Navigating through the dark: getting medical device compliance right

The British Standards Institution (BSI) tells Med-Tech Innovation why it developed Compliance Navigator – a workflow tool that takes the leg-work out of managing medical compliance.

Technological developments and continuous innovation have made the regulatory landscape for medical devices a rapidly changing one.  After receiving positive votes in the European Council and Parliament, the Medical Devices Regulation (MDR) - Regulation (EU) 2017/745 - and In Vitro Diagnostic Medical Devices Regulation (IVDR) - Regulation (EU) 2017/746 - have been published.  The new Regulations are calling for increased requirements for safety and put patient welfare at the core of the medical device manufacturers’ processes.

Failing to interpret and meet the compliance demands can not only cost companies millions and result in product withdrawal from the market, but also endanger patient safety. BSI developed workflow tool, Compliance Navigator, to help manufacturers manage their medical device compliance with UK and EU requirements, simplifying their processes, so that they can get to market faster and maximise ROI. Compliance Navigator is the only tool on the market that provides manufacturers with an array of features to help them gain competitive advantage, ensuring that they are always a step ahead, throughout their development pipeline.

Not only are the new regulations changing the way manufacturers develop and monitor their devices, but they are also changing the medical device standards industry, as up to 400 standards will be amended in order to align with the new regulations.

For manufacturers, reviewing and interpreting each changing standard is not only time consuming and costly, but also prone to risk and leaves room for omission. No longer do manufacturers need to scour the internet, their notified bodies and standards organisations to maintain vigilance, nor do they need to spend hours manually comparing PDF copies of standards. Compliance Navigator guides manufacturers with advance warnings to upcoming changes before and after they happen, so that they can reduce risk and prepare ahead of time. Missing the slightest detail can be detrimental, so users are able to interpret changes with redlining and expert commentary, allowing them to understand what the changes mean to their business and giving them a competitive edge. Compliance Navigator helps manufacturers to find standards and regulations quickly and then organise their files by device specific profiles, so that they only monitor information that’s relevant to their business.

With the new regulations and growing industry uncertainty, Compliance Navigator also seeks to help manufacturers prepare for the transition with a new feature called MDR and IVDR Smart Support. Here, prevalent topics in the new regulations, such as clinical data requirements, reclassifying devices and UDI are analysed by industry experts and an easy to interpret review is provided to manufacturers. This includes, an executive summary suitable for senior management; detailed practical guidance on what has changed and what this means for organisations; and actions to take now and a summary of what is still to change, so that manufacturers can feel confident in their transition plans.

One convert to the tool is Axonics Modulation Technologies.

The Axonics Modulation team brings over 15 years of medical device design and development experience to its products, which include a new implantable system to treat urinary and bowel dysfunction. The Axonics Sacral Neuromodulation System is the first CE-marked rechargeable SNM system designed to improve the experience of both clinicians and patients suffering from urinary and faecal dysfunction.

Biomedical engineer Rinda Sama comes from a medical device design background and as VP for operations, quality and regulatory affairs now heads up the team responsible for design, engineering, and manufacturing compliance. He’s worked with BSI’s notified body for 15 years.

“It’s an additional burden on the company to keep buying individual standards. Moreover the standards are not static, new updates and revisions are released almost every other year.” As part of a team that has developed and sold three medical device start-up companies, Rinda had experience of the different methods of purchasing standards. He found that the large database model could be very expensive and so prior to investing in Compliance Navigator, Axonics Modulation Technologies was purchasing single standards. Rinda’s team experienced the drawbacks of the single standards model. Licences for single standards were available only on a single computer, and it was difficult for the start-up to justify the cost of multiple licences. “This was a problem,” says Rinda, “because determining the applicability of a particular standard, and appropriate test methods is a collaborative effort. The whole team had to be able to see the standard, particularly colleagues from engineering, and decide whether to test to a certain requirement, or meet that requirement.” With such a brand new innovative product, the question of applicability was particularly difficult.

Both cardiac and neuro medical device products have leads which are placed inside the body. As the patient moves, the leads need to move with them. So the lead is subject to the mechanical stresses of movement. As neuro is an area of innovation, neuro standards don’t specify the number of cycles needed to test bending of the leads and establish that they can move safely. The team needed access to standards in order to assess applicability, so even though a specific standard may not be applicable to a particular product line, they needed to be able to determine that this was indeed the case. Equally, there could be testing and validation methods described in some standards that were relevant to the R&D and compliance process for new products. For instance, standards in the neuromodulation space are not as mature as cardiac standards, because implantable systems are a relatively new product in this area. The team needed information from a wide variety of standards to help them develop test methods that would qualify the new products, and ensure they are safe from a patient perspective. As developers of an innovative new product, Rinda’s team also needed to know when standards were changing.

A BSI roadshow offered Rinda the answer to these workflow issues when he saw a demonstration of Compliance Navigator. He followed up with a live demo and made a purchase. As Rinda said: “Everyone can now access and review the standards. And for applicability, I don’t have to buy single standard only to find out it is not applicable to the product I’m developing.” Compliance Navigator offers Axonics Modulation Technologies an enormous amount of standards covering many different aspects of medical device design, but without the cost burden of a large database. “It’s not expensive like the old fashioned databases used to be,” he said, “and that’s another reason we like it so much.” The team was able to use Compliance Navigator to search, review and determine the most appropriate tests for developing new products. For example, they were able to review several different standards and found that the cardiac standards had the best and most detailed information on how to ensure the lead would be safe. The cardiac standards were used to qualify the implantable lead on the new neuro product and make sure it was safe for patient use.

A couple of months after initial purchase, the entire company had moved to using Compliance Navigator. “There’s no-one who would want to go back to the old system now,” Rinda explained. Soon after mastering the basics, the team began to explore the additional features of the product, and were particularly impressed with the ability to group individual standards together and then share the different groups with different teams and colleagues according to the product they’re working on. After being tied to one computer that contained standards, the ability to share information with different team members is one of the strongest features, but most important is the notifications feature: “It’s a great tool, especially when we are in the middle of testing or the middle of regulatory review.”

Axonics Modulation Technologies has experienced a direct time saving as a result of switching to Compliance Navigator. But more important is the accelerated workflow Rinda now sees:

“If someone asks me something in a meeting, I can quickly check the information. Before, I would have to note it down, go away, check at the computer that has access to all the standards and report back at the next meeting, which might be a week later. Now I can provide an answer straight away. It saves a tremendous amount of time. So it’s not just the direct time saving of locating information quickly, it’s a much faster, accelerated workflow.”

Rinda estimates a 50 – 60% cost saving on compliance in the R&D phase, by eliminating the time spent searching for applicable standards.