It’s no secret that manufacturing and technology are evolving with the global economy, as evolution is a fundamental component in all industries. Rate of change, however, has increased dramatically over the past few years, and nowhere is this more evident than in MedTech. The ever-changing landscape in the healthcare industry has placed an enormous amount of pressure on medical device manufacturers – and digitalization of the manufacturing processes is becoming vital to manufacturing success.

Economic and legislative factors continue to be of importance as medical device manufacturers look to perform efficient, compliant operations.  To do that, technology in various forms is primed to determine the growth and direction of the medical device industry. According to this post, from Ascentium Capital’s State of the Medical Device Industry last year “companies and investors that can direct existing products – or devise new ones that take advantage of AI, IoT, machine learning, and the blurring of the lines between ‘consumer device’ and ‘medical device’ – may take the lead in the market over the coming months.”  

Process Innovation and the Connected Factory

The medical device industry is experiencing tremendous pressure to innovate – not only with new products, but also with new processes.  While large medical device manufacturers continue to move forward in a digitally-evolving industry, the Small-To-Medium Medical Device Manufacturer (SMB) is caught at a crossroads of status quo (with a risk of becoming obsolete) vs. transformation into the digital manufacturing landscape (with initial financial investment, but hopefully-rapid return on that investment).   Even in as early as 2017, Industry Week was predicting that “you’ll need to make a decision on how your business will respond to the changes taking place in manufacturing now: shop floor (industrial) automation, additive manufacturing, lot sizes of one, cloud computing, analytics, mobility, and the Industrial Internet of Things (IIoT).” 

Where does this leave the SMB Manufacturer? Transitioning to the Connected Factory may become the sole factor in determining the future for these companies.  So, what is the “Connected Factory?”  The Connected Factory is the implementation of a wide variety of innovations that connect and organize factory operations.  In the Connected Factory, machines communicate with the operator – and with each other. Because of this connectivity, data is made immediately available and can be accessed in real time and communicated back to the machine and operator, allowing for immediate evolution of process to increase efficiency and effectiveness.  The human operators, then, can monitor and control the operations remotely.  This remote access allows for continual manufacturing with limited interruption (24/7 production) and increased efficiency and output.  Supervisors’ roles evolve as well to monitor the overall health of the entire process – capturing data, analyzing risk, evaluating efficiency, and monitoring overall connectivity.   Massive levels of data are collected for analysis and can be utilized to predict and alleviate factory floor issues before they occur (or immediately after).   This Connected Factory is innovative, efficient, agile, scalable, and risk-protected.

A “Total Reorganization” of Production Processes

Productivity dramatically increases in the smart, connected factory.  When machines communicate with machines (Industrial Internet of Things), potential human error in eliminated.  Connected devices allow the factory floor to become more intelligent, flexible, and efficient.  All information, then, can be gathered – and processes adjusted – to respond to customer demand, inventory flow (automatically replenishing raw materials), and other needs. 

As early as 2018, Manufacturing Tomorrow defined the future of connected manufacturing as “More than a technological revolution, the connected factory is a total reorganization of the approach to production, using existing tools and placing a greater reliance on networks.”

So…Where To Begin?

For manufacturers of all sizes, creating a collaborative, connected manufacturing process improves cost, time and quality.  Moving an enterprise from digitalization concept to established business practice, however, can be daunting.  Where does an SMB begin the journey toward digitalization?  According to Siemens Digital Enterprise Consultants T. Doering and H. Sand at Realize Live 2019, SMBs must thoroughly UNDERSTAND the transition before they begin to PLAN and IMPLEMENT this digital transformation. To fully understand this transition, an SMB must be able to ask and answer the following:

Why:  What are the primary drivers for the organization to transform to a digital manufacturing environment (i.e. cost, efficiency, customer demand)?

What:  What is the organization’s current state (financial health, culture, etc.) and targets for completion (what will be considered “successful” implementation)?

When:  What is the organization’s timeline for transformation – and what steps need to be taken to complete this timeline?  Is there a “roadmap” for the organization’s digital transformation?

How:  How does digital transformation align to the goals of the organization?  How will digitalization coincide with strategic initiatives?  How does the digitalization process begin – and with what projects?

 – Realize Live, Digital Enterprise Consulting.  Timo Doering and Hans Christian Sand.   2019

Transitioning to a Connected Factory is going to be tantamount to the success of the Small-To-Medium Medical Device manufacturer.  Although there is a cost associated with any process change, Connected Manufacturing provides benefits not previously seen in the industry.  We at Seabrook Technology Group believe that as SMBs begin to transition to the Connected Factory, they can quickly realize significant reduction in paper cost, cycle times, manufacturing-related complaints, scrap, product review and release time. In addition to the many benefits, implementation is often easier than expected, regardless of the size and scope of the enterprise. 

Questions about transforming your manufacturing to a digital environment?  Let Seabrook help! Seabrook Technology Group consists of a team of global manufacturing experts and industry thought leaders.  As Connected Manufacturing experts, we bring end-to-end manufacturing solutions (people, processes, technology) together in a harmonized fashion to enable operational excellence for medical device manufacturers.  Our team consists of MESA Certified Consultants​, a CamstarTM Certified Team​, APICS, CPIM Certified Consultants​, PMP Certified Consultants​, and FDA Regulation Experts.  Our entire team brings their passion for Integration, Manufacturing Intelligence and DHR Requirements skillsets to their work.  Seabrook Technology Group is a global, privately held company which was founded in 1989.   ​

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