Engineering quality in organizations to better meet patient needs with Matt Wictome from Datod Consulting

 

 

We've know many who have or had the job title of "Quality Engineer" however many outside the industry may not consider "quality engineers" to be actual engineers in the traditional sense (like mechanical engineering) - Matt Wictome's children think this way. But Matt explains how quality really is an engineering function because processes, products, and companies are being built or fixed—just as a mechanical engineer may build or fix an airplane.

Tune into this episode to learn more about how quality can be a central part of meeting patient needs.

About Matt and Datod Consulting
Matthew P. Wictome, PhD, is Managing Director and founder of Datod Consulting. Datod specializes in building better and more effective Quality organizations. Over the past thirty years he has worked closely with a wide range of companies implementing impactful change to better serve the customer, benefit the shareholder, and improve regulatory compliance. As well as holding qualifications in lean & Six Sigma he is an ISO 13485 Quality System lead auditor. He holds a PhD and graduate degree in Biochemistry and an Executive Masters in Strategy, Change and Leadership with the University of Bristol.  He is passionate in designing and implementing quality systems that are effective, efficient and outcome driven. His interests include how organizations function in the real world and the role of organizational culture has on the management of quality.

Datod's mission is to be the go-to partner for medical device companies who want to transform their Quality organizations to better serve their patients and grow their businesses.

www.datod-consulting.co.uk

Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

Music by keldez

Transcript

Transcript is automatically generated. Please kindly excuse any grammatical and spelling errors. 

Kelly Stanton: 

Hi, I'm Kelly from Qualio and I'm your host here at From Lab to Launch. Thanks for joining the show today. We've published over 60 interviews with innovators and life sciences across the world. It's been so inspiring to hear the stories of perseverance and innovation to improve human health and save lives. If you've enjoyed the conversations, please consider subscribing and giving us a review on Apple or Spotify. And if you wanna be on from Lab to launch, please see the application linked in the show notes. Today we're speaking with Matt Wictome who's a director at Datod Consulting in Wales, and we're excited to talk to him What they've been up to. Hi Matt. Thanks for joining us today.

Matt Wictome: 

Yeah, thanks that, Thanks for inviting me to, uh, give half an hour just to, to describe what I'm doing and what my consultancy does and how I can help the quality fraternity. It might help with a little background of where I've come from. I'm actually a biochemist by training and many people may know me from my, my sort of quality profession, but actually my background is in r and d asset development asset design. cuz really 20, 30 years ago, you know, a quality profession wasn't on, wasn't on the menu at school or a university, you know, basically you came from a, a technical background and now there's lots of opportunities to, to come in from a, a more sort of pure quality position. I actually got offered a job 20 years ago as a quality engineer and I didn't even know what that, that job entailed and I said, Oh, that will be different. And actually for the next 20, 30 years, I moved up the quality profession in different jobs. My kid, my kids found it really funny that in my job title I had the word engineer for somebody that's actually quite mechanically inept. But, you know, I was very proud of myself at the beginning. I was a quality engineer, so, uh, that was my start of my quality profession. And really. One of the reasons I stayed in quality is, is that the rolling quality really is quite powerful in terms of your ability to make an impact across an organization and also touch every part of the organization from, asset development to product development to write up to marketing. Really, you do touch every single, every single function. So that's the reason I've actually stayed within the, with quality. In terms of the company three years ago I set up Datod I think it was, it was one of those examples where life gives you an opportunity to do something different, and you and I, I managed to grab it in terms of setting the company up. Datod is actually the Welsh word for unravel. And a lot of the work I do with, with the consultancy is actually trying to unravel some of the complexity and the knots that organizations get themselves into. So, in many ways, I've become an engineer in some way in terms of fixed in organizations and trying to, to make them better. So even though my kids laughter the word engineer, actually, that's more or less what I'd do. I don't necessarily fix mechanical things, but I, I help fix, you know, organizations and, and quality systems in, in terms of making them better. The motivation for setting the company up was really, I felt there was a better way to deliver quality to organizations for patients. And really we're, we're different in two ways. Over the last couple of years, probably five years, there's been a real focus on the regulations and standards, especially within the, the European market in terms of I V D R and mdr. Uh, and that's been the narrative over the last couple of years and still is in terms of meeting those regulations. I set up the company really to try and move the conversation within organizations. Not to sort of ignore those, those regulations cuz you need to meet them. But actually really to sort of move the organization, quality organizations back into the sort of original perception of quality in terms of meeting patient needs. And I'll come onto that in, in a minute. So really the focus was on, on the regulations, but really my, my passion is sort of a purest quality. Purist in terms of how you can improve patient outcomes and, and build better products to, to serve the market. Uh, and obviously regulations have their place and standards, but in many ways over recent years, the, the focus on regulations, I feel has sort of resulted in a, a degree of patient unmet need in terms of Their requirements.

