Challenge

A medical device company specialising in advanced diagnostic imaging equipment aimed to enter the European market. They faced:

Regulatory Barriers: Strict medical device regulations and approval processes.
Market Penetration: High competition from established medical device manufacturers.
Healthcare System Complexity: Navigating the public and private healthcare sectors.

Solution

Regulatory Strategy Development:
CE Marking Assistance: Guided the client through the CE marking process required for medical devices in Europe.
ANSM Coordination: Liaised with the French National Agency for Medicines and Health Products Safety (ANSM) to ensure compliance.

Clinical Validation:
Clinical Trials: Coordinated with leading hospitals to conduct necessary clinical evaluations.
 Data Collection and Reporting: Managed the collection of clinical data to support regulatory submissions.

Market Access Strategy:
Reimbursement Pathways: Analysed and identified appropriate reimbursement codes and pathways within the French healthcare system.
Health Economics Analysis: Demonstrated cost-effectiveness and value proposition to healthcare providers and payers.

Stakeholder Engagement:
 KOL Relationships: Established connections with key opinion leaders in radiology and diagnostics.
Educational Workshops: Organised training sessions for medical professionals to demonstrate the device's capabilities.

Competitor Benchmarking:
Product Differentiation: Highlighted unique technological advantages over competitors.
Pricing Strategy: Developed competitive pricing models, including leasing and service agreements.

Results

Regulatory Approval: Achieved CE marking and ANSM approval within one year.
Market Entry: Launched the product successfully, securing contracts with five major hospital networks.
Revenue Generation: Exceeded first-year sales targets by 25%.
Industry Recognition: Received accolades at major healthcare technology conferences, enhancing brand credibility.