Efficient and accessible user manuals are important for any products, but when it comes to medical devices it is essential. In vitro diagnostic product (IVD) consultancy company IFUcare is at the forefront of E-Labelling and electronic instructions for use (eIFU) services that enable medical device manufacturers to replace paper-based IFU with digitalised instructions.
Developed by a team of regulatory experts, eIFUs can save on paper costs, simplify the documentation process, and provide better control over risk mitigation. Since 2019, Bonebridge, a Swiss manufacturer of smart orthopaedic trauma implants, has been partnered with IFUcare to develop eIFU for their products.
At the start of the partnership, Bonebridge was still a start-up, and digitalised instructions allowed the company to reduce the initial time and money spent on producing a paper IFU, as well as ensuring that up-to-date instructions were always accessible to their user base.
According to Alex Häusler, co-founder of Bonebridge: “We started in 2018, so a little more than three years ago, and we are focusing on osteosynthesis implants and instruments. Our goal essentially is what’s written underneath our logo: to reduce complexity. We want to do this not only with the implants and instruments in mind, but essentially across the board, with everything we do.
“We started interacting with IFUcare pretty early on, only a few months after we began operations, essentially because of this reducing complexity approach. For us, it just wasn’t imaginable to start a company in the twenty-first century and hand out paper IFUs. We knew we wanted to go digital.
“We were looking around at what options there were and were made aware of IFUcare through one of our regulatory consultants. The decision to go with IFUcare was based on the calls we had with the company at the beginning, at the demonstration stage, and just while using the tool itself. The knowledge that the platform was used not only by small companies, like us, but by big players as well, helped with our decision.”
With its experience working with companies of all sizes, IFUcare’s capabilities are particularly attractive to start-ups such as Bonebridge. Not only does it mean that the company can support organisations when they are new, but its ability to work with major players means that start-ups do not have to worry about outgrowing the company and needing to search for a new partnership further down the line.
“When you launch a company and start developing products, the learning curve at the beginning is really steep,” Häusler explains. “The changes to IFUs at the beginning can be relatively high as you get a lot of customer feedback, as well as feedback from the certification bodies. Maybe the IFU or the surgical technique that you created initially and printed isn’t up to date anymore, and then what do you do? You must recall them and send out additional information to all of your users. This didn’t really seem to be a valid solution.”
Bonebridge’s customers are the hospitals themselves, so providing paper IFU would involve putting a paper copy with every shipment they sent out. However, one problem that Häusler identified was that this documentation could be easily lost or thrown away.
“As a legal manufacturer, which we are of medical products, you are obliged to provide your users with instructions for use and the surgical technique,” Häusler adds. “The way in which you want to do this is essentially up to you, it just has to be ensured that any user anywhere in the markets that you supply has access to the information needed to use the product.”
IFUcare’s tool allows customers to upload the labels and IFUs to a user-friendly website for customers to download, ensuring that information is not thrown away or lost, and always available to users that need it.
“If we want to change anything in the IFU, or if there’s a new version, if something needs to be amended, or if a new language is available, we can do it all ourselves. It’s essentially a self-service portal,” Häusler explains. “It’s really straightforward, no more effort required than necessary.
“IFUcare works efficiently and effectively, there’s really nothing bad to say about their services, we’re really happy with the work we’ve done together. If we need something, they’re there for us with support and they’re responsive. With the recent upgrade of the tool, it was managed well, and they offer good training. There’s really nothing to complain about.”