GxP Lifeline

Attain the Manufacturing Trifecta: Decrease Expenses, Increase Efficiency, and Accelerate Product Release

Medical Device Manufacturing Digital Solution

The Challenge

Not too long ago, I worked with a medical device manufacturer to help address a challenge. They were working across disparate systems. As a result, engineers needed to perform manual tasks, or when an engineer was unavailable, another employee would try to perm these same tasks, which caused faults in the system.

The medical device engineers were frustrated because rather than using their expertise to come up with innovative new solutions, they were performing repetitive, manual tasks. The other employees also wanted to contribute more, but like the engineers, they were stuck time-consuming tasks. Because everything was being done manually, mistakes made their way into the manufacturing process, which resulted in lengthy review times, and delayed speed to market.

In short, the medical device manufacturer needed a connected business system, which would allow them to leverage separate systems by integrating them and effectively creating the equivalent of a single platform.

The Solution: Bridging the Gaps Between Two Manufacturing Systems

The medical device manufacturer was eager to find a way to bridge the gap between the two systems. The solution took some creative problem solving, but the organization got exactly what they needed:

  • Two critical systems were connected, which helped them reduce errors, avoid costs related to those errors, and shorten review times.
  • A central data repository that serves as a single source of truth. This ensures their data is complete, secure, and easily accessible.
  • The uploads of Computer Aided Design (CAD) documents are now automated, and engineers now have time to work on innovative new products, and other revenue-generating efforts.

By addressing one of their largest pain points and connecting two systems, they gained the benefits above while achieving outcomes that had a significant impact on the organization as a whole.


By connecting disparate systems, the medical device manufacturer had three primary goals, which were cost avoidance, cost reduction, and increased efficiency.

1. Cost Avoidance

Before implementing their new digitized solution, the manual work that was being done resulted mistakes that led to additional costs. For example, the organization inadvertently sent the wrong drawing to their manufacturing facility, which included an unintended change. Due to using incorrect specifications, the manufacturer produced an unusable batch of product, resulting in a costly corrective action. After implementing a digital system, they were able to reduce review times, eliminate human errors, and reconcile engineering changes. This eliminated costly errors, and ever since they started working from a connected business system with a single source of truth, the situation described above has not happened again.

2. Cost Reduction

By adopting the solution described above, the medical device manufacturer immediately saved $42,000 per year in operational engineering expenses. As the company grows, the savings will continue to grow exponentially. With their new manufacturing solution, the company can manufacture their products at a faster rate, creating a stronger stream of revenue. This connector enhanced the quality of their products, increased their ROI, and established a new, connected system that drastically decreased future errors and costs.

3. Increased Satisfaction and Efficiency

The process of manually correcting or checking for errors erodes employee morale and organizational efficiency. A single source of truth between the two systems creates a functional improvement by eliminating time-consuming cross-checks between the two systems. With their new digital manufacturing solution, the medical device manufacturer is able to prioritize efficiency and cost savings, which boosts productivity and morale.


With the right solution, it’s possible to attain the manufacturing trifecta: decrease expenses, increase efficiency, and accelerate product release. It’s important to have a good understanding of what you hope to accomplish, and then work with a team who wants to help you achieve your goals. Even if you know what you want, but you haven’t seen it on the market, it never hurts to collaborate with group that isn’t afraid to try out creative solutions.


In his current role at SPK and Associates, Edwin Chung is responsible for managing a team of Application Engineers that provide architecture, implementation, process reengineering, and ongoing support for MCAD/EE applications. Edwin’s knowledge of FDA Regulations and GxP Quality Systems, combined with his experience using Python for Machine Learning and Data Engineering, enables him to innovate legacy system automations, integrate cloud or IoT products, and increase engineering efficiency. He applies his multiple M.S and B.S. degrees in Biomedical, Electrical and Computer Engineering to architect solutions that solve interdisciplinary business problems. With 20 years of experience, Edwin strives for excellence by prioritizing customer satisfaction and quality.

SPK can be reached online, via email, or phone (888) 310-4540.

Free Resource
The Ultimate Guide to Digitizing the Shop Floor

Enjoying this blog? Learn More.

The Ultimate Guide to Digitizing the Shop Floor

Get the Guide
[ { "key": "fid#1", "value": ["GxP Lifeline Blog"] } ]