1. 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. 2 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 InforMedix Marketing Research, Inc. 2008 3 Non-sterile OR supplies and processes (e.g. disposal systems) Products that cannot be properly evaluated in a focus group or interview setting.

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 4

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 5

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 6

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 7

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 … 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 InforMedix Marketing Research, Inc. 2008 8

9. 6. Get everyone on board Whats in it for them? How do they know its 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 9

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 10

11. 8. Check in periodically Visit the site to see how its 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 InforMedix Marketing Research, Inc. 2008 11 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?

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.) InforMedix Marketing Research, Inc. 2008 12 Learn about the experience of product testing in the facility.

13. 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 InforMedix Marketing Research, Inc. 2008 13