Bronze Medical Devices and Medical Equipment Design · 2024
Smarthaler Smart pMDI Inhaler
by Jacek Mikosz
- A' Design Award 2024 Bronze Winner in Medical Devices and Medical Equipment Design
- Awarded April 15, 2024
- CLIENT: FindAir
- Estimated Number of Design Views: 49,985
- Verification code 47C73ADE59 · Verify this award
About Smarthaler Smart pMDI Inhaler
Smarthaler is a digital pMDI Inhaler, that uses real-time AI analysis and data collection to guide asthma and COPD patients toward correct inhalation technique and enhanced drug deposition. Its modular design incorporates advanced flow sensing algorithms, allowing it to operate like a standard inhaler while offering the added benefit of a reusable electronic module attached to the back of the aerosol dispenser. After each usage, it provides instant feedback on inhalation quality. This data is sent to an app for immediate sharing with doctors or care teams, facilitating better care.
Press Kit
- Unique Properties
- The modular smart inhaler device features a measurement system that enables real-time identification and correction of inhalation errors, enhancing the effectiveness of drug delivery without disrupting the inhalation process. Integrating a verification system directly into the actuator's design, ensures patients can more efficiently and effectively adhere to prescribed therapies while developing correct inhalation techniques habits. Information is sent to an app, where it can also be shared.
- Dimensions & Packaging
- Device Dimensions: 29,7 mm x 57 mm x 93 mm
Packaging Dimension: 107 mm x 40 mm x 140 mm
Material: PP/ABS
Battery: Rechargeable
Port type: USB-C
Connection: Bluetooth Low Energy
Compatible Apps: FindAir Smarthaler (Android/iOS), FindAir Doctor Web App
Accessories:
USB Hub that enables using it without the phone
HFA Placebo Bottles
Additional Actuators - Tags
- smart inhaler, iot, medical device, modular, digital health, telemedicine, education, pMDI, inhaler, inhaler technique
- Production Technology
- The solution results from extensive user research, clinical trials, and data collection from patients and medical professionals. It represents a multidisciplinary collaboration, combining expertise from design, medical, IT, artificial intelligence, and pharmacokinetics fields. The device's electronics integration within a medical-grade plastic enclosure employs precision injection molding rigorously tested and validated through lab-based pharmacokinetic studies to ensure durability and safety.
- Design Challenge
- The primary challenge was integrating advanced technology into a design as familiar as a traditional pMDI inhaler, ensuring it was approachable yet innovative. Our objective was for users to adopt this advanced inhaler as naturally as they would their standard one, but with added functionalities for a richer experience. Developing a modular design was crucial to allow for the sustainable use of electronic components, enabling users to update or replace parts without discarding the entire device.
- Project Duration
- Project started May 2021 in (Kraków, Poland) and finished in December 2023 (Kraków, Poland) as part of FindAir research supported by a grant received from The National Centre for Research and Development.
- Operation Flow
- The inhaler functions like a regular inhaler but with an added feature: an electronic module that fits onto the back. This module is optional, allowing the inhaler to be used in its basic form or enhanced with digital feedback. After using the inhaler, users receive immediate feedback on how well they inhaled the medication. This information is sent directly to an app, where it can also be shared instantly with a doctor. The device serves dual purposes: delivering medication, or training tool.
- Research
- Research aimed to refine pmdi inhaler experience, employing a mixed-method approach. We conducted medical experiments, and observational studies complemented by desk research to gather base data and validate it in clinical trials, and lab tests. Using custom measurement setups and digital tools, we gathered data from a diverse group of patients and healthcare professionals. The findings emphasized the need for modular, intuitive inhalers that improve user inhaler technique and treatment efficacy.
- Inspiration
- The inspiration for the device emerged from observing close relatives struggle with conventional inhalers during asthma attacks, leading to insufficient relief despite multiple inhaler usage attempts. This prompted a deeper investigation into inhalation techniques research, revealing that 83,7% of users exhibit incorrect usage, primarily due to the complex coordination required by inhalers. The sequential motion set (precise timing, strength, and duration) presents a significant challenge.
- Image Credits
- FindAir Sp. z o.o. Internal Materials
- Patents
- Copyrights belong to FindAir Sp. z o.o, 2024.
