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Medical Device Case Study

case study

Medical Device Product Development Case Study


By asking questions and exploring all options in accordance with the client's needs; Take a look at how we’ve been part of successful medical device launches and how we have helped our clients to bring their products to French market.

The mission step by step for an outstanding Achievement

▪ Supporting and sponsoring the implementation of your medical device in France by creating a network of relevant stakeholders.

Identify, contact and inform stakeholders, creating correspondence by phone and emails to prepare virtual and physical meeting. We make a point to devote our time to find the right healthcare professionals in your field, and we schedule appointments with pertinent people. We assist you to organize meetings with stakeholders (physicians, specialists, pharmacist, etc.) until you can follow-up autonomously with the stakeholders and the key opinion leaders (KOLs), to achieve an implementation of an influent network and monitoring of topics related to you product, with an optional support for participation in events.

▪ Registration and referencing your products in France

We manage the mandatory registration procedure for MDs to the ANSM (National Agency for the Safety of Medicines and Health Products / Agence Nationale de Sécurité du Médicament) including additional requirements for class III and implantable products. If you claim an eligibility for your device, our specialists can save you valuable time by helping you with this mandatory step. Our knowledge of scientific and legal issues will help you move your product from the early stage of development through the entire French regulatory process and obtaining marketing authorization.

▪ Searching a distributor for your medical device

Pharmassent supervise a network of distributors and wholesalers in France and Europe. We have knowledge and experience to choose with you the most appropriate one that will fit with your demands. Furthermore, a good partnership can be very reliable to administer and solve the distribution management of your MD without worrying about it. Together we help you determine the objectives that need to be reached by the distributor to fulfill your financial goals and grow a successful business.

▪ Preparation of reimbursement process [optional]

Do you think that your product can be legitimate in the eyes of the health authorities and the social insurance in terms of prices and quality? Our consultants will work in cooperation with your scientific department in order to prepare and organize a pre-deposit appointment with the High Authority of Health (HAS) – If your medical device is eligible to the LPPR list (the list of products and services reimbursable by Health Insurance) this meeting will be a “door opener” for your product.

After this initial phase, the next step is to prepare and submit a complete application to have every advantage in this long process. Together with our consultants, we will help you to take a strategic decision for your company’s financial future to establish a plan to penetrate the market (pharmacies/hospitals/wholesalers) via the different distribution channels. In the meantime, and if your product meets the requirements, we will help you supervise the registration for the evaluation of your MD with institutional agencies like COMEDIMS, CODIMS and AGEPS to allow access to hospital tenders including APHP public markets.

With our knowledge and proficiency, we can provide customized product registration solutions, including engagement with the specific regulatory authorities.

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We stand alongside you as your trusted advisor for an outstanding achievement and for a successful market access in France.

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