Manufacturing in all sectors and industries is changing as smart manufacturing technologies, the industrial internet of things, and Industry 4.0 best practices continue to advance. What about the life sciences sector specifically? Here are the 2023 smart manufacturing trends that pharmaceutical and medical device manufacturers need to be aware of.
Integration of MES, SCADA, and ERP Systems
The integration of MES, SCADA, and ERP systems is essential for the digitalisation of manufacturing and other business processes in the life sciences industry. Achieving this integration will be a primary focus for manufacturers in the sector in the years ahead. The benefits of doing so range from product quality and patient safety to improved business performance, reduced risks, and enhanced data-driven decision-making.
Another trend that is a feature in the life sciences sector is the move away from clunky legacy MES platforms that required a lot of customisations. Pharmaceutical and medical device manufacturers are increasingly moving to more modern, adaptable, and flexible MES solutions that facilitate end-to-end connectivity.
Increasing Focus on Data Integrity
Data integrity is essential for the digitalisation and modernisation of manufacturing processes in the pharmaceutical and medical device industries. There are multiple steps that should be taken to ensure data integrity, but two primary focus areas for 2023 and beyond will be:
- Eliminating manual intervention in data collection, updating, and processing
- Bridging data gaps, both digital and paper-based
Accelerated Innovation with GAMP 5
The summer of 2022 saw the first major update of GAMP 5 since its introduction 14 years earlier. You can read more about what has changed in GAMP 5 Second Edition on our blog. One of the main outcomes, however, is an increased facilitation of innovation.
Many in the life sciences sector implemented the original version of GAMP 5 with approaches that were prescriptive and rigid. This hampered innovation.
With GAMP 5 Second Edition, there is a recognition of agile development methodologies and critical thinking, both of which encourage a move away from previous, prescriptive methods of validation. This will result in accelerated innovation in the sector over the coming years while still protecting patient safety and product quality.
Continued Development of Batch-Size-of-One Manufacturing Solutions
R&D efforts in the pharmaceutical and medical device industries are creating new, cutting-edge personalised medicine and healthcare solutions. This means there is now an increased onus on pharmaceutical and medical device companies to develop the manufacturing solutions that will enable the commercialisation of personalised drugs and medical devices.
One exciting area of this evolution of manufacturing in the life sciences sector is the concept of the factory-in-a-box, as well as microfactories. Both have significantly smaller footprints than traditional production facilities to maximise agility and flexibility, and to enable the moving of manufacturing operations closer to the patient.
ESG Considerations Driving Change
Environmental, Social, and Governance (ESG) factors have been high on the agenda of most leaders in the life sciences sector over the past 12 months. This trend is set to not only continue, but to accelerate over the coming year and beyond as pharmaceutical and medical device companies implement strategies and initiatives that deliver tangible results on their ESG commitments.
Continued Focus on Supply Chain Resilience and Capacity Building
One of the challenges faced by companies in the life sciences sector throughout 2022 was supply chain disruption. Capacity is also a common issue, with many in the sector operating with zero or close to zero spare capacity.
Both of these factors are increasing lead times for orders of many pharmaceutical and medical device products. Patients are also impacted, while life sciences sector companies are unable to take full advantage of the commercial opportunities that exist.
The sector has been adapting throughout 2022 to these challenges, and fantastic work has been done to maintain consistency and reliability in the delivery of orders. That said, supply chain and capacity challenges remain, and they are being exacerbated by current geopolitical uncertainties and turbulent economic conditions.
Therefore, we can expect a continued focus on supply chain resilience and capacity building as we move into 2023.
Innovation and Growth
Even with the challenges highlighted in the last section above, 2023 is set to be a year of innovation and progress for companies in the life sciences sector. New opportunities to streamline and improve manufacturing lines, increased levels of vertical and horizontal integration, and the ability to make better use of data, are all going to drive innovation and growth.
There are also going to be continued R&D breakthroughs in drugs and medical devices, creating new opportunities for manufacturers. The key message, therefore, is to not stand still with your smart manufacturing initiatives, projects, and strategies.