How can a MedTech manufacturer secure its position as a valued partner in the fast-changing healthcare industry? It all comes down to being reliable on many fronts. Achieving without fail high performance in quality, cost, speed, compliance, and flexibility may sound daunting. Yet leading MedTech companies are finding a solution in implementing modern MES.
Healthcare is improving, in part due to smart, connected medical devices or MedTech. Opportunities for MedTech companies are expanding rapidly. According to Statista, Medical Technology revenue is due to grow at over 4.73%,1 and other forecasts are between 5%2 and, for some segments, 6%.3 Yet, competition is also accelerating. As contract device manufacturing operations (CDMOs) proliferate, companies with only a good idea can get new medical devices approved and into the market rapidly with comparatively little capital or knowledge of validated processes.
So, the question as a MedTech manufacturer is how to become a valued partner. Whether you are a CDMO, subassembly or parts supplier, or manufacture and sell into healthcare directly, the pressures are high to deliver more value. The final value will be delivered to patients, whether you sell products they will use, their healthcare providers, or other life sciences manufacturers. Being easy and efficient to work with and able to deliver all required documentation for regulated devices is part of it. In this volatile market, everyone is seeking partners they can continuously rely on.
Much of reliability is rooted in manufacturing capabilities. No matter how impressive your development, engineering, sales, customer service, or front-office teams are, they cannot ensure the delivery of perfect products. Only manufacturing operations can do that.
Reliability is paramount to the industry today. The traditional performance dimensions matter: quality, speed, cost, and compliance. Today, flexibility and agility are vital too. Performance in all of these areas must be not only be good but also very consistent and well-documented that the customer can trust the partner. The good news is, MES can help any MedTech company ensure good, reliable performance on many fronts.
Reliable quality has always been a goal for medical devices. Quality by Design (QbD) is a known concept to achieve this. However, in the age of specific configurations for each customer or patient, process engineering and quality by design are far more complex. For most MedTech companies, low-volume product variants are an increasing part of the mix.
Additional quality complications come from the current changes many companies are implementing in their supply base.
Achieving consistently high quality is itself multi-dimensional. The materials must be right, employees must avoid errors, and quality checks must be ongoing. For manufacturing to do this reliably, MES is a logical support. The best MES not only provides error-proofing but does it so that even less-experienced or low-eyesight employees can perform their tasks efficiently.
Efficiency and speed are crucial elements to success in any tech-based industry. For MedTech, speed matters both in innovation and delivery.
The long cycle from ideation through development to approved devices means product innovation is a constant challenge to profitability. The top challenges for new products typically include ensuring manufacturability and validating the process. The manufacturing software must be ready to deliver helpful information to R&D and enable new product test runs to mix into the factory with production orders and minimal disruption.
For established products, speed in delivery is also crucial to partnership success. Customers want products and sub-assemblies quickly. When demand grows, the manufacturing operation must be able to keep pace, or the company loses revenue opportunities – and often market share. MES has been proven to increase efficiency and keep operations moving.
The MedTech market has not been immune to supply chain and inflation-based price pressures. Major healthcare and life sciences companies are actively seeking ways to mitigate rising prices for labor and materials. A partner who can keep prices at reasonable levels or lock in prices will be desirable.
While a contract can lock in a price, maintaining margin is something the operations is responsible for. If prices rise, the manufacturer must be able to find cost-savings or efficiencies in other areas. MES can enable manufacturing with no paper and minimal double-checking needed, saving labor. MES typically also lowers the cost of quality due to error-proofing, alarms, and notifications when problems arise. This prevents scrap and rework. MES can also save on costs through better on-the-job training for employees.
One key advantage MedTech has over traditional treatments is often that the electronics can accommodate customers’ and even specific patients’ needs more completely. Every application, market, or patient may demand shapes, sizes, or even personalized features for optimal results. Flexibility and agility to accommodate special or new requests is a characteristic everyone wants in their partner.
Companies expect supplier partners to be able to flex to accommodate changes in specific models needed, locations that need them, and specification changes. Accommodating this level of variety is highly complex and challenging without modern MES to support assured operations no matter the mix and speed of change. MES enables flexibility for both automated and manual elements of the MedTech production process.
Much of what was mentioned to this point might apply to any high tech manufacturer. Yet, in MedTech, all of this must come with perfect compliance. Compliance must come through the validated processes to create regulated products. Tracking each unit with unique device identifiers (UDI) and a complete product genealogy and auditrail is a must.
As you probably already know, as many or more of the violations auditors and regulators find are in the documentation as in the process or products. This is another area where modern MES plays a critical role. Not only can the MES error-proof and compare actuals against the validated process specifications, but it also generates compliant documentation and ensures e-signatures as it goes along. With MES, there are no handwritten scribbles, no delays where a person can forget or misreport data, and minimal need for extensive documentation checks that postpone shipments.
Stepping up to Partner
Every MedTech company wants to be a valued partner. Attaining that status in competitive markets means the winners will be those who step up their game in manufacturing. Companies who can prove (and continuously improve) their reliability in quality, speed, cost, compliance, and flexibility will gain trusted partner status in the industry’s ecosystem.
Consider your company’s current practices in production, quality, and documentation. Are you ready and entirely dependable? Would you be comfortable buying from your own plants? Or will true reliability require greater maturity and fewer gaps in digital data flow?
More and more MedTech companies have started initiatives to implement MES company-wide. They are seeking MES partners who can deliver software that will support them in increasing reliability. Compared to other possible investment programs, MES is far more likely to improve reliability on all fronts customers want from their valued MedTech partners.
Those who invest in MES now can gain a competitive advantage. As the entire high tech supply chain is re-formulating, MedTech manufacturers can become the partner of choice if they act now, choose wisely, and implement with proven methods they can validate.
- Medical Technology Worldwide https://www.statista.com/outlook/hmo/medical-technology/worldwide, © Statista, 2023
- U.S. Medical Device Manufacturers Market Size, Share & Trends Analysis Report By Type (Diagnostic Imaging, Consumables, Patient Aids, Orthopedics), And Segment Forecasts, 2021 – 2028, Grand View Research, 2021
- Life Science Intelligence, Health Research International: Medical Devices and Diagnostics Report, 2021