laboratory equipment working for sterilization

COVID-19 is an inflection point for Medical Device manufacturing

The ongoing COVID-19 pandemic broke out and started to scale back in March of 2020. Initially, everything came to a standstill with global leaders and governments trying to get a grip on what they were dealing with in terms of the novel coronavirus. While some industries, such as non-essential goods, were brought to a complete halt, other industries supplying goods to battle the disease (the Pharmaceutical, Clinical Diagnostic and Medical Device sectors), were expected to scale rapidly to meet the global demand for their products.

One thing became evident at the very beginning of the pandemic-many manufacturers lacked the capability to meet suddenly inflated or deflated demands. In the US, invoking the Defense Production Act required companies to suddenly pivot, and start producing goods that met the base needs of treatment, security and protection—drugs, masks, respirators, etc. The companies that responded weren’t necessarily in the medical industry—automotive, CPG and consumer electronics companies brought their technology, and manufacturing prowess, to meet new demand.

For medical device companies, COVID-19 changed their business in undeniable ways: suddenly, elective surgeries were being cancelled or delayed. Product mix and demand drastically changed. They were forced to either adapt, or sit it out.

Chris Parsons – VP of Marketing at Critical Manufacturing, points out that many MedTech plants are inefficient, lacking the visibility through the production process to effectively increase or decrease capacity and throughput. This visibility (and resultant flexibility) proved to be an inflection point when responding to COVID-19.

Chris states that the major issue which plagues the MedTech industry is their reliance on legacy systems, which stems from the fear of process disruption and unexpected complications that could impact the smooth execution of the set manufacturing process. This reliance on the old, and fear of the new, contributes to inefficiencies, lack of flexibility and keeps the industry from reaching its true potential from an Industry 4.0 perspective. Industry leaders need to understand that in order to ensure minimal disruption to their processes and operations, they need to make the right choices when it comes to technology. 

How can this be done? Industry 4.0 (which incorporates new technologies leading to digital transformation) helps MedTech manufacturers become resilient on multiple fronts: 

  • Industry 4.0, based on an IIoT platform, allows medical device manufacturers to create smart manufacturing facilities where material/products (cyber-physical systems, or CPS) and process equipment (cyber-physical process systems, or CPPS) negotiate and allow for most efficient production planning in an automated manner, helping plants become more agile in customizing products.
  • Technologies like AR and VR allow remote work; remote access, remote training and help in maintaining requisite social distancing and safety norms, ensuring operations are not subject to disruptions due to lack or unavailability of workers/personnel. Activities like maintenance and production training can be enhanced with such technologies. Employee capability and the increasing skill gap have been a big concern; only Industry 4.0 technology has the tools to alleviate. 
  • Modern MES applications collect large amounts of data, generated through IIoT sensors and equipment, to provide much needed context to information which directly improves analytics, leading to better, more proactive decision making, allowing for the flexibility to become the DNA of the manufacturing process itself.
  • Elimination of paper. Leading MES applications support the regulatory requirements of MedTech. For paper reduction, all of the data and process records are stored, allowing eDHRs (Electronic Device History Records) to be easily generated. Simply eliminating paperwork can be a big win for companies from a compliance and manpower engagement standpoint, not to mention that paper-based systems only operate in retrospective. MES makes data and intelligence proactive, raising alerts and prompting action.
  • AI and ML deployed in the process create predictive models for quality, production and maintenance, allowing these functions to move from planned to predictive to even prescriptive modes. When action is taken before something goes wrong, it not only saves cost, but the time and efforts saved and disruptions averted can be a massive gain.
  • Industry 4.0, when built on the solid foundation of an industry-specific and modern IIoT enabled MES, can allow for manufacturers to view their entire business data on a unified platform, increasing efficiency through automated control and throughput through better planning.
  • Leaders can view their plant of multiple production sites on a single platform, where the digital twin of each plant can be altered in the best suited manner to make the entire operation much more agile and allowing for changes made in the cyber world to be reflected in the physical world.
  • 3-D printing (Additive Manufacturing), proved to be one of the most valuable technologies during the pandemic, allowing manufacturers to print their own parts and assemblies to cope with their disrupted supply chain. Medical Device manufacturers and their OEM partners can fully leverage this technology, which enables rapid transformation of design to production, with requisite levels of compliance to meet FDA oversight requirements, through the right MES.

