Pharma / Bio / Device

The Lewin Group has extensive multidisciplinary experience conducting and managing analyses of technological innovation, regulation, payment, diffusion, and costs. 

Each year, medical product companies develop innovative new products to help detect and manage diseases effectively. Manufacturers must address complex health care and payer requirements early in their development plans or risk delayed product acceptance and significant expense.


We provide analysis and results-focused strategies demonstrating the value of medical products to public and private sectors payers, clinicians, health care facilities, patients, and policymakers. We also provide policy insight and guidance to industry clients on evolving trends and their impacts. We augment our extensive policy and analytical expertise with our access to claims and other administrative data for tens of millions of covered lives under Medicare fee-for-service, Medicare Part C, Medicaid, self-funded employer groups, commercially insured plans, and other payers. 

Policy Analysis
  • Analyze and project the impact of trends, policy developments in evidence-based medicine, health technology assessment, coverage with evidence development, and comparative effectiveness research
  • Analyze and project the impact of trends and policy developments in regulatory policy
Demonstrating Value
  • Analyze evidence requirements for securing coverage for medical products
  • Analyze clinical and economic burden of diseases and conditions that may be addressed by new medical products
  • Develop economic models and related analyses to assess clinical and cost impact, cost-effectiveness, and other value aspects of medical technologies
  • Other analyses and resources for supporting reimbursement and strategy

Our Clients

Our pharma/bio/medical device clients have included:
  • Abbott Laboratories
  • Advanced Biohealing
  • Amgen
  • Boehringer Ingelheim
  • EMD Serono
  • Novo Nordisk
  • Olympus America, Inc.
  • Patton Medical Devices
  • Pfizer
  • Wyeth Consumer Healthcare

 See the full list of Lewin services


Implant System for Low Back Pain: Evidence Review and Strategy

For a major orthopedic implants company, The Lewin Group reviewed the scope and quality of available evidence on the use of a novel implant system for treating low back pain. Based on the findings of this review and analysis of emerging evidence from available and continuing clinical trials, The Lewin Group identified strategic considerations for pursuing Medicare and other public and private reimbursement.

We reviewed unpublished and published peer-reviewed and other substantive literature for this class of implants, including alternative pedicle screw-based and interspinous systems. In addition to journal articles, our literature review included technology assessments, guidelines, coverage policies, and regulations in the United States and abroad. The Lewin Group evaluated the strength of evidence for the implant system and how payers would interpret and use this evidence in coverage policies, and provided recommendations for the design of further research to strengthen the case for coverage.

"Throughout the engagement, Lewin consultants listened to us and delivered superb analyses and thoughtful guidance–not canned solutions."