Greenlight Guru has been marketed since 2013 as the first digital eQMS (electronic Quality Management System) designed specifically for Medical Device companies and its reputation has been growing ever since.
But what’s it like to use today?
What is Greenlight Guru?
Greenlight Guru is a cloud-based QMS platform designed as a response to the archaic paper-based systems that many established medical tech companies were clinging on to, even in the face of the widespread digitisation of other sectors.
Greenlight Guru offered those established companies battling with legacy systems, the digital tools they needed to streamline and automate their planning and quality processes, but in line with the demands of this highly regulated industry. It helped them with the documentation and audit requirements necessary for FDA compliance and ISO 13485, ultimately enabling many companies to get safe products to market faster.
But how suitable is it for a start-up or SME today, looking for a cost-efficient and compliant QMS solution to take them through their journey from ideation to regulatory submission and new product introduction?
What are the benefits of Greenlight Guru?
The functionality Greenlight Guru offers is extremely powerful with lots of automation to make life easier for developers. The matrix capabilities are such that you can upload your user needs with your design and risk management inputs, and Greenlight Guru will present you with a compliant design system out of the box which will meet FDA requirements from Day 1. It gives medical device companies full, digital traceability between risk requirements, user requirements, design outputs and verification activities.
It’s worth noting, however, that some of Greenlight Guru’s other claims have been seen in reality to fall short of expectation. Although Greenlight’s ‘Standard Operating Procedures’ (SOP's) can be tailored to your specific needs, their ‘Off-the-shelf’ or ‘canned’ set of procedures have proven to fall short. While they claim that these conform to ISO 13485 requirements, one company found quite substantial gaps were revealed by a stage 1 audit of their QMS and they had to rework a lot of them to get them up to scratch. Of course, this tends to be the case with many other company’s ‘canned’ SOPs, not just Greenlight’s!
What’s the cost?
But all this comes at a price. For smaller companies, there is an entry-level rate of around $15,000 pa (with a reported 3 year minimum contract), but for companies valued at over a $1,000,000 the price jumps considerably to between $25 - $30K pa. As this is based on the capitalisation of your company, you can still be charged the top rate even if you’re not generating any revenue yet. If your company is 3 - 4 years away from taking your product to market, this is a huge outlay to be committing to.
Indeed, as pricing is also done on a per seat basis, the potential expense could be holding you back from giving everyone on your team access to the product. This would rather defeat the object of a communications enhancing piece of software designed to be the ‘single source of truth for an entire organisation’.
Greenlight Guru reputedly charge companies extra for their CAPA module (compulsory for those using the platform for product management). This seems a lot to swallow for a company that may be raising only a handful of CAPA issues a year.
The Greenlight Guru Way
Another downside to Greenlight Guru is that by trying to offer a ready to go, out of the box solution they have ended up offering a very prescriptive one size fits all approach for Medical Device companies.
Some users and quality consultants complain that its customisation features are limited. For example, the way the platform dictates how document control ’will be done’, irrespective of how you may want to do it, is likely to frustrate some companies.
In many areas Greenlight Guru are deciding how you have do things (quite apart from any regulatory requirements) and regardless of what makes commercial sense for different businesses at different stages of maturity. As one consultant puts it:
“You have to follow their workflows and so they’re going to determine how your workflows operate. And modifying those workflows is very difficult. Of course, if their workflow matches with the style of your business and how you want to operate, and it’s going to be effective and efficient for you, then that’s fine. If not, you’ve got work to do”.
Despite Greenlight’s obvious strengths, this sort of thing has led some to find their system too cumbersome, convoluted and with too high an overhead, to be truly practical in a start up context.
It should also be mentioned that Greenlight is heavily focused on the FDA requirements for generating Design History Files and Device Master Records. So, when it comes to the medical device file and technical file, that's where those working to deliver in the EU market have to deviate from predetermined workflows, creating workarounds and often duplicating work to fulfil those different requirements.
Is there another way?
The regulation surrounding Medical Device Development is increasingly based around Risk Based Thinking, an approach which encourages the governance measures you take to be commensurate with the level of risk of harm that the failure of those measures could represent.
For those starting out, choosing a more scalable, flexible eQMS could allow you to work at a more basic (but still robust) level of risk and compliance management to begin with, then add the tools and functionality which will see it grow into a fully blown, auditable medical device quality system as your project develops.
There is no doubt that Greenlight Guru is a powerful eQMS solution, but the expense it represents and its ‘one size fits all approach’ has frustrated many and led them to look for solutions elsewhere. Luckily, there are now other more flexible med-tech QMS options on the market that can grow with you and flex with your changing needs.