Smart Manufacturing Considerations for Pharma and MedTech Manufacturers

Smart Manufacturing Considerations for Pharma and MedTech Manufacturers

Most pharmaceutical and medical device manufacturers have implemented new technologies and processes over the past number of years that would come under the smart manufacturing umbrella. You are probably also now considering the next stage on your journey. What are the smart manufacturing solutions and opportunities that you should explore next?

There are a number of factors that are essential to consider when deciding on smart manufacturing projects and solutions. Crucially, those factors go way beyond the technical components, as it is important to also take into account business, resource, and process factors.

We’ll start with business and resource considerations before looking at processes and workflows. We’ll then finish off with the main technical considerations.

Smart Manufacturing Considerations – Business and Resources

Business Alignment

It is important to look at the short, medium, and long-term market and product strategies for your facility and throughout the organisation. What new markets do you plan to target? What new products do you expect to introduce? How do you see the industry evolving over the long term and how will your organisation remain competitive? What decisions are being taken in other parts of the business that will impact what happens on the factory floor?

When answering these questions, it is essential there is alignment between your smart manufacturing strategy and the strategies, plans, and objectives of the wider business. Furthermore, there should always be a business-led approach to technology implementations.

Wider Digital Transformation Initiatives in the Business

Efforts to improve your smart manufacturing capabilities should also be aligned with the wider digital transformation initiatives of the business.

For example, smart manufacturing and digital transformation technologies are creating new business models in the life sciences sector. Examples of these new business models include service rather than product-based business models and the expected growth of personalised medicines and treatments.

Buy-In from Senior Executives

Smart manufacturing technologies and solutions will play a major role in the digital transformation of pharmaceutical and medical device companies over the coming years and decades. This is in addition to the immediate positive impacts that advanced technologies and best practices can have on your business, from productivity improvements to increases in profitability.

Therefore, it is important senior executives are involved in the process and buy into the strategy.

Embracing New Approaches

Smart manufacturing solutions and other developments present opportunities for the life sciences sector to do things differently. Traditionally, however, the sector is slow to change, not least because of patient safety, quality, and regulatory concerns.

Change now needs to be accelerated in areas such as embracing data-driven and automated decision-making or moving to modern compliance frameworks. Just because things have been done a certain way in the past doesn’t mean they should continue like that in the future.

Other Business and Resource Considerations

The other main business and resource considerations for smart manufacturing strategies and projects include:

  • Supply chain resilience – given the spotlight on supply chain resilience in the pharmaceutical and medical device industries, how can smart manufacturing solutions make an impact?
  • Sustainability targets and objectives – it’s important to view smart manufacturing solutions and projects through the lens of sustainability, as there are often opportunities to make small changes that can have a positive impact.
  • Regulatory compliance – there is a need for ongoing regulatory compliance, but there are also opportunities to improve compliance processes by making them more efficient, data-driven, and risk-based rather than procedural.
  • Investment scale – how much are you willing to invest and when? What are your ROI expectations?
  • Resource availability and multi-functional teams – what resources do you have available to work on smart manufacturing project implementations? Who will be part of the leadership group, and will the teams be multi-functional with members from different departments and business units?
  • Third-party partners – you will also need to decide on a smart manufacturing solution and integration partner. The best approach is to select a partner that offers an end-to-end range of services and that has specific experience in the life sciences sector.

Smart Manufacturing Process and Workflow Considerations

Process and workflow factors also need careful consideration in smart manufacturing projects. Examples include:

  • Get a full understanding of existing processes and workflows, including getting the viewpoints of those on the frontline. This is essential as the theory or perception of a process can be very different from the reality.
  • Conduct a critical analysis of all processes and workflows once there is a good level of understanding. It is helpful to ask why you do things the way you do, and could certain workflows and processes be done better.
  • What is the level of data integrity in the organisation and what steps should be taken to make improvements?
  • What repetitive and time-consuming tasks can be automated?
  • What tasks that are prone to human error can be automated or semi-automated?
  • How can you improve processes and workflows to make production and the wider business more agile and adaptable?
  • How can you enhance collaboration, especially cross-function collaboration?
  • What is the change management strategy, and how will you communicate and solicit feedback from members of the team, particularly those directly impacted by the changes that smart manufacturing solutions will bring?
  • What level of staff training will be required and how will that training be delivered?
  • Where automated solutions replace manual processes, how will you reallocate resources?

Smart Manufacturing Technical Considerations

Finally, we come to the technical considerations that are important in smart manufacturing projects. The main examples include:

  • The existing technology and equipment infrastructure and components.
  • Equipment systems integration plans, i.e., what existing systems and equipment are staying so need to be integrated, and what is being added or replaced?
  • Integration at all levels of the technology stack, including at the SCADA and PLC level on the factory floor as well as Manufacturing Execution (MES) and Enterprise Resource Planning (ERP) systems.
  • The level of horizontal and vertical integration you want to achieve, i.e., integration between production operations and other parts of the business, as well as integration across the supply chain.
  • How you currently use data and how that can be improved, enhanced, and optimised, from collection to transmission to storage, processing, and use.
  • Strategies for legacy systems that are staying, especially in relation to the standardisation of processes, terms, data, etc.
  • Your cloud strategy within the operational technology (OT) environment and how that is aligned and linked with the cloud strategy within the organisation’s IT infrastructure.
  • Cybersecurity and the increased level of risk that comes with connecting more devices and expanding the potential attack surface of your organisation.

Getting the Right Expertise and Support

The lists and points above are not exhaustive, as there are typically other considerations that apply on a case-by-case basis. What they highlight is there are extensive considerations that have an influence on your direction of travel and potential for success when implementing a smart manufacturing project.

Therefore, it is important you get expert advice and support. To speak to one of our smart manufacturing specialists, please contact us at SL Controls today.