Transcript

[DISCLAIMER] The following transcript is being delivered UNEDITED via a streaming service. This transcript has not been proofread. It is a draft transcript, NOT a certified transcript. It may contain computer-generated mistranslations and spelling errors.

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Introduction: Be’Anka Ashaolu, Director of Marketing, Propel (BA)

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Be’Anka Ashaolu: spinning off a $1 billion company in a regulated industry is no easy feat and standing up an entirely new IP stack in less than 12 months only adds the complexity.

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BA: In this session here, best practices from a company that recently did just that.

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BA: Learn how a unified platform strategy accelerates product. Time to value improve patient outcomes and increases customer satisfaction, all while remaining compliant with FDA regulations.

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BA: September Higham, VP of professional services at propel on this panel of leaders for advanced sterilization products Chanda Owens VP of global quality and regulatory compliance and Johnson Lai CIO and VP of it, share their experiences next over to us at Timur

Session

Moderator: September Higham, VP of Professional Services, Propel

Panel:

Chanda Owens, ASP

Johnson Lai, ASP

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SH: Welcome Chanda and welcome Johnson. Thank you for joining us today. I'd like to start out by talking about the amazing implementation that you did.

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SH: At ASP where you had to replace an entire technology stack in a very short amount of time.

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SH: You were part of Johnson and Johnson and then you were spun off and acquired by Fordham and you had a very short amount of time to replace all of your business systems.

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SH: What were some of the challenges and opportunities that you encountered as part of this 

JL: September. Thank you for having us. And answering your first question here.

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JL: Challenges and Opportunities are really one in the same. And for us, we were looking at 300 applications across the entire portfolio.

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JL: And we knew we had to simplify and reduce the number of applications we are running. If we were to be successful in getting off change a systems and standing up our own systems and so

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JL: The real opportunity or the challenge.

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JL: Because how do we do that in a timely fashion. How do we do that without harming our customers and shareholders that depend on us. And so it requires partnering with great technology partners, but also partnering internally with our business functional leaders.

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SH: Okay and shatter you are the owner of many applications five of which we replaced and rolled into propel matrix, when are easy.edu Maximo med Vantage unity and compliance wire and those were

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SH: Big business critical, critical

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SH: Applications and we roll those all into propel and you pulled this off within nine months. In fact, after four months, we had the first processes, ready to go and completely validated. That's a huge undertaking. Can you tell us a little bit about that.

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SH: And I'm not so sure huge undertaking isn't Justice. Right. 

CO: So anybody who's had to run entirely brand new quality management system can probably understand. You know what we were going through

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CO: I think the key there is really thinking about it is it's not just about the it and the technology, but it's also about the processes and the business and the change management.

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CO: So one of the key things that was for us was to really recognize how do we do what we do and how we do it in a different way.

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CO: It was how do we look at our process workflows and how do we make sure that the requirements are still the same, because we are on a regulated environment and need to meet those applications and those requirements.

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CO: But that doesn't mean that the tool that we use has to be done the same way I think once we got the team over that challenge. It was really good about planning.

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CO: And really clearly understanding what were my styles. What are nice to have. And then executing together, you know, with our it partners.

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CO: You know, with the technology with propel to say how can we make this all work together. So it wasn't easy. But if you think about it from not just an IT perspective, but from a process and a business perspective, it can be done.

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SH: Great. And Johnson, you had some interesting thoughts at the beginning of the implementation on

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SH: How to motivate the team, the very large team to implement these systems in a new way. Can you remind us what some of those thoughts were

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JL: Sure, I'm often when you ask people, what should we build from an IT perspective, they go back to what they know and what they know is the last system they're using or their current system.

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JL: So often, you, you have the rare opportunity or the challenge to stand up a new quality management system for us. It wasn't just that those are your

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JL: sandals every single application, and we know the initial conversation started with. Well, I wanted to work just like what I had.

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JL: And then the question often becomes if you want just what you had why we stand up a new system.

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JL: And so we mentally challenged ourselves to say, let's not think about what we have, how we do something. But how can we do it better, faster, and then more efficient manner.

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JL: We also challenged ourselves to say what do we think our systems needs our quality processes would be in the future. How do those fit together and you know the Wayne Gretzky quotes it skate to where the puck is going up.

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JL: When we have functionality and technology being new the paradigm of buying a license on servers, putting it in your data center was love to time costly as well as too expensive.

