Katina Michael, Ph.D.

Keynote: Product Life-cycle Management for Therapeutic Devices

It is estimated in the USA alone that 10% of the population have implantable devices for therapeutic reasons. While we do not know the exact figures for the number of people who bear prosthetic implantables worldwide, we can speculate that it is in the hundreds of millions, given individual reports on various types, including, biomedical devices for the heart, brain, ears, throat, hip, knee, etc. While the market is still dominated by few biomedical industry manufacturers specialising in various biomedical devices, the market can still be considered in some segments to be in its early phases of exploration. Over time these devices will proliferate not just for therapeutics, but repurposed for everyday applications in the name of convenience. Biomedical companies who help the deaf to hear, stabilise the effects of Parkinson’s disease or Tourette’s syndrome ,provide limited mobility to those who are either wheelchair-bound or have lost a limb, are looked upon as providing the miraculous services. But speak to any recipient of an internal biomedical device, and you will soon realise the complexity of recovery, rehabilitation, and most importantly ongoing maintenance. Companies until now have not really been held accountable, for infection suffered by the patient as a result of adopting an implantable device, for defective devices that simply do not work, for missed programming in the application that communicates with the hardware on board, and as we have more recently heard potentially life-threatening cyber security issues. At the present time there are limited ways in which patients can communicate with the manufacturers who have supplied their devices. Their first point of call is there medical specialist, a letter to the company itself, communications in the case of the USA to the Food and Drug Administration and to the Federal Communications commission. While there is confirmation that documentation has been received, little has been done to address the significant problems that are encountered by the industry. Patients are caught in a difficult situation which has them weighing up life sustaining technologies that could possibly be faulty or not work appropriately, versus medical conditions that are near impossible to live with. The attitude for now seems to be, we’re giving you something that will better your life, it’s better than your life beforehand so don’t dare complain or stir up significant trouble. This is not patient engagement by various stakeholders in the biomedical space. And this is unacceptable if we continue down the path that encourages implantable is for medical conditions. I predict that is a greater number of players into the market,, companies will be forced to address patient concerns. One of the ways in which companies are considering gaining quantitative based feedback from patients, is by connecting them to an Internet of things infrastructure, but which there is machine to machine correspondence, rather than qualitative personal – related feedback. Apart from the serious potentiality for cyber hacking Internet of things devices, most patients do not want to devices connected to the Internet in any shape or form. We need to get serious about product life-cycle management, and the richest source of feedback has always been the end user, it just so happens that the end-user in this instance has an embedded device on which their life depends.

Panel: Wearable and Implantables Panel


Katina Michael is a professor in the Faculty of Engineering and Information Sciences at the University of Wollongong. She is Editor in Chief of IEEE Technology and Society Magazine, and also Senior Editor of IEEE Consumer Electronics Magazine. Katina has previously served as a representative of consumers Federation of Australia between 2010 and 2016. She has been researching the socio-ethical implications of biomedical devices over the last 20 years.