An Introduction To Manufacturing Execution Systems For The Medical Device Industry

By Christian Fortunel and Siobhan Fleming, LZ Lifescience

Manufacturing Execution System (MES) solutions have the potential to generate efficiencies, improve productivity, and simplify compliance within the medical device manufacturing industry. Used to manage production activities, this class of software typically provides the ability to schedule activity, deliver instructions to operators, synchronize manual activities with automated processes, and integrate with manufacturing computer systems to enable quality control, deviation management and effective enterprise resource planning (ERP), equipment management, and the documenting of floor activities for monitoring and reporting purposes.

MES technology enables the replacement of paper documentation with computerized records, known as electronic device history records (EDHRs), which can be accessed in real-time by all users. Put simply, MES is concerned with providing the right information, at the right time, to the right party, whether this is a human operator or an automated system, to achieve “right first time” production.

While automation systems are responsible for controlling the manufacturing process and enterprise resource planning (ERP) systems focus on managing the entire supply chain, there is an information and/or time lag between these two automation layers, often addressed within the manufacturing department using spreadsheets or word documents.  MES focuses on plant operations to address this gap, so that materials and information flow smoothly through the plant to produce quality products, while maintaining low levels of inventory.

Benefits of MES include greater regulatory compliance, lower production costs, a centralized point of information in line with good manufacturing practices (GMPs), real-time production visibility, and increased equipment efficiency.

A Changing Landscape

Today, MES solutions are being adopted by the Iife sciences industry at a faster rate than any other vertical market (Frost & Sullivan NA7E-10). Many factors are driving this, including changes to regulatory standards, cost pressures, the need for more accurate and timely data, globalization, and merger and acquisition (M&A) activity. Companies need to monitor and overcome potential quality issues in real-time, reduce waste, and ensure fast product release. Errors cost time, and time means money, as well as having the potential to cause a compliance issue, potential 483 or warning letters, and reputational damage.

Life science manufacturers must deliver their products or devices to precise parameters, in an increasingly competitive market, while maintaining regulatory compliance. Changing compliance requirements and regulatory standards are making traceability more difficult to achieve with manual or hybrid systems.

In parallel, market price pressures from governments and insurers are squeezing margins. Many organizations are increasing their investments and IT budgets to reduce the overall costs of production.

Global expansion of manufacturing facilities and a greater need to replicate information and streamline processes across multiple sites are also driving the adoption of MES solutions. Increasingly life science organisations are standardizing the systems deployed across multiple sites.

The strong trend in mergers and acquisitions results in a larger network of sites to manage and a requirement for better corporate-level visibility into site-level operations. This can be facilitated through a cloud or web technology based MES that provides real-time visibility and distribution of information, regardless of location.

An aging workforce is also pushing organisations to implement newer IT systems; there is a growing need for a more comprehensive up-to-date solution independent of the skill set of the workforce.

Despite the recognized benefits, the prohibitive cost of implementing and licensing “traditional” MES has essentially resulted in it being adopted by only the largest life science manufacturers. Smaller medical device makers have been excluded from using MES solutions and have tended to scale their workforce to match production requirements, which means that increased production comes with increased overhead.

The MES platforms traditionally deployed were designed for general industry rather than with the needs of the life sciences sector in mind. They were equipped to handle continuous processes, such as those found in the oil & gas and bulk chemicals industries, and were less adaptable to new and changing requirements that the medical device industry faces.

The life science sector requires affordable, modular, and flexible systems designed with the industry’s unique challenges in mind. With such a solution, it is possible to achieve gains of >25% in productivity, as well as reduce the time and stress associated with managing manufacturing using paper-based and hybrid systems. Such “disruptive” technologies are now enabling the adoption of MES within smaller organizations.

Debunking The Myths Of MES Adoption

A number of developments within the MES industry now make it possible for companies of all sizes to access the technology.

One of the biggest myths associated with the introduction of any new IT infrastructure is that there must always be a large upfront cost, with the requirement for new and costly hardware and equipment. However, a web-based architecture, which is possible in today’s environment, removes the need for a heavy IT footprint and means that MES can be easily scalable to needs and budget. For example, companies can use their existing Microsoft SQL server database and do not need an Oracle instance or Citrix farm to enable seamless deployment to all users.

