“The Da Vinci Health Group has been critical in helping us understand and evaluate our options around seeking FDA clearance for our digital health products. Audrey's guidance around the importance of creating a reimbursement strategy at the same time as we are doing our FDA planning has saved us months, if not years, of headaches and delays. Audrey and her team are able to serve as our regulatory and reimbursement subject matter experts, offering critical knowledge, advice, and support when we need it. Highly recommended. - COO, Digital Health Company”

“We engaged Da Vinci Health Group to help us with two of our FDA approved biologics. Our company was experiencing non-payment issues for both products, and Da Vinci Health Group provided us a roadmap to repair the coverage and reimbursement barriers. They went above and beyond in their analysis, providing us a new pathway to increase market acceptance due to recent changes in CMS policy. Their expertise in FDA, CMS, and healthcare market acceptance is unsurpassed. Senior Director Managed Care, NYSE Biologics Company”

“Da Vinci Health Group provided our French medical device start-up with an invaluable go-to-market reimbursement plan. Their work gave us critical information to build out our market entry plan into the United States, including market positioning, optimal pricing, and product growth opportunities. We highly recommend Audrey’s team of market access experts.” – CEO, Medical Device Company, Paris, France.

“We partnered with Da Vinci Health Group on global health economic positioning of our medical device for minimal invasive surgical procedures. Through global medical collaboration, Audrey and her team developed a health economic model that informed our product pricing and helped us prove the value of our device in specific minimally invasive surgeries. The result has offered our company a value-based healthcare approach that is customizable across multiple different country settings. Da Vinci Health Groups’ market access and health economic expertise can’t be overstated.” – Global Vice President Marketing, NYSE Medical Device Company.

“We recently partnered with Da Vinci Health Group on the reimbursement and healthcare economics portion of diligence we were performing on a potential acquisition. Our Executive Leadership Team and Board of Directors were impressed with the insight we gathered from Da Vinci Health Group. Reimbursement was a critical factor in the market dynamics and there was some uncertainty about the future state of reimbursement. Based on the work of Da Vinci, which was unbiased and factual, we felt very comfortable with the current and future reimbursement landscape. Based on their final report, where we once had concern, we now had a good handle on the risks. We eventually purchased the asset with this work playing a critical role in the decision making process. In addition, we had a very tight timeline and required quick turnaround. Audrey and her team were extremely collaborative and on time with all of their deliverables. – Global Vice President Business Development, NASDAQ traded Medical Device Company

Our Mission

To optimize market adoption and payment for innovative health solutions that improve patient lives and contribute towards population health

About Us

Da Vinci Health Group provides healthcare market access services and consultancy for innovative medical devices, pharmaceuticals, biotechnologies, and digital health solutions. Our aim is to optimize market adoption and payment for health solutions that improve patient’s lives and advance population health. We help our clients identify, develop and execute healthcare access strategy through providing comprehensive services in regulatory, clinical, reimbursement, and health economics. We are a team of healthcare industry experts with over 200 years of combined experience in global market access. Together we provide accelerated market adoption for your innovative technology. Our boutique and comprehensive approach to global market access ensures efficient use of your limited resources. Our passion to help patients places us in a unique position to take on innovative projects that other market access firms would refuse.

Case Studies

Case 1

Global market access strategy for virtual patient monitoring systems (VPMP): A Clinical Decision Support System

Our team successfully launched 3 HEOR studies, 2 retrospective and 1 prospective, which identified the health economic value of the clinical decision support system. We collected, evaluated and reported the patient outcome and cost impact compared to the current standard of care in hospitals. We then isolated the value proposition for providers, payers, physicians, and patients. The combined results informed our global market access strategy for product acceptance and uptake by hospitals and health authorities around the world.

Case 2

Software as a Medical Device (SaMD)

Our team worked with the product development team of a software (SaMD) client to design an automated intervention for sepsis. The software was designed to automate sepsis detection and timing of intervention in order to improve overall patient outcomes. Algorithms were built from published medical society guidelines and CDC standards of care documentation. Our team evaluated the sepsis SaMD to determine and guide feature development that addressed existing care gaps and workflow inefficiencies. Our team developed relevant value propositions for the sepsis software based on current and trending health policy, federal and state legislation, and reimbursement policy, including NQF and CMS quality measures. We reviewed all relevant health technology assessments (HTAs), and peer reviewed publications on patient outcomes associated with detection, and timing of interventions. A retrospective analysis of an all payer medical claims database was conducted to identify the volume, prevalence, incidence, location, timing, and overall cost of care during the hospital stay. This information was used to evaluate and estimate the hospital and payer economics associated with the sepsis SaMD compared to existing standards. All existing and potential coding, coverage and reimbursement was reviewed and summarized. We then synthesized all information to develop the potential health economic value this sepsis SaMD would provide to patients, physicians, nurses, hospitals, and payers. The combined results informed our global market access strategy for product acceptance and uptake by hospitals and health authorities around the world.

