From concept to market, drawing up a business plan for a medical device

Abstract

Patients suffering from kidney failure are often treated with hemodialysis. This heavy treatment, 12 hours a week, does not offer an adequate solution for the end of the dialysis cycle. In fact, the main vascular access used is the arteriovenous fistula and requires appropriate compression to ensure that the two puncture sites used to filter blood in an external way, coagulate. This is where EDGY comes in.

EDGY was born out of an university project based on the creation of a medical device to fill a unmet need. It is the work of three students who studied civil engineering with a biomedical focus. Their goal is to bring this medical device to market, which is why this business plan is drawn up. The device is composed of two compression bracelets, each consisting of a capsule to compress the puncture site and a rigid part to fasten around the forearm. These two bracelets are connected to a control box that sets the compression parameters. The aim of this medical device is to compress the two puncture points in a punctual, decreasing manner, adapted to each patient in order to increase the lifespan of the fistula. Research and intellectual property procedures are carried out and several opportunities for future development have been identified in this study.

The dialysis sector is a large market, mainly located in Europe, the USA and Japan, but which is expanding rapidly in emerging countries. Belgium, France, Germany, Italy, the Netherlands and Luxembourg are the countries targeted by EDGY in Europe, along with the USA. In this work, these market segments are identified and characterized in order to estimate the number of devices EDGY could sell in them.

The environment in which EDGY operates is studied, starting with its value chain to understand the various stakeholders involved in the company. This is followed by an in-depth analysis of the competition, highlighting features specific to EDGY that are not found in competitors' products, as well as the potential threat from new market entrants. EDGY's regulatory framework is defined by the fact that its device is a Class 1 medical device. The regulatory pathways and applicable standards are studied. Finally, the device's specifiers are the nurses, for use of the product in the department, and the purchasing department, for purchase of the box.

The added value of the EDGY product lies in two points: the fistula-preserving that comes with a patient-friendly compression and the time-saving for the nursing staff. This effect is provided by relieving nursing staff of the burden of compressing fistulas themselves, enabling them to put their work to a higher-value task. The choice of business model studied in this business plan is B2B. The boxes will be rented to dialysis units with after-sales service. This will be combined with the sale of the wristband part, which is EDGY's consumable. Pricing, marketing and communication strategies are explained, and the environmental, social and governance aspects are studied in order to bring a viable future vision to the project.

The EDGY Gantt chart for the next few years starts with the current situation, then moves on to the development testing, verification and validation, clinical study, IP strategy, certification and reimbursement study phases. The human, material and immaterial resources relating to these phases are developed, leading to the final objective, which is to carry out the best possible financial modelling of EDGY's next 5 years, integrating the financing requirements to ensure the presence of sufficient cash flow.