Medical Devices

Boston Healthcare has worked with established and emerging medical device companies to create innovative market and reimbursement strategies. Below are summaries of typical project case studies:

Implementation Strategy to Influence Technology Adoption and Increase Reimbursement in Multiple Sites of Care
A medical device company wants to launch a new device for conducting an existing surgical procedure. The device offers numerous clinical and operational benefits, including the ability to visualize the surgical field more effectively and complete the procedure in approximately half the time it takes to operate using traditional technologies. However, since the technology is utilized in both inpatient and outpatient hospital settings and freestanding ambulatory surgical centers, it is impacted by multiple coverage and reimbursement systems and is subject to geographic and payer-related variations in payment rates. This highly complex reimbursement environment is negatively influencing technology adoption. Boston Healthcare is engaged to assess the situation and develop a strategy for securing appropriate and consistent coding, coverage and payment throughout the United States. Boston Healthcare works to develop an interactive cost effectiveness model to demonstrate the financial and operational impact of adopting the new technology. After introducing the reimbursement tools developed by Boston Healthcare, the client company realizes a greater than 30% increase in sales of its product in the United States.

Portfolio Growth Strategy for Wound Care Technologies
Boston Healthcare worked with a global wound care company to examine its entire product and technology portfolio and the market in which its products compete. The assignment involved identifying market drivers and a detailed analysis of the competitive landscape and pipeline, pricing pressures, reimbursement, contracting, and competitor marketing and sales structures. Issues addressed included a gap analysis of the client’s portfolio and its licensing strategy to identify and acquire new technologies.

Submissions Strategy for a Small Medical Device Company
A small company ready to enter the medical device arena has no current experience gaining clearance with the FDA. Boston Healthcare explains the regulatory process, advises on the documents needed, and provides the framework for the 510(k) submission. We provide templates and help author many of the 510(k) sections, as well as provide training in areas foreign to them such as Risk Management, Software Validation, Clinical testing, and Substantial Equivalence. After gaining a full understanding of the 510(k) process, the company successfully submits and receives clearance for their 510(k).