Manufacturing Execution Systems (MES): Beyond ROI, a New Look at Business Payback

To date, ROI has been a dominant method for MES business justification. Various case studies have been written to document this, and as such the life sciences manufacturing sector has many examples of quantifiable business payback. Quantifiable analysis involves comparing current state manufacturing metrics to predicted future state metrics based on an assumption of how much MES projects/programmes will improve these metrics. But the success of this approach depends largely on the operational excellence maturity of the company in terms of consistently measuring the “as is” current state. So quantifiable payback analysis is typically less difficult for large corporates with strong operational excellence programmes, and more difficult for small to mid-sized organizations. This is especially true for organisations with limited MES experience in addition to limitations in operational excellence focus. The “future state” MES-driven improvement is variable depending on MES solution fit, EPR design, and deployment strategy. Which solution will work best for us? Do we go with “paper on glass” or fully integrated MES to optimize payback? Do we “go live” as a “big bang” or in phases, and if so, how do we approach phasing? These questions all have a bearing on business payback schedule.

Focus on Manufacturing Modalities

Considering the functional maturity level and broad adaption rates of MES solutions today, it makes sense to make business payback analysis methods and data available to all life sciences companies embarking on an MES journey, including large and small/mid-sized companies. The industry needs more standardised, consolidated information about the level of improvement we can expect in the future state due to MES deployment, assuming a sound MES strategy is employed. We also need to recognise that the different benefit types and improvement levels will be more specific to one treatment and manufacturing modality than another. For example, oral dose manufacturing is typified by highly repetitious material handling processes, high volumes of different raw material types, high labour head count, and islands of semi-automated equipment. For this modality, benefit types like efficiency, head-count reduction and quality risk-reducing benefits will be of high value. Specific benefit examples include reduction of cycle time, effort, paper volume, right-first-time errors, material identification errors, and improved production consistency.

On the other hand, cell and gene therapy manufacturing is typified by personalised treatments, chain of custody, identity tracking, variable input materials, need for flexible processes, and variable batch scheduling needs due to patient illness dynamics. For this modality, MES contribution to contamination control (through material identification and equipment management), MES-controlled process flexibility, and timely batch release control are high value MES benefits. Unique characteristics that impact MES payback can be applied to all life sciences manufacturing modalities, including bulk API, devices, vaccines, and biologics.

Focus on Strategic Benefits

All systems benefits can potentially be quantified pre-deployment depending on operational excellence maturity and stakeholder appetite for accepting future-state predictions. However, the highest MES value benefits trend towards qualitative benefits that give significant support to the over-arching business and regulatory priorities of the company. These strategic MES benefits reflect the uniqueness of Life Sciences industries compared to other industries in terms of patient focus, deep regulation, and high product development and manufacturing costs.

Examples of these benefits include overall patient risk, catastrophic regulatory failure avoidance, avoidance of batch loss costs, competitive advantage, support for impending business expansion, and support for broader company programmes like Pharma 4.0™, sustainability targets, and regulatory remediation. Any one of these benefits can potentially overshadow countless individual quantifiable benefits which are known throughout industry to be achievable from MES.

To again emphasise the strategic qualitative benefits of MES, consider that digital manufacturing is now part of the regulatory dialect as regulators are now comfortable with inspecting electronic batch systems, and see the significant value of a well-managed MES over paper in terms of data integrity and manufacturing control. To ensure that high value is placed on these strategic benefits, it is critical that MES justification assessment models should accommodate qualitative benefits, and that the assessments are strongly represented by senior stakeholders across key company departments like Quality/Compliance, Operations, Engineering, Supply Chain, and Operational Excellence in addition to procurement and finance stakeholders.

Conclusion

The ROI metric has been applied to MES justification for years to predict MES profitability. However, in the context of the current life sciences digital age, strategic qualitative benefits are equally if not more important in overall business case development. A well-considered pre-implementation strategic assessment with broad senior stakeholder representation across all departments is critical to ensuring that strategic qualitative benefits are at the heart of an MES business justification. Moreover, to ensure MES business cases are specific enough to provide real value, it is recommended that companies should leverage MES business case “future state” data that considers the unique challenges of their specific sub-sector or treatment modality. MES business justification and payback analysis is not a “one size fits all” across the life sciences industry. The MES ROI group is a working group within the GAMP MES Special Interest Group (SIG) working to develop the themes above to assist industry stakeholders in approaching MES business justification.