How to Maintain Velocity Without Sacrificing Quality: Interview with Qualio Founder and CEO Robert Fenton

Fast, good, or cheap — you can only pick two, so which will it be? It’s a common question, but it’s probably not one that’s best suited for the medtech and healthtech industries.

For many, quality is viewed as a hurdle, slowing a project’s velocity, but Robert Fenton founder and CEO at Qualio is determined to change that reality for companies developing life-saving products.

While working in drug development for some of the world’s largest pharmaceutical companies, including Pfizer and LEO Pharma, Robert observed how an organization moves an idea from bench science to proof of concept and beyond.

“What really struck me is that companies make a clinical promise: First, do no harm,” he says. “If you’re working on a medical device that’s going to diagnose or treat something really important, it must be safe, it must work effectively, and it must work consistently, which is, essentially, the promise of quality.”

Robert set out to develop a cloud-based quality management system that would help life sciences companies launch and scale their life-saving products without sacrificing quality or slowing down the multistage process.

In this episode of Medsider, Robert shares his predictions for the life sciences industry in 2022. He also discusses how Qualio can support (and not hinder) medtech and healthtech companies as they move through the complex process of taking a product from conception to the market.

Guest

Robert Fenton

Founder and CEO of Qualio

Robert Fenton is the founder and CEO of Qualio, a cloud-based all-in-one quality management system (QMS) for life sciences companies. Prior to founding Qualio in 2012, Robert studied pharmacy for five years at the University College Cork, practiced as a community pharmacist, and spent time in quality and R&D roles at global pharmaceutical companies including Pfizer and LEO Pharma. Robert made the move to San Francisco in 2016 after bootstrapping Qualio in his home country of Ireland.

Listen to the Interview with Robert Fenton

Key Learnings from Robert's Experiences

  • Funneling all involved parties through a single quality management system (QMS) increases efficiency and allows medtech and healthtech companies to move with speed (without sacrificing quality).
  • Sharing data with integrated APIs will unlock quality and create a flow of information. While quality control has historically been viewed as a bottleneck, new technologies allow the quality function to become valuable partners, contributing to improved therapies without slowing the process.
  • The medtech industry is on the precipice of a new era. People want to pursue meaningful work. As a result, there’s never been a better time for medtech companies to scout out new talent.

Quality Management Doesn’t Have To Be a Bottleneck

Quality management systems have a bit of a reputation in the medtech and life sciences industry: they’re a drag — literally.

Most systems are tedious and universally disliked by medtech innovators everywhere.

Archaic operating systems coupled with the pressures to move through the many stages of developing a life-saving product means that many life science leaders face a choice: pursue a rapid path to production or prioritize quality.

According to Robert, it’s a mindset that’s “still embedded in the industry,” but that he’s determined to change.

Eliminating the false binary choice is the angle of attack for every conversation within Qualio as it continues to develop quality management system (QMS) products to support innovative life sciences companies.

Qualio simplifies the FDA and ISO regulatory compliance process by funneling the required steps and data through a single source. Internal issues, external issues, product development, traceability, design controls — it all aggregates in one location, allowing medtech developers to get to market as efficiently as possible.

“We don’t celebrate you passing an audit; we celebrate you getting to market. We don’t celebrate you having a 5% improvement in some topics; we celebrate you feeling like you can move at a velocity that gets your business where it needs to be. That’s the reason people choose Qualio — it’s our customer success-focus on business goals.”

The company serves a broad range of customers, from small three- or four-person companies to household names in the pharma business. “We’re the only company out there right now that can demonstrate scale the whole way through to IPO and beyond,” says Robert.

What To Expect From a Next-Generation QMS

With over $63 million in raised capital, Qualio is clearly onto something. The QMS platform, in just a few short years, has grown from employing a dozen people to over 250, serving more than 400 customers.

Partnering with a diverse group of life sciences companies has provided unique insight into the future of the industry, which Qualio shared in its 2022 Life Science Quality Trends Report.

Robert discusses four primary trends he believes will take center stage this year:

1. An interconnected ecosystem

Robert envisions a “closed-loop ecosystem” for the life sciences industry, with a fully connected supply chain for life-saving devices.

From devices to therapeutics to vendors, when all aspects of the industry have access to shared communication and operational channels, that’s where the value lies.

The interdependence of the many players in the life cycle of a life sciences product means Qualio possesses a first principles-level understanding of what’s happening in the world that no one else can have. In addition, the ability to connect the ecosystem is a way to “generate value across its entire network,” says Robert.

The idea that development and production occur in a vacuum is a misnomer. Take the COVID-19 vaccine, for example.

“Pfizer and BioNTech created that vaccine, really. So how do you parse that [out]?”

It’s a real-world example (that many of us have in our bodies) demonstrating the shift to partnerships and an interconnected network of life sciences companies.

Collaboration and the sharing of resources provide tremendous opportunity but can also complicate systems and processes, which is where Qualio plans to serve as a support, facilitating the exchange of ideas and data, streamlining opportunities for cross-pollination of ideas.

2. Data sharing with APIs

Even the life sciences network can’t be viewed in isolation. “We have to look at it as an economic whole,” says Robert.

Meaning for cross-pollination to truly work, collaboration and the exchange of ideas and information needs to extend beyond intellectual property and include the sharing of data.

These days, the majority of Quality data isn’t generated in-house, but rather it comes from vendors.

But some big challenges come with this shift: namely, are companies open to sharing data, and are application programming interfaces (APIs) in place to make it all possible?

Robert sees that a common source of fragmentation comes when working with outside vendors and data sources. As a result, Qualio has invested significant time and resources into developing integrations that allow for an easier exchange of information.

The long-term vision is a Salesforce-inspired platform, connecting the dots between medical device companies, vendors, data sources, and supporting technology.

“Integrations and automating through APIs is the unlock — turning [those who safeguard quality] into partners, not obstacles.”

For example, take one of Qualio’s customers, Empathic Clinical Software, a medical device product that builds algorithms based on human behavior and AI to support project management in Behavioral Health.

The company integrated Jira this past year, automating many of the software’s documentation functions. The integration cut the company’s time down by a factor of 10.

“That’s real velocity,” says Robert.

3. Quality as an enabler

Healthcare companies employ some of the most brilliant minds in the world. Yet, many large companies continue to manage their quality systems with paper and/or manual processes. Robert believes the switch to cloud-based QMS software is changing the industry.

A digital approach to quality management eliminates stop gaps and speeds up archaic processes so that life sciences companies can focus less on paperwork and more on the exchange of ideas, securing financing, and meeting regulatory requirements.

Cloud-based QMS software makes efficient quality management possible.

4. Mission-driven work

Employees care increasingly about culture. The workforce is experiencing a global paradigm shift — people want to feel fulfilled by their work.

As employees seek out companies that align with their values and life purposes, mission-driven opportunities are becoming increasingly popular, which is good news for companies focused on developing life-saving products and technologies.

Stanford University, an academic institution long-known for its contributions to the startup economy, has seen a significant uptick in enrollment for its biomedical courses. The department’s numbers now rival the school’s prestigious computer science department.

Robert thinks the trend is a direct reflection of the unique appeal that the life sciences industry has for today’s students: why choose between an innovation-focused career and making a lasting impact on society? With medtech and healthtech, you can do both.

“People are being more critical,” he says. “Am I just building a widget? Or am I building a widget that might do something that's really impactful for somebody?” When this purpose-focused approach to work is married with the speed that Qualio enables, the life sciences industry is positioned to scale new heights.

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