Smarthaler® - Registred EUIPO trademark
EU patent filling:
EP22461546.8 – AN ACTUATOR FOR AN INHALER
EP22461592.2 – A DEVICE FOR MONITORING USE OF AN INHALER
EP3856305 – METHOD FOR MONITORING DRUG INTAKE
Colors of Smarthaler Smart pMDI Inhaler
Design Interview about Smarthaler Smart pMDI Inhaler
Learning a new technique, especially one that changes behavior, takes time. It’s all about feedback and visualization. Inhalation techniques are tough to master, so the device focuses on giving immediate feedback to help users get better. The tools for process of constant improvement is at the core of what we do.
Our main focus in designing this inhaler was to create a device that’s both highly functional and user-friendly. We wanted to achieve two key goals: first, to ensure the effective delivery of medication, and second, to help users develop proper inhalation techniques. By integrating an optional electronic module, we provide immediate feedback, making it easier for users to improve their technique. This dual functionality aims to enhance the overall user experience and improve health outcomes.
Ourplans include expanding its market presence and establishing collaborations with pharmaceutical companies. We also aim to promote inhaler training education, helping more users develop proper techniques for better health outcomes.
We worked on this inhaler for almost three years.
The inspiration for this device came from observing close relatives struggle with conventional inhalers during asthma attacks, leading to insufficient relief despite multiple attempts. Designing a fully integrated smart inhaler was always part of our original plan for the company. However, such a complex project required the right timing, a skilled team, and significant resources to bring it to life.
We currently manufacture with our capabilities with some help from a partners. However, we are open to licensing it if the right partner comes along for a particular market.
Our target customers are healthcare providers, who can use our product as a training tool both on-site and remotely. Additionally, it is a fully developed drug delivery device that meets pharmaceutical industry requirements, making it suitable for broader medical use when needed.
What sets this design apart from similar concepts is its modularity and flexibility. While there have been efforts to create smart inhalers before, they typically had integrated electronics that couldn't be removed or transferred. Our inhaler is modular and can function as a typical pMDI inhaler. With the Smarthaler module, it expands its capabilities. The electronics are not disposable; you can reuse them with your next inhaler when the canister is finished. This approach not only enhances functionality but also promotes sustainability.
The name "Smarthaler" is a natural progression from the term "smart inhaler," which is becoming common in digital health. Many inhalation devices end with "haler," and since our product is an inhalation device, Smarthaler was a fitting and intuitive choice.
We used several design tools while working on this project. On a daily basis, we employed 3D scanning, CAD, and CFD analysis. Additionally, we utilized analytical software and conducted numerous 3D print tests with prototypes in various technologies.
From a design perspective, is its modularity. This feature allows a standard inhaler to be transformed into a smart inhaler, addressing regulatory limitations and enabling pharmaceutical companies to enter the market with smart technologies with less risk. From a technological standpoint, our Flow Sensing technology is a standout. It allowed us to minimize the device, making it both ergonomic and easy to use.
We collaborated with specialists from various backgrounds to bring this design to life. Our solution is the result of extensive user research, clinical trials, and data collection from patients and medical professionals. It was a multidisciplinary effort, combining expertise from design, medical, IT, artificial intelligence, and pharmacokinetics fields. We integrated the device's electronics within a medical-grade plastic enclosure using precision injection molding. This approach was rigorously tested and validated through lab-based pharmacokinetic studies to ensure durability and safety.
We developed Flow Sensing Technology with an AI algorithm that measures the flow during inhalation using numerous sensors, all without requiring difficult calibration. This system also reviews each inhalation in terms of the user's technique. This technology enabled us to create a device that is easy to use and provides instant feedback on the inhaler screen about the performed inhalation.
We condudcted research that aimed to refine pmdi inhaler experience, employing a mixed-method approach. We conducted medical experiments, and observational studies complemented by desk research to gather base data and validated in clinical trials, and lab tests. Using custom measurement setups and digital tools, we gathered data from a diverse group of patients and healthcare professionals. The findings emphasized the need for modular, intuitive inhalers that improve user inhaler technique and treatment efficacy.
The primary challenge was integrating advanced technology into a design as familiar as a traditional pMDI inhaler, ensuring it was approachable yet innovative. Our objective was for users to adopt this advanced inhaler as naturally as they would their standard one, but with added functionalities for a richer experience. Developing a modular design was crucial to allow for the sustainable use of electronic components, enabling users to update or replace parts without discarding the entire device.
We wanted our work to be evaluated by other design specialists. We're open to feedback and eager to learn from each comment, as it helps us improve and grow.
We significantly expanded our capabilities. We moved from designing sensors for inhalers to creating fully integrated drug delivery devices. This process involved going through all the necessary stages to develop a product ready for market entry. It taught us a lot about the intricacies of product development, regulatory requirements, and the importance of user feedback.