You May Have Found a Way to Be Compliant with DSCSA, but Are Those System and Process Changes Making Any Difference Elsewhere in Your Organization?
Two healthcare and pharmaceutical sector experts say resistance to change is causing many organizations to miss out on the benefits of automation and experience preventable disruptions in their operations.
How much has the Drug Supply Chain Security Act (DSCSA) impacted your business?
I suspect you’re putting new technology systems or processes in place to comply with the forthcoming regulation. But have the required changes offered unexpected operational benefits?
If you’ve only been focused on putting a minimally viable product in place to hit that compliance date, you may not even be assessing the business impact. However, we’re sort of at a crossroads in the healthcare space right now in that you can use this forced change to gain operational efficiencies that have long been missing. This is true whether you’re a drug manufacturer, pharmaceutical distributor or healthcare provider.
If you have to track and trace every drug produced, distributed, and administered and verify its authenticity and quality at multiple touchpoints, there’s a lot to be learned from the data that will be collected during those processes. That’s assuming you have the right data collection and analysis systems in place and this process doesn’t become a burden on your team.
So, I recently sat down with Michieva Flores, Senior Advisor, Strategic Business Development at Zebra, as well as Bill Erderly, a senior solution architect from Körber Supply Chain Consulting, to understand how you can better turn DSCSA requirements into business advantages.
Michieva and Bill both have extensive backgrounds in the healthcare space in various roles, including supply chain and compliance, and both have seen the power of technology and the missed opportunities for operational improvements in working with healthcare organizations.
And since they have both been in environments – or consulted for organizations – where legacy solutions were used to meet modern regulation requirements and safety standards, I wanted to find out if there were any liabilities assumed by organizations when trying to retrofit systems that weren’t meant for this type of track and trace application. Here’s what they shared:
I was also curious if they have seen a lot of effort being made within the healthcare supply chain to automate data collection and analysis as it pertains to product inspection, track and trace and so on – whether the goal is to build DSCSA-compliant solutions or otherwise solve business problems. Their feedback was surprising:
Of course, this had me wondering what’s causing the resistance to automation, so I asked them to summarize some of the “closed-door” conversations they’ve been having with healthcare supply chain leaders. I suppose I’m not too shocked by what they shared, though I am a little concerned given how important it is to automate data collection and, to a certain extent, decision-making to help front-line workers work more efficiently and better serve patients’ needs.
As you’ll hear both Bill and Michieva explain in this next clip, there’s a lot to lose by only doing the minimum to check the box. In fact, many healthcare organizations and pharmaceutical supply chain companies are starting to admit they’re unhappy with the “solutions” they originally implemented for the sake of DSCSA compliance because they didn’t think bigger picture or were afraid that doing more than the bare minimum would be disruptive.
Fortunately, Bill and Michieva are accustomed to working with healthcare and supply chain leaders and front-line workers who are resistant to change, and they know how to make people more comfortable with it. So, if you or someone on your team needs more convincing of the value of automating temperature checks or product authentications – that the time and money you’re going to have to commit to automate across your value chain will pay off in a big way – you’ll want to hit play on this next video. Bill and Michieva do a great job of articulating the risk vs. reward. They also share “good, better, and best” approaches to integrating the processing of serialized inventory into your business processes and garnering a positive labor efficiency impact from automation. Listen to this:
Now that you’ve got what you need to garner support for greater automation across your organization – not just for the sake of DSCSA compliance but for the good of your business – let’s talk a bit about next steps.
As you get the right people in the room and start considering what you want to holistically accomplish as an organization or with your value chain partners, it’s very important to map out exactly what you want to do, why you want to do it, and how you want to do it. Only once you have alignment on that strategy and approach can you start to consider which hardware and software will best support those ambitions. You have to back into the technology versus lead with it, which is why it’s important that you have people like Bill and Michieva who understand your business and can help connect those dots in that room with your team.
They can point out whether technology-related decisions or process changes made with DSCSA compliance at the forefront, for example, offer any benefit or if you should prioritize business requirements when adjusting your tech stack. In fact, even though Michieva works for a tech company, she admits that she’s not joining conversations to make IT recommendations. She’s there to advise on how to make business process improvements. If technology can help, then it certainly comes into the conversation. But putting new systems in place just because “it’s time” or there’s a new regulation that you must follow can lead to regret. You’ll definitely want to tune into this part of our discussion:
If you’d like to hear our full 45-minute conversation, you can download the MP3 below to listen to at your convenience.
How to Use DSCSA Requirements to Your Advantage
I hope the insights Bill and Michieva shared and the experience they’ve gained in their 20+ year careers in the healthcare and pharmaceutical sectors prove to be of value to you. If you have questions for them, you can email them directly:
Bill Erdely, Senior Solution Architect, Körber Supply Chain Consulting
Michieva Flores, Senior Advisor, Strategic Business Development, Zebra Technologies
