In July of 2017, then-Executive Director of Seabrook Technology Group, Sean O’Sullivan, published a piece in MedTech Intelligence spotlighting the need for Medical Device Manufacturers to transform their production to paperless manufacturing (MedTech Intelligence, July 5, 2017).
Two years later, the urgency has increased greatly for companies to manufacture products in a paperless environment, as they realize that digitization is key to transforming their enterprise to meet the demands of Industry 4.0. Transformation to Industry 4.0 won’t be easy, as pain points exist – including quality control, cost, data management, complex production pressures, and compliance. With the ever-growing complexity of medical devices and the evolution of digitalization, manufacturers need to embrace these changes, or they will find themselves left behind as their competitors continue to make strides.
Let’s revisit the benefits of transformation to a paperless environment, as discussed by Mr. O’Sullivan:
Paperless Manufacturing: Five Key Benefits for Medical Device Manufacturers (originally published 7.5.2017; summary; edited).
MES is a digital production management system that enables integration and communication of real-time data from the inception of the product all the way through the manufacturing process. It also systematically enforces your device manufacturing requirements at the point of use to immediately detect defects and prevent errors.
The following are five quantifiable benefits for medical device manufacturers who make the switch to paperless.
1. Improved Quality Control
Increased data collection and process automation greatly improves full product traceability.
Real-time product traceability information provided by digital display can prevent a product recall by quickly isolating a bad batch or device. In addition, paperless manufacturing can facilitate a fast response to any issue that arises. A fast response rate is key to reducing the amount of product lost, keeping recalls at a minimum.
2. Reduction in Costs
The primary benefit of paperless manufacturing is the significant reduction in operational costs. Eliminating the need for a paper trail, the software can lead to marked reductions in paperwork costs and the time needed to complete them. In a recent post-MES assessment undertaken for a cardiac resuscitation device client, we found that there was an annual reduction of $88,000 in paperwork management as well as an annual drop of $32,600 in paper costs, storage and boxing costs.
In addition, when all the maintenance, planning and production processes within paper-based systems are streamlined or eliminated, staff can be freed up from the operating line. Our report also showed that in one year, the same company saved $6,000 in operator training.
3. Enhanced Productivity
Paperless manufacturing systems record real-time data and share it with all relevant departments. This data can then be examined. If any steps in the manufacturing process are unprofitable or inefficient, measures can then be taken to improve productivity.
For example, the assessment at a cardiac resuscitation company revealed a 6% increase in productivity in one year. In simple terms, these systems allow for the right information to be viewed by the right people, at the right time. This data collection can also reduce human error, reducing the time and money spent correcting these mistakes.
4. Fostering Manufacturing Excellence
Paperless systems facilitate improved collaboration, creating a platform for employees across functions and departments to access and work with real-time data, with the ability to edit, revise and share ideas. Employees also benefit from having access to accurate and up-to-date information, allowing them to effectively respond to customer demands and material shortages.
Considering the amount of paper that can pile up between orders, schedules and reports as well as their subsequent disposal, eliminating unnecessary paper can improve an organization and increase team morale. Moving to a digital system also allows for remote access to documents, creating new opportunities for a global workforce.
5. Enforcement of Regulatory Compliance
By facilitating accurate and easily accessible documentation of both actions and results, paperless manufacturing enforces compliance with standard procedures and regulations.
Paperless manufacturing provides full traceability throughout the manufacturing process while the enhanced reporting capabilities increase responsiveness in providing critical information during audits. It also makes it virtually impossible to lose track of a document and enforces systematic capture and management of abnormal events. As regulations evolve, a paperless system can be easily updated to meet any new requirements.
With constantly changing regulations and growing device complexity, medical device manufacturers need systems such as MES to ensure quality and compliance. Companies that introduce paperless manufacturing have fewer non-conformance issues, increased efficiency and more consistent product quality, allowing them to focus on innovation and improving the end-user experience.
Seabrook Technology Group celebrates its 30th year in 2019!
Consisting of a team of global experts and industry thought leaders, Seabrook brings 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 skill sets to their work. Seabrook Technology Group is a global, privately held company which was founded in 1989.
We offer expert products and services for medical device manufacturers. Let us help you experience the benefits of paperless manufacturing. Please contact us at:
IRELAND OFFICE (HQ): Mainline Place, Sarsfield Rd., Wilton, Cork, T12 DY80, Ireland
Tel: +353 21 4800 840 | [email protected]