Patient Journey App
Interactive Studios is at the forefront of developing e-health solutions, such as the Patient Journey App. Taking the lead as your middle name translates to more than technological advancements. Interactive Studios chose to prepare itself for the transition from the Medical Devices Directives to the Medical Devices Regulation well before the expiration of the soft transition period.
Client: Interactive Studios
Topic: Medical Devices Regulation
Interviewee: Thomas Timmers, CEO
Patient Journey App
Interactive Studios is at the forefront of developing e-health solutions, such as the Patient Journey App. Taking the lead as your middle name translates to more than technological advancements. Interactive Studios chose to prepare itself for the transition from the Medical Devices Directives to the Medical Devices Regulation well before the expiration of the soft transition period.
Client: Interactive Studios
Topic: Medical Devices Regulation
Interviewee: Thomas Timmers, CEO
CHALLENGE
Making a significant improvement in processes and technical documentation to meet EU MDR obligations following “up-classification”.
Under the Medical Devices Directive, Interactive Studios’ Patient Journey App was a Class I medical device. With the advent of the Medical Devices Regulation, a lot of things change for software developers, and so it does for Interactive Studios. “After intense discussion, we have determined that Patient Journey App will be classified as Class IIa under the MDR, with all of the implications that this entails.”
Because the MDR contains a set of tightened requirements compared to the MDD, and in addition to that the “up-classification” of the Patient Journey App from Class I to Class IIa, Interactive Studios had to make a significant improvement in processes and technical documentation to meet its obligations.
“This became such a distant thing for us and was so far from what we like to spend our time on, that we sought support. We started looking for people who really understand e-health and medical device legislation.”
– Thomas Timmers, CEO
“This became such a distant thing for us and was so far from what we like to spend our time on, that we sought support. We started looking for people who really understand e-health and medical device legislation.”
– Thomas Timmers, CEO
THE PROJECT
NAALA provided Interactive Studios with a comprehensive toolkit that includes the translation of MDR requirements into required documentation suiting the Patient Journey App and compliance efforts previously undertaken.
The project leading up to compliance with the MDR has been a joint one, with both Interactive Studios and NAALA doing what they do best; Interactive Studios knows their company best and NAALA can translate static requirements into practical steps to follow that match Interactive Studios’ ways of working.
In order to enable Interactive Studios to comply with the requirements of the MDR, NAALA provided Interactive Studios with a comprehensive toolkit that includes the translation of MDR requirements into required documentation suiting the Patient Journey App and compliance efforts previously undertaken considering ISO 27001, NEN 7510 and the MDD. In this way, the systems and documentation were structured, and Interactive Studios did not have to figure out for themselves which requirements they needed to fulfill to be in compliance with the MDR.
Up to Interactive Studios in this process is the task of fitting their operational processes, visions, goals, and other knowledge that concerns them into the documentation that NAALA has prepared for them. By subsequently doing a final check on the completed documents, we try to capture as best we can that the processes and documentation are understandable and complete.
“This MDR is super important, super necessary, but too complex and too abstract for us as a company to do the entire implementation ourselves. It’s just not going to work, simple as that. For us, it is very nice to work with people who have real knowledge of the subject, and who are willing to cooperate in an approachable and accessible way.“
– Thomas Timmers, CEO
“This MDR is super important, super necessary, but too complex and too abstract for us as a company to do the entire implementation ourselves. It’s just not going to work, simple as that. For us, it is very nice to work with people who have real knowledge of the subject, and who are willing to cooperate in an approachable and accessible way.“
– Thomas Timmers, CEO
THE RESULT
Interactive Studios will be prepared well in time for the audit by the Notified Body.
Patient Journey App still enjoys a transition period until May 26, 2024, due to the difference in classification under MDD and MDR. So, while it is not yet an urgent matter, Interactive Studios has chosen to get its processes and documentation in order at the beginning of the transition period (which started on May 26, 2021). Through NAALA’s support, this is currently going according to plan, and Interactive Studios will be prepared well in time for the audit by the notified body.
NAALA saved Interactive Studios 520 hours with this assignment.
With an additional 80-hour in-house commitment, Interactive Studios has the full QMS documentation standing, and structure for Technical File reports.
NAALA received a 9/10 rating from Interactive Studios for this assignment for their promptness, flexibility and quality.
FUTURE
The title of Thomas’ PhD thesis describes well what Patient Journey App currently serves: ‘Patient Empowerment through Timely Information‘. Slowly but surely, that will grow to “Patient and Provider Empowerment through Timely Information”.
Patient Journey App will of course continue to be developed. Links with activity trackers, for example, are currently being worked on, and of course market development.
The title of Thomas’ PhD thesis describes well what Patient Journey App currently serves: ‘Patient Empowerment through Timely Information’. Slowly but surely, that will grow to “Patient and Provider Empowerment through Timely Information. Information will still be sent from the provider to the patient, but occasionally information will also be drawn from the patient to the provider through questionnaires. This results in much more personalized care, with more time and attention.
NAALA will continue supporting Interactive Studios in this journey by ensuring (additional) requirements remain translated in a way that fits advanced medical technology.
HOW IAS CAME ABOUT
Interactive Studios
The success of Interactive Studios is rooted in a collaboration between Thomas Timmers (CEO), Floris Valenkamp (COO) and Paul Sprangers (CTO) during their studies in Computer Science. Back then they started building websites, but soon their college showed interest in a piece of software they could build. Other colleges quickly followed, and they started working for large parties like the Dutch Employee Insurance Agency (UWV) and ABN AMRO bank.
In 2011 they were approached by an orthopedic surgeon who remarked that an improvement in healthcare was needed for obtaining patient-reported outcomes. After gaining practical experience in various hospitals and healthcare institutions, the founders of Interactive Studios noticed that the information available about a treatment was not sufficiently converted into knowledge by the patient about his treatment.
Although there was no lack of good intention, in practice it turned out that the patient was unable to follow what the doctor was saying, while the doctor was trying extremely hard to lower the level of information disclosure to the patient’s level of knowledge.
The first prototype of the Patient Journey App was well received: the Algemeen Dagblad newspaper wrote about the use of the app in the Haga hospital in The Hague, the Brabants Dagblad newspaper published an article from ViaSana and UMC Utrecht won a science prize with it. Suddenly it appeared that the low hanging fruit had not yet been removed up until then. By giving patients dosed information over time that is of use to them at that moment, they become involved in their own treatment process.
The problem of getting the patient on board in terms of their level of knowledge turned out to be universal: Patient Journey App has now grown enormously in both territorial and material terms. In some countries whole books are written for patients undergoing orthopedic treatment, while in other countries patients only receive an A4 piece of text as preparation. The gradual provision of information in the form of a timeline appears to be universally applicable. Moreover, it turned out to be a solution not only for orthopedics, but for practically all disciplines.