It’s no surprise that Manufacturing Execution Systems (MES) are a natural ally of MedTech to combat Covid-19. For over 20 years, medical device manufacturers have been using MES to assist with both regulatory compliance (21 CFR Part 820 and 21 CFR Part 11) as well as the more plant-related performance improvements including operational visibility and productivity. Our VP of Marketing, Chris Parsons, wrote earlier this month about how MES can improve process capacity for medical device manufacturers as part of Industry 4.0 digitization.
The Medical Device industry is historically a large and vigorous market. The United States remains the largest Medical Device market in the world: $156 billion (40% of the global medical device market in 2017). By 2023, it is expected to grow to $208 billion.
As the MedTech industry grapples with the supply chain disruptions, shifting demands and on the spot innovations for testing and equipment development, ensuring quick ‘best practices’ development and process standardization is imperative to meeting these new demands. Quick ramp up to meet the Defense Protection Act delivery (now for just a handful of companies) still assumes that companies must quickly assemble new teams, processes and supply chains. A foundational platform like MES ensures that standardization and proliferation of new practices are captured.
As the adoption of MES increases, Medical Devices will become the second largest market for MES by 2027, according to Market Research Future, This is not a surprise, as we see MES having a critical contribution to the following areas for Medical Devices, and for MedTech in particular.
Simply by going paperless with an MES, companies can save hard costs (labor, materials). However, the big gains are with improved productivity, quality and collaboration, while maintaining higher levels of compliance requirements with less effort—the system does it automatically. This survey from 2018 from ARC/Automation World shows the highest value gained is production, followed by quality management:
There are a number of ways through which MES contributes to Productivity, such as increased automation, optimization of resources using scheduling or dispatching, increased real time status and visibility, proactive actions and alarms (e.g. Inventory levels, expiration dates, maintenance tasks), monitoring of performance KPI’s (e.g. Overall Equipment Effectiveness – OEE), data analysis, etc.
Specifically in the Medtech sector, the current situation makes clear certain vulnerabilities in terms of supply chain. While companies think about reshoring medical device production, usually from lower cost countries, the productivity aspect will become of utmost importance, since the lower labor cost (and the associated productivity) has been the main reason for the offshoring in the first place.
When a Medtech company is audited by the FDA, the process can be long and expensive. Rather than a focus on compliance, the FDA’s Case for Quality Initiative looks for manufacturers to shift their focus to ensuring that quality is built into products and processes rather than inspected out at the end. MES can help companies achieve this, remove a lot of the pain associated with audits, and reduce both cost and risk in the manufacturing processes.
The shift from focusing on compliance to concentrating on product quality, with compliance simply as a baseline, is important on numerous levels. A reactive approach of tackling problems as they arise makes no sense compared with a proactive approach of preventing the problems in the first place. By adopting this methodology, production becomes more efficient, costs are lowered, the brand is strengthened, and risks to the business are reduced. For any manufacturer, a product recall is a costly process. To recall an implantable medical device, such as a cardioverter defibrillator, however, could have the added issues of surgical removal and replacement—and the costs could become astronomical!
Still, in an Axendia research, 85% of medical industry practitioners questioned said the role of quality was compliance. Only 10% stated that their role was process or product improvement. What this means is that there’s a long way to go, and the FDA is pivotal in this required mindset change.
Another important aspect of MES for MedTech is flexibility. Flexible, modern MES systems enable manufacturers to quickly change products and shift to a different product set, or to suddenly increase capacity in a specific product line.
Gartner’s “Survey Analysis: The Business Value of Manufacturing Execution Systems” done for MES, shows that Streamlining Engineering Change Management Processes is one of the key benefits of MES, with respondents saying that the benefits on this particular topic have been obtained within 3 months (16%) or within 12 months (45%).
Accelerating new product introductions (NPI) is not the only result of implementing change management processes within MES, but undoubtedly one of the most visible ones, especially during the current pandemic.
For example, Medtronic has already increased production of ventilators by 40 percent, with forecasts to double capacity. Other manufacturers are quickly shifting to new products from existing factories, such as the SpaceX/Medtronic collaboration building ventilator parts in Tesla factories, or Dyson receiving 10,000 orders for ventilators from the British government.
To accelerate the restart of their factories in China, Foxconn announced in early February that part of its production in a factory in Shenzhen would produce 2 million surgical mask per day. In April, the company started producing masks in its US-based manufacturing plant in Mount Pleasant , Wisconsin.
At the same time, several distillers and breweries worldwide started to produce hand sanitizers from alcohol in order to address the current shortfall in supply.
The ability to perform such quick shift to new products or accelerate the production of existing one does not depend solely on the MES. But MES existence can not only accelerate production, but also make sure that the underlying processes are under control and that the products have the desired levels of quality.
The pandemic brought a much clearer perception of the importance of automation, as was so clearly explained in this post. In essence, with fewer operators and other personnel on the shop floor, operations could have been maintained, without affecting the output of the manufacturing facilities.
As MES systems support paperless manufacturing and higher levels of automation, it also puts less burden on the operators themselves to monitor the lines in the plants. An unfortunate example of people dependency is the Covid-19 outbreak in the food processing plants of South Dakota. Close working conditions, lack of automation and a dependence upon human labor was an unfortunate recipe for disaster.
Despite the high demand for (at least some) medical devices, life is not easy for MedTech companies with low automation, with several companies reporting reduced number of workers per shift to maintain distance, among other changes in material handling related procedures.
MES helps MedTech not only cope, but thrive
Even without the current pandemic, MedTech had a strong growth and market vibrancy. An aging population, innovation to meet new health demands, and an expanding global market contributed to the overall surge within MedTech. Coupled now with the urgency of response to Covid-19 and the market whiplash (less elective surgeries; delayed FDA approvals for pending product introductions) is causing MedTech companies to rethink their product mixes to either innovate or partner with other technology companies to answer the pandemic needs. MES has reinforced its place as a critical component in GMP for these companies, facilitating quicker reconfigurations, bolstering employee productivity (with less staff for now) and maintaining required processes and procedures for compliance. MES is truly the partner for MedTech in this war.
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