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JL: So when we started looking at the cross. Everything we thought, gosh, what tomorrow's applications sweets. Look, why

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JL: Their cloud base there on certain platforms. And so we chose and we looked at the elements. Again, it wasn't about what we had. But what do we think tomorrow's needs are and how do we build those today as we take advantage of both the opportunity and the challenges.

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SH: And Chanda when you're thinking about looking to where the puck is going and what our needs are in the future actually present some interesting regulatory challenges because you've got to stay compliant. What were some of those challenges that you had to navigate

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CO: That. No, that's a great question and maybe going back a little bit further to something that Johnson said

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CO: You know, my favorite quote when talking about innovation, right. People always think about research and development as innovation or new product or we can innovate with our solutions as well. And our tools.

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CO: And it's a hearing foreclosed as if I've asked people what they wanted, they would have told me they want it faster horses. Right.

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CO: Um, and it's not a, not a car. And so I think that the. Think about that. The same way we think about building our quality management systems and our tools.

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CO: Um, because you have to look at how do you innovate. Right. And then how do you take out a regulated environment. So for us it was what are my requirements, right, not the how I'm doing it. But what is actually the requirements.

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CO: And if you can navigate and you're still getting the same requirements, then you can play around a lot with the house right it's the one that can't change right

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CO: And I think that getting people to understand that aspect really help a lot with the talk about financial assistance from a regulated environment.

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CO: Now, all of us are in different situations in terms of our regulated.

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CO: ASP very complex and the fact that we're regulated differently, around the world, whether it be drugged regulations or medical device regulations were regulated as

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CO: Biocides for also regulators disinfectants. So we have a lot of different compliance regulations that we had to navigate. But we were still able to put a system in place and

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CO: Really I think someone's because propel gave us the options of being elegy modular based changes right and a lot of other platforms is very specific in terms of how they do it or it's customization and for us to give us that flexibility to really work on the. How about you.

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SH: Know, I'm sure. One of the challenges that you faced was your team was used to using

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SH: Five separate systems, a system that was purpose built for pls one that was purpose built for Q AMP is purpose built for equipment calibration.

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SH: So you were bringing it all of those into one system. What were some of the benefits of putting everything on one system and what were some of the challenges.

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CO: That wasn't benefits and everything being on one system is really that full seamless chase ability of all your quality records.

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CO: A lot of the quality systems do tied to each other, your non conformance is can escalate to cap as your campus can escalate to build actions, your complaints control your field actions.

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CO: Um, and in in our situation also, you know, we're obviously LinkedIn tight right up system as well.

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CO: I'm also having that seamless integration is amazing and and also from an IT perspective and even if

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CO: A software validation perspective and being your part 11 compliant. You're not integrating and redoing validation to

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CO: The five different systems, right, it's one system with the same platform.

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CO: A lot of times the same you know user friendly application, the same login with a lot of things that you can simplify from your validation strategy when you're on one system.

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CO: I think the challenges are that each of those individual platforms were very well geared and customize and state of the art for that one quality system.

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CO: So anytime you're going to go to, you know, one size for all you may lose some of that customization.

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CO: And so for us, it was the balance between what is it that we're willing to say it's not necessary and not needed versus whether we want to do.

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CO: You know configuration for to gain that back. And so I think you have to know that up front plan for it and then make sure that you you're able to, you know, have a robust conversation change management is big.

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CO: With us organization, our size we tend to have different business partners that are managing each of those different quality elements. So getting them to understand what is the greater good.

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CO: In terms of, you may not have that system the way you had it work. But overall, as a falling apart in the system and the functionality is working better for us. So I would say change management is very key and making sure you get that buy in early with the different posting on

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SH: A. Right. And not only did you were verge five systems into propel but you had to integrate with additional systems as well. For example, you integrated with

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SH: SAP with S 4 HANA Johnson. I wonder if you could tell us a little bit about that experience and what the benefits of integrating with SAP where

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JL: Sure, there are so many touch points between the quality management system in your order to cash earpiece system and we were able to at least

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JL: through just a few technical integrations enable that information to flow through one another and so as Chanda even mentioned even between all those five pieces of

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JL: Past applications needed to be tied together and that was had its own challenges. So I simplifying that and funneling it all into the VRP that gave us a lot of

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JL: I think cross functional and benefits that we didn't even anticipate

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JL: I know Chanda can talk a lot about how something happens on the panel time and they can automatically feed our PRP and give her teams capabilities that did not always exist in the previous environment.

