Sarah Welsh is responsible for the development of Q-Submissions, 510(K)s, De Novos, Breakthrough Device Requests, and PMAs for clients. Sarah also works to develop regulatory strategies, product landscape analyses, as well as recommendations for pre-clinical testing and clinical data requirements. Additionally, she is very experienced with literature analysis and evaluations. Sarah also has experience in drafting and preparing international (EU) regulatory submissions, notably, Clinical Evaluation Reports.

Palmer Smith is responsible for the development of Q-Submissions, 510(K)s, De Novos, Breakthrough Device Requests, IDEs, and PMAs. Palmer helps clients navigate intensive regulatory landscapes by developing strategies and recommendations that efficiently bring their devices to market. Palmer collaborates across all MCRA service arms to ensure all clients’ pre-market needs are met. Additionally, Palmer helps lead the Compassionate Use Program service at MCRA that provides clients and physicians a unique FDA-pathway to better treat patients.

At MCRA, Chaya is responsible for providing expert coding analysis and education that supports MCRA’s clients’ needs by providing thorough coding assessments for reimbursement and market access landscape assessments.  She works collaboratively with MCRA’s various teams to prepare and present coding-related deliverables. She regularly attends the CPT Editorial Panel Meetings and has been successful in numerous coding and payment applications (CPT, PLA, ICD-10-PCS, NTAP, and HCPCS).

As Associate Director, John leads client engagement teams in developing reimbursement landscape assessments, market entry recommendations, business model strategies and financial models. John prioritizes collaboration across MCRA’s RHEMA department to ensure clients are put in the best position to succeed in all stages of the product commercialization lifecycle, including product ideation, fundraising, market entry, growth and diversification.