Quality Done Right From Day One: How OmniBuds Built Its Foundation With a QMS Starter Package

When you're launching a medical device startup, every decision carries weight. Should you start on paper and migrate later? Build incrementally and fix problems as they arise? Or invest in a digital quality foundation from the very beginning?

For OmniBuds Senior Director of Quality and Regulatory Tom Golden, the answer was clear. With three decades of quality management experience under his belt, he knew exactly which path would set his new company up for success.

OmniBuds: Heart Health Never Sounded So Good

OmniBuds¹ is reimagining cardiovascular monitoring for the modern world. Picture this: earbuds that look and function like your favorite wireless audio devices, but with sophisticated sensors that are being developed to measure blood‑pressure‑related and heart‑related signals in the ear.

"It's like wearing bluetooth earbuds, but monitoring blood pressure and heart rate," Golden explained. OmniBuds is developing the kind of innovation that demands a quality management system (QMS) capable of supporting rapid growth, regulatory complexity, and the rigorous standards of medical device manufacturing.

For a startup with just six team members at launch, that's a tall order.

Building on Two Decades of System Knowledge

Golden's relationship with leading QMS provider MasterControl stretches back to 2005, when he worked as a system administrator. Over the years, he's guided multiple organizations through implementations, managed 30-plus regulatory audits across the U.S. Food and Drug Administration (FDA), Notified Bodies, and international agencies, always working in a collaborative capacity with the MasterControl team.

"My voice was heard over those years, and the MasterControl team implemented a lot of what I voiced for enhancements," Golden shared when reflecting on his partnership with MasterControl over the years. "I know MasterControl listens to their customers."

When OmniBuds brought him on board, one of Golden's first conversations with leadership centered on quality infrastructure. His pitch was simple but compelling: "Let's not start on paper. We can build from the ground up electronically. It'll save us tons of headaches and hours."

Leadership gave him the green light. Then Golden discovered something that didn't exist during his paper-based startup days: the Quality Excellence (Qx) Starter Package.

A Quick Start Built to Scale

The Qx Starter Package transforms the MasterControl implementation timeline for startups. Where traditional implementations can stretch months and require significant financial investment, Qx Starter delivers a pre-configured system designed specifically for emerging companies—with the same enterprise-grade foundation that scales as you grow.

Even with 20 years of MasterControl expertise, Golden found value in the starter configuration. The system arrives with document numbering structures, vault configurations, and training frameworks already established—critical scaffolding for teams without deep quality management experience.

"For anybody that does not have the experience that I have, man, that starter is a win-win," Golden emphasized. "Having your document numbering system, the configuration from vaults all the way through—that'll help immensely."

Implementation at Startup Speed

OmniBuds went live in about 30 days, ahead of the standard implementation schedule. But Golden cautions against viewing that timeline as typical for most startups.

The Qx Starter implementation typically spans around 90 days, and Golden recommends new teams use every hour. "Get to know the system, because there's a lot of bells and whistles," he said.

What matters most isn't speed—it's building the right foundation. MasterControl provides implementation support throughout the process, and companies that invest the time emerge with systems configured correctly from day one.

For OmniBuds' team, adoption came quickly. Golden leveraged customized training sessions, adapting his approach to each person's technical comfort level. Rather than overwhelming new users with the full system capabilities, he focused on immediate needs: "Here's how our system is set up. Here's what you need to do right now. I'll teach you as we go along."

That learn-as-you-grow approach mirrors the Qx Starter philosophy itself: start with what you need today, expand as your requirements evolve.

The Numbers Tell the Story

While OmniBuds hasn't reached full quality management system maturity yet, Golden can point to decades of quantifiable results from previous MasterControl implementations:

• Throughput improvements: 70%-75% compared to paper-based systems. Document routing that once crawled through physical mailboxes now moves at digital speed.
• Significant error reduction across document management and training processes. Electronic workflows eliminate the scribbled notes, lost revisions, and misfiled records that plague paper systems.
• Audit efficiency that turns heads. Regulators typically allocate one to two hours for document management system review. With MasterControl, Golden consistently wrapped those reviews in 30 minutes and he recalled that every auditor was complimentary. "Especially if they've got background on it, they were like, 'Oh, we've seen MasterControl. Okay, we're good.'"
• For FDA and Notified Body audits, the MasterControl system's ability to instantly pull training histories, document trails, and change records transformed what's often the most stressful part of regulatory compliance into a streamlined demonstration of control.

Built to Grow With You

The Qx Starter Package addresses a fundamental startup challenge: how do you avoid outgrowing your QMS in 18 months?

The answer lies in the architecture. Qx Starter isn't a lightweight alternative to MasterControl's enterprise platform—it IS the enterprise platform, configured and priced for startup needs. When OmniBuds needs to add manufacturing modules, expand into additional forms beyond the five included out-of-box, or bolt on clinical trial management, the infrastructure is already there.

"I've experienced it," Golden confirmed. "We started with just the document management and training modules on a couple of forms back in the early days. We scaled to where we put all our regulatory filings, clinical files, and manufacturing. As we grew from spec developer to distribution to manufacturing, it was easy as an administrator to bolt on a few things, test in the dev environment, and away we go."

As Golden looks ahead, he's preparing to leverage capabilities that come standard with Qx Starter: corrective action/preventive action (CAPA) forms, deviation tracking, and nonconforming materials management—all configured and ready when the company's processes mature to require them.

When OmniBuds scales from eight people to 80, from pre-market to postmarket, from a single product to a full portfolio, their QMS won't be a bottleneck. It'll be an accelerator.

That's the Qx Starter promise in action: start lean, grow deliberately, never hit a wall that forces you to migrate systems mid-flight.

The Foundation for What's Next

Golden's advice for other startups considering their quality management approach distills down to a simple truth: "Let's not start on paper."

The upfront investment in digital quality management, especially through a startup-optimized package like Qx Starter, pays dividends immediately and compounds over time. The hours you don't spend printing, filing, and chasing signatures become hours invested in product development. The audit preparation that doesn't consume weeks of panicked document gathering becomes a 30-minute demonstration of system maturity. The foundation you build correctly from day one becomes the platform that carries you through Series B, regulatory submissions, and beyond.

For companies like OmniBuds, pushing the boundaries of medical device innovation, that's not just an operational advantage. It's a competitive necessity.

Ready to build your quality foundation the right way from day one?

Learn more about MasterControl's Qx Starter Package and how it helps life sciences startups scale without limits.

1. OmniBuds is an investigational technology not cleared or approved by the FDA and is not available for clinical use.