Online Exclusives

Building Medical Quality at Scale Through Connected Manufacturing Data

Professionals who design or develop medical devices must maintain tight oversight of all internal practices and procedures.

Photo: Kampan/stock.adobe.com

Professionals who design or develop medical devices must maintain tight oversight of all internal practices and procedures, mainly because these products are highly regulated and can change people’s lives. This means patients, providers, and the public expect product makers to prioritize high-quality outcomes. Connected production data is a significant part of achieving that challenging yet reachable aim.

Getting Started with a Connected Data Initiative

Many medical device manufacturing facilities have information silos and fragmented systems. These shortcomings can disrupt productivity and limit visibility. Decision-makers should begin by verifying the number and type of separate systems they use to run their businesses and processes. That typically means connecting a manufacturing execution system, enterprise resource planning platform, quality management system, Internet of Things devices, and any other systems related to the shop floor.

Linking all these systems takes time and dedication from people at all company levels. The commitment pays off, however, because it allows businesses to move away from disconnected spreadsheets that may contain numerous errors and require people to slow their workflows to perform manual tasks. They can instead embrace real-time data shared with all relevant parties.

This improvement gives people the information they need to do their best work. It reduces or eliminates instances where they lack the details necessary to adequately supervise operations and implement enhanced processes.

Those tasked with leading the data connection initiative should create detailed timelines that outline what must be completed by specific dates and list the responsible parties. This approach creates accountability and transparency.

How Connected Data Improves Medical Quality

Although leaders may initially focus on compliance as the primary reason for connecting systems that collect manufacturing data for medical devices, most companies see business impacts beyond satisfying regulators.

Cutting Costs While Improving Processes

One example occurred when a medical device manufacturer streamlined operations by enabling collaboration and providing shared access to its lean manufacturing systems. Some of the goals associated with this transition were to shorten the time to market while simultaneously reducing costs and improving quality.

It made substantial strides in these areas, including eliminating waste and streamlining processes. The brand also reduced its total costs by up to 25% and solidified an ongoing cultural shift that continues to influence operations.

Tightening Quality Control

A connected manufacturing data strategy also reduces the time and costs associated with scrap and rework. Real-time information streams allow people to detect and address problems sooner. They can schedule additional training or coaching sessions for employees with histories of above-average mistakes, a lack of confidence, or other issues that can lead to medical device imperfections.

Improved visibility increases proactiveness, enabling professionals to appropriately manage adverse marketplace forces. Johnson & Johnson monitors for counterfeiting-related challenges before and after launching new medical devices. Professionals use internal data and an external partner network to assess the likelihood of criminals causing disruptions and then deploy controls to manage them. This method would be difficult or impossible without connected systems, especially for such a large and influential company.

Encouraging Trust and Promoting Safety

Keeping manufacturing systems connected is a practical way to strengthen patient safety and elevate brand trust. Many medical devices perform essential tasks, such as regulating someone’s blood sugar or heartbeat. Healthcare practitioners rely on them to check and monitor patients’ vital signs, whether remotely or on-site in hospitals and similar settings.

Numerous offerings also support ongoing wellness by featuring biometric sensors that help people track their lifestyle and fitness goals. When those who consider or use medical devices believe that the companies making them take quality control seriously, they will be more likely to adopt and recommend the products.

Succeeding With a Purposeful Plan

Once decision makers commit to connecting manufacturing data and begin anticipating the likely benefits, they can increase positive outcomes and keep workers motivated by implementing a detailed roadmap. It should include date-based milestones and accommodate potential slowdowns, as these are near certainties throughout the phases of new projects.

Leaders can help employees look forward to internal changes by remaining accessible and encouraging when addressing their questions and concerns. This openness will make them feel supported and equipped for the future.

Choosing the desired technology platforms and vendors is also important. Microsoft Dynamics 365 ERP is a viable solution because it centralizes and links manufacturing data, enabling users to realize a core theme in building quality at scale through connected systems. If the company currently faces many challenges, leaders may find it useful to create a list of the most prominent ones and determine how faster, automated services could address them.

Thorough, actionable training is also essential when advancing a connected data strategy. Many employees may need to adopt new workflows or learn additional skills to meet the goals envisioned by their superiors. Broadening capabilities takes time because people require relevant knowledge and opportunities to practice what they have learned. Because manufacturing workers may not have offices or desks, training coordinators should explore options to maximize flexibility.

They should also account for different learning styles and preferences, recognizing that individuals often retain content best through highly interactive experiences. A government scheme in the United Kingdom will use virtual reality to encourage more people to enter the pharmaceutical industry. Learners can then repeat tasks 100 times without using consumable equipment.

The pharmaceutical and medical device industries abide by similarly strict regulations, highlighting how VR could expand training opportunities in device production facilities.

Connectedness Drives Positive Results

Companies that link formerly separate systems take decisive action to maximize brand value by raising customer trust levels, minimizing defects and enhancing interdepartmental communications. Regardless of the number and type of medical devices produced, now is an excellent time to explore data connectivity solutions for better manufacturing oversight.


Interested in having content like this delivered directly to your inbox? Click here to sign up for MPO’s The Source eNewsletter!

Keep Up With Our Content. Subscribe To Medical Product Outsourcing Newsletters