1. DALE A FLOWERS, MBA, CFO, PN MEDICAL

2. The New Business Case: Integrating Medical Device Design with Your Strategy for Evidencing Value

3. DESIGNING MEDICAL DEVICE SOLUTIONS THAT ARE COMMITTED TO REDUCING HOSPITAL READMISSIONS Integrating Medical Device Design with Your Strategy for Evidencing Value

4. Legacy Product – Breather I COPD ASTHMA DYSPHAGIA

5. Reducing Readmissions – Design Approach First design draft Empathy sessions Redesign Patient profile Target disease processes Connectivity

6. Reducing Readmissions – Design Approach Device captures protocol, usage stats, data Data sent to cloud-based practitioner Practitioner sees Compliance and Pulmonary data on dashboard

7. Reasons for Readmissions HOME ALONE EFFECT (Patient Non-adherence) Patient does not remember/understand treatment protocol Multiple conditions / multiple treatments / multiple devices Complication of device use Infrequent monitoring Lack of family engagement Result: Condition set-back Readmission $12,000

8. Reasons for Readmissions IssueSolution Non-adherence – treatment understanding Built-in protocols Non-adherence – patient experience / ease of use / multiple devices Simple design / One device / One step treatment Monitoring frequencyData collection & reporting up to 600x / year Lack of Family engagementText alerts to patient-authorized family members

9. New Product – Breather II Technology packed Connected (EMR) Remote Monitoring Practitioner Dashboard Remote Care Therapist on Demand

10. Reducing Readmissions Research reasons for admissions Incorporate solutions into product design Add services Design for improved engagement Leverage technology

11. BEST PRACTICES FOR DEMONSTRATING A VALUE-BASED BUSINESS CASE TO THE FDA AND CMS Integrating Medical Device Design with Your Strategy for Evidencing Value

12. Best Practices | FDA | CMS Credibility Shared values Shared Priorities Alignment with Strategic Goals & Initiatives Lower cost of health care

13. Best Practices | Credibility Current Position in Vertical Clinical Experience and Expertise Team Strategic Partners / Supporters

14. CEO CMO CCO CFO VP FDA CHAIRMAN BOARD BOARD ADVISORY CHIEF ENG SCIENTIST Credibility - Team

15. Credibility – Strategic Partners

16. Shared Values| FDA / CDRH PriorityFDA / CDRHPN Medical Public Health Focus ✔✔ Science-Based Decisions ✔✔ Our People ✔✔ Innovation ✔✔ Lower Cost of Health Care ✔✔

17. Shared Priorities| FDA / CDRH PriorityFDA / CDRHPN Medical Leverage big data ✔✔ Enhance Digital Health and device cyber security ✔✔ Incorporate human factors engineering into device design ✔✔ Improve Outcomes ✔✔ Reprocessing reusable medical devices ✔

18. Aligned Strategic Goals| CMS PriorityCMSPN Medical Make delivery of care safer ✔✔ Strengthen patient and family engagement ✔✔ Promote effective communication and coordination of care ✔✔ Improve Outcomes ✔✔ Promote best practices of healthy living within communities ✔ Make care affordable (Lower Cost of Health Care) ✔✔

19. + + + = $ 10 $20 $60 $120 Lower the Cost of Health Care $139

20. Lower the Cost of Health Care Readmissions for COPD – 190,000 / year Average Cost of Readmission - $12,000 System Cost: $2.3Billion Annually

21. Lower the Cost of Health Care Cost of Intervention / Office Visit - $25 Potential savings impact to system: $460 Million to $1.2 Billion Annually

22. Best Practices FDA / CMS - Business Case Demonstrate credibility Demonstrate shared Mission / Values / Priorities / Strategy Demonstrate lower cost of care

23. INNOVATING FOR LONG-TERM CONSUMER AND PATIENT ENGAGEMENT Integrating Medical Device Design with Your Strategy for Evidencing Value

24. Innovating for Engagement Device Design –Simplicity –Durability –Leverage manufacturing technology Enable Services

25. + + + = Innovating for Engagement = Simplicity

26. Innovating for Engagement One Device Simple Design Ease of Use Connected

27. Innovating for Engagement Remote Care

28. Innovating for Engagement Remote Monitoring

29. Innovating for Engagement Intervention

30. Innovating for Engagement Keep it Simple Leverage Technology Wrap services around care Enable early intervention

31. DALE A FLOWERS, MBA, CFO, PN MEDICAL