Manufacturing Control System Development for an In Vitro Diagnostic Product Platform

Abstract

The current in vitro diagnostic design process is a combination of methods from engineering disciplines and from government regulatory agencies. The goal of design processes that have been developed is to ensure that a new product meets the user’s expectations and is safe and effective in providing its claimed benefits and proper functioning, otherwise known as the essential design outputs. In order to improve the ability of designers and auditors to ascertain the safety and efficacy of a product, the use of design controls has been adopted that specify a method of evaluating the design process at several key stages. The main objective of this research was to examine the resolution and architectural details necessary to build an adequate manufacturing control system to assure the EDO outputs in large IVD instruments in the company under study. The control system is the defined inspections and test processes to delineate between acceptable and unacceptable product before release for sale. The authors reviewed current design control regulatory requirements within the IVD industry, as well as design controls in other regulated industries. This research was completed to determine what opportunities could be transferred to large in-vitro IVD instruments using an IVD manufacturer as a case study. In conclusion, the research identified three areas where a properly configured EDO can add value within IVD instrument design and manufacture, namely: (1) development of a control system which is fit for purpose; (2) a mechanism to manage and proliferate key design knowledge within the organisation and thereby manage outsourced services; and (3) implementing a scaled engineering change process because changes impacting EDO naturally require extra regulatory and engineering oversight.

Barriers and Enablers for Continuous Improvement Methodologies within the Irish Pharmaceutical Industry

“…Chowdary and George [14] have highlighted the lack of Lean application in pharma clean room environments describing it as "feeble". Another study by Boylan et al in 2021 described its aim of redesigning its design control process without affecting regulatory compliance [42].…”

A Review of Lean Adoption in the Irish MedTech Industry

“…The MedTech sector is generally perceived as averse to risk and change [30,31]. In their paper on MedTech design process improvement, Boylan et al [32] also discussed their objective of improving the process without invoking extra regulatory approval and oversight. Regulatory compliance is perceived to be a barrier that stifles innovation and continuous improvement within the industry, significantly limiting the scope for design changes and innovation and especially changes once launched [33,34].…”

“…The researchers also seek to ascertain the reasons for implementation, understand what type of Lean tools are most utilised and if different to other industries, and what benefits and results are observed. As previously mentioned there is a dearth of literature related to Lean deployment in Irish Medtech and in Medtech in general [18,19,32,36].…”

A Review of Lean Methodology Application and Its Integration in Medical Device New Product Introduction Processes

“…There was much cooperation between the EU and the FDA at the time of the Code of Federal Regulations (CFR) updates in the 1990s to incorporate design controls (or product development guidelines). The FDA Design Control Guidance for Medical Device Manufacturers, published in 1997 [32], describes the relationship and linkages between the FDA's design control guidance and the ISO 13485 standard for a quality management system in medical devices as being "cross-referenced" to each other [33]. This publication addressed the entire area of design controls in a "waterfall" iterative format from design and development planning, design input, design output, design reviews and design transfer and then design changes, verification, and validation, and finally the design history file [32,34] .…”

“…The design process is intended to assist manufacturers with their quality management system (QMS) requirements in relation to design controls and new product development. There are interrelated sets of practices and procedures that are embedded into the design and development process within the device regulations [33]. These provide managers with better visibility of the design process itself, thereby enabling them to identify opportunities earlier in the process, thus avoiding costly errors later in the cycle.…”