Addressing legacy software in MedTech with MES

After addressing how Industry 4.0 may possibly impact and automate almost every aspect of a Medical Device manufacturing process, let’s address the aspect of transitioning from a legacy system to a COTS (commercial off the shelf) MES. 

Rightly so, the main concerns in transition are loss of momentum within the process (training, new integrations, configuration of UIs and other functionality). Specifically for MedTech companies, the legacy software can reflect decades of best practices, capturing nuances of design, manufacture and test that may not easily be replicated in an off the shelf purchase.

As Chris says in his article, ‘a modern MES can provide a pathway to a smart factory.’ Leveraging the latest in technology, a modern MES will bring efficiencies, insight and best practice enforcement to the MedTech manufacturer. It will be modular enough to accommodate areas of urgent need, so that core capabilities can first be addressed and put in place, and then gradually be extended to the larger enterprise. In other cases it will be flexible enough to become the ‘system of record’ for the overall process. Any modern MES application should be able to integrate both with legacy applications and modern IIoT-enabled devices alike, which would alleviate fears of disruption.

For MedTech specifically, a modern MES enables:

  • More effective NPI cycles
  • Fully integrated quality management
  • Ease in traceability and regulatory reporting
  • Boosts in efficiency and profitability

Careful selection is key

As with any overarching solution, it needs to be researched, reviewed and vetted prior to implementation. An MES is no exception, especially with the role it plays as the backbone of any Industry 4.0 transformation. The key is to do the due diligence, understand your own processes and the capability of the application to deliver both immediate and long term needs. A good read on how to successfully replace an existing legacy application with a modern MES can be found here.

What’s next?

The COVID-19 pandemic has truly been an inflection point worldwide for manufacturers, with Industry 4.0 and associated technologies playing a decisive role in the pandemic response. 

McKinsey states that there are three major outcomes as a direct result of the pandemic:

  • A win for companies which had invested in and were well on their way from an Industry 4.0 digital transformation perspective
  • A reality-check for companies still in the process of scaling their efforts
  • A wake-up call for those that hadn’t even begun their Industry 4.0 journey when the pandemic hit

The companies that invested in technology used everything from Digital Twin-based simulations to Augmented Reality. Industry 4.0 allowed them to react better in adverse scenarios, because they were more digital, more automated and more flexible, which in turn made them more agile and resilient.

The pandemic also tested the efficiency of companies responding to Industry 4.0 projects. Almost half of companies responding to a McKinsey survey believed their efforts to scale were inadequate. The most interesting finding is that over half of the companies reported their lack of Industry 4.0 foundation constrained their ability to respond to the pandemic. 

Reshaping priorities

The pandemic has reshaped the priorities for manufacturers and companies the world over. Agility to scale operations and flexibility to customize products has come out as the top two priorities from an Industry 4.0 implementation.

Remote work through video conferencing and remote access, connectivity through data visualization, Robotics/Automation, Predictive Analytics and AR/VR enabled wearables are now a major focus for most companies.

For MedTech manufacturers, it’s all about flexibility. Rethinking supply chains, accommodating a remote workforce, educating and enforcing best practices with new workers and bringing Industry 4.0 to the forefront will be their challenges, and priorities, to regain a ‘new normal.’

The pandemic has brought out both the resiliency, and the weaknesses in companies within the MedTech industry. Now is the time to bring that flexibility, and improvements, into play. Plan your recovery by starting with a modern MES as the foundation for your Industry 4.0 journey. A modern MES can safeguard existing value and unleash Industry 4.0 benefits, bringing both immediate relief and solidifying long term strategies for competitive advantage and future success.

Filipa Dorey
FilipadOrey@criticalmanufacturing.com

Filipa d’Orey is Industry 4.0 Business Development Specialist for Critical Manufacturing. Working hard and working out go hand-in-hand in her life. She’s been recently named as one of the Top Industry 4.0 Influential Voices & Brands from Onalytics. Filipa has a degree in Engineering and Industrial Management and focuses on the digitalization needs of manufacturers with a focus on MES, IIoT, Digital Twin, Predictive Maintenance and ROI.

No Comments