Cybersecurity issues: are those that affect biomedical device recipients and place patients at risk of an unauthorised intervention. Hackers can attempt to hi-jack and administer incorrect levels of dosage to a recipient by penetrating proprietary code. These hackers are known as predatory hackers, given the harm they can cause persons who rely on life-sustaining technology.
Implantables: are technologies that sense parameters of various diseases and can either transfer data to a remote center, direct the patient to take a specific action, or automatically perform a function based on what the sensors are reading. There are implantables that have sensors that monitor, and those that facilitate direct drug delivery, or those that do both.
Participatory Design: is synonymous with a co-design strategy of development of biomedical devices. It is an approach that tries to incorporate various stakeholders in the process of design, such as engineers, medical practitioners, partners, manufacturers, surgeons, patients, ethics and privacy-related NGOs, end-users, to ensure that resultant needs are met.
Product Lifecycle Management: is the process of managing the entire lifecycle of a biomedical device from inception, through engineering design and manufacture, to service and disposal of manufactured products. Importantly, PLM is being extended to the ongoing monitoring of the embedded biomedical device in the patient, remotely using wireless capabilities.
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Citation: Excerpt from Gary Olhoeft and Katina Michael (2018), Product Lifecycle Management for Brain Pacemakers: Risks, Issues and Challenges Technology and Society (Vol. 2), University of Wollongong (Faculty of Engineering and Information Services), ISBN: 978-1-74128-270-2.