Pharma and Medical Device Companies share their experiences with transforming their operations with digital platforms like Tulip. This is the final part of a three-part series. Read and watch the second part here.
Q: What about GMP compliance, how important is it and does it need to change?
Paper obviously brings up the conversation of GMP. What do you see in customers when trying to chip them away from this obsession with paper? Here is what David has to offer:
(David Holt, FactoryTalk) I personally believe that it has to do with the systems that are available. A lot of the fallback from trying to go paperless happened because traditional MES shifted from custom software that met requirements at the local level to these big standardized systems that are not particularly flexible. In fact, what needed to happen in this shift was giving people the flexibility to do things exactly the way they want them done. As a result, there was this creeping back from digitization.
When you’re talking about GMP and removing paper from that process, you need the right sort of platform technology. You obviously need to have the right device controls, but you most importantly need something that’s standard enough to work across the entire organization and be able to funnel the data through. That’s why zero code has been the right step towards a digital solution in my perspective. Zero code solutions are technically configurable from a GMP system point of view, but also highly customizable. This opens up a good opportunity to introduce a simplistic way to move away from paper solutions.
Zero code platforms also have the added benefits of replacing a ton of texts with videos, and the ability to do error proofing. So once people see this technology, they have more of a will to really give this new technology a go.
(Patrick Hyett, GSK) I completely agree with that point. With the democratization of these types of tools comes the idea of self-service, whether it’s the RPA, BI dashboards, or certain machine learning technologies. We’re able to put the technology in the hands of the operators without a great deal of re-skilling. And what organizations have to do is navigate the challenges of putting a wrap-up around the operational use of these no-code tools – giving people enough flexibility to use them but under a level of support, guidance, and quality control. And that is the stage GSK is currently in the moment.
Q: What were the challenges in getting buy-in from the org?
(Rey Medina, Johnson & Johnson) What’s interesting to see in the digital space is that we have less buy-in challenges because businesses are pulling us along and introducing the new technologies they want to use. So the main challenge there is just fitting that into the source, test, scale process, and making sure we’re doing due diligence in the space and on the technologies.
Sometimes it makes for a very hectic and fast-paced workday when all of our business partners are coming in and saying, “Hey, we want some new tech”, but frankly, it is a great position to be in. It is about aligning the new tech that they want to test with what we’re looking to scale. So we’ve been fortunate in that regard.
(Patrick Hyett, GSK) What we see is that when the business partners are seeking out the technology, they’re much more in tune with providing a strong business case for ROI. They’re very much willing to do the work to vet the ROI a little more thoroughly.
One of the key things to getting buy-in is to demonstrate how a project is going to scale. You shouldn’t be in this cycle of constant proof-of-concept and or proof-of-value. Senior managers and site managers all want to see a route to scale and see the entire business benefits, rather than the benefits of just an experiment.
Q: What advice would you provide to someone to find ROI with a digital tool?
Here is a quick word of advice on how to find ROI with a digital tool, whether you are a small company or a big corporation. Here is what our panelists had to say:
(Rey Medina, Johnson & Johnson) I mentioned earlier how businesses should find ways of bringing new key capabilities through digital technologies, instead of just going back to their efficiency-driven labor metrics. In addition to that, what we found to be most successful is defining an implementation plan that’s going to provide more value over time. In order to shorten that time-to-value, we worked to define a minimum viable product, quickly implemented, generated value, and then layered in the new features and capabilities down the road. This approach returned the value sooner, and the sooner you see that the more you gain (ROI).
It’s all about the quick adoption cycles and starting out with MVPs.
(Patrick Hyett, GSK) I would say really focus on the use cases and the value propositions at an early stage with the right disciplines. This often means involving data scientists, process engineers, chemical engineers, and practitioners right from the get-go. If you can quickly build a team that can work together on the use cases and the value propositions, you will have the opportunity to fail fast on paper, and save a lot of time. And then, you can really build up to a key project that can be executed.
(David Holt, FactoryTalk) There is actually this one example that we’re working on at the moment that’s relevant to this question. We are currently working with a vaccines company in Singapore, where they’re both developing products and manufacturing at a small scale. We’ve been helping them come up with a GMP and regulated IT strategy, and we’ve learned that it makes sense for them to digitize their lab operations to make it easier to record what tests they’re doing and when they’re doing development work. And what they started to do is use the same lab and the process in GMP work for their manufacturing. And so what we’ve ended up doing, by process of elimination of looking at the high priorities, is building a QbD focused solution on Tulip. We already had central data sets in the app, and we could use the same data on the same platform for conducting GMP work. When you start to understand the magnitude of impact a digital tool can have, that’s when you know you’re looking at something that will create significant ROI.