Kelly Stanton: 

I, I would agree with you on that. And I love you know, that you mentioned that quality purists, you know, we believe with that very strongly here at CUO as well, let's get back to what the regulations really require us to do instead of all of this, uh, activity that's, you know, really just for regulation's sake, right. Checking boxes and, and not staying with that customer centric approach, which is how I interpret what you mean when you talk about, you know, back focus back on the patient.

Matt Wictome: 

Exactly. Yeah. And the other way were different I was lucky enough to do a executive masters a couple of years ago in in strategy and, and change in leadership. One of the things that I was exposed to was, Some of the work from the social sciences in terms of how complex organizations actually work and actually help some of the recent research in terms of how quality systems are actually, you know, complex adaptive systems and they're not necessarily linear in, in the way that we look at them. So some of this thinking I really wanted to bring to the table in terms of helping organizations sort of understand themselves and make themselves better. But really sort of the core of it was really quality and compliance and not the same. I did see a recent poll in LinkedIn, in terms of quality professionals felt that I think 85% of them felt that there'd been more focus on meeting regulations in the past few years and actually meeting patient needs. And as I said, you know, I think really, you know, patient needs have been underserved. Definitely I'm, I'm not saying that, you know, regulations aren't needed. You know, compliance is a given, but when you go and purchase a car, you don't buy it because it's actually meeting all the electrical safety standards. You buy the car because it, it fulfills the need and got a requirement for it. And there are other sort of, you know, requirements of the car. You know, the, the compliance aspect of the car is just a given. So I hope in the coming years we'll put the focus back onto obviously meeting the regulations, but obviously really sort of meeting the patient in terms of patient needs. So really in a nutshell, my sort of, my company is sort of, uh, focused in terms of. Rebalance quality systems and, and put the focus back on the patient and, uh, use some of the new thinking that sort of I've been exposed to over the last couple of years in terms of how you can improve quality systems.

Kelly Stanton: 

definitely. It's interesting too, you know, I, I've spent part of my career in device and part of it in drug. And um, device Site is very focused on patient needs and patient outcomes. It's part of the design control inputs, but on the drug side I've always felt like that lacked, like we just didn't spend any time considering those things. Um, And then using those things to drive activities and risk within all of our activities in the organization, whether it's manufacturing or, you know, internal auditing. Like, are these, are these items really critical? Yeah. From a patient safety or product quality perspective. so. I'm interested in hearing a little bit more about approaches that you might recommend to become more customer centric. Yeah,

Matt Wictome: 

I mean, in terms of when you talk about customer, customer centric quality system, I mean, the obvious question is who are the customs of the quality system? That, that really depends who you ask and. If you ask a group of leaders, you'll get different answers. But, and obviously the one one group is regulation compliance. Obviously any quality system has to obey the law. The other big bucket is, is customer experience. We talked about the patient. Is the patient getting what they want in terms of their needs? And the other bucket that's often forgotten is, is actually, I call it business health. It's the financials. Sometimes if you get the companies have to make a profit and they have to sell products and be commercially viable. And this is quite an interesting one cuz there's been a. Very often a history within quality that we don't feel that we need to talk about cost and price and profitability. You know, that's a dirty word, but you know, that that's a, that's a real, really important factor in making sure that patients get the products they need. So, so an example within quality engineering, do all the individuals know the, the general price of the raw materials? You know, that's not always the case. Mm-hmm. and really, really sort of, To rebalance the quality system and really sort of make sure these three customer groups are actually being satisfied at the same time. So it's not just compliance, it's, it's the customer need and it's also also the business health in terms of the profitability of the business.

