Production pressure has never been more abundant for medical device, diagnostics, and biotech manufacturers.  Among other pressures, regulatory compliance issues, new product demand, Covid-19 fallout, and pressure to innovate are pushing manufacturers into a new era of production. 

Yet, even as these pressures mount, many Medical Device Manufacturers continue to operate at “status quo,” utilizing paper processes to drive, record, and qualify the manufacture.

If you are operating with paper-based processes, knowing whether the 5Ms are in control is nearly impossible in this environment of constant change and increased complexity. Manufacturing errors, lack of visibility, inefficiency, inability to make data-driven decisions, and increased waste are potentially damaging your bottom line, your reputation, and your desire to impact the Life Sciences industry.

As a reminder, this is a fundamental truth in manufacturing: the efficient delivery of quality products means controlling the 5Ms – man, material, machine, method, and measure. Because we have a better way of maintaining control over the 5Ms, understanding these five factors is key in strengthening the production process, ensuring efficiency, and securing an economic and regulatory foundation.

For our second “5Ms” Blog Series entry (see “M1: Man” in our blog history), we will discuss the importance of digital transformation as it relates to the MATERIAL in Medical Device and Diagnostic manufacturing. 

The Second M: Material

“Good materials make good products.”
 – Riccardo Consonni, Siemens Digital Industries Software

When we think about control of material, the first area of focus has to be the importance of utilizing only the materials designed and intended for the product – and we want those materials to be in best possible working order.  If material is vital to the success of the manufacture, then (and I think we can all agree on that), how does a digital solution control this? Let’s take a quick look at three areas of impact. The impact of a digital solution (such as a full MES, an eDHR, Manufacturing Apps, etc.) on the success of your organization is great.  Digital solutions support the enforcement and control of materials in the following ways:

  • Bill of Materials:  digital solutions are designed to contain the bill of materials (BOM) list that defines what materials should be used for every step of the manufacturing operation. 
  • Compliant Materials and Self-Audits: best-in-class solutions automatically check whether material lots are valid, and signals to the operator when non-compliant materials are introduced.  Additionally, these solutions are “self-auditing,” meaning that they automatically enforce the use of the correct materials throughout the manufacture.
  • Device History Records that Remove Paper: digital solutions that we support will include an electronic Device History Record (eDHR), which records what materials were used, volume of materials etc.  This eDHR, which replaces a cumbersome and error-prone paper-based process, creates full traceability for each product. 

As “M #2” of the “5Ms of Manufacturing,” it is important that manufacturers not overlook the importance of the material in the manufacture. In today’s highly scrutinized manufacturing environment, the pressure to succeed is immense.  The support, control, and enforcement of proper materials is key to the success of today’s manufacturers.   To balance pressure, solve the pains of manufacturing, and thrive, implementation of a digital solution is vital.  Through increased digitalization, smart manufacturers are seeing that these advancements aid the control of materials – increasing quality and reducing scrap – which helps the organization to survive and thrive even in this high pressure environment. 

Stay tuned for the next “M”: Machine.  Look for the next blog coming soon!