DALE A FLOWERS, MBA, CFO, PN MEDICAL

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

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

Legacy Product – Breather I COPD ASTHMA DYSPHAGIA

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

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

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

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

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

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

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

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

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

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

Credibility – Strategic Partners

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

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 ✔

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) ✔✔

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

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

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

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

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

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

+ + + = Innovating for Engagement = Simplicity

Innovating for Engagement One Device Simple Design Ease of Use Connected

Innovating for Engagement Remote Care

Innovating for Engagement Remote Monitoring

Innovating for Engagement Intervention

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

DALE A FLOWERS, MBA, CFO, PN MEDICAL