Medical devices have a product profile
As a part of development and industrialization projects, I have gained many different experiences. Nearly all these projects have one thing in common: the industry of medical technology.
It is meant not only in a purely regulatory way (https://de.wikipedia.org/wiki/Medizinproduktegesetz). Because medical devices naturally are safety-critical equipment, special requirements need to be met for the usability of said devices. Therefore apart from usability factors such as efficiency, effectiveness, and satisfaction, one must also take into consideration the safety (https://en.wikipedia.org/wiki/Usability).
Our Experience – Product examples
I was able to incorporate my many knowledge into a multitude of projects concerning Diabetes Care. From the development of skin-prick aids over 10 years ago as far as programs for the industrialization of sophisticated devices for continuous glucose measurements. (https://en.wikipedia.org/wiki/Continuous_glucose_monitor).
Any time medical devices made from plastic parts by the million with highly automated processes, then you’ve come to the right place.
Processes such as auto-injectors (https://en.wikipedia.org/wiki/Autoinjector). I’ve been in charge of program management for DFM and DFA projects where I optimized the high-volume design, for example, using Moldflow- and FEM analyses to finally develop concepts for complex automation systems.
Apart from that, I developed cartridges for molecular test systems such as PCR. The experience of transferring a development project you designed for production is not only fascinating but a chance to learn life long lessons.
An excellent example of ongoing trends are so-called tracked devices, wearable computing such as Smartwatches (https://en.wikipedia.org/wiki/Wearable_computer). These modules can monitor the patient’s user behavior and send the data via Bluetooth. They can also be installed into almost any medical device. I managed the transfer of development project to series production where dry-powder inhalers (https://en.wikipedia.org/wiki/Dry-powder_inhaler) were upgraded with such modules.