Introducing our series of employee blogs and interviews with the uMotif team.
We're kicking off a series of blog pieces, interviews and insights into what our wonderful team here at uMotif get up to. We're delighted to showcase the passion and experience working every day to create modern data capture tools that patients love to use.
Our first feature is an interview with Michael Burke, our QMS specialist, focussed on two of the most important areas in our industry: patients and quality.
Keep a look out for further 'uWrites' over the coming months.
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Michael, thank you for taking the time to talk about what the quality team at uMotif gets up to. Could you tell me a bit about your role and background?
I am the QMS Specialist here at uMotif. I am responsible for embedding quality into all our activities, so we can deliver the best product today and into the future for every project.
I first worked as an analytical chemist, but for the last 18 years I have worked in pharmaceutical Quality for GSK, Fisher Clinical Services and Clinigen Group. During that time, I built and maintained Pharmaceutical Quality Systems to UK, European and US standards, which had to work around the world.
So what's the role of a quality function in Life Sciences?
Whenever I interview a potential candidate for a role in a quality function, whether for pharma or computer software for life sciences, I always ask this question first: “What is the role of quality?"
I get a lot of different answers, but only one-in-five say the magic word: Patients. Quality exists to support the end-user patient, whether for a medical intervention or a piece of technology that is used in a healthcare setting. By supporting the patient, the whole ecosystem benefits - from the team of healthcare professionals, through to a clinical trial sponsor.
It's a misnomer that quality functions exist solely to add process, to nitpick, or to pick holes in the way organisations are working. No: Quality exists for one reason alone, making sure that what is produced is suitable for the end customer to use. In uMotif's case, that is the study participant. Our quality department works to ensure that patients, clinicians and researchers all trust our applications to manage and deliver their data.
How do you go about embedding quality in uMotif?
Embedding quality is not a fire-and-forget exercise. That's the old way of doing things, where quality systems were built once and never touched again. This may be fine in theory, but what happens if there's a failure? You may be lucky and catch the defect before launch, sending you and your development back to the drawing board, losing lots of time and pushing release dates back who knows how long. Or, even worse, you miss the defect. In the life sciences industry, this can have ramifications not worth thinking about.
So we take a modern approach. We ensure quality ways of working throughout our organisation – it's a core part of how we do things every day: all the way through developing our product; the suppliers we work with; how we test our platform; how we deliver to our customers; and how we communicate the value of the product to the market. By putting quality at the heart of everything we do, we increase confidence in our product at every step.
What's so exciting is that by working like this, quality is a function that enables the business to continually improve and optimise, improving how everyone makes an impact for patients.
Is it unusual to have a quality function in a software company?
No, it's a downright necessity!
We are developing the next generation data capture platform for clinical research that patients love to use. Patients, their care team and study sponsors will rely on our software to collect data in clinical trials that will form part of the results of clinical research. The outcomes of this research will affect the future use of the intervention tested in the trial. We need to make sure that the patient and healthcare professional know that the data entered will be used in the right way, that the data is of high quality and - most importantly - that the data used in the analysis has been properly captured by the study participant.
What about patient privacy and data ownership?
Great question. This is crucial. Our view is that patients should own and control their own data. Full stop. Their data is always safe. We only provide access to the study or care team of a patient where they provide their explicit permission. At the start of a trial a patient will provide their consent for their data to be used by the study team. The data doesn't go anywhere else – which is just what patients would expect.
Why do you do it?
I go to work each day knowing that what I do will speed up the process of getting new treatments to the patients who need them. Along the way, it's great to know that the uMotif platform helps patients and their care team to better manage their condition during their study, with high confidence and trust in our application.
Thank you for your time Michael.