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SH: I would love to hear more about that. 

CO: yeah i think it's both from a compliance perspective right having tighter controls on

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CO: Not just product on the back end, but also in the front end, but then also from a people perspective, right. So as an example.

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CO: Our PLM and system is tied to an earpiece system. So when we use a change management. We have a new bomb a new setup and that gives a group of rules seamlessly down to how it's going to be done. The bomb.

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CO: How production is going to be able to launch something or how somebody can then on the distribution side shipping those requirements all built in flow seamlessly.

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CO: Prior to that, you had to rely on a manual process of somebody saying oh yeah that's approved. So now you can go ahead and launch it in production. Somebody has to manually. Take the drawing and the process and move it over here.

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CO: On the opposite side of that, if you have a quality issue a challenge as we like to call them.

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CO: Then if you need to hold products that doesn't go any further, while you're investigating that issue. It was a manual step precedent, go back

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CO: And put that on hold, but not just in one DC but multiple disease around the world. We operate in 130 countries.

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CO: So being able to put on hold in one place and hold them instantly around the world to prevent a non conformance and getting out to the field is really putting our first person patients first. And so it wasn't just

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CO: From the perspective of quality, but it was from the perspective of really making sure we're thinking about, you know, how do we make sure that quality system issues do not get to our customer

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SH: Um, I was there throughout the implementation and I recall that the integration from propel to Sep was actually fairly smooth and quick integration to stand up. We also worked on another integration that was

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SH: Keys to complain. So we took Salesforce case records and made complaints out of them. That was also a fairly smooth integration. Can you tell us one of you tell us about the benefits of that particular process falling integration.

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JL: I think I could start that one and Chanda, could you add to that towards I mean for for us.

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JL: There are different stakeholders, our service teams are our lead out of a different organization as Chanda said that they're spread throughout the entire world and

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JL: Many of our complaints happen because our service people are in front of our customers and they'll give them information.

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JL: Or they're actually doing preventive maintenance on the piece of equipment and then they'll lodge information directly in it. So we were able to take all those entry points.

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JL: One very common entry point service and complaints and actually funnel it through one one process one interface and directly hand that to our quality team so that they could do their assessments and take the actions paintings

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JL: I would say prior to having a automatic innovation pass through from service over into the groupings of the system.

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CO: You had a lot of people working on their own manual Excel based platforms.

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CO: And then they would create that complaint and then I would get emailed to a centralized complaint team that they would have to interpret that complaint.

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CO: And then have to go back and ask questions if they didn't quite get everything correctly before you know the process you literally additive 30 to 45 days to each complaint from a

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CO: If she could say from a timeline perspective. So having a meal to go into the system. One, the team sees it immediately. So there's any questions they have, they can be funneled back

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CO: Into it gives us a capability of being able to put a fraud screening questions.

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CO: So that as you're inputting it in, they can ask the right questions to be ending on what the product structure is in the complaint and again that ties back that also having it.

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CO: Integrated with an earpiece system so we know by this product platform, you know, what are the typical types of questions to ask for the two types of complaints. So again, it's all about that seamless transfer of knowledge and information.

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JL: Would you say at the end. It's about ensuring our products have quality behind it and should anything happen. We want to be able to respond in the most efficient and most rapid manner.

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CO: Yeah, did you, um, I would say that we want to be able to trend in track and we believe we have high quality products, but no organization is perfect. And when we don't have that we want to go to correct equipment.

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SH: When you were evaluating or when you found yourself in the position of having to replace your entire technology stack and Johnson, I think you said you replaced about 200 systems.

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SH: And Johnson and Johnson systems. So when you were thinking about the PLM and QMS and the cumulus equipment calibration.

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SH: And so on. Were you thinking, I want to do this on the Salesforce platform or did that just naturally happen because propose on the Salesforce platform and it covered. So many of those areas. What were your thought processes there.

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JL: You know i i would say if you're you're asking a question that's hard to answer, but I didn't do my best. Because I think it's a little bit of chicken in a did we pick propel because of Salesforce or did did

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JL: He was good.

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JL: We picked her pal Salesforce as a platform. We picked and propel was just part of it. It's hard to say. What was the cause and effect.

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JL: But we do know for us. We started off by looking at our sales process every organization is challenged to grow and we're no different than anyone else. Although we have almost a billion dollars in revenue. And we're bringing it ironic in our startup.

