Product Usage Testing in Clinical Settings

1. Product Usage Testingin Clinical Settings Steve Fuller InforMedix Marketing Research, Inc. Medical-Surgical Market Research Group April 3, 2008

2. 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. InforMedix Marketing Research, Inc. 2008

3. 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. InforMedix Marketing Research, Inc. 2008

4. 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 InforMedix Marketing Research, Inc. 2008

5. 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. InforMedix Marketing Research, Inc. 2008

6. 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. InforMedix Marketing Research, Inc. 2008

7. 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. InforMedix Marketing Research, Inc. 2008

8. 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 … • An orientation meeting, at their location • Demonstrations of product use • A written explanation of expected frequency of use, plans for evaluations, timeline, etc. • A contact point (e.g. local salesperson) to help InforMedix Marketing Research, Inc. 2008

9. 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? InforMedix Marketing Research, Inc. 2008

10. 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? InforMedix Marketing Research, Inc. 2008

11. 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? InforMedix Marketing Research, Inc. 2008

12. 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. InforMedix Marketing Research, Inc. 2008

13. Product Usage Testing in Clinical Settings • Define your goals • Meet regulatory requirements • Select the sites for testing • Select individuals to champion the process • Define the process for users • Get everyone on board • Supply the product • Check in periodically • Do a final debriefing with users InforMedix Marketing Research, Inc. 2008