What drives DiHeSys? The company’s conviction, which is shared by industry observers, that in the brave new digital world of healthcare things are changing rapidly, traditional business models are becoming obsolete and IT giants are forcing their way into a highly regulated market that is characterized by an elusive network of interests. There is also the will to actively help shape this market, instead of drowning in the maelstrom of change.

DiHeSys stands for Digital Health Systems. As DiHeSys has only just been established, the name may sound grandiose to some. However, one might think differently when looking at the professional background of the people that founded the company in early 2018. They are long-term scientists and senior managers from the pharmaceutical and healthcare sectors, with many years of experience in research, development, distribution, wholesale as well as from pharmacies and hospitals.

What does DiHeSys want? What the company wants is to ensure efficient and effective, but also affordable individual healthcare for patients. In pilot projects with partners from the healthcare industry, DiHeSys is developing and testing networked Healthcare 4.0 case studies. Here, the GP prescribes a drug for a patient. The data required for producing the drug, which requires digitized chemistry, is picked up by the platform technology, processed and sent to a decentralized 3D printer. The printer, which might be located in a hospital or pharmacy, prints the individualized drug, which is then transported to the patient. As the patient is equipped with portable digital helpers and sensors - the interfaces between the analogue and the digital worlds - the data related to taking the drug is returned to the platform. This allows the platform to act as the data-integrating communication medium between the various parts of the process. Doctors and health insurance companies will know whether the therapy was successful and whether the patient has taken the prescribed drug and, importantly, whether the patient has taken it correctly.

Is this a pipedream? DiHeSys managing director Dachtler does not think so and says: “Medicine is becoming more and more precise, individualized, and requires new manufacturing technologies. The mass-market-oriented blockbuster business model of the pharmaceutical industry ("one fits all") will soon be outdated.” A conservative, highly regulated pharmaceutical world, which the DiHeSys managers know only too well, meets a dynamic IT sector in the course of ongoing digitization, in which DiHeSys partner Admir Kulin (m.Doc GmbH) is an expert. Admir Kulin represents the “Di” in the company name and shows that the start-up from Ulm aims at bringing together two widely contrasting worlds.

In contrast to a drug approved in the US in 2015, which was manufactured for the mass market using a 3-D powder printing process, DiHeSys relies on a filament process, which incorporates the active pharmaceutical ingredient(s) into polymers/filaments. The filament process is basically suitable for all molecules and is being developed to market readiness by Dachtler's Munich-based company Gen-Plus GmbH & Co. KG in cooperation with partners. Currently, the company is specifically focused on small molecules, mostly patent-free drugs with a narrow therapeutic range in solid dosage form. The company is in constant contact with regulatory authorities with regard to basic questions that must be clarified before a digital manufacturing process can obtain marketing approval. A particularly important question is: What needs to be approved if an individual drug is specifically destined for a single individual?

From the founders’ point of view, on-demand drug production has benefits for many people in the healthcare sector. Studies have shown that half of the tablets on the market are not used or needed; Markus Dachtler therefore finds that on-demand drug manufacturing has economic benefits. With the new, rapidly developing printing technologies, drugs do not need a storage life of several years, but need to be stable for a few weeks only. The money could be used for research and development rather than for quality control, and thus make the development of drugs less costly.

The DiHeSys producers are convinced that it is, first and foremost, the patient that benefits from digital manufacturing. 3D printers can be used to produce tablets with a drug dose that is specifically adapted to each patient, be they adults or children. Children then no longer have to be given tablets with a fixed, adult-matched active ingredient dose, and will experience fewer side effects and drug interactions. The same would be true for old, multimorbid patients with chronic diseases who have to take a variety of deceptively similar tablets every day. In this case, 3D printing would allow the production of tablets in many different colours and shapes that dissolve much faster, thus improving drug safety as the patients would be able to identify different drugs more easily. DiHeSys is also convinced that patients would benefit from the so-called polypill, a tablet that contains several active ingredients and eliminates the need for taking several pills. This would benefit patients with dysphagia in particular. The subsequent step towards what are known as smart pills would involve the use of implants to monitor the correct intake of such pills.

Nobody really knows how Healthcare 4.0. is developing. Although the DiHeSys producers are not clairvoyants, their wealth of experience tells them that instead of individual solutions (“silos”) future solutions will be networked ones. The company consortium brings together all the necessary expertise from pharmacy, manufacturing technology, logistics and distribution to healthcare platform technologies where the data streams of all involved instances converge in order to be integrated, processed, mirrored and returned to a data cycle across different segments and sectors, centering on the patient around whom the healthcare community participants are regrouping and possibly find themselves part of new alliances, presuming that they survive the digital transformation.

The DiHeSys founders and partners believe that their company can provide answers to questions such as: How should individual medication be delivered to the patient? The company’s holistic approach includes consulting, project planning as well as the development of new patents. The approach covers the entire health-related value chain, starting with prevention and does not end with therapy, but also covers rehabilitation, the actual treatment outcome.

The company’s managing directors, Dr. Markus Dachtler and Thomas Ehmann, are confident that DiHeSys will grow relatively quickly, as in the healthcare sector the pressure to act is high. Initially, the company will focus on the German and European markets.