The Power of Quality Data

Key Learnings From Don’s Experience

• In the startup world, there’s no room for inefficiency. Spreading your efforts too thin can be risky. Choose a focus—one that aligns with your company’s strengths—and direct your efforts there.

• Precise, clean data is the backbone of any data-driven technology. With high-quality data, everything else—whether solving a problem or training an algorithm—becomes much simpler. Keeping things in-house gives you the control you need to design trials carefully and ensure accuracy and reliability at every step. It also lets you connect directly with potential users, gathering valuable insights, building trust, and refining your technology based on real-world feedback.

• Transparency and mutual respect among team members are crucial for an efficient startup. Be open about goals, challenges, and successes, and show respect for everyone’s ideas and contributions. When hiring, prioritize flexibility and growth. Start by bringing in consultants or part-timers to assess their fit before committing to full-time roles.

Don Crawford is back on Medsider after 8 years, this time as President and CEO of CorVista Health, a subsidiary of the Toronto-based Analytics for Life, which has developed ML-driven, point-of-care diagnostic systems for coronary artery disease (CAD) and pulmonary hypertension (PH). In our previous interview, we spoke about Sapheon’s incredible journey that led to a $238 million exit to Covidien. 

After earning his chemical engineering degree from Georgia Tech, Don joined Medtronic as a clinical service rep. He spent the next twenty years working in sales, specifically focused on cardiac rhythm management and interventional cardiology. Over two decades, he navigated multiple mergers and held roles at major companies like Medtronic, Guidant, and Boston Scientific. Meanwhile, he pursued an MBA at Emory University. 

After leaving corporate life in 2006, Don started consulting. During that time, one of his physician clients had a venous-related idea, literally on a napkin, which would later become Sapheon. “And six years later, after clinical trials, FDA, PMA approval, we ultimately sold that idea to Medtronic,” Don shares. Today, Sapheon continues to thrive, having shipped over one million kits worldwide. 

Sapheon’s success stemmed from its lean and efficient approach to product development and its commitment to quality management systems. “From the time I joined CorVista, everything was implemented through a quality management system, almost as early as employee number two or three,” Don shares. 

CorVista’s technology offers non-invasive, radiation-free testing with results in under 15 minutes, streamlining diagnostics and expanding access to cardiac care, especially in underserved areas. The CorVista System, the world’s first point-of-care solution for evaluating the presence of significant CAD and PH, has achieved FDA clearance for both indications, and earning breakthrough designation status for the PH add-on, on the basis of its superior performance to the standard of care.

Don’t Spread Your Research Thin

CorVista’s early work was processing physiological signals—electrical, hemodynamic, and imaging—with a team of data scientists who had no prior experience in medical devices. They collaborated with a doctor, gathered signals, and, on a modest $2 million budget over two or three years, demonstrated that their technology could potentially detect abnormalities in the body. 

Achieving this in such a short time and with limited resources was no small feat. Don credits this success to the team’s commitment to remain focused. While the company holds patents in cardiology, neurology, and oncology, they chose to focus on cardiology, because, in medtech, resources and time are limited. As Don puts simply,”The key to a small company is to stay focused.” 

So, how do you decide how to narrow down your focus? For CorVista, their research pointed the way. The team identified coronary artery disease (CAD) as not only one of the most critical global health issues but also an area where their technology could make a significant impact. Despite decades of treatment options, CAD remains a leading cause of death globally. The efforts in reducing mortality rates have unfortunately made limited progress. This lack of impact is what drew CorVista’s attention to CAD. Don explains, “If you take the energy, the three-dimensional electrical energy produced by a heart, you can detect signals that are being released from the body; we could interpret those signals and see a difference between a disease state versus a healthy state.” 

This focused approach also improved resource efficiency. If Don hadn’t chosen to concentrate on a single indication, the team wouldn’t have been able to demonstrate hard evidence of their technology’s capabilities with just a $2 million budget. 

Moreover, a focused strategy helps maintain regulatory and quality standards. At CorVista, implementing a quality management system early on—specifically tailored around their target indications—ensured consistency and compliance throughout product development. Don emphasizes, “From the time I joined CorVista, everything was done through a quality management system, almost as early as employee number two or three.” 

In short, by zeroing in on cardiology and building a solid foundation early on, Don was able to develop a powerful, targeted solution with limited resources. Thanks to their concentrated efforts, CorVista filed 180 patents, with 81 already granted—a substantial base of intellectual property built from the early days of AI and machine learning in an emerging field.