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JL: We do know that having the right tools in the right hands is what drives revenue growth we were committed to having a sales process discipline sales process.

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JL: Salesforce became that when we looked at to amass and we we saw there was something built on Salesforce that reinforce our commitment to the platform itself. So we also knew that

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JL: Interfaces we built between any of the Salesforce tools and our earpiece and such could leverage and then on top of that, the efficiencies of having a staff work on as fewest platform as possible.

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JL: To us certain amount of economies of scale. Then lastly, we were building something, not just for ASP. Our company is committed to growing in the healthcare sector.

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JL: And as we grew organically and in organically, we needed something we could scale up with

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JL: And having a tool like propel or the Salesforce platform has almost infinite scale that we can just continuously add people and not worry about what servers do I buy what my data center handle it became a real advantageous element. So our decision 

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CO: Me, I'd like to add to that, because I think everything that Johnson said is that as a business owner

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CO: Who owns all those platforms. I wasn't looking at it from a sales force perspective at all. I was looking at it from the perspective of what is the best system.

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CO: Out there that I think will give me, you know, the most quality related processes for my team across all those platforms, it was clear for us that we wanted to have one system.

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CO: And we interviewed and we do a lot of demos for a lot of different platforms. And at the end of the day for palace, the one that we thought would give us the most in terms of not just

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CO: What we need to do now, but to Johnson's perspective what we would do in the future. I'm able to add on. How can I easily change my workflow.

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CO: And the big piece of this is can mind to do some of those changes for that we're not just, I have to now go to a coder, who's going to hard code something that's not the reality.

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CO: So you know how what aspect that is configurable. Those are key things for me as a business owner on the quality side.

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CO: And propel methods needs. Luckily for me. It also meant all the it news and Johnson just even though we didn't have to have, you know, a battle between ourselves, in terms of from dude shoes.

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CO: But, you know, that was really critical to me. It was really a matter of giving the best options across all the quality management systems and then he for us was is it configurable. It is something that we can move forward and change as processes and procedures muted.

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SH: Right, thank you for that perspective. So, earlier this morning we announced the launch of propel for medical device. And there's three components to this one is electronic instructions for use

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SH: The second is global product registration and the third is digital FDA reporting. So you are, you have an initiative to implement global product registration. I'd love to hear about your plans in that area. Yeah.

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JL: I am excited about this because truth be told, we were actually tracking towards another us technical solution. And when we had heard that this functionality was part of the next release, you know, having

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JL: Seen some of the previews and and and understand what you guys were offering led us to the conclusion that and in the coming months to next year we will be turning on the the registration capabilities that you just talked about.

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JL: You know Chanda talked about the ability to actually stop ship from anywhere in the world based on a complaint that changes into capital, whatever the case may be, that she has and her team has that capability something

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JL: turned on or off in propel changes what we do in the ER P system now with the regulatory capabilities we want that same element.

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JL: That the approvals from a country level on what products should go into a country or could be sold.

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JL: The inclusion exclusion roles can be actually done and propel and that will report back all the way to the order to cash. Your PV systems. And so we're excited about that. And our intention is to turn on that functionality as soon as we can.

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SH: Almost instantly. All right. Well, we're excited to work with you on that.

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SH: And evening. How are you managing the system. How are you managing global product registration now on. What are some of the gaps that you think you'll be able to fill

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SH: Using an integrated system like propel on the Salesforce platform.

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CO: Well, currently today and with I have two systems as you had mentioned earlier we invested from Johnson. Johnson. So we did have a global system.

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CO: As part of that process, but it was never connected to him. So it was born system its own platform that helps so

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CO: Um, you know that integration between regulatory and quality was manual and again between the regulations and what countries have been shipped to in the earpiece systems.

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CO: So the biggest benefit that we're going to get us now having any propel it's going to be enlightening with our technical documentation is how

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CO: So in terms of all the requirements that are needed for our registrations will be all there in one system.

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CO: It will be tied to our quality management system. A lot of times even registrations. You need to understand

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CO: Field action data capitated nonconformist data. That's all. Now in one system and then as Johnson was saying it and now seamlessly integrate into our earpiece systems. So in terms of controlling what countries, we can shift to not

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CO: That's really that exciting part about being on so it really touches a little bit of everything and

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SH: That's impressive. So one of the most impressive things that I saw as PJ during the implementation phase is you did some really interesting automation that were made possible because

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SH: You did choose the Salesforce platform as a backbone for your system. So just remembering all of the processes that you implemented.

