A Case Study – How to Utilize the Holistic Approach

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Real life experience: We had a UK client with a medical device that wanted to launch on the US market.  They had already completed the FDA process by the time they came to us for assistance with reimbursement.  The predicate device they decided on for their 510K submission did not have coverage or payment.  It had a code, but it didn’t have coverage and payment attached to the code.  The company couldn’t sustain the financial burden or the time involved in redoing their clinical studies to support a new FDA submission with a new predicate.

Solution: If they have developed a reimbursement strategy in conjunction with their regulatory and clinical paths they could have avoided the situation they found themselves in and made it to the market.   Reimbursement planning should be included in your very first business plan!

Real life experience: We had a client that received approval from the FDA for a 510K.  They launched their product to the market but had difficulty getting market acceptance.  They realized they needed help with reimbursement because they had not done any planning prior to launch.  They were also getting push back from physicians that they did not have the clinical evidence necessary for them to use their technology.  They also didn’t have the clinical evidence necessary to secure reimbursement.  They were only able to sell a handful of their products.

Solution: If they had planned a more comprehensive clinical study while doing their feasibility study for the FDA they would have had the clinical evidence to secure reimbursement and gain market acceptance.  It might seem expensive and time consuming to acquire the clinical evidence early in the development process, but in order for the company to secure coding, coverage and payment and to gain market acceptance they had to go back and do another clinical trial to obtain the clinical evidence required by CMS, payers and physicians to use and pay for their technology.  It took them another 3 years and a lot more funding before they were able to successfully launch on the market.