MES for Life Science Manufacturers: Why and When?

At the core of any digital transformation journey for manufacturers, a few primary questions must be answered:

– What is Paperless Manufacturing?
– What is a Manufacturing Execution System (MES), and
– Why and when do I need an MES?

During the past decade or so, many Medical Device, Diagnostics, and Biotech manufacturers have been improving their IT systems to comply with the industry’s requirements, focusing heavily on their business operations, inventories, and sales – resulting in the neglect of other improvements for the manufacturing process and the plant itself.

Many organizations have invested large amounts of capital in these types of projects, with many of them involving ERP implementations. Recently, being aware of the actual return on these investments, leaders are much more educated and have a more realistic understanding and expectation of the results of these implementations. This realization can lead to skepticism toward large capital investments, as manufacturers may not fully see the expected return on investment that was originally expected. For example, a successful ERP is vital to operational excellence, but when a strong MES solution is partnered with an ERP, the return on investment is significantly magnified.

Currently, however, manufacturing is one of the most heavily regulated industries, and more so are the branches of manufacturing related to Medical Devices, Biotech, and Life Sciences. Thus, many in these industries are faced with the challenge of redirecting their efforts to increase efficiency, improve quality, gather data to make better decisions, to upgrade their manufacturing processes. Because of this, the question arises, again: Why and when do I need an MES?

A few of points to consider:

1. Do you have critical manufacturing issues?

2. Does your organization have the size to implement an MES?

This is a subjective question but is one that must be considered. Specifically, what benefits will a manufacturing organization realize vs. what is the actual cost of ownership of this type of implementation? MES implementations usually are more beneficial for larger companies in which the complicity is augmented either because of the variety of production lines or because of the high volume they manage. Nonetheless, MES prices vary from one system to another, from one vendor to the another, and questions that need to be considered include: “Is it an OOTB type of solution? Is this solution cloud-based? Can it be implemented in stages?” etc.

All of these questions that each organization would ask themselves are needed to consider whether an MES is worth implementing – or whether their pain points could be addressed with another solution.

3.Does your organization rely heavily on quality?

Now, here lies the tricky part. After considering all these points, if the return on investment doesn’t seem rapid enough, or if the cost of ownership is too high, there remains a question that should be answered: is quality and reputation vital to the success of your manufacturing? In other words, as a Medical Device, Biotech, Diagnostics, or Pharmaceutical manufacturer, can quality or reputation can be compromised? In such instances, a fully functional Manufacturing Execution System that is implemented and supported by industry experts becomes mandatory.

What MES to choose?

Now, if you’ve concluded that maybe an MES is what you need, the real work starts here: There are many things to consider before deploying any MES solution, and MES greatly varies from a vendor to another.

Seabrook Technology Group is a boutique type organization specialized in Connected Manufacturing (Industry 4.0) for the biotech medical devices and diagnostics industries. During the past 30 years the organization has been working alongside these companies (see Clients) to improve their manufacturing and operations through Smart Manufacturing Solutions.

The Digital Manufacturing Cloud