The task
For people whose hands are fully or largely paralysed, the medical technology start-up HKK Bionics developed a novel mechatronic orthosis that enables them to move their fingers again.
The orthosis is pulled over the affected hand like a glove and stabilised with an arm splint. Individually fitted exomechanics, driven by four DC micromotors, make it possible to close and open the fingers. This allows everyday activities such as cooking, carrying shopping bags or opening packaging to be performed once again with the paralysed hand.
For part of the electronics development, HKK Bionics was looking for a partner with experience in the development of medical technology. NewTec was able to impress here with its comprehensive expertise. One challenge lay in achieving miniaturisation while maintaining high performance.
The solution
Following a thorough requirements analysis, the NewTec team of hardware and software engineers developed functionally safe power electronics for the orthosis touch display and power supply. The electronics allow the wearer to select the appropriate type of grip and to adjust the sensitivity of the control to their personal needs.
The development was carried out in accordance with all relevant standards. Alongside ISO 13485 for the quality management of medical technology products, these also included IEC 60601 for the development of electrical equipment, IEC 62304 for software development and the risk standard IEC 14971. NewTec also produced the documentation of standards compliance required for approval.
Beyond the joint development of the electronics, NewTec helped HKK Bionics ensure electromagnetic compatibility (EMC) and implement battery management in line with the particular safety requirements for medical technology.
Thanks to its many years of experience in the approval of medical technology devices, NewTec was also able to support HKK Bionics with the medical approval of the orthosis and with testing.
