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
• Undeveloped pricing strategy

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
• Specialist services such as retrieval and processing of explanted or unused devices, including infected or blood-contaminated material
• Very flexible logistics, warehousing, billing, customs and tax, and shipping available 24/7, that is ideally suited to low volume, unpredictable product configurations, and/or complex devices needing experts to commission, train or troubleshoot
• Tangible base for Clients direct employees to work from (Netherlands) with back-office support for them, and back-up during vacation, sickness, etc.
• 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 that is developing a catheter-based device for valve repair. They have carried out a few cases in Europe (first –in-man study) and will soon start their CE Mark Study. But… they ship (from our facility) sixteen large boxes of catheters to each case, and bring them back again after the case. So we do the logistics, traceability, and handling of the (used / blood contaminated) tools for analysis post-case.
• A US start-up that has an interventional device aimed at heart failure patients, about to start a CE-Mark Study. We have been doing center selection and qualification, and will provide clinical support to their cases. In addition they have specialised equipment used for study patient follow-up that we will ship to and from study sites, decontaminate and re-test in between uses.
• A European device developer for cardiac surgery, currently only in R&D, expecting to have about 8 to 10 study sites at the end of 2014 or early 2015. We help them to develop their strategy, interact with investors, select sites and run their KOL interactions.
• A US company that has a CE-Marked device for heart failure, where we manage their direct employee, support their clinical operations with clinical specialists, and provide 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