Bottom Line: Medical device manufacturers face a myriad of challenging constraints, costs and compliance requirements. At the center of what makes any medical device manufacturer competitive is the ability to make quality a foundation of every sourcing, procurement, production and service process.
In striving to attain this level of coordination and consistency across their value chains, medical device manufacturers must focus on how the digital thread unifies their value chains with well-orchestrated processes. Manufacturing Operations Management (MOM) strategies are designed specifically to answer this need and ensure compliance, quality and time-to-market goals are met.
Top Five Reasons Why Medical Device Manufacturers Need Manufacturing Operations Management Now
The following are the top five reasons why medical device manufacturers need to look at the benefits of adopting an enterprise-wide MOM strategy now:
- Attaining enterprise-wide compliance and quality management on a consistent basis takes a medical device manufacturer to an entirely new – and highly competitive – level of performance. In the Medical Device industry obtaining full FDA compliance is top priority. Enterprise-wide MOM strategies have the ability to capture and report all eDHR information – part information, bills of material, supplier and purchase order information, lot numbers, serial numbers, inspection and test results, non-conformances, document revisions, electronic signatures, and tools used during assembly – in one system. Having a streamlined and integrated approach throughout the value chain and product lifecycle ensures FDA regulations/standards are met.
- Accelerate time-to-market and make product introductions a revenue-generating event that refines the competitive landscape of their industries. With an urgent need to stay competitive and relevant to their customers, Medical Device manufacturers must launch products to market quicker than their competitors. Manufacturing Operations Management strategies that leverage integrations to PLM systems allow engineering design changes to smoothly flow to production, ensuring the product is built on time and to correct specifications. This collaboration between systems assists organizations in maintaining high levels of productivity, quality, and compliance when launching products to market and/or managing NPIs (New Product Introductions).
- Enabling real-time visibility and control that translates into higher product quality, fewer recalls & returns and greater customer satisfaction. Manufacturing success and efficiency relies on making every production minute count. With a unified approach to MOM strategies throughout production, Medical Device manufacturers are able to develop and access more strategic manufacturing intelligence and analytics. This new-found visibility throughout the manufacturing value chain generates continuous quality and operating efficiency improvements, where fewer quality errors are made and production productivity increases.
- Continually improving supply chain visibility and performance. Quality and performance of business processes directly impact revenue and customer satisfaction. For medical device manufacturers who compete in highly regulated markets, their supply chains are their lifeblood – they are core to their current and future revenue growth. High performing MOM strategies provide medical device manufacturers with the ability to define, manage, communicate and verify product specifications and requirements with suppliers. By tracking quality, inspection, non-conformances and many other factors, manufacturers are able to align internal processes with their suppliers to ensure greater efficiency. Having a highly collaborative approach to quality management and compliance speeds up processes, reduces quality errors, and improves time-to-market performance, resulting in better customer satisfaction and more sales.
- Enabling paperless manufacturing to galvanize compliance and quality management across the shop floor. The “digital thread”, we’ve all heard about it. However, few manufacturers actually take advantage of its true potential across their value chains. Probably because integrating and feeding digital communications between engineering and execution is easier said than done. MOM strategies are just as important as PLM and ERP strategies, and in order for a manufacturer to begin realizing the digital thread’s capabilities, these diverse systems must coordinate flawlessly together. Removing paper from the shop floor opens the door to a whole new world of increased productivity and efficiency. Electronic work instructions supported by a Manufacturing Operations Management strategy provide technicians with accurate, up-to-date instructions, which boosts quality, and means products are built right the first time.
Devon Morris is a Sr. Business Development Representative with more than nine years of enterprise software experience. At iBASEt, he engages with complex discrete manufacturing leaders to understand their challenges and strategy for digital manufacturing.