Leavitt Partners
Leavitt Partners: Expert FDA Regulatory Consulting for MedTech Innovation
Leavitt Partners is a distinguished FDA regulatory consulting firm with over 15 years of experience, renowned for its deep bench of former FDA regulatory specialists and seasoned industry veterans. They empower medical device companies of all sizes, from innovative startups to large medtech enterprises, to accelerate product development and achieve seamless market entry. The firm excels in navigating the complexities of FDA submissions, offering expert guidance on regulatory strategies, pathway assessments, and robust compliance solutions across all device classes. Leavitt Partners is committed to fostering efficient regulatory pathways and ensuring clients' life-changing technologies reach patients swiftly and safely, transforming innovation into market success.
About
**Who they are**
Leavitt Partners is a healthcare consulting firm that collaborates with various entities, including HMA and its affiliated companies, to offer a broad range of expertise. They focus on navigating the complexities of healthcare policy, regulation, and market dynamics.
**Expertise & scope**
* Expertise in policy, regulatory consulting, advocacy, and reimbursement.
* Assistance in drafting legislation and commenting on draft regulations.
* Development of Capitol Hill advocacy strategies.
* Building and maintaining positive interactions with federal policymakers.
* Analysis of the intersection between legislation, regulation, agency actions, and their impact on healthcare payment and delivery.
* Tracking federal health policy, political, and personnel developments in Washington, D.C., providing weekly insights.
* Collaboration with Health Management Associates (HMA) and other HMA companies, including 720 Strategies and Wakely Consulting Group.
**Reputation / proof points**
* The Federal Insights and Advocacy team is respected for integrity, expertise, and a long record of success.
* Experts have been involved in most major healthcare policy changes over the last 15 years.
Leavitt Partners is a healthcare consulting firm that collaborates with various entities, including HMA and its affiliated companies, to offer a broad range of expertise. They focus on navigating the complexities of healthcare policy, regulation, and market dynamics.
**Expertise & scope**
* Expertise in policy, regulatory consulting, advocacy, and reimbursement.
* Assistance in drafting legislation and commenting on draft regulations.
* Development of Capitol Hill advocacy strategies.
* Building and maintaining positive interactions with federal policymakers.
* Analysis of the intersection between legislation, regulation, agency actions, and their impact on healthcare payment and delivery.
* Tracking federal health policy, political, and personnel developments in Washington, D.C., providing weekly insights.
* Collaboration with Health Management Associates (HMA) and other HMA companies, including 720 Strategies and Wakely Consulting Group.
**Reputation / proof points**
* The Federal Insights and Advocacy team is respected for integrity, expertise, and a long record of success.
* Experts have been involved in most major healthcare policy changes over the last 15 years.
Additional information
Leavitt Partners provides critical federal health policy tracking, offering weekly insights to help clients anticipate and interpret key developments in Washington, D.C. This service is designed for organizations that are significantly impacted by federal actions. Their approach involves understanding the intricate connections between legislation, regulation, and agency actions, and how these influence healthcare payment and delivery systems. They also engage in developing advocacy strategies and fostering relationships with federal policymakers, which can be crucial for clients seeking to influence or adapt to policy changes.
Key Highlights
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Leavitt Partners' Federal Insights and Advocacy team combines expertise in policy, regulatory consulting, advocacy, and reimbursement.
Source
“The Leavitt Partners Federal Insights and Advocacy team combines expertise in policy, regulatory consulting, advocacy, and reimbursement.”
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They help clients draft legislation, comment on draft regulations, and develop Capitol Hill advocacy strategies.
Source
“We help clients draft legislation and comment on draft regulations, develop Capitol Hill advocacy strategies”
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Their experts have been involved in most of the major healthcare policy changes over the last 15 years.
Source
“Our experts have been involved in most of the major healthcare policy changes over the last 15 years”
Certifications & Trust Signals
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Leavitt Partners is a healthcare consulting firm with expertise in federal policy and regulation.
Source
“Leavitt Partners | Healthcare Consulting Services for All Your Needs”
Buyer Snapshot
Best for
- Organizations navigating federal healthcare policy changes.
- Companies needing to engage with federal policymakers.
- Businesses seeking insights into healthcare regulation and legislation.
How engagement typically works
- Collaborative strategy development.
- Direct engagement with federal policy.
- Information dissemination and analysis.
Typical deliverables
- Legislative and regulatory comment drafting.
- Advocacy strategy development.
- Policy impact analysis.
- Weekly federal health policy updates.
Good to know
- Best when clients require deep understanding of federal healthcare policy and its implications.
HQ:
Washington D.C., US
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, FDA Meeting Support (Q-Sub / Type C), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, Pre-Sub / Q-Sub
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
No
Supports Predicate Research:
Yes
Years Experience:
10
Num510k Submitted:
25
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
ivd, cardiovascular, neurology, radiology, orthopedic, wearable_digital
Technology Types:
samd, ai_ml, mobile_app, cloud_platform, wearable_patch, implantable, ivd_test, combo_product
Accepting New Clients:
Yes
Supports Estar:
No
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Engagement Models:
Project-based
