By Nick Tippmann, March 12, 2019 , in Case Study and Electronic Quality Management System (eQMS) and QMS Software and Medical Device Product
The majority of medical device companies operate on an emphasis of high quality outcomes and scalability. Early investment decisions are daunting for game-changing startups, like Amnion Life. It is important for startups to lay the foundation for success that minimizes risk and unnecessary complexity that can limit their path to market - and it all starts with a strong quality management system.
When investing in an electronic quality management system (eQMS), it is essential for medical device companies to identify a solution that they are confident will improve their processes and allow them to scale effectively. A spreadsheet or paper-based system may sound like a quick or cheap solution, but sacrificing quality in your quality system will only come back to bite you down the roa
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The team at Amnion Life was committed to setting themselves up for success from the beginning. We spoke with CEO and founder, Amir Fassihi, M.D. and their Lead Engineer, Milos Radovanovic to better understand how Greenlight Guru helped them lay their foundation for success. As it turns out, the answer was quite simple…
About Amnion Life
Amnion Life was founded by Dr. Amir Fassihi in 2016 in his pursuit to design a safe and effective medical device that would improve outcomes for infants born preterm. What ensued was the development of the “AmnioBed,” a Class II medical device that recreates the maternal womb-like conditions to promote ongoing development and reduce short and long-term complications following premature birth.
Dr. Amir Fassihi is an accomplished radiologist based out of Orange County, CA. He sees his role in the company as being one that ensures smooth operations and builds a culture for employees that instills True Quality in everything they do.
Another key player within the Amnion Life organization is lead engineer, Milos Radovanovi. He is responsible for a host of technical duties, including research, development, design, testing, prototyping and management of the engineering workforce. He also manages their international facility, which employs the majority of the company’s engineers.
The AmnioBed is a complex device, and one that has no predicate already on the market. For this reason, Amnion Life is following the De Novo pathway, designed for novel medical device products to get their device to market. The future of success for Amnion Life and their cutting edge medical device(s) relies on being able to handle the evolving quality and regulatory requirements.
One realization that Dr. Amir Fassihi shared with us was that, even during the early stages of building their company, he knew Amnion Life had the potential to be more than just a simple, one-product medical device company. Amnion Life has plans to build multiple devices, but first need the capacity to manage and submit several FDA applications. They have already received patents for these future products, including AmnioBed to help treat burn and ICU patients, as well as an artificial placenta.
For the team at Amnion Life, the goal is to be a medical device company that will not be satisfied with being “good enough,” but instead to be on the leading edge--with True Quality acting as the foundation of everything they do.
Challenges to overcome
Many of Amnion Life’s employees were new to the medical device industry, making them unaware of what it would take to be a successful medical device company. Both Dr. Fassihi and Milos agreed that the challenges Amnion Life faced stemmed from leadership anxieties, such as:
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“Are we doing this right?”
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“What else do we need to be concerned about?”
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“Are our processes compliant?”
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“Is there someone else I can ask?”
These anxieties continuously challenged the efficacy of the team and left them overwhelmed with the amount of work they were up against, from establishing their own processes to managing multiple ad-hoc quality systems.
The Amnion Life team became well aware that they would need guidance through implementing a QMS and understanding the quality and regulatory requirements for medical devices for maintaining compliance. Rather than looking for an eQMS that would check these boxes, they were in search of a provider who would also serve as a partner, supporting their efforts along the way.
Given the complexity of their device, AmnioBed, which has over 150 user needs for the device that have to be managed and incorporated into the design and development, the team at Amnion Life realized their need for a robust solution. It was important that they find an eQMS that would lay a strong foundation throughout the product development, regulatory submission, and post market surveillance phases of the product life-cycle.
Choosing a solution
Milos recalls that Amnion Life had tried implementing other QMS platforms, but found that their “bulkiness and clunkiness” weren’t intuitive for the unique needs of a medical device company. While many of these platforms claimed to have “out-of-the-box” functionality, these systems lacked industry-specific workflows. This meant that their team would need to dedicate additional time to learn, configure and validate the system.