Case 3

Health economic proof to overcome payer coverage objections

Our team developed health economic evidence for an Intermittent Pneumatic Compression Device. We created a customizable budget impact model comparing IPC to commonly used drug interventions for the prevention of venous thromboembolism. The US version of the BIM was adapted to Germany, Australia, Canada, India and published in peer reviewed medical journals and presented at medical society meetings. A groundbreaking two country cost-effectiveness study, Australia and the United States, was completed in collaboration with global clinical experts in VTE prevention and published in ClinicoEconomics and Outcomes Research Journal in 2017. From this health economic work we were able to develop value based healthcare agreements with LTC, SNF and hospital groups.

Case 4

Payer acceptance at launch for new technologies

We planned and developed payer market research, pricing and contract strategy, and payer materials for launch of 5 difference HIV and HCV biologic therapies. Our team conducted health economic evaluations along with reimbursement evaluation to inform the ideal price range for market acceptance. Our team managed the collection, evaluation, and reporting of payer market research. We combined the health economic price range and the payer market research to arrive at the appropriate market position for optimal payer acceptance and uptake. We achieved 100% public and private payer coverage within the first six months after launch for each of our new biologics.

Case 5

Successfully reassigned cardiac procedure to new and higher paying DRG

Our team determined that DRG reclassification was necessary for the endovascular abdominal aneurysm repair (EVAR) procedure. Under existing DRGs, there was no room to grow with technological advances. We worked for over 1 year analyzing Medicare DRG 237 and 238, and validating the needed elements to argue our case with CMS for DRG reassignment. After two attempts with CMS applications for reassignment our team was successful in gaining higher paying DRG 268 and 269 assignment for the EVAR procedure. This allowed room for the technology to grow and offer patients a less invasive, and safer option to correct this cardiac condition.

Case 6

VBHC partnerships with US Hospital Systems and Payers

Our team followed a specific methodology to identify, qualify, assess, and summarize value for a several different interventions including biologics, devices, and digital health products. We then determined the likelihood these interventions could deliver for select patient outcomes, the cost expenditure to achieve those outcomes and the number needed to treat to realize the expected outcomes. Then we compared our end result to the “standard of care” to determine a viable VBHC arrangement. We have successfully completed VBHC agreements for reduction in pre-mature births, VTE events, respiratory compromise events, and morbidities associated with cardiac procedures with over 20 payers and providers in the USA and OUS. These partnerships have resulted in increased utilization of the right intervention, at the right time, in the right patient.


Intermittent pneumatic compression is a cost-effective method of orthopedic postsurgical venous thromboembolism prophylaxis

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Hospital Inpatient Admissions with Dehydration and/or Malnutrition in Medicare Beneficiaries Receiving Enteral Nutrition: A Cohort Study

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Allergy immunotherapy among Medicaid-enrolled children with allergic rhinitis: Patterns of care, resource use, and costs

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Scientific Posters

International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Annual International meeting, Washington DC, USA, 21-25 May 2016

International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Annual European Congress, Vienna, Austria – 29 October-2 November 2016

A Retrospective Analysis of NHS Hospital Episode Statistic (HES) dataset: In Hospital Prevalence of Respiratory Compromise in England, 35th ESCIM, 2017

IPC for Prevention of VTE in Australia: An Economic Analysis, Health Technology Assessment International (HTAi), 2018, Vancover, Canada

Intermittent pneumatic compression can reduce the burden of venous thromboembolism in India

Our Philosophy

We can accomplish more together than we can alone.

Our Promise

Full collaboration with experienced professionals who will take responsibility for delivering top quality work and excellent customer service.

Our Aprroach

DaVinci Health Group will handle all of your market access needs to overcome regulatory, clinical, health economic, health policy, and reimbursement barriers in order to gain rapid and sustainable access to healthcare markets. We believe partnership at the product concept stage for medical devices and at Phase II-III for biologics is the most efficient and effective approach for our clients: saving them time, effort, and money in the long run. Strategic market access planning and generation of clinical and economic evidence will support the proof of value required in today’s healthcare marketplace. However, we work with clients at any point along the product development process and have demonstrated market access successes in the post-launch phase.