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Commercial Strategy for Medical Device Enterprises

PASB can address any gaps in your commercial strategy to ensure it aligns with your regulatory strategy and product development plans. Our expertise and experience encompass the following areas:

Business Case Analysis

Do you know your target markets, competitive landscape and payers?  We can perform market research to determine the addressable market size for your innovation, generate potential revenue models and quantify benefits/costs of your technology so target customers can readily understand their prospective ROI.

Reimbursement Analysis

To develop a successful U.S. market access strategy, medtech firms need to address the separate but linked strategic components of coverage, coding and reimbursement. With our trusted partners, PASB can assess your product categorization, any existing code coverage and the requirement for new code application to facilitate informed decision-making.

For the Canadian market, we can guide offshore medical device companies through the provincial healthcare procurement system and connect them with potential decision makers at healthcare authorities, clinician advocates and product validation programs to gain market access.

Value Dossier (VD) Development

The VD is a fundamental market access tool that communicates your innovation’s value proposition to decision makers and is prepared in a widely accepted standard format for payers and potential investors.

Canadian Importation and Distribution Strategy

For offshore organizations seeking to enter the Canadian market, we can evaluate regulatory, importation, and commercial implications for various potential distribution scenarios in Canada.

Business Planning

The business plan includes the elements above as well as the regulatory strategy in a professional, comprehensive package that clearly demonstrates the future value of the organization/product line to potential commercial partners, investors, and funding agencies.