Life consists of four consecutive phases. Having arrived at phase IV, I decided to share my experiences. This will take some time, and while writing Chapters about The Eye, I will share personal impressions in the form of Anecdotes, and further information, considerations, and news as Blog.
I studied physics and medicine at the Technical University Munich in Germany and the University Regensburg, and in 1977 achieved my PhD in physics. The first years of my studies coincided with the student revolution. In 1969/70 I was the speaker of my physics class of 165 students, and from 1970 on I acted as a mentor for younger students. From 1977 to 1980 I was employed as Head of Product Development by the leading European contact lens manufacturer (Titmus Eurocon, which in 1983 was merged with Ciba Vision, now Alcon). I was responsible for clinical research, engineering, patents and regulatory affairs. Ever since then I had a particular interest in the eye.
In 1980 I decided in favor of self-employment. I had identified two unmet needs: (1) In industry there was at that time a significant lack of understanding of biocompatibility, i.e. the interaction between medical devices and the human body, and there were no test houses offering biocompatibility testing, and (2) the medical device regulations were emerging globally, starting from the 1976 US Medical Device Amendments to the Food, Drug, and Cosmetic Act. From 1978 to 1980 I had been in charge of the first FDA approval project of a non-US made soft contact lens, and during that time established close cooperation with US consultants. Consequently I established a test house specialized in biological testing and offered international regulatory consultancy. We were the first test house in Germany offering in vitro cytotoxicity testing. In the coming years the biological laboratory diversified into biotechnology, including development and manufacture of monoclonal antibodies, development of immunological test methods, as well as pharmacological testing. As a regulatory consultant I became from the mid-1980s involved in the global harmonization movement. I was appointed as the Convenor of the International Standards Organization (ISO) working group on contact lens care products, and as a novelty was the first Convenor who achieved experts from the US FDA to join his working group. My global network of contacts to experts, regulators and medical device industry expanded exponentially.
At the dawn of the European Medical Devices Directive I decided in 1989 to exclusively focus on medical devices. Consequently I separated from my test house (now Eurofins BioPharma Testing Munich) and started a new test house offering comprehensive testing to medical device industry (mdt medical device testing, meanwhile part of Underwriters’ Laboratories). This same year I was appointed as Chairman of the German Standards Institute (DIN) Committee on Medical Device Biocompatibility Testing, and represented DIN at the inaugural meeting of the International Standards Organization Technical Committee ISO/TC 194 ‘Biological Evaluation of Medical Devices’. At this meeting I was appointed as the Convenor of the working group ISO/TC 194/WG 6 ‘Mutagenicity, Carcinogenicity and Reproductive Toxicity’. Under my convenorship we achieved only three years later to publish the first version of the international standard ISO 10993-3 Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. Later from 1995 to 2001 I became the Chairman of ISO/TC 194.
During the preparation phase of the European Medical Devices Directive a served as an expert delegate of the German Precision Mechanics and Optics Manufacturers Association (Verband Feinmechanik und Optik, now Spectaris) at the European Commission. In parallel I set up the European Notified Body mdc medical device certification, which was accredited in 1994 (CE0483), and achieved 2000+ international clients in the years to come. On behalf of the European Commission I was part of a working group who established the risk management training program for experts of European Notified Bodies, engaged during the BSE crisis in the risk management of devices containing materials of animal origin, acted as an expert on the risk management of dental amalgam, and convened the consensus working group on breast implants.
Part of my engagement in favor of global harmonization was the organization of five annual international meetings under the motto ‘Medical Device Forum’. Moreover, I initiated in the early 1990s the joint venture Zhejiang ML Medical Device Consultant Company in Hangzhou, China and acted for 12 years its Chairman of the Board of Directors. Our target was to support the mutual understanding of industry and regulators of the cultural roots and current medical device regulations in Europe and China. Between 1989 and 1999 I supported a significant number of companies worldwide in establishing and adjusting their quality management system and technical documentation to international requirements. One of the outstanding experts which I met during that period was Professor Endre A Balazs, the father of medical grade hyaluronan. He started as a client and developed into a close friend of mine; friends call him Bandi. Bandi triggered the next phase of my life by drawing my attention to the tremendous potential of hyaluronan.
I decided to phase out my service business, and from 1999 onward use the multidisciplinary experience I had meanwhile gained to focus on developing and manufacturing highest quality products for the treatment of ocular diseases. Consequently and to avoid potential conflicts of interest I separated in 1998 from my shares in the Notified Body mdc medical device certification and in 1999 from my shares in the test house mdt medical device testing. I devoted all my energy in the establishment and development of my companies i.com medical GmbH and MIRO GmbH as cutting edge technology leaders in the treatment of ocular surface disease.
In 2017 I initiated the non-profit organization CORONIS Foundation to support medical research, post-graduate medical education in developing countries, as well as the treatment of patients in need. CORONIS Foundation focuses on ophthalmology.