Commit to Clean Data for Clearer Diagnostics

“The key is that in data science, poor data is like garbage in, garbage out. But if you put in really great data that you collected, you know exactly where it came from and that it was clean and clear, then you can actually obtain or decipher information about that data very well,” Don shares. This focus on data quality has been central to CorVista’s mission of creating a technology that accurately diagnoses CAD and PH. 

You don’t have to be a data scientist to appreciate the value of high-quality data. Without it, you risk compromising the accuracy and credibility of your findings. To avoid this, CorVista made a decision early on—they managed their trials internally instead of outsourcing to CROs. Don explains, “We did so internally because the data was so important; we had to make sure that data was pristine.” Keeping this function in-house gave CorVista full control over the data collection process, and the integrity and precision they needed. This also allowed CorVista to build direct relationships with end users—physicians and clinicians who would eventually rely on their diagnostic system. Working closely with their future users, CorVista could gather valuable feedback and insights while strengthening trust and understanding within their target market. 

The sheer volume and precision of the data collected were also critical. Through FDA-sanctioned clinical trials, CorVista gathered information from over 11,000 patients, building a robust dataset to train and refine their algorithms. This extensive database allowed them to differentiate between healthy and diseased states with impressive accuracy. “We can detect significant coronary disease...and the lack of significant blockage with a 99% negative predictive value,” Don states. This high level of accuracy is only achievable because of the well-structured, high-quality data they collected. 

Today, the CorVista System delivers immediate, actionable results. In a doctor’s office, the test takes only three minutes, with no invasive procedures or radiation involved. Don explains that their system collects over 10 million data points per patient and processes these through cloud computing to generate a report that helps physicians diagnose conditions like CAD and PH. The simplicity and speed of this workflow make advanced diagnostics accessible even at the primary care level. 

In short, when it comes to your approach to clinical studies, make every effort to maintain control over the process to guarantee the quality of data. Managing trials internally ensures not only clean, reliable data but also fosters direct engagement with end users. By being on the ground with it, you gather valuable insights, build trust, and refine your technology based on real-world feedback. With quality data and user engagement in place, everything else—whether solving a problem or training an algorithm—becomes much easier.

How to Build the Right Culture for Your Company

For Don, the foundation of CorVista’s culture is transparency and respect. He says, “If you're a shareholder, you have my respect, and you certainly have our transparency.” This approach extends beyond investors to team members as well. By valuing employees' ideas and being transparent about the company’s goals and challenges, CorVista has created an environment where people feel involved and appreciated, which fosters the collaboration and innovation startups need to thrive. 

Building this culture, however, requires more than just talking about values; it demands consistent action. Don emphasizes the importance of engaging your team actively, especially in a small company. “I’ve always been really, really strong about the teamwork requirement,” he says. “It didn’t matter what function you were—clinical, regulatory, or research—we were all working together to solve the problem.” 

These values are reinforced through regular team meetings and workshops, even when working remotely. “We’ve been using Zoom for meetings long before it became the norm during COVID,” Don says. In every interaction, he ensures the team knows the company’s values are more than just words on a wall. When issues arise, they’re addressed directly. “We would take a time out and actually talk about it, bring someone over to the side,” he adds. Such a hands-on approach ensures that problems are resolved quickly, and everyone stays aligned. 

This proactive engagement also extends to hiring. Don uses a phased approach, which was especially helpful in the early stages of the company. Instead of immediately bringing on full-time employees, CorVista initially hires consultants to test whether they are a good fit for the long term. For example, they brought in a legal advisor as a consultant to handle early legal work. After a period of successful collaboration, he transitioned into a full-time role. This method allows CorVista to manage resources efficiently while ensuring that new hires align with the company’s culture.

In a startup environment, where resources are often limited, employees need to be flexible and take on multiple roles. To accommodate this, Don has implemented a “player-coach” system. New hires start as hands-on contributors—“players”—and as they gain experience, they evolve into leadership roles as “coaches.” This system keeps the team lean and adaptable as the company scales.

Integrating functions within this lean team structure is another priority. At CorVista, clinical, marketing, and operations work closely together to ensure that product development is aligned with both customer needs and regulatory requirements. “Clinical had to be embedded in the team,” Don notes, highlighting the importance of collaboration across departments. This setup allows CorVista to respond quickly to challenges and continuously refine its product, maintaining efficiency and alignment throughout development.