Periodic Reporting for period 1 - SmartRespDx (Development of a scalable respiratory diagnostic platform)
Berichtszeitraum: 2023-07-01 bis 2024-04-30
Chronic obstructive respiratory disease (COPD) affects 10% of the adult population and is a big health concern — the third leading cause of death. It makes it hard to breathe, limits daily activities, and can lead to social isolation. One big problem is that many cases of COPD are missed or diagnosed late, which means people don't get the right treatment in time. In fact, 3 out of 4 people in Europe with COPD remain undiagnosed. The disease worsens without them knowing, which leads to more hospital stays and even death, which costs a lot for healthcare systems apart from the huge impact on patients and their families.
We found out that the tools doctors use to diagnose COPD aren't great for GPs, where this initial diagnosis and case-finding needs to happen. They're complicated and rely on patients doing difficult breathing tests, which often give wrong results. This makes people doubt the technology and leads to COPD being missed because doctors don't use the tests enough.
Our solution is a simple and accurate tool that doesn't need patients to do much at all — just breathe normally. It can be used in any doctor's consultation, especially by non-lung health specialists, like GPs or nurses. It's based on what lung experts already know, and helps doctors make quick and smart decisions about COPD. Diagnosing COPD early and keeping track of it helps doctors guide treatment and educate patients when it can still make a big difference in their lung health. This saves a lot of money for healthcare systems, avoiding expensive hospital visits, and improves patient outcomes.
Our project, SmartRespDx, has three main goals: 1) Gather proof from real medical settings that our solution works well. 2) Get feedback from users to make sure our solution fits their needs. 3) Protect our new ideas and technology.
When we achieve these goals, we will be able to attract investors to help us finish the development and bring our product to market in the EU and elsewhere, so that the people who need it can start using it, and patients can receive early and accurate diagnosis for their lung condition.
We found out that the tools doctors use to diagnose COPD aren't great for GPs, where this initial diagnosis and case-finding needs to happen. They're complicated and rely on patients doing difficult breathing tests, which often give wrong results. This makes people doubt the technology and leads to COPD being missed because doctors don't use the tests enough.
Our solution is a simple and accurate tool that doesn't need patients to do much at all — just breathe normally. It can be used in any doctor's consultation, especially by non-lung health specialists, like GPs or nurses. It's based on what lung experts already know, and helps doctors make quick and smart decisions about COPD. Diagnosing COPD early and keeping track of it helps doctors guide treatment and educate patients when it can still make a big difference in their lung health. This saves a lot of money for healthcare systems, avoiding expensive hospital visits, and improves patient outcomes.
Our project, SmartRespDx, has three main goals: 1) Gather proof from real medical settings that our solution works well. 2) Get feedback from users to make sure our solution fits their needs. 3) Protect our new ideas and technology.
When we achieve these goals, we will be able to attract investors to help us finish the development and bring our product to market in the EU and elsewhere, so that the people who need it can start using it, and patients can receive early and accurate diagnosis for their lung condition.
Tasks related to clinical evidence collection - Proof of Concept (PoC) Study: We performed our first tests on humans in a clinical study to ensure our device is safe and works as well as other devices already on the market. We tested it at the lung function lab of Hospital Germans Trias i Pujol in nearly 40 subjects. We had both healthy people and those already diagnosed with COPD take part. They used our BREAZ prototype, an existing comparator device on the market, and the gold-standard spirometry test to measure lung function. Our study showed that our device is safe for patients to use and works as well as the comparator device.
Tasks related to usability testing: We performed observational usability testing, with six healthcare workers from different settings and healthcare centers to try out our device and to gain valuable feedback on the current prototype. This helped us understand how easy it is to use and what changes we might need to make to the design.
Tasks related to IP protection strategy: We've engaged patent lawyers to explore the best pathways to protect the intellectual property of our idea and devise a staged strategy. Once we advance further in development, we'll apply for a patent to protect our innovation and keep other aspects as a trade secret.
Tasks related to usability testing: We performed observational usability testing, with six healthcare workers from different settings and healthcare centers to try out our device and to gain valuable feedback on the current prototype. This helped us understand how easy it is to use and what changes we might need to make to the design.
Tasks related to IP protection strategy: We've engaged patent lawyers to explore the best pathways to protect the intellectual property of our idea and devise a staged strategy. Once we advance further in development, we'll apply for a patent to protect our innovation and keep other aspects as a trade secret.
The Women TechEU project allowed us to achieve critical milestones, advancing our TRL level and testing our device successfully in a hospital setting. We also obtained important first user feedback as well as advanced our IP protection strategy.
The project allowed us to obtain essential training and know-how regarding 1) clinical trial setup and execution for further device development and regulatory approval. This will create sufficient confidence in healthcare professionals and sites to participate in future trials, as well as private and public funding entities to support our project. 2) UX testing which helps us to perform additional usability testing in the end-user setting at future development stages 3) IP protection as well as competitive landscape.
The project helped to identify the key next steps to take regarding development: large-scale clinical trial for data collection, incorporation of further hardware sensing advancements and adjustments to device usability to match users needs.
The project allowed us to obtain essential training and know-how regarding 1) clinical trial setup and execution for further device development and regulatory approval. This will create sufficient confidence in healthcare professionals and sites to participate in future trials, as well as private and public funding entities to support our project. 2) UX testing which helps us to perform additional usability testing in the end-user setting at future development stages 3) IP protection as well as competitive landscape.
The project helped to identify the key next steps to take regarding development: large-scale clinical trial for data collection, incorporation of further hardware sensing advancements and adjustments to device usability to match users needs.