Reimbursement & Market Access

Getting your medical device to market

Our experts have a combined experience of 35 years helping healthcare companies demonstrating the value of their products, developing access to market and increasing sales.

Initial Market Research

Our experts will pinpoint the 3-5 most promising markets for the product to be validated by the analysis of the methodology of a Health technology Assessment (HTA).

Reimbursement Analysis

The Reimbursement Analysis determines the ideal positioning and pricing model, answers what health economic evidence needs to be collected in the clinical strategy for achieving and sustaining coverage/reimbursement for the product and lists the factors that could affect the value of the device.

Budget Impact Analyses (BIA)

The Budget Impact Analyses (BIA) is a strategic selling tool that demonstrates the financial impact of investing in the device while considering its economic impact in expenses and costs to the purchaser. It also highlights the key economic data required to fully assess the value of the device.

Health Technology Assessment (HTA)

An HTA are the pivotal health economic analyses of a device on a target market, giving crucial information on costs and effect presented to decision makers. For some companies the format of an early HTA, give economic knowledge both for development and market access. A HTA would comprise of 5 main topics: Technology, Patient, Organization, Ethics and Economic evaluation.

Commercial Due Diligence

Applies current market data and analysis to translate the product’s clinical and economic benefits into financial value for investors. This approach calculates the targeted market size and potential, validates unmet needs and supports the estimation of sales timelines

Submissions, Notified Bodies and Regulatory Authorities

We take care of device approval submission, maintain efficient contact with Notified Bodies and relevant Regulatory Authorities.

Post Market Surveillance

We take care of vigilance, post market clinical follow-up and update of the technical file.

Global Regulatory Community

Our consulting team has an in-depth knowledge of regulatory systems world-wide. Combined with our knowledge of the notified bodies and regulatory authorities, this means that we can help you with device registration and/or approvals quickly and efficiently.

Contact us to find out more about Regulatory Affairs.