Hull Associates
In a World of Personalized Medicine, Customized Solutions for Market Access

When he began his market access career nearly 25 years ago, founder and president of Hull Associates LLC Stephen Hull remembers the forecasts of the leading market access experts: medical device companies will evolve to behave more like pharma companies, investing earlier in higher value studies to address a full spectrum of evidence demands.

That prediction, surprisingly, has not held true for many device innovations, as the Food and Drug Administration has developed more progressive approaches to approving innovations for market, while payers have become entrenched in demands for evidence of “value” to support their coverage decisions.

This growing divide between the FDA and the U.S. public and commercial payers poses ever growing challenges for the medical device industry as innovator firms have to balance their priorities – rapid entry into the market – versus a staged or delayed entry with more robust evidence.

The solution, according to Hull, is to develop a targeted, highly customized solution for each innovative device that bridges both regulatory and reimbursement demands for evidence.

“Over twenty-five years of work in market access has taught one lesson: for true innovations, there are no cookie-cutter answers,” says Hull.

Designing Reimbursement into Medical Technologies

Hull explains that the nature of most medical technology innovation is purely practical – to find solutions that improve patient wellbeing, ease the time and expense burdens on providers, or reduce downstream complications and interventions. But payers do not value all innovations equally and are primarily focused on healthcare inputs that create financial risk to their plans.

“For example, innovator companies are thrilled to develop systems that enable earlier diagnosis of cancer,” explains Hull. “That sounds intuitively great for patients, but payers think ‘what will this do to actually reduce the burdens and costs of the disease?’”

Hull explains that his team works with each customer to align its strategies with payer demands. “The critical path always requires alignment of the key value proposition to payers and development of the right evidence to prove that value,” says Hull.

At the end of the day, our focus is enabling good physicians to use good products for the betterment of patients and their health

With an expert team in the Boston area, and key field consultants in Europe, Asia and Latin America, Hull Associates helps companies think through its overall strategy, so that there is alignment with the strategies for the U.S. market and the rest of the world.


“There are plenty of innovations that are valuable yet do not ‘fit’ into reimbursement systems and cannot be monetized,” says Hull. “There are also sometimes strategic choices a company can make to better position itself to succeed in already-existing reimbursement pathways.”

A Core Team of Experts

According to Hull, the critical asset of his firm are the core experts on his team, both in the US and overseas. Each field consultant has a minimum of 10 years industry experience and then works as part of an integral team to derive client solutions specific to each market.

In its 14 years, Hull Associates has served over 350 companies across all disease areas, and among 22 major global markets. Since its inception, Hull Associates has worked on almost every major innovative device produced in the medical industry, such as the percutaneous heart valves, robotic surgical systems, and the latest in vitro diagnostics.

What truly differentiates Hull Associates is its focus on field execution and advocacy work for payers to help clients succeed in the marketplace. “There are very few companies that do both,” says Hull. “We do not believe you can give strategic advice without having implemented successful strategies.”

Adding to that is the company’s exposure and understanding of international markets. Since its founding in 2007, Hull Associates has had a major focus on supporting companies among the leading global markets, so that clients can develop evidence plans that truly address their major launches. “We are equally focused on helping support launches overseas, as we are in the US,” says Hull.

Hull Associates offers strategic market access and reimbursement consulting to enable pharmaceutical, medical device, and diagnostics organizations develop targeted strategies for their products such that they are recognized by payment systems and readily adopted by healthcare providers. “Our focus is to help organizations with their strategic decision making, evidence strategies, and execution of those strategies in each market to optimize reimbursement from each payment system,” says Hull.