In addition, modular licensing structures often mean that only the deployed functions are paid for, allowing growing organisations to “start small” and increase the scope of the system as their needs and production grow. Some vendors offer a licensing system by concurrent user. As a result, only the users on the system at any one time require a license, which dramatically reduces the user license cost.

Another common belief is that any major change to operational management, such as the introduction of new technology, must result in significant upheaval and downtime. Solutions developed specifically for the life science sector make the implementation process significantly faster, as the typical functions required are already built in. Implementation times of only three to six months are very achievable, meaning there is little impact on business productivity. Much of this activity takes place away from the shop floor and causes minimal disruption to production.

It is also thought that paper-based systems offer a level of flexibility that cannot be achieved through MES technology. This is perhaps true of traditional systems that were designed with set processes and requirements in mind. Modern solutions allow manufacturers to adapt quickly to changing trends and customer requirements.

This is a key consideration. For example, the trend towards individualized medicine, and the proliferation of companies targeting therapies for patient populations that are becoming smaller and smaller, means that manufacturing systems must be flexible enough to accommodate frequent line or product changeovers without adversely affecting compliance.

On the change management side of a dynamic manufacturing environment, one of the hardest requirements is to maintain the same level of flexibility that paper provides. However, this is possible with a modular and scalable MES system.

For any business, ROI is the main consideration when making a change to business operations. It is often thought that ROI can only be achieved in the long term, but the availability of MES options at a lower price point is changing that. Seeing an ROI within a shorter timeframe is particularly important for smaller medical device companies, which often have less capital to spare. Lower-cost MES is enabling these organisations to access the benefits without disrupting cash-flow.

When implementing a flexible and scalable MES solution, ROI is feasible within 12 months. It can be achieved by a combination of reducing working capital such as materials and inventory, lowering direct costs, increasing reliability and therefore reducing downtime, improving operational efficiencies, and reducing manufacturing operation and supply chain risk.

The Wider Industry Impact

The greater adoption of MES among a wider part of the market will impact the medical device industry in a number of ways.

As competition increases and pressures to lower price continue to rise from the healthcare industry, companies will need to serve smaller patient populations and/ or lower socio-economic classes with their products. As small- to medium-sized companies become more cost efficient by improving performance with MES, they can pass cost savings on to customers.

Companies that adopt MES are more likely to be able to maintain their gross margins and grow faster because they are in a better position to meet client needs. As production performance and flexibility increase and compliance is no longer a major challenge, companies are also in the position to scale production and bring new products to market.

The availability of MES technology may also influence M&A activity and consolidation within the industry. The industry can expect to see some consolidation where companies with the most efficient production capabilities can absorb less efficient organizations. At the same time, companies that have achieved high levels of efficiency through MES will also present as attractive investment opportunities for larger organisations.

Staying In The Race

Medical device manufacturers are operating in an increasingly competitive and fast-moving environment. Many factors, such as price pressures, ever-more-complex regulatory requirements, and globalization are creating new pressures and challenges that can be simplified through the right technology. Those companies that embrace new advances in technology including the cloud, are placing themselves at a competitive advantage, with the ability to accelerate their time-to-market by improving efficiencies throughout the manufacturing process. This is driving the adoption of more scalable and flexible MES solutions.

About The Authors

Christian Fortunel is VP at LZ Lifescience Inc. (USA). He is responsible for operations management and the successful financial running of the U.S. business, as well as bringing a wealth of manufacturing execution system (MES) solution deployment expertise to his role. Christian has over 20 years’ experience developing, managing and deploying MES solutions, having worked with many of the top 30 pharmaceutical and biotechnology companies across the world to manage large scale MES implementations. He earned his Master’s Degree in computer science from Columbia University.

Siobhan Fleming is business development manager at LZ Lifescience. Operating primarily in mainland Europe and Ireland, Siobhan is responsible for meeting market demand for the company’s manufacturing execution system (MES) technology, building relationships and supporting customers in the life sciences industry. Siobhan has worked in the automation and life sciences industries in a variety of roles and has strong knowledge of the full software lifecycle in the life sciences manufacturing environment. She holds a Masters in Technology Management from University College Cork, a Graduate Diploma in Technical Communication from the University of Limerick, and a Diploma in Marketing Strategy from the Irish Management Institute.