From factory floor automation to back office administration, manufacturing execution systems (MES) are crossing the divide in medical device development, providing solutions that enhance efficiency across all areas. Pharmaceutical companies are under pressure to achieve better control of their production processes, and to increase transparency and traceability. This is where MES comes into play: companies can now capture real-time data and make it available across multiple sites. By connecting equipment to information systems and operator interfaces, it is possible to regulate every aspect of production, while optimising compliance.

Within the manufacturing industry, IT has been transformed over the past 20 years, shifting its focus from data collection and storage to the more dynamic approach of processing. MES integrates a number of the technologies deployed at the manufacturing operations management (MOM) level, including enterprise resource planning (ERP) systems, automation and other components in the value chain.

All this is now recognised as best practice across the industry, which is evidenced by the fact that new manufacturing sites are launching with MES in place.

Corporate converts

On the back of several pharmaceutical heavyweights announcing plans to optimise manufacturing operations, MES development has experienced an interesting few months. Adopting innovative MES technology to futureproof a business has become the industry standard, providing an edge over competitors that are falling behind in the digital revolution.

Critical Manufacturing – a global provider of MOM solutions for advanced manufacturing – and other MES vendors are entering the market, providing solutions that are built on new platforms, which have been tailored to meet the demands of smart manufacturing or industry 4.0.

In October 2017, the company announced that it will implement its leading medical device manufacturing execution system (MES/MOM) at B. Braun Medical Industries, which has production sites around the world and ten in the Asia- Pacific region alone. Penang, in Malaysia, is the group’s largest manufacturing site, comprising more than 7,500 employees who work across five large plants, where they specialise in surgical instruments, infusion solutions and intravenous access devices.

The deal should enable B. Braun to leverage paperless digital manufacturing processes, thereby improving flexibility, agility, operational effectiveness and product quality while cutting costs.

In a press release, Critical Manufacturing CEO Francisco Almada Lobo said, “Industry 4.0 capabilities will be a game changer for medical device manufacturers, such as B. Braun. Critical Manufacturing’s MES was designed and built from the ground up to make industry 4.0 a reality for innovative and complex manufacturers.”

February saw tech giant Siemens announce that Sinocare selected its Camstar Enterprise platform to build its MES. Since the latter was established in 2002, it has become one of the leading manufacturers of rapid diagnosis testing and biosensor technology in China. The company’s products include blood glucose monitoring systems and mobile sample testing devices. Sinocare recently underwent a global expansion, recognising the need for a digital enterprise platform to improve its production processing, and the ability to comply with regulatory pressure from the US FDA and ISO.

“As we are expanding and growing our global footprint, we face the challenges of visibility, traceability and regulatory compliance enforcement in [the] production process, and all these factors influence product quality and operation cost in this industry,” explains Gu Zhongfei, Sinocare’s director of manufacturing.

Siemens’ state-of-the-art MES is one of the medical device sector’s foremost systems, particularly for its focus on preventing process errors, and supporting seamless paper-free manufacturing and electronic device historic records (eDHR).

According to Sinocare, the Camstar Medical Device Suite is an effective solution that helps medical and diagnosis device companies deal with the challenges of balancing expenditure, reducing production costs, ensuring regulatory compliance and maintaining a high level of product quality.

“We see Siemens’ Camstar has been deployed in many medical device enterprises as [a] reliable MES system, and we trust Siemens in building our digital transformation to help us realise the goal of global manufacturing,” Zhongfei states.

Business confidence

Rene Wolf, senior vice-president of MOM software at Siemens PLM Software, put the industry’s confidence down to the innovative features of Camstar’s MES. He adds, “The latest version of the solution has a strong focus on out-of-the box capabilities, as well as interoperability and interfaces, making it more suited than ever to realise the full potential of the digital enterprise.”

The first wave of MES systems were developed to manage continuous processes, like those found in the gas, oil and chemicals industries, and were less able to adapt to the challenges and requirements faced by the medical device industry. However, the latest MES solutions are set to future-proof big pharma, as it moves towards industry 4.0.

Siemens’ market confidence is further explained by Desmond Savage, an MOM/ MES consultant at ATS Applied Tech Systems, an independent solution provider for smart digital transformation. “Siemens’ Camstar MES solution dominates the medical device industry. It is the benchmark that other MES providers have worked towards,” he explains. “Camstar is a mature offering, though perhaps not as flexible as new vendors on the market. However, from a quality perspective, this is often seen as a positive.”

Despite this, Savage is keen to point out that Camstar is unlikely to be used by core pharmaceutical manufacturers.

