Bill Overview
Title: A bill to allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.
Description: This bill allows changes to be made to medical devices without the need for supplemental applications or premarket notifications if the changes are made in accordance with a predetermined change control plan.
Sponsors: Sen. Braun, Mike [R-IN]
Target Audience
Population: People using or relying on medical devices
Estimated Size: 300000000
- Medical devices are used globally in healthcare settings by a variety of medical professionals and patients.
- The bill pertains to regulatory procedures for modifying medical devices, affecting manufacturers' processes and timelines.
- The bill may also impact healthcare providers who use these medical devices, potentially improving or complicating care with device alterations.
- Patients who rely on medical devices for their health and wellbeing might experience changes in their care due to this legislation.
- Including general medical procedures and surgeries, the vast number of patients worldwide could be indirectly affected.
Reasoning
- Medical devices reach a large segment of the U.S. population, potentially impacting patient outcomes.
- The bill might streamline manufacturing and approval processes, affecting device availability and patient care.
- This policy can indirectly influence healthcare systems by addressing how medical devices can be adapted to new uses or environments more quickly and potentially at lower costs.
Simulated Interviews
Cardiologist (New York, NY)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 15/20
Statement of Opinion:
- The ability to make changes without going through lengthy approvals might speed up getting better devices to my patients.
- There is some concern about the safety checks being overlooked.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 7 |
Retired (Miami, FL)
Age: 70 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 12/20
Statement of Opinion:
- If my device can be improved quicker, that sounds beneficial.
- My main concern is whether these changes are thoroughly tested.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 7 |
Software Engineer (San Francisco, CA)
Age: 30 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 20/20
Statement of Opinion:
- This policy doesn't directly affect me, but it might affect my healthcare indirectly.
- Quicker updates to devices could potentially lower healthcare costs.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Medical Device Engineer (Houston, TX)
Age: 55 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- This policy could simplify our work processes.
- There might be initial confusion in adjusting to new regulatory expectations.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 5 |
Nurse (Chicago, IL)
Age: 38 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 15/20
Statement of Opinion:
- Faster updates to devices might improve patient care in my unit.
- I'm wary of devices not being adequately tested before use.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 7 |
Freelance Artist (Portland, OR)
Age: 27 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 18/20
Statement of Opinion:
- I hope policies like this make devices safer and more reliable.
- It's hard to understand how technical changes will affect people like me.
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 | 7 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 6 |
Public Health Official (Seattle, WA)
Age: 62 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 5/20
Statement of Opinion:
- Streamlining approvals can benefit public health, but we must ensure safe practices.
- I hope this leads to quicker, more affordable technology access.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Orthopedic Surgeon (Atlanta, GA)
Age: 50 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 15.0 years
Commonness: 8/20
Statement of Opinion:
- Improving device update processes may enhance surgical outcomes.
- We need to keep regulatory oversight strong to maintain device quality.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 10 | 9 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Medical Device Sales Representative (Austin, TX)
Age: 29 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 12/20
Statement of Opinion:
- This could speed up sales cycles and reduce waiting times for new device versions.
- I hope safety and efficacy standards remain high.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 7 |
Patient Advocate (Phoenix, AZ)
Age: 65 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 10/20
Statement of Opinion:
- I hope this policy gives patients access to better devices sooner.
- We must advocate for continued oversight to ensure patient safety.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Cost Estimates
Year 1: $500000000 (Low: $400000000, High: $600000000)
Year 2: $500000000 (Low: $400000000, High: $600000000)
Year 3: $500000000 (Low: $400000000, High: $600000000)
Year 5: $500000000 (Low: $400000000, High: $600000000)
Year 10: $500000000 (Low: $400000000, High: $600000000)
Year 100: $500000000 (Low: $400000000, High: $600000000)
Key Considerations
- Balancing regulatory oversight with innovation and market competition is crucial to maintaining device safety and efficacy.
- Monitoring the policy's impact on healthcare outcomes and costs is vital to ensure no adverse effects on patients.
- The implementation of predetermined change control plans requires clear guidance and possible international harmonization for companies operating globally.