Ramya Sriram, digital content manager of freelance platform for scientists Kolabtree, explores three tools that are helping medical device SMBs to work remotely.
Following positive experience during lockdown, a Hubble HQ survey found that the number of UK employees who want to continue working remotely for at least one day a week has risen to 86%. However, some small and medium-sized businesses (SMBs) that are new to remote working have found it challenging, particularly in industries such as medical device manufacturing, because companies must adapt to new arrangements while juggling the regulatory approval process.
While the COVID-19 pandemic has created constraints for the medical device industry, such as limiting on-site inspections, the regulatory process itself hasn’t stopped. In June 2020, the US Food and Drug Administration (FDA) announced that during the pandemic it had continued to meet its target of reviewing at least 90% of brand, generic and biosimilar drug applications. This means that manufacturers must find new ways to navigate the approval process effectively, even while working away from the office or laboratory.
Setting up a robust quality management system (QMS) that covers all aspects of design, manufacturing and risk management is the first key step to an efficient remote working setup. The complexity of the QMS will vary with device classification, for instance companies producing high-risk devices (Class III) will require a different strategy to low-risk, non-sterile surgical instruments (Class I).
Here are some of the several electronic quality management systems (eQMS) available that medical device SMBs can access wherever they work.
When seeking regulatory approval, one of the biggest challenges for manufacturers is streamlining quality processes to reduce the time it takes to get the product to market. Traditionally, companies rely on paper-based systems to track quality —users often find these difficult to organise and struggle to access specific data when required. Founded in 2013, Greenlight Guru has been marketed as the first digital eQMS, designed specifically to automate and streamline the QMS process and prevent these issues.
Greenlight Guru is a cloud-based platform and is the only quality management software designed specifically for medical devices. Manufacturers can use it in various ways if they’re working away from the office or are not in regular contact with QMS experts. For instance, you can upload your risk management inputs and the platform will provide a compliant design system. By simplifying FDA and ISO compliance, the software makes it easier to manage quality processes like audits and document control, enabling you to get your medical device on the market even while working remotely.
In 2018, Greenlight Guru integrated its platform with project tracking software JIRA to make it easier for manufacturers to manage product development and post-market quality. JIRA enables users to create roadmaps that set out all projects in progress, so that manufacturers can effectively plan and track all the relevant aspects of the regulatory process and monitor work against deadlines. This may include completing a table of contents or compiling your device’s design and development information.
When small and medium-sized manufacturers are managing their projects remotely, JIRA can be configured with various add-ons to ensure ISO 13485 compliance. An example of this is complaint management because it can track initial evaluations, risk assessments and known issues with the device. This means you can manage your project workflows wherever you are.
Post-market surveillance and complaint management are crucial elements of your medical device application and it’s important that you have the necessary skills on board. QMS systems can help, but sometimes there’s no substitute for the human interaction you would’ve had pre-lockdown. One way you can solve this is by consulting with a freelance specialist. If you hire a medical device expert from Kolabtree, they will map out the regulatory stages you need to go through and advise you on how your device can remain compliant. You can collaborate with them using Zoom and Microsoft Teams.
For most manufacturers working remotely, controlling the flow of documentation and ensuring that everyone has access to the same information can be an issue. You will need to show the notified body (NB) that you have organised your QMS and this means having everyone on the same page throughout the device’s development.
AssurX is a versatile software that allows manufacturers to communicate and coordinate information with colleagues. It uses dashboards to provide live views of all activities in different parts of the business and it can produce electronic workflows of tasks, alerts and approvals. This not only helps you stay on top of the regulatory process, it can bridge any gaps in communication when working remotely. This means you can stay connected with your colleagues and avoid miscommunication while controlling risk exposure.
If nearly 90% of people are open to working remotely, we could see many business structures change in the future to embrace this new way of working. For SMBs in the medical device industry knowing the tools that can help you thrive is an important part of the transition to remote working. For small and medium-sized medical device manufacturers, there are several eQMS platforms that can help them navigate the regulatory process while staying connected to the rest of the business.
While these tools can help you transition to remote working more smoothly, it does not offer the same benefits as working directly with human experts. Consulting a freelance specialist can help you gain the expertise you need in a range of disciplines without requiring a team of people to be in the same facility.