Executive Summary

FirstClinTech targets start-up companies that are first entering the European medical device market. Our clients are characterised by some (or even all) of the following:
• Little or no resources yet in Europe
• No employees
• No entity
• No warehouse
• Good understanding of the market opportunity
• Some understanding of the regulatory landscape
• Some existing contacts with clinics / doctors
• A belief that they can support European clinical development from the United States
• Prototypical manufacturing, shipping, packaging and distribution

We offer to “fill the gaps” in their European strategy by offering the following “menu” of services:
• Provide clinical support specialists to train, proctor, troubleshoot devices in the field
• Provide knowledgeable center selection and qualification; then work with a CRO if necessary
• Service engineers to test, install, repair and maintain electronic equipment (through our partner organisation)
• Specialist services such as retrieval and processing of explanted or unused devices, including infected or blood-contaminated material
• Local support for Client’s R&D effort – less time away from the company for key Client staff

Our goal is to provide a local presence for the Client, without the Client investing significant time and money resources in supporting European clinics. We try to be very cost-effective, and in doing so de-risk a EU strategy. Our Clients can postpone big decisions on hiring staff, creating an entity in Europe, signing Distributor Agreements etc., maximizing their bargaining positions with potential acquirers, investors or strategic partners.

Below are some examples of our Clients that illustrate what we do:

• A US start-up developing a catheter-based device for valve repair. FirstClinTech provided the logistics, traceability, and handling of the (used / blood contaminated) devices and tools for analysis post-case.

• A Japanese company with a device to achieve hemostasis in a broad range of procedures, including GI Endoscopy, vascular, hepato-billiary, cardiac and other surgical specialties. We provided strategic input and local clinical specialists to drive adoption and study recruitment.

• A US start-up with an interventional device aimed at heart failure patients. We first supported the CE-Mark Study, e.g. center selection and qualification, plus provision of clinical support at cases. FirstClinTech managed specialized equipment used for study patient follow-up including shipping to and from study sites, decontamination and re-test in between uses.

• A European device developer for cardiac surgery currently in R&D. We help them to develop their strategy, interact with investors, select sites and managed their KOL interactions.

• A US developer of a novel device used for resection of GI mucosal tissue in endoscopy, working with them to expand the market, supporting cases and marketing efforts.

• A US company that has a CE-Marked device for heart failure, with management their direct employees, support for their clinical operations with clinical specialists, and provision sales and marketing support in certain areas and at congresses etc.

• Other companies in earlier stages, who engage FirstClinTech to help with their input criteria, risk analysis, design, training development, sales strategy.

• Some “legacy” device support for implanted blood pumps where the manufacturer has exited the market and no longer provides manufacturer support.

Although we tend to specialize in cardiac devices, other specialties can benefit from our resources too. For more information please go to www.firstclintech.com or e-mail info@firstclintech.com