Towards a Verification and Validating Testing Framework to Develop Bespoke Medical Products in Research-Funded Projects

Abstract

Research funded projects are often concerned with the development of proof-of-concept products. Consequently, activities related to verification and validation testing (VVT) are often not considered in depth, even though various design iterations are carried out to refine an idea. Furthermore, the introduction of additive manufacturing (AM) has facilitated, in particular, the development of bespoke medical products. End bespoke products, which will be used by relevant stakeholders (e.g. patients and clinicians) are fabricated with the same manufacturing technologies used during prototyping. As a result, the detailed design stage of products fabricated by AM is much shorter. Therefore, to improve the market-readiness of bespoke medical devices, testing must be integrated within the development from an early stage, allowing better planning of resources. To address these issues, in this paper, a comprehensive VVT framework is proposed for research projects, which lack a VVT infrastructure. The framework builds up on previous studies and methods utilised in industry to enable project key experts to capture risks as early as the concept design stage.

A Novel User-Centred Framework for the Holistic Design of Therapeutic Medical Devices

“…Complying and observing the applicable ISO and industry standards, together with product certification, is frequently regarded as a challenging and restricting task in design. Substantial time and budget are exhausted on verification and validation testing (VVT) of medical devices (Balzan et al, 2021). The introduction of ISO 14971:2019 and ISO 13485:2016 has put designers under huge pressure to amend their design processes, whilst placing a barrier to innovation.…”

A Designers' Perspective on Additive Manufactured Smart Wearables for Paediatric Habilitation

“…This goes in-line with the study by Yeong and Chua (2013) who emphasised the significance of standards and regulations when AM medical devices. Additionally, the framework considers verification and validation, abiding with the proposed framework by Balzan et al (2021) to verify and validate additive manufactured bespoke medical devices. All of the designers favoured that the framework should be presented as a computer-based support tool, instead of a paper-based format, as it would be better accessible and provide more in-depth specifications, as well as for enhanced communication in a team-based environment.…”