Developing a medical device to improve end-of-life patient comfort
Medical patients with terminal diagnoses often experience pain or discomfort on a daily basis from a build-up of fluid in their chest cavity. Palliative care/home care provides specialised medical treatment to improve the quality of life for those with serious conditions, like cancer. It is aimed at relieving patients’ discomfort alongside, or at times in place of, curative treatments while enabling them to live at home with key medical supports.
Bearpac Medical is a medical device start-up focused on improving care for patients who suffer from malignant pleural effusion (MPE). MPE is a condition where fluid builds up in a patient’s pleural cavity, the space between their lungs and chest wall, making it difficult to breathe.
We partnered with Bearpac to develop the Passio™ Pump Drainage System, a digital handheld, single patient use device that offers significant advantages over the current market-leading solution. We provided healthcare and medical device expertise, product and service design capabilities and process and tool training.
- Conducted user research to learn about patients’ needs and experiences with MPE drainage devices
- Cut drain time with Passio
- Improved patient comfort by reducing vacuum pressure compared to other systems, and giving patients control to further lower pressure as needed
- Developed a system that solidifies waste, making disposal cleaner and simpler
- Provided a final concept that Bearpac engineered and is taking to market
Improving patient comfort and control
In the US, it’s estimated that 1.9 million cases of cancer will be diagnosed in 2021, including 284,200 breast cancer and 235,760 lung and bronchus cancer diagnoses. Both of these diagnoses, especially late-stage cases, are associated with debilitating MPE.
When patients experience fluid build-up in their pleural cavity it can be quite frightening, uncomfortable and painful. There have also been limited innovations to date for removing that fluid.
A patient typically visits a surgeon to get a catheter implanted in a hospital setting, who then trains the patient or a caregiver on how to use drainage devices on an ongoing basis. At home, the designated caregiver or home healthcare provider will perform the drainage therapy. It’s historically been comprised of a vacuum bottle that removes the fluid from the patient’s chest. The patient has little to no control over the process, other than to tell the device operator to slow down fluid flow. Fluid is removed at approximately -900 cm H2O of pressure, which can cause pain to the patient during the time it takes to drain their chest. “Market-leading malignant pleural effusion (MPE) drainage devices are more than 40 years old. Thanks to PA’s partnership, Bearpac saw an opportunity to innovate a medical device to improve patient care and comfort, while giving patients more control over the drainage process,” said Jay Zimmerman, President, Bearpac Medical.
Empowering a start-up to develop a user-centric medical device
We provide practical end-to-end product innovation services, helping start-ups and global companies develop solutions, navigate regulatory compliance and then scale manufacturing processes. For this project, our team provided initial user research and training on how to conduct this research, concept development and engineering, industrial design and usability evaluation.
“PA trained Bearpac on its user research process, including conducting initial field visits, so that our team could execute most of the user interviews and studies later on,” said Zimmerman. “As a start-up, we needed to stretch our resources for the multi-year development and regulatory compliance process, so we were appreciative for the tools and expertise PA provided.”
Bearpac leaders had a strong vision of their product, as a tabletop device with controls centralised on its console. As we jointly conducted user interviews in-hospital and at home – observing catheter insertion, how patients were trained to use the system, how healthcare providers used the system, and how the patients ultimately used the system – we uncovered a different set of needs.
Patients wanted a simple, easy to use device, as the experience of draining their chests was stressful and they didn’t like watching their chest fluid collect in eye-level devices. In addition, chest drainage was something that was done to them, rather than a process they could control.
“Together with Bearpac, we explored a range of design concepts and product configurations that would improve the patient experience, while still being easy to manufacture, assemble, use and dispose of,” said John Devlin, engineering expert at PA.
After generating an initial concept around reusability, we quickly pivoted to a single-use disposable product. We created sketches and CAD drawings for Bearpac’s review. We also developed non-functional physical prototypes of final concepts that we tested with patients to get their feedback and used that input to refine the designs further.
The final design, Passio Pump Drainage System, has a lay-flat, disposable collection bag with a soft material that can be placed anywhere close to the patient. The input and output hoses and catheter connector are connected to the bag to avoid assembly challenges at the point of use. A remote handheld control unit with a digital readout and detachable pump-head puts patients in the driver seat.
While the device uses a lower vacuum pressure of -45 and -70 cm H2O pressure to remove fluid, patients can reduce the speed of flow or stop the flow if they feel uncomfortable, which is a feature that other market solutions lack. The time to drain patients’ chests is also not compromised with Passio. Finally, patients’ pleural fluid solidifies in the bag, enabling them to discard the used bag and disposable pump in the trash.
“With PA’s final design in hand, we were able to engineer the device, move forward with patient trials and submit findings for regulatory review,” said Zimmerman. “While the COVID-19 pandemic slowed this process, Bearpac recently received US Food and Drug Administration (FDA) approval for the Passio Pump Drainage System.”
“PA’s user research and design was key to developing a medical device that is highly differentiated from other devices on the market,” said Zimmerman. “We know that this device will help improve late-stage patient comfort at a difficult time in their care journey.”