R&D managerDiepenbeek, Belgium
Since August 2012
q care medical services is specialized in the Treatment of complex wounds and wound care in general. they started developing a wound healing stimulator with wound electrodes but were not able to bring on to the market due to internal problems. i was asked as a Consultant to make a swot Analysis of the product and the necessary amount of resources to finalize it and bring it into the market.
after this Analysis i was asked to actually finalize the product and put it in the market and thus taking care of all aspects, Quality Management, Regulatory Affairs, CE Certification, supplier contracts, Clinical evaluations, etc…
- Product Development, Marketing
- medical classification, risk Analysis, technical file
- overall supplier selection and evaluation (qa/ra experts, pcb/Software Development- production, etc…)
- building a knowledge network with experts, universities, knowledge centra’s etc…
- setting up the product pipeline for future products
acquiring the knowledge for developing the wound electrode was challenging because it’s a disposable that needed to be sterilized, i had no experience in that until now. the certification process is very intense because of the use of silver in the electrode. even for the notified bodies it’s not clear how to classify such Medical Devices.
Q Care Medical Services is specialized in the treatment of complex wounds and wound care in general. They started developing a wound healing stimulator with wound electrodes but were not able to bring on to the market due to internal problems. I was asked as a consultant to make a SWOT analysis of the product and the necessary amount of resources to finalize it and bring it into the market.
After this analysis I was asked to actually finalize the product and put it in the market and thus taking care of all aspects, quality management, regulatory affairs, CE certification, supplier contracts, clinical evaluations, etc…
- Product development, Marketing
- Medical classification, Risk analysis, Technical file
- Overall supplier selection and evaluation (QA/RA experts, pcb/software development- production, etc…)
- Building a knowledge network with experts, universities, knowledge centra’s etc…
- Setting up the product pipeline for future products
Acquiring the knowledge for developing the wound electrode was challenging because it’s a disposable that needed to be sterilized, I had no experience in that until now. The certification process is very intense because of the use of silver in the electrode. Even for the notified bodies it’s not clear how to classify such medical devices.
General ManagerGenk, Belgium
Since November 2006
in 2006 i started my own Consulting company.
the main focus is to help startup companies find their way in developping innovative Medical Devices.
they can use the skills and netwerk that i have build over the last 20 years.
In 2006 I started my own consulting company.
The main focus is to help startup companies find their way in developping innovative medical devices.
They can use the skills and netwerk that I have build over the last 20 years.
I can help them in almost all stages of the (medical) product development. From idea geneartion - development - production - regulatory affairs - sales (asia) etc...
CTO / Business Development Manager Bilzen, BelgiumNovember 1995 --- June 2016
gymnauniphy is a key supplier of innovative and high quality products for the medical and wellness market. gymnauniphy offers a complete range of medical equipment (Physiotherapy and rehabilitation market) and wellness devices (fitness, professional sports, beauty market). the brands 'gymna' and 'uniphy' have been in the Physiotherapy market for more than 30 years and are distributed in more than 70 countries. the company was taken over, sold and bought again hence i experienced the merger of two companies, departments, product lines and the impact of a management buyout, Outsourcing of production and r&d processes, reorganizations, etc. looking back at it, the biggest impact was when we decided to start “innovating", get rid of the soldering irons, schematic design workstations etc., thereupon i started building a network of “knowledge institutes”, funding organizations and -models, technology suppliers, experts, consultants, distribution channels etc..., from all over the world. the last years were more focused on Business Development and searching for synergies between companies and departments, collaborations models etc. Career overview in gymna-gymnauniphy • cto april 2006 - nov 2011 o responsible for r&d and new product/Business Development o coordinating, supporting r&d of the daughter company in berlin (germany) and bilzen (belgium) • r&d and Innovation manager jan 2002 - april 2006 o defining/implementing Innovation Strategy o outsource production processes and partial r&d process o ad Interim quality manager • r&d Coordinator jan 2001-jan 2002 o merger of the r&d departments of the companies uniphy (nl) and gymna (b) o development of a family of devices with the same look and feel o increase component reusability and cost reduction of the devices in order to realize the Outsourcing of the production. o ad Interim IT Manager • Software Engineer nov 1995-jan 2001 o developing graphical user interface Software for embedded systems in Physiotherapy devices. o make existing Medical Devices made compliant with the mdd
Hardware Software Engineer Hasselt, BelgiumSeptember 1991 --- November 1995
after my studies (bachelor in Electronics/Telecommunications), i started my carreer as a service and software engineer in a small telecom company. after almost a year a got the opportunity to start in the development department of philips hasselt, where i worked as a software engineer on cd/cdi/dcc in hasselt, eindhoven (nl) and vienna(au).