Steps to Jumpstart Your UDI Program

This blog was co-authored by Cathi Crist, partner, and Scott Gibbard, senior manager, Kalypso.

Part one of this series addressed the top six questions medical device manufacturers need to ask themselves to get ready for UDI. Part two addressed what medical device manufacturers need to know about the FDA final rule system. This, final installment will wrap up the action you need to take to get your UDI program going. As the September deadline approaches for manufacturers of class III medical devices to meet FDA’s final rule for Unique Device Identification (UDI), Kalypso experts provide analysis on how to jumpstart your UDI program.

The recent observation is that many companies--especially those without class III devices--are in a “wait and see” mode, or at best, have delivered an informal communication to the obvious UDI stakeholders and had a loose planning session or two. But there often is no formal strategy to achieve UDI compliance, no designated project team, no structured work plan, and likely no approved funding. Often UDI is not yet on the executive management’s radar; hence ownership for UDI is often diffuse and too low in the organization to get the proper attention. If this sounds like your organization, keep reading.

Build Your Program for Success

Strategic initiatives like UDI are never implemented by accident. Thoughtful companies will launch their UDI program using the same discipline and rigor they would use for any other strategic initiative that affects people, processes, and technology across many functional areas. Implementing UDI may not be as complex as implementing ERP or launching a new business unit, for example, but many of the same principles apply.

Understanding and communicating the implications of the regulation is only the first step. Delivering a compliant UDI capability for your company requires a project team, funding, a comprehensive plan, and strong executive sponsorship/governance.

 

                What to Do                                   Why This Is Important

Think Holistically:

A common misperception is that UDI is just a project for “the Labeling group” (or “the Regulatory group”). UDI will affect many functions in your company (Quality, Product Development, Engineering, Supply Chain, Operations, IT, etc.). Your program should be structured accordingly.

 

Taking too narrow a view on UDI may allow things to fall through the cracks, which increases the risk of missing a compliance deadline

Involving all upstream/downstream functions early on will not only help you satisfy UDI compliance requirements, but enable you to build in the hooks to realize the future operational benefits of using UDI

Build Sponsorship and Team Accountability:

A successful UDI program requires timely cross-functional decision-making and agile execution. Program governance/sponsorship should be established with clear decision boundaries. Work stream leads should be empowered by their function to make decisions and should be chosen, in part, by their ability to connect thedots and a demonstrated ability to influence their peers.

 

A “light but frequent” cadence with a UDI steering/ governance committee will ensure the team does not waste time in wait-for-approval loops

As with most cross-functional initiatives, facilitating thoughtful tradeoffs will require team members who can simultaneously represent the interests of their function and still do what’s best for the company

Understand Your Portfolio:

Most companies have a rough idea how many SKUs will be affected by the UDI regulation, but few begin their UDI journey with a clear analysis of their product portfolio, broken down by:

Device class (I-II-III)

Manufacturing location

OEM vs. In-house

Reprocessed products

 

The distribution of your products by device class may significantly influence your program, particularly your approach to collecting data and submitting to the FDA Global UDI Database (GUDID)

The geographic dispersion of your manufacturing and labeling operations will dictate when/how to involve site operations into your UDI program

Deciding who will be the “labeler” and clearly defining roles and responsibilities associated with UDI are critical decisions to make with your external partners

Find Your Product Data…If You Can:

Even companies with established master data practices will be surprised how few of the necessary UDI fields will be easily extracted from PLM or ERP systems. Many data elements will exist only in document stores or within desktop spreadsheets. Other fields will not currently exist anywhere and will need to be created.

 

Assessing your UDI data availability should be one of the first activities to start on, since it does not require a significant resource commitment and is almost always underestimated by companies

Distinguish between “one-time” data aggregation (current products) vs. building a process for “new” data creation (future products)

Prepare for Process Changes:

Process changes in a regulated industry are never pleasant, but the UDI rule and subsequent conforming amendments to other regulations will drive many changes to business processes--beginning with your quality systems and new product development processes. If you don’t currently have data owners/stewards and a process to manage data quality, you may need to define them.

 

In addition to process changes resulting directly from Part 830 (UDI), other changes will be required as a result of future amendments to other medical device regulations (e.g., Part 801 Labeling, Part 803 Medical Device Reporting, etc.)

Resist the temptation to treat UDI as a one-time event. You must build a durable process to effectively manage your UDI data throughout the product lifecycle

Assess Your Technology Options:

Map your IT system architecture to identify all possible sources and owners of product and regulatory data. The UDI technology solution could involve manual entry into the FDA UDI portal, custom development, implementation of a packaged software product, or engaging a third party UDI submission service provider.

 

The complexity of a UDI technical solution may vary considerably--but should never be an afterthought

Alignment with corporate IT architecture, implementation complexity and overall cost of ownership should be considered when evaluating options

Connect With External Business Partners:

FDA allows medical device companies to decide with their partners who will be the “labeler” for each product (and thus submit the product data to the FDA). But, do not limit yourself to reaching out to manufacturing partners only. Supply chain partners, healthcare providers and end-users are all stakeholders who should be engaged.

 

It’s essential to align with your business partners on which party will submit data to the FDA. Only one party should submit data for a given product

Working with customers/providers and supply chain partners will ensure you get the most out of UDI, both for patient safety and operational efficiencies

Consider Engaging a UDI Partner:

Navigating the nuances of the UDI regulation can make for some implementation bumps. One option is finding a partner who specializes in one or more aspects of UDI (e.g., managing process and role changes, building a data quality strategy, or implementing UDI technology solutions).

 

Partners can provide advice and implementation support for UDI best practices, with the advantage of having worked with many companies to see what works or doesn’t work

Support from a UDI partner is temporary, with no need to backfill resources

 

It’s No Time to Rest

Companies with class III devices that feel they are well positioned to comply with the immediate deadline should not rest on their laurels. Processes built to handle a few class III devices may not scale well to handle the higher volume of class I-II devices, and may not be designed to deliver longer-term business operational benefits. The UDI program should stay in place to improve performance and extend the processes to accommodate higher volumes and future benefits beyond just compliance.

 

Companies with only class I-II devices … it is time to get started!

 

Cathi Crist, Partner at Kalypso, Cathi has over 20 years of engineering, product development, operations management and consulting experience across multiple industries with an emphasis in life sciences.

 

 

 

 

 

 

Scott Gibbard has over 20 years of engineering, product development and consulting experience across several technology and science-driven industries, with a particular focus in biopharmaceuticals.

 

 

 

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Ruthann Browning

Ruthann Browning is a 28-year veteran of process equipment and automation. She currently handles Technical Sales in Automation in Comco’s western division and spearheads sales and marketing for...

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