Aging & Social Change: Eleventh Interdisciplinary Conference

Abstract

Agile project management for new pandemic focused IVDR’s, wearables, medical devices and combination products involves an iterative approach to quality, regulatory, safety, cyber security & privacy involved in delivery of projects throughout, their life cycle. Med tech companies recognize aging consumers can benefit through agile competencies expediting new biosecurity and pandemic preparedness technologies which can be utilized collectively, concurrently, serially and individually to advance time to market in innovations to diagnose, treat, immunize against and manage new threats from emerging infectious diseases such as COVID 19. Beneficial biosecurity innovations designed to help aging patients need to plan projects based on recently adopted approaches (eg., “CSA”) adopted by global Regulators, who are adopting new, less burdensome approaches to reduce paperwork burden, focusing first on critical and risk thinking. This is a study that uses Risk scoring data (per ISO 14791; 13485) to applies Agile and project management thinking to propose a Least Burdensome Approach (LDA) to regulatory affairs, combining minimum viable registration requirements, alongside assurance needs, testing activities, and documentation requirements. Data derived from registration data from recently successful “approvals” and listings globally, comparing and contrasting project wearables (Covid 19 wristbands), IVDR’s (various Covid 19 product classes, from Rapid Antigen, PCR, saliva and breath testing) and combination products, plus animal health biosecurity comparator. Agile elements compared, on risk basis, application of processes methods, knowledge, skills, project objectives, and “deliverables achieved.” Key success factors for increasing LDA approach included tighter “requirements;” change-configurations. Results support using project management to expedite benefits.