Team:KU Leuven/Entrepreneurship


Entrepreneurship

In its mission to help patients in need of therapeutic drug monitoring, not only the technology is important. We should also make sure that the technology would reach the patient. For this purpose, we imagined the start-up HEKcite.


Costumers

To better understand who the company’s clients are, a couple of brainstorm sessions were held. The results can be summarized in what is called a business model canvas.


As can be seen in the canvas, medical doctors would be the company’s customers, opting for a HEKcite device when prescribing certain medication to their patients. The customers are thus, highly specialized medical staff, who take the decisions about their patients alone. Depending on where the patient works, he makes the purchasing decision alone or in consultation with the hospital directory board.
Because of the high specialization level of the customers, the company must try to reach them through rather niche channels. A good example are symposia where a group of medical doctors with the same specialization come together, so the device can be presented for a larger group. The company also relies on the fact that these experts keep up with the new developments in their fields and take advice from other experts. Other channels to reach potential customers include publications and papers, and direct contact with the company, such as brochures provided or contact with a sales person.

But why would medical doctors opt for a HEKcite product? It is a well-known fact amongst both medical staff and patients, that for certain types of medication continuous monitoring is needed. There are currently no sensors available on the market that can do this, while the demand is there. On a more personal note, on the doctor’s side, there is also the high need to perform. Medical specialists experience high competition amongst fellows. The goal of HEKcite is thus to convince them our device will improve patient contentment and even provide better outcome of whatever condition they are treating. Also, the feedback they are getting from the device will help to improve their treatment skills and procedures so they can keep learning themselves. Several patient interviews conducted by the team confirmed the former. Be sure to navigate to the human practices page for more information on this.

To obtain even better insight into the mind of the costumer, another brainstorm session was held, this time in the form of a value proposition canvas. Note that this is just a more detailed version of some of the segments in the business model canvas.


To summarize the chart, it can be concluded that HEKcite will provide a device and an app, that allows customers to monitor multiple patients, with an easy to use interface, all with the goal of providing better patient care and reaching a higher level of contentment with patients.

Company

Now that it is clear who we want to reach, it is time to decide on how to this. As a young company, HEKcite would obviously need some sort of start capital. Perhaps starting as a spin off from our very own university KU Leuven would be a good starting point, while the technology is further developed. Their experience with transferring technology to the market could be of great importance for HEKcite.

During the first years of being in business, the technology will still have to be further developed and investors will be needed to fund further research and eventual clinical trials for the device. As a way of surviving the “valley of death” (a concept that describes the period of time in a new product development where more money is spent than received, this period is known to be longer for medical devices than for any other), HEKcite could first sell the device to labs for in vitro tests, while the company goes through the regulatory affairs needed for implanting the device and using it in vivo. This is based on the business principle of “plucking the low hanging fruit” first.
For further research in the first years of HEKcite, the company could again collaborate with the university for the use of specialized labs and equipment. HEKcite will continue the partnership with imec or other nanotechnology centers to further minimize and optimize the multi-electrode array. For more information on the working of the HEKcite device, please navigate to the applied design page. While still in development, HEKcite could make use of an advice board with several third-party field specialists to reach technology goals.

As stated before there are no competitors on the market yet that can measure medication concentration in the blood continuously. The current solution for measuring blood level concentrations is the withdrawal of blood by medical staff every few weeks, months, … This is of course not continuous, which illustrates the unique selling point of HEKcite. More information about the advantages of continuous monitoring, can be found here or here. Only one attempt is currently known to be made for obtaining a device that can monitor drugs continuously. The project is called NanoDem, by the company ProbeScientific. This project is known to have received almost four million euros by the European Commission1, illustrating the demand for bringing such a device on the market. One could say the action in this field is taking place now, and HEKcite is excited to be a part of it.

HEKcite’s goal is to provide a device for implantation and an easy to use app to go with this. HEKcite itself could be the distributor for these products or we could take part in a collaboration with a large pharmaceutical company, making use of their existing client database to immediately reach higher numbers of customers. Partner deals with other companies will also have to take place to provide HEKcite with the membranes and integrated circuits still needed for the device.

With respect to intellectual property, HEKcite will patent the device and trademark the name.

Regulatory affairs (in collaboration with law student Louise Versin)

Of course, implanting a device as HEKcite cannot be done without going through several regulatory steps. The device will in Europe probably be classified under a high class medical device and several steps will have to be taken to obtain CE marking.

In Europe devices need to have a CE-marking before they can be sold on the European free market. The CE-marking is necessary for all devices brought into the European Union. Most medical devices are subject to a conformity assessment by a certification body. The CE marking may be affixed to the medical devices by this institution if the compliance procedure indicates that the device meets the essential requirements set out in a number of European directives. The CE marking proves that the product has been evaluated and meets all EU requirements in terms of safety, health and environmental protection. Medical devices are governed by three European directives, which have been converted into three Belgian Royal Decrees. The developed device is a medical device as described in article 1 Directive 93/42/EEC of 14 June 1993 concerning medical devices. The devices are divided into four classes, namely Class I, Class IIa, Class IIb and Class III, depending on the risk they form on the patient’s health. This classification is based on the classification criteria described in Annex IX of the Directive 93/43 / EEC. The application of the classification rules is determined by the destination of the devices. The different products are divided into three different categories, namely: 1) non-invasive tools 2) invasive tools and 3) Active tools. The products are then further divided by category into the four classes already discussed. The classification into classes is important because the conformity assessment procedure to be followed by the manufacturer depends on the class in which the tool was classified.

Medical devices may only be marketed if they meet the requirements of Directive 93/42 / EEC. The Council states that the rules on the design and manufacture of medical devices should be limited to the provisions necessary to meet the essential requirements. These requirements must be compatible with a high level of health and safety protection. These essential requirements are listed in Annex I of the Directive. The general essential requirements imply that tools must be designed and manufactured so that their use does not endanger the clinical condition or safety of patients. The notified bodies must, in addition to assessing whether the product complies with the essential requirements, also carry out a conformity assessment. If this procedure determines that a medical device complies with European requirements, a CE mark may be affixed to the device. The CE marking must be visible, legible and indelible on the device or on the package that guarantees the sterility.2

1. Cordis.europa.eu. (2017). European Commission : CORDIS : Projects and Results : NANOphotonic DEvice for Multiple therapeutic drug monitoring. [online] Available at: http://cordis.europa.eu/project/rcn/104915_en.html
2. www.wellkang.net, W. and www.wellkang.net, W. (2017). What is CE Marking (CE mark)?. [online] Ce-marking.org. Available at: http://www.ce-marking.org/what-is-ce-marking.html

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