Bill Overview
Title: A bill to strengthen medical device supply chains.
Description: This bill requires the Food and Drug Administration (FDA) to publish and periodically update a list of medical devices that are critical during a public health emergency and for which manufacturers must notify the FDA about shortages. The bill also requires manufacturers to develop risk management plans with respect to the supply chain for such devices.
Sponsors: Sen. Braun, Mike [R-IN]
Target Audience
Population: People reliant on medical devices for critical care during public health emergencies
Estimated Size: 331000000
- The bill aims to ensure the availability of critical medical devices during public health emergencies, which could impact healthcare systems globally.
- Healthcare providers rely on a stable supply chain for medical devices to provide effective care.
- Patients in need of critical medical devices will be directly impacted by changes in their availability due to better supply chain management.
- Manufacturers of medical devices will have to adapt to new regulations, which could affect their operation.
Reasoning
- The budget constraints require a focused approach to implementation, targeting key manufacturers and critical devices that will most impact public health during emergencies. This means prioritizing devices that have been historically prone to shortages or have the highest impact on saving lives.
- The target population includes vulnerable groups who depend on medical devices, like those with chronic health conditions or disabilities requiring continuous use of such devices.
- Manufacturers will likely need to invest in developing and maintaining their supply chain risk management plans, which could incur costs initially but lead to more reliable supply chains in the long term.
- Healthcare facilities, especially larger hospitals, may not feel an immediate impact due to existing stockpiling practices, but smaller clinics and outpatient services might benefit significantly from improved device availability.
Simulated Interviews
Medical Device Manufacturer Representative (Los Angeles, CA)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- The policy might initially increase our costs due to compliance requirements, but in the long run, it should stabilize demand.
- Better transparency with the FDA can help us better prepare for future emergencies.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 8 | 4 |
Chronic Obstructive Pulmonary Disease (COPD) Patient (Houston, TX)
Age: 62 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 2/20
Statement of Opinion:
- Having access to reliable oxygen supply is critical during an emergency; I'm glad the policy addresses this.
- This policy can assure me and others like me that we won't suddenly find ourselves without necessary equipment.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 4 |
| Year 10 | 8 | 3 |
| Year 20 | 8 | 2 |
Nurse in a Public Hospital (Seattle, WA)
Age: 30 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- Policies like this are essential for safeguarding public health, especially in hospitals where equipment is life-saving.
- Although we have not faced shortages recently, knowing there's a system in place is reassuring.
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 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 8 | 5 |
Retired (New York, NY)
Age: 70 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- I'm worried about what would happen if my pacemaker or its monitoring devices became unavailable.
- This policy could reduce some anxiety about device shortages.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 3 |
| Year 3 | 7 | 2 |
| Year 5 | 7 | 2 |
| Year 10 | 6 | 1 |
| Year 20 | 5 | 0 |
Software Developer (Phoenix, AZ)
Age: 28 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 0.0 years
Commonness: 10/20
Statement of Opinion:
- The policy seems aimed at healthcare systems rather than people like me, but I'm glad it exists for those who need it.
- A well-prepared medical system indirectly benefits everyone.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Medical Supply Chain Manager (Chicago, IL)
Age: 37 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- Streamlining the supply chain during emergencies is crucial; this policy will help prevent disruptions.
- We're used to handling such regulations, as it's part of risk management.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 6 |
| Year 5 | 9 | 6 |
| Year 10 | 9 | 5 |
| Year 20 | 8 | 5 |
Policymaker in Healthcare (Miami, FL)
Age: 56 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 20.0 years
Commonness: 4/20
Statement of Opinion:
- Ensuring that regulations improve supply chain resilience is a top priority, especially as emergencies become more frequent.
- I'm pleased to see federal alignment with the state on this issue.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 9 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 6 |
| Year 20 | 9 | 5 |
Researcher in Medical Device Innovation (Boston, MA)
Age: 48 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- This policy could steer new guidelines for future innovations, possibly leading to more robust devices.
- However, it could also limit some smaller innovators due to increased documentation and compliance.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Public Health Official (Denver, CO)
Age: 33 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- Public health relies on a controlled supply chain during emergencies, and this policy could bolster our readiness.
- While it might not directly affect individuals, its impact on health system resilience is critical.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 8 | 5 |
Entrepreneur in Healthcare Tech (Atlanta, GA)
Age: 29 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- Understanding supply chain risks is vital for my startup, as this can affect our market entry.
- The policy might increase the barrier for new entrants by imposing more initial requirements.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 5 |
| Year 20 | 7 | 5 |
Cost Estimates
Year 1: $250000000 (Low: $200000000, High: $300000000)
Year 2: $240000000 (Low: $190000000, High: $290000000)
Year 3: $230000000 (Low: $180000000, High: $280000000)
Year 5: $220000000 (Low: $170000000, High: $270000000)
Year 10: $200000000 (Low: $150000000, High: $250000000)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- Effectiveness of risk management plans can vary greatly among different manufacturers and types of medical devices, affecting overall impact of the bill.
- Relationship and coordination between the FDA and manufacturers would be crucial for timely updates and reporting, impacting the success of the program.
- Greater supply chain transparency could have long-term positive impacts on healthcare logistics and delivery efficiency.