Using NoSQL to get a 360 view of medical device compliance

Profile picture for user ddpreez By Derek du Preez June 14, 2016
Summary:
BSI Group is using NoSQL technology from MarkLogic to rethink how it provides standards and regulatory guidance to its customers building medical devices.

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As one can imagine, the creation of medical devices isn’t a simple process. There are extensive guidelines, standards and regulations that are to be adhered to before you can sell a product on the market for medical use.

And this process of finding and understanding the standards that apply to a potentially life saving product is complicated. It’s a constant evolution of new product innovations being introduced and the regulatory environment changing - meaning that keeping your products compliant can be a tremendous, but vital, task.

BSI Group is a British standards body that is looking to make this process much simpler for its customers, the creators of medical devices, by smoothing the path to discovery of information as it relates to compliance and regulatory requirements.

It is doing this through the use of a new standards and regulatory based management tool, which is being underpinned by MarkLogic’s NoSQL technology.

Shirley Bailey-Wood, director of information solutions at BSI, was speaking at MarkLogic’s user event in London this week, where she explained that her job has been focused on moving customers away from a document-focused understanding of standards, to one that’s more intuitive. She said:

For the last seven years I’ve been working at BSI, focused on the standards team. And the interest there for us has been the challenge of moving the standards documentation out of very document centric provision to our end users. Trying to understand the value that could be provided to the market by moving the dial on how they’re accessing, managing and getting value from that content.

[I always describe the new tool] as almost as far as we could get from our current provision of PDF and documents centric library.

The project

Bailey-Wood said that there were a number of challenges in moving away from a PDF-focused format and moving towards more accessible content for the end user that could add value. This is complicated by the fact that end users don’t just need information on the regulations and standards, and how they’re changing, but also information on the specific devices. She said that it’s “quite a heavily regulated industry” and added:

So as we started to gather the information around what their challenges were, we could see that there they were dealing with all these disparate sources of content. And they were doing all the running around. The content was in a variety of places and all the workaround was at the customer level, not at the service that was providing that content to them.

So we set ourselves the challenge of how we could create a different experience for them and how we could guide their discovery more. Our whole intention was to empower them in their different ways, so that they could do the discovery in a very quick and efficient means. And then manage that information on an ongoing basis.

The two things that they would always say to us, is that they don’t know if they’ve got everything that they need and they really struggle to discover what’s relevant to them. As well as the timeliness and comprehensiveness. A lot of them would do Google searches and it was really hit and miss around what they would discover.

We had the challenge of bringing semantics in, we needed to make our content intelligent about itself and how it related to other content.

360 view

Bailey-Wood said that when she started on the project she was “suddenly getting the sense” they could provide BSI customers with a 360 view of all the data, which had never been possible before. This involved streaming in data from a number of databases, a number of third parties and, of course, Excel spreadsheets. She said:

We had all of that challenge and we found that by using NoSQL we could start to bring that data together very easily, very quickly, without huge investment and timeframes that would make our expiration of the market disproportionate to what we might achieve commercially.

It was a really exciting time for the product team, the customers and the developers to be working with that variety of content and suddenly seeing not only what we thought we could bring together, but getting real insights into data touchpoints that we never even thought that we would be able to infer.

And according to Bailey-Wood, the customers have been “stunned” at what BSI has managed to achieve. The group did a lot of marketing and market awareness in the UK and the US around the new product, but she said that they seemed to just “get it in a heartbeat”. She added:

The transformation of what we’ve done was instantly evident to them. Some shock factors of some teams saying: ‘but that’s my job, I can’t possibly buy that product, that’s my job, what will I be doing?’ And then explaining that their job will move on to assisting the rest of the team in innovation and that new products are keeping viable and are regulatorily sound. But they continue to be excited because we continue to cut new innovations into the product.

Challenges

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However, despite the benefits BSI and its customers have seen, it of course hasn’t all been plain sailing. Bailey-Wood said that her and her team definitely have some “battle scars” and that there have been some sharp learning pains along the way. She said:

It was a big journey for the developers of course, because we weren’t using the technology [that they were used to]. But we also took the view that we needed the business teams to understand it, so we had some really helpful business explanations from the technology team about the new gains we were going to achieve.

We built the appetite and awareness and direction of the business exec and the product development team. And then of course the developers were going on their own journey about learning the software.

We took some consultancy support, which for us was particularly useful, I don’t think we would have done it as quickly if we didn’t have the hand holding that we had had from MarkLogic in the early days. And of course our developers have gone from strength to strength, it’s absolutely delightful to hear them talk about the code and the fact that they can update it really easily, understand the business requirements and able to translate. Almost every two months they are cutting something new into the product. But we continue that learning curve.

And the next challenge is going to be using the NoSQL technology and platform to broaden the scope and provide similar services to customers in other fields. She said:

We will have the next challenge of broadening out from medical devices. Broadening out to a whole array of sectors and disciplines that are covered by the collection of standards that we create. One of the interesting challenges again, for a standards body, is the fact that standards are dynamic documents.

The industries are constantly evolving and moving, so there is no sense of ‘that’s it done and dusted’, every standard will go through its periodic review and some new technology is emerging that will make that standard change.

Image credit - Medical team working at the hospital all together © Production Perig - Fotolia.com

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