Accelerating implementation of your health innovation
This practical workshop series is available for everyone within Twente University that is involved in health technologies. These workshops are relevant for everyone in medical technology, eHealth, in-vitro applications, public health, wellbeing, home care or lifestyle.
This series is practical in nature and tailored to the needs within the University. During the workshops you will learn about regulations, documentation, how to successfully implement your innovation, research on human subjects, research data management and privacy. The workshop are hands-on with easy to use templates so you have everything you need to get started. This documentation is tremendously important if you intend to test your innovation on humans, license it or start a company. The earlier you start building it, the easier it becomes. The goal of the workshops is to help you setup 80% - 90% of everything you need to push your innovations forward.
THE 6 SESSIONS
In June/July 2021, new sessions of The TechMed Series (online) took place every Thursday between 3:00 PM and 5:00 PM, focusing on the steps of implementing health innovations and accelerating this process.
Click on the session for more information and recorded video.
- 1. Is my innovation a medical device
The new EU Medical Device Regulation (MDR) that comes into effect on May 26th contains a very broad definition of what constitutes a medical device. Even though your innovation might appear not to be a medical device, chances are it falls under the new definition. The new definition covers basically any technology (hardware and software) that works on/with/near humans and the data generated by them.
This workshop contains the following topics
- How to determine whether an innovation falls under the scope of the MDR.
- What are the consequences for my innovation.
- How to determine the right classification.
- The upcoming European Artificial Intelligence Act and how it connects to the MDR.
- How to use the technical documentation template.
Recorded video
- 2. Why risk management is important and how to implement it
Risk management is essential when it comes to health innovations. It is the basis of the MDR. Without risk management, no research on human subjects. Risk management is closely connected to the classification discussed in the first workshop. The risk management process starts the day you commence your project and ends long after your innovation is recycled.
This workshop contains the following topics
- What is risk management
- How to manage risks
- Risk Team
- Risk planning & reporting
- How to use the risk template
Recorded video
- 3. What is design documentation and how to implement it
Design and risk management are connected, one follows the other. Even though design and development processes are based on the ISO 13485, we will provide easy-to-use templates to get you started. You will save yourself a lot of time and frustration by maintaining a design log. Design documentation also allows for recording and transference of important information that might be lost when personnel changes.
This workshop contains the following topics
- Design and development processes
- The design and risk loop
- Design and development documentation
- Maintaining a design and development log
- How to use the design and development template
- 4. Why validation and verification are essential and how to implement them
Validation and verification are essential to getting your innovation to the human research phase. Everything comes together in validation and verification. Thinking ahead is key because you can incorporate validation and verification in the research done at your department. All you need to do is understand the how, why and what.
This workshop contains the following topics
- Understanding validation and verification
- Validation and verification: product, process, pre-clinical, clinical, field, volunteer and public
Recorded video
- 5. Increase the chance of making and implementing a 'successful' product
A majority of promising innovations aimed at healthcare does not reach healthcare practice. Let’s take advantage of knowing this for a fact by learning from these cases and anticipate on potential barriers. In this workshop we focus on the large number of aspects that play an important role by the implementation of ‘successful’ innovations. How could you systematically assess these crucial aspects and how to increase the chance of implementing your innovation (or to increase the chance that you will receive the required financial support for your (follow-up) research? As showing the added value (cost-benefit) of your innovative medical technology has a substantial role in this process, this will be also addressed. Altogether, this session promises to provide you with theoretical and practical guidance to increase your chances of developing and implementing a successful innovation.
This workshop contains the following topics
- What makes a healthcare technology successful?
- Aspects related to successful development and implementation
- How to assess these aspects?
- Health technology assessment; how to evaluate the “added value” of your innovation?
Recorded video
- 6. Research on Human Subjects: patients, volunteers, users and public
Clinical evidence on the safety and effectiveness of health innovations is key in their implementation. It is important to assess whether the risks of use are in reasonable proportion to the expected benefits. This asks for a qualitative and quantitative evaluation of the clinical benefit against the clinical risks, including undesirable side effects, in the target group and indication. Evidence can come from various sources however often human subject research has to be performed. The Scientific Research involving Human Subject Act (in Dutch: WMO) is applicable to this type of research. This workshop will give an introduction to this legislation and corresponding procedures.
Recorded video
