Greenlight Guru: A Healthcare-Only Quality Management System

Quality medical devices are hard to invent and create, but there’s a few companies that may help get that quality quicker. In this story we take a closer look at Greenlight Guru - a quality management system developed specifically for medical devices.

It’s no news that medical devices and technology are leading most breakthroughs in the healthcare ecosystem. After all, medical devices go a long way in making healthcare affordable, quick-to-dispense and easily accessible. And in a country like India where quality healthcare is not accessible everywhere, doctor to patient ratio is low, and medical device regulations are constantly changing; the inventors need all the help they can get ... at the earliest. Enter Greenlight Guru. The only quality management platform designed specially for medical device companies. Greenlight Guru provides a platform for companies to get safe products to market quicker. It also compiles the regulatory requirements and documents the entire quality compliance process including CAPAs (preventive actions), risks, audits, training procedures, resource safety and design control under a single ecosystem.

CEO & Co-founder of Greenlight Guru, David DeRam said: “To find that more than 80% of organisations are asking their quality and engineering teams to ‘make do’ with legacy tools and solutions is as an eye-opener. Quality isn’t a department, but a cultural mindset within a business. Quality cannot be treated as a check-the-box activity - unfortunately, even when mandated by law, we’re seeing companies do the bare minimum.”

According to Jon Speer, VP of QA/RA at Greenlight Guru: “Medical device manufacturers are taking huge gambles with their risk management; if management teams lack adequate insights into device risk, auditors lack sufficient insights, too. I foresee the regulatory environment changing in the very near future where a medical device specific QMS will no longer be a nice-to-have, but a need-to-have solution.”

Ongoings in the Medical Device Regulations Ecosystem in India

In India, the medical device regulatory system gets increasingly complicated each year. For beginners, medical devices are regulated under the broader umbrella of drugs’ by the CDSCO. Add their lack of insights and experience in medical devices, and one can begin to see the cracks in the system.

Nidhin Varghese, Senior Design Engineer at SenseSemi had this to say, “Medical devices are segregated into categories, and only the ‘high risk’ category of devices need to be registered. Although this hasn’t changed, there is a trend of pushing products previously not placed in this category into the ‘high risk’ category. For eg, blood pressure monitors were not considered high risk before. It is only now that the government is taking erroneous readings seriously as they pose a significant health risk when measured incorrectly. This change in the field has led to medical device makers queuing up for device registrations.”

Medical Device Makers in Specialty Parks

The government of India has planned and approved four medical devices parks with an aim to produce affordable, high-quality medical equipment. However, the medical device makers ecosystem is still in its infancy with both inventors and investors still making their way to parks and finding the one which suits them best. Couple this with a lack of understanding the need for specialty parks from the government, and one can immediately begin to see the drawbacks of the current medical device park infrastructure.

The biggest being - since medical devices manufacturing takes time and is an interdisciplinary field, just creating a space doesn’t ensure anything. There is a lack of speciality operators and labour available in these areas. There is also a lack of collaboration between government, industry and academia with device manufacturers. The most troubling of all, investors expect to see growth on par with m-commerce and e-commerce industries.

Stigma Associated with Medical Devices From India

Indian doctors don’t unquestionably accept devices made in India, often time trusting their global counterparts. This mistrust is well rooted. There have been numerous instances in times bygone where Indian medical devices did not meet the quality standards of the industry. As a result, there’s a high volume of import of medical devices.

According to Nidhin “In India, there were no regulations as a result of which any medical device could enter the market - without undergoing the proper quality tests. In such a condition, any and every device would flood the market… simply because they could sell without stringent quality checks or certificates. “

Introducing Quality and Compliance in Medical Devices

All this further serves the purpose of a company like Greenlight Guru, and highlights their role in the process of getting medical devices market ready.

In India, there’s some turmoil within the regulations and the regulatory board, due to which companies have several more challenges to overcome. Process planning and traceability goes a long way in ensuring a product comes to market, and also allows investors to make a confident investment while being mindful of their returns. It also helps to have continuous, regular quality checks and automated quality assessment processes as these go a long way in quality and risk management.

But where Greenlight Guru truly shines is by allowing medical device makers be up to date with the latest ISO/FDA practices and operating procedures. The software has built-in SOPs into every feature allowing makers to always be on top of the quality requirements and standards their products must meet. The centralized system makes it easy to organize and manage the manufacturing process, even streamlining team communication, thereby letting device makers maximize their time in research and development.

In summation, quality assessment is a must have for medical devices and companies like Greenlight Guru go a long way in helping medical devices come to the market. The entire ecosystem may get a boost by following industry standard practices at each step, and Indian medical devices will be able to reach the same level of trust and compliance as their global counterparts.

It may seem quite obvious but quality management systems, are essential for market success and Indian medical device makers will do well paying heed to the industry standards right from product inception.