Team Discussion
Our industry faces many challenges when developing new and novel medical devices, but to make sure we innovate consistently and safely, we employ quality standards to harmonise ways of working and define a set of clear instructions to follow.
The broad spectrum of quality standards and legislation governing product development and lifecycle processes typically comes into effect as the development process enters it latter stages (Phase or Gate 2/4). At this point, product manufacturing processes are finalised, validation and verification protocols designed and executed and the overall operations landscape realised.
This is the stage at which organisations are amassing final data and objective evidence to support submissions.
These regimented processes for product development, submission and launch processes have been widely documented in an array of standards, best practice documents and guidelines. These are issued by a plethora of reputable sources and regulatory bodies, such as the FDA, International Conference on Harmonisation (ICH), International Organisation for Standardisations (ISO) and International Society for Pharmaceutical Engineering (ISPE) to name a few.
Documents from these organisations are a great source of guidance and regulation, with clear requirements and ‘must haves’ for product development. However, can this level of proceduralised requirements become overbearing and stifle innovation and creativity?
Considering Quality systems earlier in development
The majority of Quality systems and Good Practices (GxP processes) need to be defined, in place and in use at the Gate 2 to 4 transition, with this ‘ramp up’ of GxP implementations taking place over a short period of months. However, this transition and ramp up can be costly if early Phase product design and development has not evolved with quality in mind.
Figure 1: Traditional and emerging approaches to quality oversight and GxP application in product development
The illustration shows the steep traditional ‘ramp up’ of quality systems and GxP application from Gate 2 to 4 (dark green curve), with the final quality system and production processes in place and used for ongoing manufacturing by Gate 5.
The other curve (white) illustrates the opportunity for a smoother transition to established quality and production processes by applying GxP concepts earlier in the product development lifecycle.
The deliverables expected at each Gate remain the same, but by having a quality representative ‘in the room’ during ideation, the project team can ensure design principles incorporate the GxP requirements that will have to be satisfied later in the product development and submission process. To achieve this, all the functions governing the product development process must adopt and display quality culture characteristics, with the handoffs and linkages between each Gate underpinned by strong relationships built on openness and information sharing. But does this still allow room for innovation?
The transition from design to manufacture is a complex activity with multiple moving parts. A focussed approach is required to ensure the knowledge and process understanding accumulated in the early stages of design follow through to Gate 5.
Is QbD the answer?
The answer could lie in the use of Quality by Design (QbD) principles. QbD was first outlined by quality expert Joseph M. Juran who gave guidance on focussed planning, identification and management of variability, establishment of defined transfer processes and process performance monitoring. All of these steps are vital for a successful transition from design to full scale manufacturing.
The pharmaceutical industry has utilised Juran’s principles to good effect with QbD as the staple diet of many technical development functions worldwide. Regulatory agencies like the FDA have also embraced these principles by establishing an Office of New Drug Quality Assessment (ONDQA), a risk-based pharmaceutical quality assessment system (PQAS) on the application of product and process understanding.
In addition to the QbD framework outlined by Juran, it is also important to consider other tools and GxP concepts that can complement product development, such as knowledge management and continuous improvement (CI). These concepts, when utilised effectively push us towards operational excellence and increased product and process knowledge. Furthermore, less regulated and delicate factors like social dynamics, interdepartmental cultural characteristics and communication pathways have a large influence over successful collaborations and learning.
The traditional ‘plan, do, check, act’ cycle is a key figurehead of GxP concepts supporting the product development and CI processes. But these approaches, together with the stage Gate model in Figure 1 and QbD, are more successful when coupled with a supportive quality culture.
Developing Quality Culture
The Harvard Business Review expressed a need for an organisation to understand its current culture in order to develop a robust quality system. ‘A company’s ability to effectively develop and successfully implement effective quality management systems requires a supportive organizational culture’3.
These attitudes are echoed by the FDA itself as new guidance discussions on quality culture and the link with a successful quality management system (QMS) evolves.
As organisations take a more risk averse and cost effective approach to product development, conducting reviews of historical implementations, and taking more time to reflect on past experiences, knowledge capture and management are becoming more commonplace, with these approaches becoming embedded within standard procedures and guidance documents.
As a result, the benefits of applying GxP principles earlier in product development, tailored to the project goals, can give the organisation a quality ‘head start’ and a sound quality positioning for ongoing manufacture and future developments. This foresight should mean that innovation or creativity aren’t stifled.
A pragmatic, functional and flexible approach will enable the product development team to access the benefits (and structure) that a quality culture can deliver – before Gate 3 – and also a context in which quality takes on a more advisory and consultancy role, rather than a draconian approach which would dampen the fire of creativity.
As a result, if executed correctly, the introduction of quality practices – and especially cultures and behaviours – at the beginning of the development phase can deliver big wins downstream (Table 1).
Table 1: Benefits vs risks of early quality oversight
References
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