonovi
• Università Bocconi
• Medtech Forum
• October 15th, 2008
• Brussels

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AGENDA

• THE RELEVANCE OF THE TOPIC
• EVALUATING MD MAIN CHALLENGES
• EVALUATING MD SHIFTING FROM CHALLENGES TO
  OPPORTUNITIES
• EVALUATING MD WHICH OPPORTUNITIES?

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THE RELEVANCE OF THE TOPIC

• Up till now evaluation methods have mainly
  focused on pharmaceuticals and big technologies

The evaluation of MDs requires, instead, a
conceptual framework able to recognise the
peculiarities of the sector
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EVALUATING MD MAIN CHALLENGES (1)

• MD evaluation poses several challenges
• A. Product characteristics
• A.1 Price prices are more likely to change over
  time and location
• A.2Life cycle MD have a shorter life cycle,
  more dynamic market, characterised by continuous
  incremental innovations

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EVALUATING MD MAIN CHALLENGES (2)

• B. Learning Curve
• The value of MDs depend also on
• the expertise of the user, that tends to increase
  over time
• i.e. intracranial aneurysm
• the volume of activity performed with the new
  device

The evaluation process should not refer to a
steady state period, but rather be seen as an
iterative process
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USER EXPERTISE EXAMPLES

• Intracranial aneurysm coiling treatment has been
  proved to be more efficient than clipping,
  provided the neuroradiologist has enough
  experience (treatment of at least 50 cases)
• Data retrieved from CERGAS research

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EVALUATING MD MAIN CHALLENGES (3)
The relevance of the learning curve poses 2
additional challenges B.1. What are we really
assessing?
Not yet consolidated experience with the
procedure involving new device A VS Experience
with the procedure Involving old device B
Device A (NEW) VS Device B (OLD)
?
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EVALUATING MD MAIN CHALLENGES (4)

• B.2. The availability of comparative clinical
  studies
• Usually technologies are required to be supported
  by randomized controlled trials (RCTs)

Nevertheless, it is difficult to undertake RCTs
for MD, especially if they compare with invasive
surgical procedures
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EVALUATING MD SHIFTING FROM CHALLENGES TO
OPPORTUNITIES
As seen, assessing
MD poses several challenges It is therefore
essential to identify and recognize such
challenges, in order to
correctly estimate the value of MD
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EVALUATING MD WHICH OPPORTUNITIES? (1)
What is meant by value of MD?

• Two complementary perspectives
• Health status perspective
• Economic-social perspective

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EVALUATING MD WHICH OPPORTUNITIES? (2)

• A. Health status perspective
• The value is estimated by measuring the impact
  on the basis of health indicators (survival
  rates, QALY, )
• This will be the focus of the next
  phase of research..

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EVALUATING MD WHICH OPPORTUNITIES? (3)
Next phase of research

• Objective investigate the impact of medical
  devices (utilization) in selected clinical areas
  (i.e. cardiovascular)
• at regional level
• over a decade
• on selected health outcomes
• Inpatient (hospital) mortality and hospital
  efficiency (LOS)
• Hospital readmission rates.

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EVALUATING MD WHICH OPPORTUNITIES? (4)
Next phase of research (cont.)

• The object of the study will be addressed through
  original empirical research based on the
  collection and analysis of primary data at
  Regional level

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EVALUATING MD WHICH OPPORTUNITIES? (5)
B. Economic-social perspective

• The value of MDs can be assessed in the long term
  by measuring the
• Economic contribution contribution to wealth
  increase, condition for the progress of the
  society
• Social contribution direct or indirect
  contribution to the wellbeing of
  individuals/society as a whole.

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EVALUATING MD WHICH OPPORTUNITIES? (6)
B. Economic-social perspective
Medical Devices do impact on populations
productivity Enhanced productivity is
functional to the economic growth and welfare of
European countries This impact can be
measured in terms of

• GDP (total/per capita)
• Consumptions
• Savings
• Investments

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EVALUATING MD WHICH OPPORTUNITIES? (7)

• The ultimate aim of the research will be to
  access the economic value of improved health
  outcomes
• The estimated improvements in health indicators
  will be transformed into measures of economic
  growth.