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While the current health crisis has served as a catalyst for innovation for medical device companies, many have still been exposed to new challenges and disruptions.
According to findings from our 2021 State of Medical Device original research report, 59% of medical device professionals reported their time to market has been negatively impacted by the COVID-19 pandemic.
Now more than ever, medical device companies are finding themselves navigating an increasingly digital world. Whether it be competitive strategy or merely by happenstance, device makers around the world are realizing the importance of investing in quality tools that enable team collaboration and promote quality as a collective responsibility of each member throughout the organization.
Delta Development found that in addition to leveraging technology, finding a “partner” who could guide them along the journey of bringing a medical device to market would in fact support their need for speed and quality management.
There’s one niche market within the device industry that rarely gets the attention it deserves: products designed for military applications and use in other emergency settings. Delta Development Team, an early stage company based out of Tucson, Arizona, set out to innovate existing technologies to find a solution for an unmet need from the U.S. Department of Defense.
While working in a previous engineering role, Robert Futch, CTO at Delta Development Team, and his colleagues saw the opportunity to develop a portable refrigeration unit that could withstand extreme military applications. With help from retired Army veteran, Monti Leija, CEO of Delta Development Team, and end-user feedback they began developing a device that would revolutionize rescue operations.
The Autonomous Portable Refrigeration Unit (APRU) is a type of medical refrigeration used by medical professionals. It provides constant cooling of blood products, vaccines, virus samples, and temperature-controlled medications.
Due to the complex nature of this device and its applications, the team at Delta Development has taken extreme pride in the high-quality, collaborative systems that support their work in delivering a high-quality, safe product.
Early on during their feasibility study, the team at Delta Development learned that their product would be regulated by the FDA as a Class II exempt medical device. In addition to understanding and following military requirements and expectations, their medical device journey would involve further learning and understanding of the regulatory guidelines that apply.
Delta Development was committed to keeping all product development and manufacturing in-house, which influenced their decision to also manage regulatory aspects of their work in-house, as well. This allowed them to maintain control of something they believed to be paramount to the success of their product: speed-to-market. So their next logical step was determining what, exactly, they would need to do to meet the necessary regulatory requirements.
While Robert had some previous quality management experience with ISO 9001, he claims to have still “learned quality the hard way,” which included using disconnected systems coupled with the lack of preparedness and confidence in the quality system.
As a part of working with many critical stakeholders and components, their team was aware of the many incoming inspections and evaluations that needed to be done and managed properly. Robert knew that “being able to manage multiple critical components, suppliers, and processes that support development - it is essential for us to have a really good way to manage all these critical components in our quality management system.”
From the beginning, Robert was looking for an electronic and collaborative quality solution for his team. “The last thing I wanted to do was introduce something manual and cumbersome to our team,” he shares.
After a quick google search for “how to manage a QMS yourself,” they came across the medical device quality management system (MDQMS) from Greenlight Guru and began exploring the possibility of being able to manage quality both electronically and in-house.
At the start of their quest to keep quality management in-house, they began exploring the capabilities of options, such as Google Suite tools and document storage. It was quickly decided that these tools would not support the technological needs and compliance requirements of their device and development process.
With the end goal in mind, the Delta Development team knew just how valuable it was to have easily accessible linkages between different points in their quality system, particularly during an audit. Being able to link all of their quality system data, especially within the device’s design itself, would help them achieve the traceability and efficiency needed to perform well in an audit and keep their efforts moving forward - quickly.
There were two jobs they wanted their solution to accomplish:
A database-like architecture that supported their quality information
A high level of automation needed to help manage their critical components
With Greenlight Guru still top of mind, the Delta Development team decided to attend a True Quality Roadshow event where they had the chance to learn directly from medical device industry-veterans about what it means to have your quality system double as a database—exactly what they were looking to accomplish themselves.
After hearing from seasoned, industry professionals and recognizing the value of an electronic quality system, Delta Development elected to go with Greenlight Guru’s medical device QMS (MDQMS).