Kelly Stanton: 

Yeah, needs, needs of the business definitely need to be considered.

Matt Wictome: 

Yeah, so you need to grow the business. I mean, then you, you want be a successful business that grows and sells products. In terms of ways to be more customer centric. There's a lot, there's a lot of work in the, in sort of the lean fraternity in terms of how, you know, manufacturing have looked at, you know, what, what's, what's value in the eyes of the customer. And some of this methodology, if you apply it to the quality system, is quite interesting. So an example would be the control. Control of non-conforming product. This is a requirement in the regulations that you bond products that's defective. So the regulatory perspective of that, when they, they, they examine you, is that they would like to see a, a system where your, your material is actually bonded and you don't release defective product. Now, in terms of the customer looking at this part of the quality system, they're more concerned with, you know, are they getting the product they want? Rather than are you bonding the product, you know, as you should within the factory. But the operational, the business health perspective of this, of this part of the quality system is more concerned around, you know, are you scrapping the product off quickly? Are you making a quality decision quickly enough as such that I can manufacture? Uh, and if you are gonna scrap the product, are you exploring every avenue possible to make sure that is a valid, you know, a justifiable reason? So essentially by looking at the quality system from. Three different angles and putting sort of, you know, three different metaphorical hats on you can generate, you know, uh, indicators and, and, and metrics that really sort of measure whether your quality system is actually satisfying these different, and they're often conflicting viewpoints of the quality system. Rather than saying, is it just compliant? Does it meet the regs? Will it pass an inspection? Well, it, yet it has to do that. But really it has to do more than that. It has to make money and it also has to satisfy the patient and, and, and the end user and the customer of the products. So really some of the lean, lean thinking that's been around for many years is, is quite, it's not often it's applied to the transactional processes of the quality system, but it can be and, and it should be. And some of this thinking is actually quite useful. Definitely.

Kelly Stanton: 

Definitely. So tell me a little bit about the importance of change in risk management associated with all of.

Matt Wictome: 

I think for me, change in risk management, they really do underpin in terms of if you're gonna transform an organization. And very often we talk about change management. We actually organizations are concerned with, you know, how you make that change. Or very often organizations talk about change management and they actually talk about that. What they really mean is how they change documents. But it really goes more beyond that in terms of how you embed that change, how you understand that change. But one of the questions that change boards very rarely ask when they look at a change is, are you making the correct change? Are you fixing the right problem with the right solution? Are you actually doing the right thing rather than are you implementing it in a, in a controlled manner? Are you fixing the right problems with the right solutions? So really this is a, this is a question that really should go before a lot. The change control sort of, you know, Steps that are actually implemented. It's not about the implement. You can implement very well, a very bad idea, and many organizations do do that very effectively. But that's really, there's, there is a proceeding question in terms of are you fixing the right problems? It's really, are you, have you got that sort of, that ethos of, of root cause analysis and, and investigation within the organization and that sort of underpin. All goes along with, uh, risk management in terms of very often within, certainly medical devices. Risk management is actually sort of restricted. How, how you design the product, how you sort of build it, and how you sort of put it together. Really, risk management should go across all of the organization in terms of how you manage risk. Because really the risk management is the essence of being a quality engineer. You are taking risk based decisions every day in terms of whether you bond product, you release product, your rework product. So really effective risk management goes beyond just how you design the products. It really goes across the whole of the organization. So these go hand in hand. The ability to, to make the right changes in a controlled manner and assess risks as you go, the, these are the real drivers if you wanna transform an organization and really make it effective.

