Soapbox

Big Data and Post Market Surveillance of Medical Devices

By John Wilkinson, Mark Wasmuth
November 25, 2019


• Categories: 03-Manufacturing Execution, 05-Quality/Regulatory, Combination Products, Market Access, Soapbox

Properly mined and analyzed, data gathered by the Global Medical Nomenclature Agency (GMDNA) has the potential to radically overhaul post-market surveillance of medical devices. This is good news for suppliers and buyers in the medtech industry, where the potential of data analytics is yet to be fully realized.

The past decade has brought significant change in how regulatory authorities worldwide wish to manage the vast amount of data coming out of the medtech sector. Medtech manufacturers want to use intelligent technologies to fundamentally change the way they develop products, retrieve information from products in use and improve future products.

This is a wide and varied industry, with more than 500,000 different medical technologies available, all share a common purpose: To have a beneficial impact on people’s health and quality of life.

Demand for standardized system for naming and grouping medical devices led to the creation of the GMDN by those responsible for medical device safety. The GMDN groups medical devices into multiple categories, representing a variety of technologies, which ranges from sterile wipes to pacemakers, and scalpels to MRI scanners.

Currently the GMDN lists more than 23,000 groups of medical devices, with around 800 new Terms created in 2018. New categories that identify breast implants with different surface textures, a sensory-neuron simulator to aid muscular rehabilitation and tumor therapy magnetic nanoparticles are just some of the examples of the diverse nature of new medical device technology that need describing.

The last year has been pivotal for the GMDN Agency, which was set up in 2005 to take responsibility for keeping the nomenclature up to date. In April, we took the decision to make the database freely available to medical device manufacturers, giving them access to the core data we keep on the database.

This has proven to be a popular decision, resulting in an 165% increase in membership in just seven months. Free access to the GMDN has given medtech manufacturers the impetus they need to sign up to a global standard for naming medical devices.

Today the GMDN is the de facto global standard for identifying medical devices for more than 6,900 registered organizations around the world. Moreover, with regulators in Australia, Canada, Russia, the United Kingdom and the United States requiring manufacturers to use the GMDN, the upward trajectory shows no sign of slowing down.

This presents the users of the GMDN with the unique opportunity to use the data it holds to enhance post-market surveillance of medical devices for the benefit of patients, buyers, manufacturers and regulators worldwide.

Data Mining

For too long this industry has lagged the pharma sector in terms of using data analytics to predict market trends. We want to change that.

With our enlarged membership, the GMDN is sitting on a wealth of data which, properly analyzed, has the potential to track trends in the medtech sector globally. When you consider that the GMDN is just one part of the global device identification system, sitting alongside the Unique Device Identification (UDI) system, then the potential for post market data analytics are transformational.

It is important to remember that the UDI is an identifier (a barcode) that is specific to the actual device itself, whereas GMDN allows all devices to be accurately categorized according to unambiguous grouping and exchange of sets of devices.

So how can we use data from the GMDN and UDI for the transformational benefit of patients? Let me explain with an example: We recently introduced different collective terms for breast implants to differentiate between implants with different surface textures. This is helpful to regulators for helping to analyse the potential link between breast implants and anaplastic large cell lymphoma (ALCL) a rare type of non-Hodgkin lymphoma (NHL). If there proves to be a link, the GMDN can be used to cross reference data held in the secure device implant register to pinpoint exactly who has used the implant and alert their caregivers to the risks.

We are already responding to opportunities that relate to UDI implementation. In the United States, for instance, we are working with clinicians who have access to more than 2 million products registered in the FDA GUDID database, a set of data that is due to grow with the inclusion of lower-risk products in mid-2020.

Other regulators are also planning to introduce national databases for medical devices that will link the value of UDI and GMDN.

What is needed now is a concerted effort from manufacturers to ensure that products are registered with the UDI. This will enable the GMDN not only to track risks associated with medical devices, but also have a clearer understanding of what products are available at any point in time. In cardiovascular, for example, we can see how many products are on the market in a certain subsector, which manufacturers are bringing those products to market, if there are any new products in the pipeline and the rate of change that represents to the lifeline of that particular product.

If regulators have access to the data analytics that they need to track trends, they will be better placed to predict the resources they need to do their job. And with regulators worldwide adopting a more harmonized and proactive stance as they strive to improve patient safety, this will prove an invaluable tool.

While regulators rightly want to see raised safety standards, we have also seen increased demand from them for improvements in the efficacy of medical devices. The challenge for most buyers is that they have the technology they need to introduce new devices but measuring the impact on patients in a systematic way is a costly and complex exercise.
Using the information provided by manufacturers to the UDI and GMDN, regulators can take a long-term view of a particular device to understand its potential in the market. Done en masse, this could be applied systematically to track the safety and performance of a certain group of devices. The information could then be fed back to hospitals and used to support demand for increased investment in a certain type of device. Moreover, if buyers and patients are in an informed position about the safety and efficacy of their existing medical device inventory, they are better placed to manage it.
For all its advances, the medtech industry is only just beginning to understand the value of the data it collates. The GMDN is also at the beginning of the data journey, but we have ambitions to scale up its operational performance.

Within five years, the GMDN will have penetrated the market significantly further, with high levels of engagement and involvement among stakeholders in the nomenclature. Health systems and regulators globally will recognize the GMDN as the go-to place for information that they can integrate into their systems.

We have the tools to sort critical information in an era where big data is opening new and faster ways of understanding products. The primary goal of the GMDN is to help stakeholders realize the full value of our system and exploit it as its potential is currently underutilized.