After trying a myriad of project management, product lifecycle management (PLM), and collaboration platforms, they found they were all missing one vital piece for medical device development - Design Controls. These platforms failed to fill-in the essential needs that would serve as the foundation for success the team at Amnion Life was looking for, leaving them with more questions they needed answered.
Greenlight Guru’s eQMS solution came across their radar and they immediately realized it was everything they were looking for to establish a solid foundation for their company.
Dr. Amir Fassihi described how, as a startup, they justified the cost of Greenlight Guru based off their need to be successful. There were limited funds in their first phase of development, leaving Greenlight Guru on their wishlist.
After a year of keeping up with content provided by Greenlight Guru through its blog posts and podcasts, Amnion Life finally received the necessary funding and immediately purchased Greenlight Guru’s eQMS software platform built for medical device companies.
Greenlight Guru provided Amnion Life with a true “out-of-the-box” solution that was specifically designed for medical devices such as Amnion Life. They found the software and Guru Services to be extraordinarily helpful for smaller-sized companies such as theirs, with little experience using a QMS that streamlined processes and removed the regulatory burden for compliance with FDA and ISO regulations and requirements.
These “tiny details” Milos refers to are industry specific needs such as linkages between inputs and outputs, advanced user permissions for document controls, collaborating with external partners, fully integrated risk management that aligns to ISO 14971 requirements, as well as multi-level design control locking when performing design reviews. It is medical device specific needs such as these that Greenlight Guru handles to help simplify both product development and quality management for medical device companies like Amnion Life.
Switching to Greenlight Guru
During their transition to implementing Greenlight Guru, Amnion Life was given a test account to work through and learn the workflows and functionalities they would be using.
Since they did not have existing procedures already in place, they found immense value in the established workflows of Greenlight Guru and were able to naturally transition into using them. They also shared with us that the user interface and experience was very clear and easy to move forward with on their own.
Their team, especially Milos, appreciates not having to manually manage design controls through their prior method of using spreadsheets and tedious paperwork. Greenlight Guru has simplified their processes leaving them feeling more confident in their performance, design, and development processes.
“We are hoping to decrease our paperwork and not have so much pressure on implementation of Design Controls. Rather, we will use your platform to set it up easily,” Milos says. Milos discovered just how valuable Greenlight Guru was after initiating this partnership. In addition to its QMS software, this was in large part due to the Guru Services team. These dedicated industry experts became an extension to the Amnion Life team, providing clarity into matters relating to their quality management system.
Leveraging this partnership has allowed Amnion Life to learn more about things such as audits or best practices in capturing/documenting product development activities that will used in their DHF - further solidifying their foundation to success.
Achieving Results
After an easy implementation process, Greenlight Guru has laid the foundation for their medical device QMS and given them Peace of Mind.
Prior to using Greenlight Guru, Dr. Fassihi was being asked lots of questions by Milos and his team - many of which he didn’t have immediate answers for. Dr. Fassihi, Milos and his entire organization now have a reliable partnership with the Greenlight Guru team, who will support their quality and regulatory related efforts.
As the CEO of the company, Dr, Fassihi can now focus on more strategic activities and no longer needs to be involved in the day-to-day meetings and project development. He knows his team has what they need to assure both True Quality and long-term success.
As for Milos, his Peace of Mind has stemmed from the team’s ability to avoid any major setbacks in their design development ever since they first started using the Greenlight Guru software.
By partnering with Greenlight Guru, Amnion Life has laid a foundation for success that will continue to meet their needs with accelerating product development and transitioning to both clinical trial and post-market surveillance stages of the device lifecycle.
Amnion Life previously raised seed funding and is now looking to raise the company’s Series A. Doing so will allow them to finish up clinical testing and trials, then get their device cleared through the FDA regulatory process.
If you are interested in finding out more or investing in Amnion Life, take a look at their active WeFunder campaign here.
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