Contract manufacturing
the needs of target users. It requires an in-depth understanding of the product’s critical quality attributes (CQAs) and the critical process parameters (CPPs) needed in the manufacturing process. On top of that, it incorporates risk assessment throughout the development process to identify all potential issues that could negatively impact on quality so that manufacturers can implement the necessary controls. The rigorous use of statistical tools further optimises design and manufacturing processes to ensure greater consistency in product quality. At the end of the process, manufacturers stand to benefit from the higher quality of their products, with fewer iterations and adjustments to the manufacturing process along the way. Rigorous risk management throughout should limit the potential for defects and ultimately product recalls. Not only is patient safety improved, but the enhanced efficiency of the product development process can play a huge role in reducing time to market and keeping manufacturing costs to a minimum without compromising quality in any way. As a result, more flexible regulatory pathways for medical devices may open, as a more proactive, science-based approach to development and manufacturing – and the deeper understanding of product and process interactions that comes along with it – can result in more efficient and adaptable regulatory submissions, potentially reducing the time and resources required for the approval stage.
The many moving parts of QbD So far, so good, but in practice QbD involves many key steps, starting with defining the CQAs – the characteristics of the medical device that are critical to its safety and efficacy. Next come the CPPs – the manufacturing process parameters that can impact the CQAs. Then there is a risk management process using tools such as failure mode and effects analysis (FMEA) – a systematic and proactive method for identifying potential failures in systems, processes or products.
15% Grand View Research 28
The quality assurance services segment is projected to attain a fast CAGR growth during a forecast period to 2030.
But that is by no means the end of it. Design of experiments (DoE) is a statistical method used to plan, conduct, analyse and interpret controlled experiments that evaluate crucial factors that influence a process or product. DoE can shed light on the relationship between CPPs and CQAs and lead to further optimisation of the manufacturing process. Then there is a need to establish process controls to maintain the CPPs within acceptable ranges during manufacturing before the validation phase, which confirms that everything is operating effectively and documents the QbD process. The results of QbD can be transformational, but there is a lot to do here and it begs the question whether this really is an area of core competence for OEMs.
An obvious opportunity for outsourcing The importance of QbD is something that regulators are keen to emphasise. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are working together to encourage the adoption of QbD frameworks that integrate successful product development processes with the needs of patients and the regulatory requirements they have set down. This is partly because the value of QbD has been frequently demonstrated in real use cases. During the Covid-19 pandemic, some 3D-printing companies in Belgium and elsewhere rapidly retooled to produce swabs and other devices to help meet shortages. In many cases, they worked with external partners to meet regulatory and quality requirements, showing how outside expertise can be critical when speed and compliance are equally important. So, does something that can contribute so much to successful product development have to be done in-house, with all the complexity and investment that would be required? The answer, it seems, is no. A growing number of medical device companies are outsourcing QbD to control costs, improve device quality and gain access to specialist expertise. In part, this trend is driven by the ever- increasing complexity of the devices they produce. This, coupled with the need to deliver these products to market faster, is putting greater pressure on the design and manufacturing processes. More than ever, OEMs need to get it right the first time.
At the same time, they want to focus on core competencies such as R&D, marketing and sales without investing in the development of in-house QbD expertise. Outsourcing allows companies to leverage the experience and resources of specialised contract manufacturers and design firms, which promise more efficient and higher- quality product development.
The industry knows well that outsourcing can significantly reduce the costs associated with manufacturing, quality control and regulatory compliance. Contract manufacturers often utilise advanced technologies for complex manufacturing and invest in keeping their technology infrastructure up to date. Outsourcing has demonstrated its ability to accelerate product development by leveraging specialist expertise and offers the ability to scale up production on demand.
In essence, medical device companies are recognising that QbD is not just about internal processes but also about strategic partnerships that can enhance their overall capabilities and competitiveness. Sure, the industry continues to spend millions on QbD, but it is imperative that those huge investments bring proportionate returns.
www.medicaldevice-developments.com
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