Robert Fenton, founder and CEO of Qualio, explains to Med-Tech Innovation News how its quality management system can help medical device companies launch their products faster.
First of all, give us some insight into Design Controls in terms of where the idea came from?
The incorrect documentation of design controls is one of the top reasons for FDA citations when medical device teams work to bring their devices to market. The observations range from not having procedures to not performing or documenting risk analysis or software validation. This is largely due to the manual work of compiling quality artifacts in paper-based or disjointed cloud-based systems.
In 2020, we began developing Qualio Design Controls to answer the market’s product development needs. We built our product based on feedback we received from both our current medical device and SaMD customers and our sales prospects. Their key issues were disjointed systems and manual documentation - both of which ultimately hindered speed to market.
Our team solved these issues by building Qualio Design Controls - a product that unites product and engineering tools like Jira, DevOps, and more directly to Qualio via API and easily compiles release documentation in one click. Our customers remained at the centre of the work we did - with countless rounds of demos, feedback, and testing as we worked to bring it to market.
What challenges and problems does this solve when it comes to quality management?
Qualio Design Controls enables teams by:
- Uniting systems and data to enable effective collaboration and reduce delays in product development – Design Controls eliminates silos between quality and engineering teams by streaming product information from Jira, Azure DevOps, and TestRail directly to Qualio, creating a single source of truth for product development.
- Maintaining end-to-end traceability across systems in real time – As mentioned above, gaps in design controls are one of the top reasons for FDA citations. With Qualio's Design Controls, teams can maintain compliance by accessing design documentation in one place, managing change and ISO 14971 and FMEA risks across systems, and approving with Part 11 compliant signatures.
- Generating release documentation with one click – Qualio's Design Controls automatically compiles artifacts into key documents like Risk Analysis and Requirement Traceability Matrices, eliminating manual collation and tedious spreadsheets — and ensuring teams deliver a safe and effective product to market with confidence and speed.
There has been a lot of talk of how much cloud is beneficial compared to paper, but what does this cloud software do that you feel others do not?
Qualio Design Controls allows you to stream data from other cloud-based systems directly to Qualio via API so all of product information is contained within one place. This makes Qualio much more configurable to a team’s current processes than other solutions in the market. Ultimately, we want teams to continue working in the systems they know and love while simultaneously enabling key quality documentation on the team’s work.
Additionally, a team can perform previously paper-based tasks within Qualio using other features of our eQMS like documents, training, events, and more. With information unified in a cloud-base system, a team can identify gaps, perform risk analysis, and compile the information into release documentation in real time.
What recommendations do you have for other medical device / software as a medical device companies when it comes to streamlining product development and quality management?
We encourage teams to build a culture of quality around their product development process by thinking of quality as a critical function in getting products to market rather than viewing it as a hindrance. This shift is not easy because it requires nearly constant collaboration across teams - something that is notoriously difficult if teams and systems aren’t speaking to each other in real time.
Qualio Design Controls solves for this by uniting all of product data within our eQMS, so Quality, Engineering, and Product can maintain their work in their source systems while ensuring compliance and enabling speed-to-market.
Do you have any advice for other early-stage medical device / SaMD companies that are still using paper-based quality management processes?
We always urge teams to explore migrating paper-based systems to the cloud as soon as possible, as cloud-based QMS are now the industry standard and enable teams to more easily comply with FDA and ISO regulations. Paper-based systems hinder collaboration, leave room for error, and are not flexible - something we saw during the pandemic, specifically. If you’re working across distributed teams without a central office location, managing a paper-based system becomes almost impossible.
Qualio’s eQMS is easy for small teams to implement across their organization in 60 days or less. If a team is looking for an eQMS married with quality expertise, we also offer Qualio Plus which many early-stage teams love. This gives this customer our eQMS and a team of expert Quality Advisors who help you implement it.
How does this software help to drive innovation within a medical device manufacturer?
Design Controls enables a team to build with quality and velocity by ensuring that you have a single source of truth for quality artifacts as you work to get to market. For many teams, a single source of truth was previously impossible, slowing their time to market as they worked to complete quality activities. With Design Controls, we’ve removed siloes and barriers within medical device teams to enable quality and speed and ultimately allow a team to focus on next iterations and innovations.
