Curious to learn a little about me?
I’m an experienced developer who has successfully brought medical devices from initial concept to CE certification for intensive care patient management.
My extensive skills were further honed and proven through founding a company and its subsequent successful acquisition by a major corporation. The challenges inherent in such development are also valuable experiences, complementing my broad problem-solving expertise gained through professional work and education.
My three core specializations—mechanical engineering, electrical engineering, and data science—enable me to develop sound technical solutions and robust design and process developments related to products, production, automation, and test methods, including their verification and validation.
Close collaboration with Regulatory Affairs and Quality Management, coupled with my extensive audit experience, addressing deficiencies, and handling CAPAs, has made me an expert in GMP, GAMP, MDR, and norm/guideline-compliant developments and their documentation.
About Me – or: How to Navigate Life with Minimal Effort and Maximum Curiosity
One could say my academic career began under the motto “efficiency is everything.” School? Done! With flying colors (not really) and surprisingly little fuss. My ticket to the first professional stop: the Technical College for Mechanical Engineering. Here too, the motto was: success with the handbrake on. But don’t worry, that was just the warm-up!
Professional Journey
From Chips, Bits, and the Urge for More – The Pragmatist in Production (and Soon, the Boss)
Here, I truly got to unleash my potential: setting up, operating, and, when things got stuck, even opening the toolbox – from minor tweaks to major operations on the open heart of the machine. And because standing still means falling behind, I also helped design a few automation enhancements.
After just one year, it was time for more responsibility! The leadership role was exciting, but my thirst for knowledge was far from quenched. The realization: there’s more to achieve!
The Extra Mile in the Fast Lane – High School Diploma by Evening Light
Parallel to the full action at the turning company, I went back to evening school. Four years later: high school diploma in hand! I remained loyal to my first employer for another year – especially as new machines arrived annually, with no end even at 10 axes – before the call of Alma Mater became undeniable.
Diving into the Deep End (or Rather, the Lecture Hall) – From Tyrol to Graz
Graz University of Technology – a new playground for my grey matter. After three years, most of the exams were done – and whoever rests, rusts…
Two is Better Than One – A Detour into the World of Medicine
Parallel to the final sprint in electrical engineering, I delved into medicine. A year later, I landed not only thematically but also physically at the Institute of Biophysics at the Medical University of Graz.
Research Spirit in the Lab – From Code Lines to Cell Cultures
My mission: completion of my Electrical and Biomedical Engineering studies. Completion of the first part of my medical studies. In addition, I actively participated in various projects at the Institute of Biophysics: IT support (yes, that too!), LabVIEW for data acquisition (data is the new gold!), the fascinating world of confocal laser microscopy with simultaneous optical measurement of transmembrane potential using fluorescent dyes on living single cells/tissues, and of course, simulations – my playgrounds were Matlab, C/Petsc, Perl, Java, and later the elegant snake, Python. Then the fun stopped – after looking after my daughter full-time on the side for 1.5 years – all the scholarships I received dried up, and I had to look for paid work.
Getting a Taste of Corporate Life – Siemens and (Not Quite) Back
The plan: join a large corporation to avoid hitting a ceiling right away. Siemens offered an exciting project: the development of chassis diagnostics for high-speed trains. THE combination of mechanical engineering, electronics, AND data science – perfect!
Working on safety-critical systems was a school in itself – risk analysis, development processes, and project management at the highest level. Very instructive!
However, it became clear: the pace in large corporations can sometimes be a bit… leisurely. When the project was discontinued for economic reasons, I realized: this rhythm isn’t quite mine.
Back to the Roots (of Research) – Full Speed into Medical Technology
The next stage: basic research that really makes a difference. My hobbyhorse here was the development of a glucose sensor. But clinical studies and other exciting projects were also on the agenda.
A particular highlight: initiating an EU project – CLINICIP (Closed-Loop-Insulin-Infusion-for-Critically-Ill-Patients). An idea that was born in my mind and ultimately laid the foundation for my own adventure…
The Eureka Moment – From Sensor to System Solution and My Own Company
The idea that wouldn’t let me rest: intensive care patients need precise blood glucose values, ideally directly from arterial blood. Patients often already have this access for blood gas analyses (BGA) and invasive blood pressure measurements. So why not combine everything? My already well-developed sensor – a clever, cost-effective injection-molded part with a fluorescent inner coating and a reusable optical reader – fit perfectly. Coupled with an infusion system that also knows about nutrient delivery – et voilà: the perfect closed-loop system for blood glucose regulation in intensive care patients. This combination was so promising that I was able to file really good basic patents for it (if you want to read more: WO002010081789A1 & WO002010081790A1, now “state of the art”).
The Next Logical Step – From Researcher to Founder
… the founding of my own spin-off! Smart Medical Solutions GmbH – or simply: Smartmed.
No sooner said than done! Together with partners, I built up the location, assembled a team, and we made good progress. However, and this is the honest truth, the expenses were a bit larger than even the most optimistic business plan had foreseen.
The solution: We sold the idea and our previous successes to B. Braun Melsungen AG. A strategic move that allowed us to further develop the product under a strong umbrella.
