I'm Qualio's chief product officer. Here's what the future of our software looks like.
I joined Qualio this year because I saw the huge potential of a product-led, customer-centric organization serving life science companies with a great (and vital) quality and compliance tool.
I also joined because I have deep personal experience with the power of life science products, from pharmaceuticals to medical devices, to change lives. I am committed to making Qualio's ever-evolving software a critical part of the work done by our life-saving customers.
I wanted to share my thoughts with our blog readers.
Qualio is only at the beginning of its journey. Here's what's coming next.
The paradigm shift
This year, Qualio's 2023 quality trends report found 49% of life science companies continuing to rely on manual, analog, time-consuming and paper-based ways of working.
That’s nearly half of an entire industry hindered by various forms of friction.
That's practically half an industry ripe for improvement.
Qualio's goal is to take an industry that is based on complicated, disconnected, manual processes and transform it into one based on connected, collaborative and automated systems.
This change requires nothing less than a total paradigm shift in the underlying mindsets, processes and technologies of the modern life science industry.
A useful analogy to look at is the dramatic impact that SaaS products have had in other industries like shipping, logistics, fintech and payroll.
As one of our European medical device customers put it:
"The medical device world still feels backwards in many ways, entrenched in paper and with resistance to adopting new tools.
It feels like banking 20 years ago, when everyone was allergic to cloud SaaS products because of fear and bureaucracy."
Daniel Aragao, Chief Technology Officer, InVivo Bionics
I see this paradigm shift emerging in 6 key ways:
1. Ecosystems, rather than giant consolidated enterprises
2. Smart automation replacing manual work
3. Convention over configuration
4. Connected systems and data to demolish silos
5. Collaborative tools rather than individual tasks
6. Quality practices, not compliance documents
I believe these 6 changes hold the key to how life science companies will do their work in an increasingly digital world.
How to change the quality software industry
Change is hard. But we have very clear ideas about how to bring it about.
Audacity
People, generally, don’t like major change.
Quality professionals in particular are cautious, risk-averse and detail-oriented people. They've been 'burned' by systems in the past, so they often default to manual approaches where they personally touch every piece and step.
Lots of them still use (and even prefer) old computerized system validation (CSV) processes to validate any software they onboard, building mountains of paper IQ, OQ and PQ documents to protect against a slap on the wrist from regulators.
This distrust of digital change, in turn, stifles innovation and holds back life science companies from the fruits of software-powered automation and acceleration.
Qualio is an eQMS made for quality professionals by quality professionals. From our CEO to our front-line customer success and Qualio+ staff, Qualio is full of people with first-hand experience doing quality work.
We therefore believe we've found a better way to do things.
We believe it with enough conviction to challenge established ways of working - and to demonstrate the concrete outcomes of our approach to other life science quality professionals who have good reasons to be skeptical.
Curiosity & humility
What real, day-to-day problems do life science quality people actually face?
We must be curious enough to dig deep into this and understand needs beyond what our customers say. It's our job to create better ways of doing things that may be difficult for our customers to imagine while mired in their day-to-day work.
In turn, we need the humility to learn from our mistakes and keep improving our product to match those needs to the letter. Humility also means we are transparent with our customers about everything we are doing and why, so they will know they can trust us.
Remember what's important
The real goal of all life science quality professionals is safe and effective life science products - not compliance or documentation.
Compliance with regulations like GxP and ISO 13485 is how most governments try to ensure safe and effective outcomes for life science products.
Regulations generally represent the bare minimum. But they become a key focus because they're well-defined and legally enforced.
This legal basis means that quality work continues to be primarily about creating and maintaining evidence (i.e. documents) that a company has met their regulatory requirements.
So much time and energy is spent creating and maintaining these documents. And they're often simply descriptions of the processes that a company says it will follow (based on their regulations) and evidence that they have followed them.
Like all legalistic systems, regulations and regulatory evidence require some interpretation. As such, compliance is almost always mediated by an auditor who spends most of their time gathering and evaluating documentation.
The net result is an over-emphasis on documents and compliance as a whole.
As the ISPE puts it:
“The FDA has identified that an excessive focus on compliance rather than quality may divert resources and management attention toward meeting regulatory compliance requirements rather than adopting best quality practices…”
GAMP 5 Enabling Innovation Good Practice Guide
We must remember that safety and effectiveness are the real goal.
No one should really care about documents – not regulatory bodies, companies, auditors, consumers, patients, or anyone else. They care about safety and effectiveness, and about whether companies are following best practice.
Our goal at Qualio is to return the focus to safety, effectiveness, and best quality practice.
Documents should just be ways of getting content in and out of the platform: a means to an end.
Where Qualio is going: join me on November 28
This is where we are going long-term as a product and platform.
It’s bold and ambitious, and we'll be working on this for a long time.
But our customers should be able to clearly see the seeds of these aspects in the following days, months, quarters and years, as we make constant and steady progress.
Customers should be signing up with Qualio because of what we can do for them today and because they can clearly see where we are going.
I'll be discussing my product philosophy and my future plans for Qualio in more detail in a fireside chat webinar on November 28 at 11am EST.
You can sign up for the session here.
See you there!
Todd