“If a life science manufacturer is combining a medical device with an active pharmaceutical ingredient for target drug delivery – producing drug-eluting stents, for example – then yes, Camstar can manage the pharma aspect in conjunction with the medical device, but if the company is 100% pharma – fill finish, tableting, bio and so on – then Siemens has another system called SIMATIC IT eBR [electronic batch record] for MES that might be more suitable. There are many other appropriate MES products on the market [as well],” he says.

Savage has consulted with several life sciences companies on their MES selection and sits on a number of steering committees for the technology’s implementation. He is also a registered trainer with the MOM Institute.

“Selecting an MES vendor that aligns with your requirements is critical for a successful implementation. The functionality offered, however, is only part of the decision-making process,” he highlights. “How the vendor will support the implementation, validation, maintenance and support are of equal importance to the life cycle of the solution.”

MES products are constantly evolving, varying significantly in functionality and cost. With this in mind, weighing up the benefits and challenges of the technology, as well as the pros and cons of different providers, is crucial.

The benefits of MES

For big pharma, MES has become the norm; returning to a paper-based approach would be regressive. The technology automates quality using in-process verification and review by exception, and captures all regulatory data a paperless form called an eBR. As Savage points out, this brings key benefits to the pharmaceutical industry: it improves visibility, accuracy and the consistency of manufacturing data, thereby enhancing decision support, process analytical technology and investigations capabilities; minimises product recalls; and reduces quality resources required for daily operations.

“With a well-designed and implemented MES, medical device companies can expect to see an improvement in factory-floor quality metrics by up to 50%,” Savage stresses. “Along with improvements in quality, inventory levels can be optimised and operational metrics, such as overall equipment effectiveness and better maintenance controls can all be achieved.”

Other advantages include improving the management of vital tools used in production for quality, tracking and auditing; better communications across all department and platforms; and introducing fully comprehensive complaint handling, as incomplete and inconsistent approaches to mitigating and processing complaints can have a detrimental impact on a brand.

From product development to clinical batches, production and supply chain management, MES can minimise risks and increase transparency, optimising compliance and the use of resources.

Challenges posed by MES

Investing in research, education and detailed strategies are crucial first steps in choosing and deploying an MES system, and organisations like the Manufacturing Enterprise Solutions Association have been set up to promote best practice in this area.

Implementing a comprehensive MES solution into an existing pharmaceutical manufacturing facility can take several years and requires significant investment, in terms of finance and practical resourcing. Savage suggests that, given the human resources required, time scale, software licences, hardware costs and initial negative impact on changing production, a budget of €2–3 million is not unusual for an MES project that is adopted by a small to medium-sized pharmaceutical operation with 200–500 employees.

However, it is possible for MES to be scaled to specific needs and budgets, if careful attention is paid to creating overarching web-based mapping, which avoids undergoing a financially draining IT outlay.

MES solutions are often viewed as IT projects, but while it is true that IT plays a crucial role in enabling the deployment, the technology needs to be handled by an operations team if it is to be successful.

“Senior management are often familiar with enterprise resource projects and perceive MES as a similar large-scale IT project,” says Savage. “MES, however, will have a direct impact on the factory floor and be transformational to everyone working within the four walls of a factory. For that reason, change management is critical and the operations department are best equipped to manage this change.”

Future developments

With the advent of smart manufacturing, industry 4.0 and the industrial internet of things (IIoT), interesting times lie ahead for MES. It is likely that companies optimising their digital initiatives will have the competitive edge, as they can easily meet client needs, maintain gross margins, scale production and even pass on cost savings to customers.

“In accordance with the ISA95 [International Society of Automation] standards, MES resides centrally in level 3, MOM. It is hard to see how complete digital transformation will happen without MES,” states Savage.

A growing trend for M&A in the pharmaceutical industry has resulted in global networks of sites that need careful management, making operational visibility and accountability of paramount importance. Will cloud technology become standard for MES as a solution to managing multiple locations? Savage believes centralising MES into one implementation across enterprises is a key challenge. “Whether the MES solutions are installed locally or will use cloud platforms is the next dilemma” he concludes.

Principal drivers for adopting MES

The International Society for Pharmaceutical Engineering’s (ISPE) GAMP guide to MES states that the benefits for operations include:

  • improved scheduling and resource use
  • improved manufacturing flexibility and process changeover
  • reduced work in progress and improved material tracking
  • shorter production cycles
  • enforced sequence of operations
  • reduced production record errors (electronic or hybrid)
  • improved visibility, accuracy and consistency of manufacturing data, enhancing decision support, PAT and investigation capabilities
  • minimised product recalls
  • increased plant reliability
  • realising paperless manufacturing
  • automated key performance indicator generation and reporting, including an OEE calculation
  • support knowledge management and PAT
  • reducing quality unit resources required for day-to-day operations by providing functionality, such as ePR and review by exception.

Source: ISPE