Kelly Stanton: 

So how do sort of these alternate views of the world help you better understand your qms

Matt Wictome: 

then? I, I, we talked about lean in terms of that being applied to sort of manufacturing over the last probably 20, 30 years. And it's been very successful. So I'm not noticing lean and process excellence. It's been really, really effective in terms of streamlining organizations. But it hasn't always worked in terms of fulfilling the, the endpoints, uh, we that we expected in terms of that methodology. And the reason for that is, is that organizations aren't machines where you can control inputs and verify outputs. Organizations are, are, are, are. Very complex systems. They're, they're living, breathing, changing organisms. And they don't often behave in terms of, if you're trying to control them in terms of, especially a quality system, it's a much more adaptive breathing system than a, than just a set of processes in a linear fashion where you can try to control. So when you try and control them, then very often you find that's, that's not always possible. And some of the thinking that, that came out of the, the studies I did a couple years ago in terms of. How social sciences looks at organizations as, as more sort of fluid entities that really is applicable to the quality system. Cause it's not just a system cause it's in its name, it's a quality system. It's actually a changing system that evolves. And some of the changes you make, it can have unexpected consequences on other parts of the system. So it's not as easy as inputs and outputs and, and this very engineering view of the. So that's one of the, sort of the new areas, sort of I, I've been working on in terms of new, some of that thinking to actually make better decisions. And there's lots of sort of methodology and framework around some of the newer thinking around how organizations behave to help quality professions make, but make better, better, better decision making in terms of, some of those tools.

Kelly Stanton: 

Definitely. Yeah. There's still people at the end of the day.

Matt Wictome: 

Yeah, exactly. Yeah.

Kelly Stanton: 

So, I think you kind of touched on this a little bit earlier, but if we could dive in a little bit more about the role of people, processes, and technology in building a transformation map for your quality system.

Matt Wictome: 

Yeah, I mean, when you, when you're putting together the map to transfer a quality organization or quality system, one point to the next, the very often the buckets use are people, process, technology. For me, it does start with people. It starts with, With their skills and behaviors. And really, I think the industry now is in a position where a lot of the, if you, if you have, if you describe the attributes of a, of a, of a quality professional, in very often they'd be very analytical, introverted, very comfortable with data. Maybe I'm probably describing myself there. those sort of, those sort of qualities, obviously you needed, You know, we need people to handle data and be comfortable with it, but I, I see the quality professional evolving in terms of we need behaviors that are, are different. They need to be inquisitive, they want to connect with customers, they want to collaborate, be pragmatic. They see their roles as teachers and mentors and coaches, and that's a very different skill set than very often the skill that attracts people into quality. So I, I'm not dis that those, those, those attributes, cuz I've got, I've got some of them myself in terms of those, those sort of, those sort of qualities. But really Really for, for, for quality of all the, the skill sets that, that are needed are actually going to be different and also where quality is embedded. So we, we talk about sort of, you know, from lab to launch really to, to, for that to be effective, quality needs to be embedded within the functions. It serves from, from the very beginning. Talking to the customers and when you design the product, not as an afterthought, you know, we built the product, we wanna sell it, let's, let's get the quality guys in to do the, do the documentation. Really, that, that in a collaborative way of, of working is needed for quality at the very beginning of, of, of a, of a design process. So that requires different behaviors in terms of people. And in terms of process and technology, really, really, they're sort of intertwined in terms of we need to build processes that meet the customer's needs. And again, it's back to the customer, customer centric quality system. And is, is it meeting the needs of those that need to execute the processes? So it's okay, a great quality system and our electronic system to. You know, within your organization. But if, if it's, if it's clunky to use and end users can't interface with it, and, and it's painful, then it is obviously not gonna meet the needs for, for the organization. And then the question always is, is it helping the customer? How is this helping the customer is the best way to help the customer? And really, essentially all decisions fall out of that. Definitely. So, so, We treat, we treat, you know, people processing technology as separate buckets. Really, for me, they're all part of a more holistic approach to satisfying patient needs there. It's not just the technology. You know, technology is very passionable and your, this is, this is a, you know, the shiny bit of kit, but more, it's more how you interface that with the people and the process to make this more rounded solution to making sure you, you're meeting patient needs.

Kelly Stanton: 

Definitely. So tell me a little bit about the practical tools and support that Datod provides Organizations, transform how they're running their qms.

