Client case: Syntach
We want to be proactive as a company
The new regulations (MDR) for medical devices means that post market surveillance must be conducted proactively and not reactively. This has not really been the case before when it was enough to look for content and information when something happened that concerned one's product. Therefore, we want to be proactive as a company and have a system in place that facilitates this work.
Victoria Krüger, Chief of RA/QA
Syntach AB is a Swedish Medtech company, based in Lund, a “Life Science-city” near Malmo and Copenhagen. The company was founded in 2012 with the goal of creating a completely new class of cardiac support devices to improve the care of the rapidly-growing number of people with heart failure.
To address these current challenges, Syntach is developing a medical device for the treatment of patients with chronic left ventricular failure. Syntach is now in an innovation and development phase with the goal to First in Man in 2023.
The Challenge of manually monitoring
As Syntach currently conducts research to develop its products, it is extremely important to keep up to date on innovations, updates on regulations, research and literature. It has also been important for Syntach to keep track of competitors and their development. Manually searching and managing the information felt like a time-consuming and complex task.
Syntach was well aware of the enormous amount of information available online and therefore wanted to find a way to streamline and automate external monitoring and prepare for the upcoming requirements for post market surveillance and the regulations regarding MDR (Medical Device Regulation).
We want to be proactive as a company
“The new regulations (MDR) for medical devices means that post market surveillance must be conducted proactively and not reactively. This has not really been the case before when it was enough to look for content and information when something happened that concerned one's product. Therefore, we want to be proactive as a company and have a system in place that facilitates this work.
We need to have our methods and processes in place so that we can actively show what is happening in the market when it comes to competitors, recalls, state of the art and so on. “
Victoria Krüger, Chief of RA/QA
Previously, Syntach worked with external monitoring intermittently, when information was needed for a specific occasion, such as searching for information about a question they needed answering then and there. The Challenge was to move away from repeated, manual searches and find a system that covers a larger area (PMS), that can be run automatically. There was no room to hire a person to work with this manually.
Hoodin for Medtech - Post market surveillance
Syntach has used Hoodin since the beginning of 2021 to automatically monitor relevant sources to gain insights about competitors, scientific articles, research and insights around their field. Syntach has chosen to use the use case post market surveillance, as even though they do not have products on the market, they think it is very important to be prepared and above all to stay updated throughout the development process for the products.
Victoria, who is the project manager for their Hoodin project, has created surveillance on sources that are relevant for them to monitor, and with the help of "matching words" it’s determined what type of content is going to be fetched into the platform. Through recommended monitoring feeds, it is easy and smooth to create monitoring on various sources to, for example, monitor databases such as Pubmed and Maude, scientific literature, forums and blogs
Let's have a chat!
"I am happy to help you automate and streamline your post market surveillance process just like Syntach.
Let's have a first chat to elaborate on your challenges
and needs. "
Chief of RA/QA
Top three sources monitored:
NIH Clinical Trials
2 Minute Medicine
Post market surveillance
Top three used monitoring feeds:
Literature search - own products
Literature search - competitors and Clinical trials - competitors
Now we can coordinate the work in a much better way
“It is difficult to say how much time we spent internally on digital searches when it was done manually, but the big problem was that the work was not coordinated. It has happened that two or three people were looking for the same information at the same time, which made it difficult to know what the other had been looking for or found.
Now we can coordinate the work in a much better way by having one place for this that everyone has access to. We no longer have to risk doing the job twice.”
Furthermore, Victoria says that Hoodin as a platform was easy to learn and implement. The challenge was rather to find relevant keywords and to not end up with a result with 1000s of articles. But by adjusting and improving the monitoring feeds, they are constantly working on creating the most relevant monitoring.
The biggest advantage for Syntach of working with Hoodin as a tool has been to have everything gathered in one place. To be able to divide the monitoring into different categories and share the results with different people, as people in the team need to see different content, is invaluable.
“One search is interesting for our clinical expert while another is interesting for the research manager. So by having everything in one place, I can easily share the content with the right person so they can decide if it’s something we need to look further at or save for later. “
The implementation process
During our first meeting together, Syntach talked about their challenges in preparing for post market surveillance and that the work was unstructured and time-consuming. Together, we looked at which sources needed to be monitored and what requirements they had for an automated content monitoring system. We quickly came to the conclusion that Hoodin could be a good solution and planned a workshop together.
During the workshop, which can be seen as an education-session about the platform's use in relation to the customer's needs, we went through how and why the platform should be used by Syntach.
“This is a very good opportunity to get to know the customer and their needs. When you work together with the platform, you get a good understanding of the customer's needs while they learn the platform's functions faster. A win-win situation! ” Emmie Olsson, Hoodin
A couple of months later, Syntach began a 14-day free trial period to test and evaluate the platform internally. It quickly felt right and Syntach now uses Hoodin in their weekly workflow to fully and automatically gain important insights about the research area, the segment they operate in and updates about competitors and their products.