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SH: It was pls Kappa is non conformance on its complaints equipment calibration and maintenance and training records and all of those had to go live in nine months.

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SH: But not only that you'd want all those processes. He wanted a lot of seamless automation between them. For example,

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SH: If somebody was renting equipment calibration and piece of equipment was out of, out of conformance you wanted a non performance to be written automatically or if someone field service person was

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SH: Was taking a case in sales for service cloud and that case met certain criteria you wanted to complete to be written automatically or you did a lot of really interesting automation with decision trees as part of the complaint an adverse event process.

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SH: G were those automation.

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SH: Things that you and a lot of those automation. We didn't even know that we needed to do at the beginning of the implementation, but we were able to do

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SH: In the process of the implementation. Can you tell me a little bit about the change management that you had to do to be able to incorporate the opportunities that nobody even never there including us at the beginning of the implementation.

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CO: I laugh when you say we didn't recognize it was going to do it. It's one of the downsides of having to move so quickly.

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CO: Um, you know, you don't get the opportunity to do as much planning up front, as you'd like to do we get a lot of that planning, but I think once you start working in the system and realize what you need.

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CO: As you're moving it becomes difficult, but we were working with a partner that was able to make those changes for us to implement the timeline that we had. That was great.

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CO: I say from a change management perspective, I think the biggest thing was, you know, obviously, some of these integrations with things we need it because of major pain points at the system right

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CO: And so in areas where we're taking the opportunity if we're going to validate validation. Can we is also nice so I made change management easy

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CO: Because people are saying, I'm now getting something that will help you is the challenge that I had on my job. I think whether change management was difficult was in, you know, people having to

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CO: Nobody likes to do more of a short timeframe. So whenever you tell somebody. Oh, by the way, we now have to add this process in there.

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CO: You have to do something differently. You have to go through the curve of. Why is that important. I think the biggest thing is you can explain the individuals. The benefit if they have

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CO: How it will change them. How old change within want to do and you can give them that buy in on that curve.

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CO: Then you have them. They really do work hard and they're willing to meet the timelines that you have. So the biggest thing for us is getting a lot of time on the why.

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CO: And what benefits, things were going to give us and then that really helped us with making sure those integrations to happen.

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SH:Right.

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JL: Before we go on, I don't want to understate the change management and I don't want to understate the leadership that Chanda really drove that process.

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JL: You know, technology, often we as technologists, we think it's easy because we were used to work more often that creator change, not necessarily always the recipient of change. And so it as we initiated all those changes right having a business leader who can actually drive. It's

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JL: Extremely important for us for better for worse, we took advantage of the time frame, the crisis created and and i would say

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JL: We chose to look at the crisis of time on on a positive note, but I would ask

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JL: Anyone who's thinking about this. What is the crisis, what is the burning platform. But what is the reason right

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JL: Because when most people are give them the choice to change versus no change. Most people would pick no change.

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JL: And unless you can find it the right catalyst with the right business leader who's driving it. It will all be very challenging. So

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JL: I was lucky enough to have a fantastic business leader to work with. Not everyone in it has that. But I if, in the absence of that.

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JL: You have to create a catalyst or crisis. And so that's a great perspective, 

SH: we have just got one minute more what what advice can you give

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SH: Other customers who need to do something similar and stand up a whole pls and que es plus environment and very short amount of time.

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CO: And it's not just about it platform. I think it's also about the people that you put on the team and the processes, right, you've got to know your processes.

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CO: You've got to be willing to look at your processes and see. Do they need to be changed. They need to be streamlined.

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CO: Right, and then look at how your process and work with it to happen and that's the number one piece of advice I can give. And you have to do something on a short time.

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CO: It's really about having all three of those work together. Where do you have any advice you'd like to leave us with yeah i i often it. People are very analytical and we look at scorecard. And we look at different measurements and the

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JL: Gartner magic quadrants, and all those types of things. But I the advice I would say is, who do you have on the project team first

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JL: And cool your partners and partners on the business side and on the technology side because picking an application without picking the right partner to work with.

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JL: Will have its challenges. So make sure you have the right talent, not only pick the right application but pick the right people to work and for us. We feel very lucky to have our business partners was to our organization.

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SH: Wonderful. Well thank you both for your words of wisdom today. And thank you for joining us.