Matt Wictome: 

Yeah, I mean, over the last video, so I've been working with a colleague of mine, Nina Wells, who's a very experienced quality VP who has been part of the transformation of numerous quality organizations. Tried to sort of, you know, really write in a book what are some practical tools and tips to, to actually help organizations, you know, start their quality journeys. So, this is gonna come out next year in terms of, you know, what are the practical things you can do to transform an organization not just in a theoretical way, but in, in sort of, you know, the hands on. So this is, this is coming out next next spring. This is this shameless plug for the book. You know, it's called Transforming Quality Organizations, So Practical Guides. So it'll come out in the spring, but that, that, that does include some of the theory, but it also includes a lot of the, the practical tips of how to sort of, to make a transformation. In terms of other tools, my, my, my company is, is very embedded in terms of helping organizations construct plans and turn those plans into reality. And one of the things we've working on over the last sort of two, three months is a diagnostic tool that companies can use to actually self-diagnose their organization and work out where ways they can self approve, improve in terms of building their roadmap. Really sort of build their, and, and if they want to, you know, part with, with my organization in terms of, you know, that making that, that, that roadmap a reality. So that tool isn't available yet. So I'm, I'm, I'm at the point now where I'm looking for me tech companies who would just wanna trial that for free in terms of piloting it. So if anybody wants to get in, touched with me after, after this podcast to get an access to the tool, then, then I'd more than happy to help them, you know, if they wanna just road test the tool. And. Basically generates the reports and some recommendations. So if any of your audience, you know, want some help with that and we just wanna have a go of the tool, then, then feel free to get in touch and I'll be more than happy to help.

Kelly Stanton: 

Okay, Perfect. so tell us what to watch out for in the future of quality.

Matt Wictome: 

I think the approach the quality's taken over the last three to four decades probably won't be adequate going forward, especially that we touched on it, the concept of the quality professional of the QA department. I see it. I can see more or less at times that quality group disappearing and being embedded within the functions. They actually, they actually serve and the skills and behaviors that we, we want, as we touched on before, I don't think necessarily that we've, we've, that satisfied us in the past will actually be good enough in the future. So there's a watch out for quality in terms of, are we. Are our skill sets changing as we go forward? I also think, you know, there's been a lot of focus on regulated compliance over the last couple of years, and I think this will settle down. Basically, it'll, it'll flush itself out and, and will get used to the new eggs and et cetera, et cetera. And then I think it positions quality to really, you know, Ask itself what it wants to be in terms of what, what's the, what's the role within the organization, You know, is it, is it more than just policing audits and, and, and, and executing audits and, and, and, and, and policing compliance? I think it offers much more for organizations if they can unap the power of their quality groups, you know, to make better products. And so sell products that the customers want and delight and actually help patients in the long run. So, you know, going back to the car analogy and my question to a quality professional is, do you want to be the, the person that's the, the quality individual that hands out speeding tickets? Or do you wanna be the quality individual that helps build a more beautiful car and a more efficient car? And I know which, which I'd wanna be, I'd rather be the person that actually designs the car than, than the one that hands out the speeding tickets. So I think the watch. For the future of quality really is quality's gonna have to change. But I think it's, as I said, you know, I've been in quality for 20, 30 years now. I've been, been in it because it is so embedded within your organization and is such a rewarding role. So I think that's, that's, uh, that's, that's a good place to be, I think.

Kelly Stanton: 

I agree. I agree. I enjoyed my time as a quality engineer as well. It was, uh, it was a lot of fun. Yeah. Absolutely. So where can we go to follow along, learn more about you, get connected. Find out more about your book and your tool.

Matt Wictome: 

Yeah, I've got, I've got a website which we, we can publish and there's a lot of information on there. Every couple of weeks I, I publish a newsletter to call Quality Rebooted, uh, which is really sort of a, a fresh look at quality from a different angle. So it's a bit lighter. It's, it's got a different stance on quality, so if people wanna pop into that, every will subscribe. every couple of weeks I publish a new topic. So basically that will give us sort of a flavor of, things I'm interested in and things that I'm passionate about. And also it might, it links to, my site and my company's site, which gives some more broader help in terms of what support we can give and information if anybody just just wants to drop me a DM and a message, then, then that's a great way to connect as well on LinkedIn or directly.

Kelly Stanton: 

Perfect. All right. Well thank you so much for your time today, Matt. It's been a lot of fun chatting about quality and how we can improve it.

Matt Wictome: 

It's been, it's been a pleasure.