Kenmark Eyewear is an employee-owned company headquartered in Louisville, Kentucky with many eyewear consultants across the U.S. and abroad. Their company is passionate about quality products, original designs, high ethical standards, sustainable practices, innovative marketing and superior customer service.  They have been committed to delivering excellence in eyewear products and services since 1972 and today that tradition continues.

Kenmark brands and collaborations include Paradigm, Vera Wang, Lilly Pulitzer, Original Penguin, Gemma Styles, Kensie and more.

Requirements

• Unique Device Identification (UDI) submission for FDA GUDID and future health authorities
• Plan UDI submission strategy process to machine-to-machine for 15,000 skus or more
• Receive experienced guidance for UDI data attribute tables and answer questions on exceptions

Solution

A provider for Unique Device Identification (UDI) submissions to global health authorities needs subject-matter expertise and the ability to assist with guidance and training as the submission strategy develops. With Reed Tech SingleSource™ for Medical Devices, Kenmark can transform and integrate medical device product data into a single repository for scaling as needed as additional regulators and customer demands arise.

Bottom Line

• Engage with subject-matter expertise and an integrated solution for planning UDI submissions for any health authorities worldwide
• Leverage a cloud-based solution to manage UDI data throughout product lifecycle changes
• Validate the UDI data values against FDA and Reed Tech business rules
• Plan global health authority UDI strategies as requirements and timelines are posted

Kenmark takes pride in mastering the details in everything they do—whether it’s their process, their product or simply a customer request, they do their best to consider all aspects, aiming to not only meet but exceed customer expectations.

At Kenmark, they believe in diversity and inclusivity for all; striving to continually do better and be better at bringing voices of all backgrounds and ethnicities to all that they do. Kenmark is committed to making mindful decisions and where possible, always making choices that are environmentally friendly, striving to reduce their carbon footprint. Kenmark provides major fashion brand eyewear to customers throughout the globe.

Like many companies, the pandemic hit them hard in early 2020. Receipt of stock shipments was delayed especially ocean freight. Shipment delays were running in many months as opposed to weeks. Almost all shipping alternatives in the supply chain were impacted. Travel became restricted and the majority of industries experienced a state of temporary paralysis due to resource and supply shortages.

Customer expectations required a reset and the day-to-day focus was slightly altered. Kenmark found that the pandemic experience was an opportunity to redefine processes, remove redundancies and gain a better understanding of their ERP system, launched two years prior.  As the close of 2021 nears, supply chain momentum is slowly coming back. With the focus on internal processes and getting lean where possible, Kenmark feels they have emerged from the pandemic disruption a stronger, more effective company in many ways.

Kenmark recognized very early that regulatory compliance with the US FDA Class I mandate required preparation and familiarity with the UDI process. Originally, UDI submissions would be due by September 2020. Due to pressures related to the pandemic, by the summer of 2020, FDA shifted the due date out to September 24, 2022. For eyewear makers, UDI labeling is a specific responsibility of the following types of scenarios:

• Manufacturer (including Kit Assemblers)
• Manufacturers (outside of the US that intend to commercially distribute in the US)
• Manufacturers of accessories or components that are packed or labeled for commercial distribution for health-related purposes to an end-user
• Private label distributors
• Relabelers and Repackagers

If a UPC is on the label, no further direct marking is required, however, UDI submission of data to FDA GUDID (Global Unique Device Identification Database) is required. Frame spectacles, sunglasses (non-prescription including photosensitive), magnifying (readers) spectacles, color and tint lenses (color vision plate illuminator) and some associated equipment carry UDI requirements for the 2022 deadline.

Susan Parker, Director Purchasing and Logistics at Kenmark Eyewear, led the UDI project, along with Kenmark’s IT team. Kenmark is an active member of The Vision Council and Susan was aware of the FDA requirements for eyewear frames, lenses and contact lenses. First, she began the process of understanding her current and future inventories and the team spent considerable time reviewing the documentation provided by the FDA. She had heard of Reed Tech through the association with The Vision Council membership as a ‘preferred’ UDI provider. When a UDI training session was offered by Reed Tech, Susan attended and found the session highly educational with real-world expertise presented for US FDA requirements, and also those of emerging health authorities.

Evaluating both risk management and the obstacles to new markets, Kenmark wanted to understand what data needed to be collected, the requirements, potential outlier exceptions and what could be done ahead of a looming US FDA deadline.

Kenmark Eyewear has about 15,000 device identifiers. For US FDA GUDID, to submit UDI data manually would have become a time-intensive, cumbersome process.  Only 500 device identifiers are accepted in a manual batch at one time. Manual entry to an online portal quickly becomes impractical. This would likely be the case for other global regulators. In addition, tracking all the various guidance and directives would require bandwidth their operation could not spare. Getting many points of data ‘moved’ from internal systems to a submission template is a tedious, repetitive process.  Additional questions lingered about following up on those products in the portfolio whose origin factory is now ‘closed’ due to the pandemic. How would the Medical Device Listing number be handled?

Reed Tech became an ally for Vision Council in 2019, providing educational opportunities for members to become aware and learn about health authority UDI requirements and timelines. With the UDI education opportunities provided by The Vision Council, Kenmark Eyewear decided to engage with Reed Tech and SingleSource™ for Medical Devices for a direct machine-to-machine option for US FDA. Eventual market expansion will include all the health authority channels where UDI submissions are required. Onboarding meetings with an Account Manager guided staff step-by-step through the submission process.

The resourceful IT team at Kenmark developed an internal tool to bring the needed data points into the proprietary Reed Tech process for upload to SingleSource™. Both sides have a clear understanding of each of their process steps. Kenmark now has a centralized repository of UDI data, validated to health authority business rules and acknowledged for submission. Future orders can easily be uploaded and maintained in one repository.

The time, energy and effort on resources to figure UDI out should not be underestimated. For risk management and managing all the data, engaging with a known UDI provider created a better comfort level. Reed Tech has become both a technology partner and a source of subject-matter expertise. When obstacles or questions are encountered, engaging with subject-matter experts is much more efficient than trying to go ‘it alone’.

Bringing the IT team to the process at the very beginning was the logical, critical step. It validated current understanding and helped identify exceptions in their inventory. Focusing first on the exceptions could easily overwhelm the big picture.  Moving forward, the bulk of their skus have already been submitted to US FDA GUDID, checking a big task off the list. Secondarily, Kenmark has time to resolve the subset of outliers requiring further guidance and plan to have all submissions done well ahead of September 2022.

So far, Kenmark has successfully transformed its regulatory process approach to UDI, turning the uncertain time of the initial pandemic stage into a positive period of ‘fine-tuning’ how they work. They diligently gained an understanding of what needed to be accomplished for UDI and chose to engage with an experienced UDI submission provider. With a ‘single source of truth’ and the know-how of trusted collaboration, Kenmark Eyewear has the foundational experience to carry them through the next phases of emerging global health authority mandates.  

Learn more about medical device product data management at Reed Tech