Medical Devices • March 25, 2016

Waiting for an eDHR Mandate? Best-in-Class Medical Device Manufacturers are Already There

Devon Morris Devon Morris

In today’s highly competitive, fast-paced medical and diagnostic device industry, manufacturer’s often struggle to find the right time to shift away from their costly, inefficient and error-prone processes, such as assembling a DHR (Device History Record) from multiple paper and spreadsheet sources. Not only does this leave manufacturers vulnerable to numerous error risks, but also vulnerable to competitive risks from companies that have moved ahead and improved their systems or processes. Competitors that are boasting more modern capabilities have a competitive advantage in the marketplace.

The real competitive world is not waiting for your perfect time to implement change or transition to a new way of doing business, it continues to change and evolve. If you are not improving, you are falling behind. Manufacturers may not want to keep postponing these types of initiatives and may want to accelerate updating old systems and processes to realize an electronic Device History Record (eDHR). When manufacturers take the approach of waiting they run the risk of the following challenges:

  1. Loss of Competitive Advantage

Competitors moving to eDHR systems means manufacturing and quality systems are unified, automatically and dynamically tracking the who, what, when, where, and how of products as they move throughout the product lifecycle and eventually to the customer. Utilizing an automatic, electronic process eliminates the inefficiencies of manual paper-based DHR processes, reducing costs and improving compliance to regulatory requirements. Ultimately, this translates into your competitors being able to produce products better, faster, and cheaper.

  1. Expensive Custom In-House Solutions

Instead of taking the big step towards improving operational inefficiencies, many manufacturers look at the lowest hanging fruit, which involves enhancing current systems or processes. Time and time again, manufacturing and support staff works around constraints and somehow manages to create custom solutions made on top of existing ERP,  Quality systems or built on spreadsheets to improve their paper-based DHR processes. In reality, maintaining these custom solutions can be very expensive.

  1. Susceptible to Excess Risk

Relying on systems or processes that are costly, inefficient, and error-prone opens the door to unnecessary excess risk. Some of the potential risks involved in relying on paper-based DHR processes are expensive recalls, legal actions, cost overruns, and product launch delays. All of these risks affect the company’s reputation, hurting the bottom line in the end. Custom in-house solutions may also be adding a big unmanaged support risk to the organization.

Ready to move forward with that eDHR project? There is no time like the present. Best-in-class medical device manufacturers have already made the switch to a Manufacturing Execution System (MES) for their eDHR needs and are realizing the benefits of transitioning away from paper-based DHR’s, traveler’s, and other processes to help handle the complexities of the modern marketplace.

The ideal day or time will never come, so don’t wait too long for that “perfect moment.”

To learn more about how iBase-t can help your company transition with ease to a paperless processes in a manner consistent with your operation’s unique needs, contact us today.