The Delta Development team was up and running in Greenlight Guru in no time with a complete quality package. Robert attests to the speed and efficacy of implementing a MDQMS as well as the intuitive flow of the software. “If you were to start with reading the regulations yourself, it would take you awhile to find the first step.” They found that with Greenlight Guru, the first step was embedded into the first-click.
Another vital piece of the implementation process was using Greenlight Guru’s QMS templates. Their team wanted to avoid re-creating the wheel of developing their own quality procedures and other documentation, but also wanted to assure they were following best practices. These audit-tested procedures, work instructions, and forms helped them accomplish both while streamlining the implementation of their quality management system.
Finally, with the help of Wade Schroeder, a medical device Guru who was assigned to ensure their success while using Greenlight Guru, the Delta Development team received the regulatory guidance they were seeking right from the start. With the added benefit of Wade’s electrical engineering knowledge and his medical device regulatory experience, he became an extension of the Delta Development team and provided the added-support needed to make key decisions about their product and regulatory compliance. Robert shares that having an engineer speak regulatory language to another engineer made it a lot easier for him to learn and understand.
Between the MDQMS software, quality templates, and Guru consultive services, it was like “our own 21 CFR compliance kit.” Partnering with Greenlight Guru has helped Delta Development get their quality system up-to-speed without skipping a beat.
Greenlight Guru has supported the Delta Development team in continuing to move quickly, while learning about and automating quality management along the way.
From leveraging the design matrix for better design control documentation to linking design components and relevant documentation, their team has built a foundation for closed-loop traceability throughout their quality system. By adopting Greenlight Guru, Delta Development has also been able to automate and streamline management sign-offs on digital design reviews and other quality documentation.
In the later stages of their development, Delta Development was able to avoid time wasted on low value-added activities and additional spend on resources while finalizing their device’s design. Going through the final engineering change orders and smaller performance improvements, they were able to trace back through their QMS and find what parts of the system would need retested or re-verified.
As they continue to build out their team and move into manufacturing, CEO Monti Leija attests to the level of automation that Greenlight Guru provides that will enable their team to manufacture these devices in a short period of time with added confidence in their device’s compliance.
In just a year, Delta Development fast-tracked their development phase and are now moving their product into manufacturing.
After seeing the ease-of-use and impact that the automation has had on their ability to streamline development, Robert has realized just how beneficial this foundation and system will be when it comes to managing post-market quality. By leveraging Greenlight Guru’s post-market quality solution, they expect to reap similar benefits from the same level of automation and linking capabilities for managing CAPAs, nonconformances and inspections reports back into their validation reports and other documentation.
From prior experiences with quality management, Robert and his colleagues knew from the beginning just how valuable it would be during an audit to easily access links between different points in their quality system. With Greenlight Guru, they have created and automated the necessary traceability, giving them the confidence and reassurance they need to prove compliance when they walk into their next audit.
When it comes to sharing words about Greenlight Guru’s MDQMS, Robert Futch and Monti Leija share the same reason for recommending the quality management software: Speed. Greenlight Guru has eliminated the need for dedicated personnel and external parties and instead has enabled their team to keep moving - fast!
Other members of their team shared similar sentiments about Greenlight Guru and its collaborative nature as a cloud-based system. Delta Development wanted to avoid having a single person responsible for all quality system knowledge and functionality. Now, with Greenlight Guru, they have a software that provides the framework and promotes quality as a collective responsibility of their team - which is a much better position to be in.
Implementing a software solution has eliminated the burden of the company needing to figure out quality themselves while maintaining their own preferences of how they organize and access their documents, design, and other quality data.
Investing in collaborative tools that support their device’s design, regulatory requirements, and automation needs has provided Delta Development with a solid foundation for managing quality that supports the speed and growth of their company as they begin to scale.
Greenlight Guru has accelerated development by offering an out-of-the-box solution that meets the unique needs of the Delta Development team for delivering a high-quality product and additional services to help them navigate the medical device regulatory environment and keep their team moving quickly and efficiently.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...