Transcript Product Usage Testing in Clinical Settings

Steve Fuller
InforMedix Marketing Research, Inc.
Medical-Surgical Market Research Group
April 3, 2008
What is “Product Usage Testing in a Clinical Setting”?
 Placement of prototype medical products in the hands of
end users, for a trial period.
 It is a simulation of actual clinical usage.
 Usage tests provide:
 Product use in a real medical environment
 Realistic time and space constraints
 Implementation by real future users of a product,
with a realistic in-service
 This is not a way to introduce new products.
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What kinds of products can be tested?
 Non-invasive, non-critical items
 Products that do not pose a risk to patients; where clinicians
can fall back to familiar products as needed.
 Diagnostic products, monitors
 Patient exam items
 Products that supplement normal clinical precision (e.g. software)
 Products meant to improve on patient comfort
 Non-sterile OR supplies and processes (e.g.
disposal systems)
 Products that cannot be properly evaluated in
a focus group or interview setting.
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1. Define your goals
 Do you want to …
 Determine the usability of a product?
 Measure its performance or benefits vs. conventional products?
 Direct product development?
 Define in-service protocols?
 Generate testimonials from users?
 You may need to design metrics, bench-
marks, or decision-points in advance
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2. Meet regulatory requirements
 Avoid medical and legal risks of using prototype products
in clinical settings.
 These decisions are not the job of the market researcher.
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3. Select the sites for testing
 Hospitals, physicians’ offices, and patients at home must
be…
 Willing to try a new product
 Able to implement usage and provide feedback
 Generate a volume of usage that is meaningful for the evaluation
 Provide diversity of settings, patient characteristics, etc.
 Be representative of future markets for the product
 Prepare for some sites to drop out after
beginning the test.
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4. Select individuals to champion the process
 At each site, you must have one or two individuals who
are willing to work for the success of the test process.
 Someone who might benefit from the success of the test
 Someone who could publish findings of the trial
 Customers who have a good relationship with your company
 The “champion” should be willing to solve some
problems, and to relay important issues to you.
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5. Define the process for users
 Users and everyone affected by the product use test
needs to know exactly what to do.
 Consistency is as important as in other market research.
 Provide the site with …
1. An orientation meeting, at their location
2. Demonstrations of product use
3. A written explanation of expected frequency of use,
plans for evaluations, timeline, etc.
4. A contact point (e.g. local salesperson) to help
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6. Get everyone on board
 What’s in it for them?
 How do they know it’s not risky?
 What about the second / third shifts? What about new
hires and agency nurses?
 If a new product or procedure is not easy to implement,
when should they …
 Continue to try?
 Call for help?
 Give up?
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7. Supply the product
 Ensure an adequate supply of products to be tested
 Install equipment, swap out or tie in existing systems
 Set up a procedure and timeline for getting products to
the site.
 Who is to be responsible for these supply issues?
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8. Check in periodically
 Visit the site to see how it’s going.
 Assess the enthusiasm of the champion and others
 Ensure that the product is actually being used and tested
 Conduct corrective or refresher training
 Extend or reduce the timeline if needed
 Is the test being performed the way you want it
to?
 At the end of the test period, will you be able to
learn what you want to learn?
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9. Do a final debriefing with users
 Focus groups of users at a hospital
 Paper questionnaires (interim as well as final)
 Individual interviews with key people
 Learn about the product
 Learn about the people involved (surgeons, nurses,
techs, patients, administration, etc.)
 Learn about the experience of product
testing in the facility.
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Product Usage Testing in Clinical Settings
1. Define your goals
2. Meet regulatory requirements
3. Select the sites for testing
4. Select individuals to champion the process
5. Define the process for users
6. Get everyone on board
7. Supply the product
8. Check in periodically
9. Do a final debriefing with users
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