Key to the successful launch of medical devices is the careful alignment of regulatory, reimbursement, and overall market and commercialization strategies.

Boston Healthcare helps medical device companies navigate the maze of reimbursement and market access options in the US, EU, and Asia-Pacific markets. From the early development stage to established global companies, we can help you understand the landscape for your medical device and provide a fully tailored and integrated approach toward commercialization.

A medical device company was facing a change in coverage of an established knee repair device due to negative clinical benefit assessment by the German SHI system, even though the procedure had been performed for 10 years in the German market with high success rates and fewer complications than alternatives. The company engaged Boston Healthcare for an evidence development strategy for discussions with payers. Boston Healthcare was challenged by the statement of insufficient evidence from the SHI review body and a complex mix of stakeholders (SHI review board, different SHI funds, and orthopedic surgeons). The Boston Healthcare team outlined an evidence-based response towards the SHI review board report and conducted a scientific, systematic literature review for benefit assessment in alignment with stakeholders. We also developed a value and communication strategy with key bodies, leveraging the support of KOLs and other relevant decision makers. While the lack of RCTs was an issue, the common agreement between stakeholders of the approach managed to move positions. Boston Healthcare’s approach to evidence assessment in nonrandomized studies added a relevant piece for the manufacturer in the discussions for further reimbursement.

Boston Healthcare was engaged by a global medical device manufacturer to support due diligence activities by assessing the US and European reimbursement landscape for the lead device product. The device was still going through the central decision making process in key European markets. Our in-market team performed primary and secondary research and accessed key central decision makers to meet project objectives. We learned that the manufacturer had an overly optimistic timeline for obtaining reimbursement in two key European markets. This finding alone had a significant impact on the valuation of the company and the final acquisition price.

A large, global medical device company asked Boston Healthcare to develop a global health economics and reimbursement (HE&R) infrastructure. This need was triggered by an evolving portfolio strategy into disruptive devices that demanded evidence-based value analysis and planning. Historically, the HE&R staff had little input into clinical evidence planning and there was no process or communication channel to feedback O-US country customization requirements. Boston Healthcare analyzed the portfolio of businesses by key HE&R drivers, and performed an internal situation analysis and external benchmarking analysis. We discussed multiple options with the company’s executive team before recommending a structure that positioned the global HE&R function to be part of a core product development team to assess, communicate, and capture global evidence needs. The implementation included development and rollout of market access and HE tools and training.