Bill Overview
Title: Diagnostic Device Advisory Committee Act
Description: This bill establishes the Real World Impact of Medical Devices Panel to advise the Food and Drug Administration on the real world impact of regulatory decisions relating to medical devices, including diagnostic devices.
Sponsors: Rep. Schrier, Kim [D-WA-8]
Target Audience
Population: Individuals impacted by the regulation and use of diagnostic medical devices
Estimated Size: 300000000
- The bill establishes a Real World Impact of Medical Devices Panel, which will consequently affect stakeholders involved with diagnostics and medical devices.
- Healthcare providers rely on diagnostic devices and will be impacted by changes in regulations advised by this panel.
- Medical device manufacturers will need to adhere to guidance coming from this committee's influence on regulatory decisions, impacting their operations and innovations.
- Patients, who are the end users of medical devices, will be impacted through changes in the availability and effectiveness of these devices based on the panel's advisory conclusions.
- Regulatory bodies and government agencies like the FDA and equivalent agencies around the world will be involved in the advisory process and influenced by the panel's conclusions.
Reasoning
- The targeted population for this policy includes healthcare providers, medical device manufacturers, patients, and regulatory bodies.
- The budget constraints mean that initial benefits might be limited mainly to those closely linked to the implementation of the advisory committee's recommendations.
- As the advisory committee begins to influence FDA decisions, those within the medical device industry and healthcare providers will see immediate effects.
- Eventually, changes will trickle down to patients, who depend on diagnostics, affecting their access to and quality of care.
- Given the widespread use of diagnostic medical devices, the policy has a potentially broad impact, though largely indirect for many individuals.
Simulated Interviews
Radiologist (New York, NY)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- I believe this panel could streamline the integration of new, effective devices into our practice.
- Concerns exist about potential delays if additional layers of bureaucracy are added.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 6 |
Patient with chronic illness (Minneapolis, MN)
Age: 38 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 12/20
Statement of Opinion:
- Any improvement in device effectiveness or cost-reduction would be beneficial.
- Uncertain if this panel will directly influence what matters to me personally.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 4 |
| Year 3 | 6 | 4 |
| Year 5 | 6 | 4 |
| Year 10 | 7 | 4 |
| Year 20 | 6 | 3 |
Medical Device Manufacturer (San Francisco, CA)
Age: 52 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 5/20
Statement of Opinion:
- This policy aligns with our focus on improving patient outcomes through cutting-edge technology.
- Could present both opportunities and challenges with regulatory compliance.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 9 | 7 |
| Year 5 | 8 | 6 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 4 |
Hospital Administrator (Houston, TX)
Age: 60 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 4.0 years
Commonness: 8/20
Statement of Opinion:
- Effective regulation is crucial for maintaining quality care, but we also need efficiency.
- I hope the panel reduces unnecessary regulatory burdens and streamlines processes.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 5 |
FDA Regulatory Analyst (Miami, FL)
Age: 42 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- The advisory panel could enhance my work by providing comprehensive real-world data.
- There may be an adjustment period for incorporating the panel's insights into workflows.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 6 |
| Year 20 | 8 | 6 |
Biomedical Engineer (Dallas, TX)
Age: 29 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- The advisory panel might stimulate innovation by providing clearer, more relevant regulatory guidelines.
- Concerns about delays during transition to new practices.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 5 |
General Practitioner (Atlanta, GA)
Age: 35 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 4.0 years
Commonness: 14/20
Statement of Opinion:
- Streamlined regulatory guidelines could improve patient access to better diagnostics.
- Balancing cost and innovation is key for sustainability in private practice.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 5 |
Insurance Adjuster (Chicago, IL)
Age: 50 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 7.0 years
Commonness: 11/20
Statement of Opinion:
- We need to better understand the implications of new devices on insurance claims.
- The advisory panel might help align device benefits with coverage policies.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 4 |
Public Health Official (Seattle, WA)
Age: 40 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 9/20
Statement of Opinion:
- An advisory panel informed by real-world data could significantly enhance public health outcomes.
- Need to balance advancement with public accessibility.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 6 |
Patient Advocate (Los Angeles, CA)
Age: 48 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- Patients rely on the timely availability of diagnostic tools. This panel might help reduce barriers to access.
- Concerns about lengthy regulatory changes causing delays.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 4 |
Cost Estimates
Year 1: $20000000 (Low: $15000000, High: $25000000)
Year 2: $20000000 (Low: $15000000, High: $25000000)
Year 3: $21000000 (Low: $16000000, High: $26000000)
Year 5: $22000000 (Low: $17000000, High: $27000000)
Year 10: $23000000 (Low: $19000000, High: $29000000)
Year 100: $150000000 (Low: $100000000, High: $200000000)
Key Considerations
- Coordination with existing FDA processes will be crucial for the panel's effectiveness and cost efficiency.
- The long-term success of the panel will depend on its ability to provide actionable insights that can be integrated into FDA regulatory practices.
- Initial cost estimates focus on establishment and operational costs; however, future financial assessments may be needed based on the panel's evolving role and impact.