In the Service of Innovation (and Sometimes as a Firefighter) – The B. Braun Melsungen AG Era
With the goal firmly in sight, we brought the product to market readiness – by 2014, product design was complete, during design-transfer we built the production machines, moved to a new site with a clean-room, established a QMS according to ISO 13485, and set up the entire production. In 2016, the ultimate accolade: the CE mark! Finally, we could actually see our system being used in intensive care units – an indescribable feeling.
My role during this phase? I was there wherever a fire needed putting out! From measurement electronics and optics to automating the measurement environment and building production machines. I tinkered with control and analysis software, hustled during clinical studies (data processing, algorithm development, and the inevitable organization), knew the clean-room like the back of my hand, and optimized manufacturing processes – from particle and solution production to injection molding, coating, and assembly to final packaging. Not to mention – product, process, and test method validations/verifications.
Almost a welcome change: developing development and project management processes suitable for the V-model, based on clean requirement management with Polarion. Structure has to be there sometimes!
The Next Challenge: The Calibration-Free Multiparameter Dream
After the success with the glucose sensor – which, to everyone’s surprise, worked extremely well and calibration-free over the entire application period – the logical next wish arose: Can’t we expand this into a complete BGA? The same precision, also calibration-free, practically the all-singing, all-dancing blood analysis device that can compete with “real” BGAs (which actually trick and calibrate internally).
Challenge accepted! With a small team, we showed: Yes, it’s possible! We demonstrated feasibility for potassium, sodium, pH, and in-vitro, for lactate only theoretically – the development of our own lactate oxidase took a bit longer.
But then came the change in management. And with it, a new assessment of my (admittedly honest) prognosis regarding the real costs for these – in my opinion unnecessarily ambitious – development goals. The long and short of it: the corporation abandoned the vision and closed the Graz site at the end of 2022.
Restart with Foresight – From Corporation to My Own Course
The closure in Graz was regrettable, but since I had anticipated something like this, I was mentally and strategically prepared. You learn, right! I promptly started my own sole proprietorship as a business consultant. Now I help others bring their innovative ideas to fruition and success – with all the experience I’ve gathered on my admittedly not entirely straightforward, but all the more exciting journey so far.
What I Can Do For You Today – Concentrated Experience for Your Project
Since I’ve unfurled my own flag in the winds of business consulting, I’ve had the pleasure of contributing my grey cells and wealth of experience to a colorful array of exciting projects. The spectrum ranges from demanding Class III medical devices to the strictly regulated world of GMP/Pharma and the latest challenges of IVDR. So, it definitely doesn’t get boring!
These projects are like a “best of” my previous stations – they often require precisely the interdisciplinary foresight I’ve acquired over the years. A large part of my service, let’s be honest, flows into the often underestimated but immensely important creation of documents. Yes, paper (or its digital equivalent) is patient, but with the right structure and know-how, I can fill it so quickly that it doesn’t even need to be.
But don’t worry, I’m not just here to type! Right after document creation, my talent in Data Science was in demand: When presented correctly, the existing data often turned out to be true treasures for upcoming process validations. Together with comprehensible consideration of measurement uncertainties and trend analyses (“statistics, you know”), I’ve often been able to save the day.
Even my skills in design and the ability to produce prototypes have been needed to make a brainstorm visible in reality.
In short: Do you have a tricky challenge in medical technology, pharmaceuticals, or related to IVDR? Do you need someone who not only talks but also understands, documents, analyzes, and tackles problems? Then we could be a pretty good team!
Education – The Foundation for Everything That Came (and Is Yet to Come)
2000 – hopefully far into the future: Attended numerous training events domestically and internationally (primarily on development processes, team leadership, project management, risk management); also personal coaching at K und K Wirtschaftscoaching (management and leadership); and continuous self-taught learning;
2000: Graduated Dipl.-Ing. in Electrical and Biomedical Engineering, Graz University of Technology
1993: Matura (Evening School)
1987: Technical College for Mechanical Engineering
Knowledge & Skills – What Else I'm Capable Of
Software & Programming: LabVIEW (with Realtime, FPGA, CI/CD), CAD/CAM incl. FEM, EDA, Matlab, C/C++, Python, Kotlin, Ditto, Polarion, Enterprise Architect, (Easy) Redmine, Jira, SAP (and whatever else is needed to solve problems and manage projects)
Specializations: Biomedical Engineering, Electrical Engineering, Data Science, Mechanical Engineering, CNC Technology, Design, Automation, Biophysics, Medical Technology, Sensor Technology (esp. optical glucose, ion, blood gas sensor technology), Closed-Loop Systems/Control Engineering, Project Management, Risk Analysis, Medical Device Development Processes, Clinical Studies, Process Engineering, Plant Construction, Cleanroom Technology. Member of ISPE (International Society for Pharmaceutical Engineering).
Languages: German (Native Speaker), English (Business fluent – and excellent for technical discussions)
Personal Superpowers: Pragmatism with a pinch of genius, insatiable thirst for knowledge, the ability to simplify complex things (mostly), firefighter qualities, a healthy dose of humor, and the gift of getting back up and restarting after a setback.