Expertise for Accurate Business Assessments
Due diligence of a medical device technology and/or company for the purposes of merger and acquisition (M&A) decisions or investment planning requires in-depth knowledge of regulatory and clinical strategies, reimbursement, quality systems, and legal compliance (such as fraud and abuse compliance) in addition to the classic due diligence requirements. RCRI knows medical devices, IVD’s, and combination products and the strategies, processes, and timelines involved in moving them from concept to successful commercialization.
Our team of qualified experts helps you optimize investment decisions by asking the right questions and providing valuable assessments early in the due diligence process, so you can make more informed business decisions and valuations.
Regulatory Affairs and Clinical Trial Design & Management
RCRI’s regulatory and clinical understanding can provide valuable insight to evaluating your investment and defining key steps to gain market access including medical technology regulatory pathway, primary endpoint selection, and clinical trial timeline assessments.
Reimbursement and Commercial Optimization Planning
RCRI understands what is required to achieve optimal commercialization for your product. We have the expertise to analyze available data to generate evidence maximizing reimbursement and key stakeholder health economics arguments. Critical to the M&A process, RCRI experts can both identify and implement opportunities for future reimbursement and commercialization success.
Quality Systems Assessments and Harmonization
RCRI understands global quality and compliance requirements and has significant experience creating quality systems that comply with FDA regulations as well as those of the European Union, China, India, Japan, Canada, and Australia. Importantly, companies often find substantial investments are required to either improve the acquisition target’s Quality System or to harmonize that system with their own following M&A activities. RCRI expertise can identify the risks that may impact your valuation.
Fraud & Abuse Compliance
RCRI can provide an analysis of the company’s compliance to legal requirements including contracts with hospitals, physician practices and physicians, fair market value payments to healthcare professionals, and reporting to state and federal governments, including the federal and state physician payment Sunshine Act and Medicare Secondary Payer law.