Customer case: Gilbert Technologies and Philips Engineering Solutions team up on medical device development
There may be new hope on the horizon for lung patients with difficult to treat conditions, like fibrotic diseases and severe asthma, thanks to Dutch start-up Gilbert Technologies. Together with Philips Engineering Solutions, the company is working to turn their proprietary soft mist technology into a first-of-a-kind medical inhaler device, which has the potential to improve treatment effectiveness for patients and reduce medical costs.
“Chronic lung diseases remain the third leading cause of death and disability worldwide,” says Maurits Huigen, CEO of Gilbert Technologies. “It’s our mission to make medical treatment easier and more effective for lung patients to save lives and help them live the life they want, while reducing the burden of care on health systems.”
Creating the inhaler of the future
Gilbert Technologies has been working on a new Electro Hydro-Dynamic Atomization (EHDA) or ‘Electrospray’ technology. Their inhaler device, currently in development with Philips Engineering Solutions, aims to simplify the inhalation technique for patients, enhance drug administration and therapy adherence, and reduce the cost of treatments.
The new Electrospray technology is being developed to overcome the drawbacks of current treatments for severe lung diseases.
These therapies involve complex and expensive medications, like e.g. biologicals or cancer drugs, that are given orally or by injection. When delivered by these routes the drugs have to travel through the entire body to reach the lungs, it delays the onset of action, may introduce side effects and requires a fairly high dosage.
Administering these drugs directly to the lungs is safer and more effective, but until now dry powder inhalers and metered dose inhalers have been limited in their ability to do this.
“Although inhalers are widely used, only about 15% of drug particles reach the right parts of the lungs with current devices,” says Professor P.N.R. (Richard) Dekhuijzen, Professor of Pulmonology, Radboud University Medical Center, Nijmegen, who is an expert in inhalation technology and has been providing clinical advice for the project. That is partly due to the limitations of current inhaler technology and partly due to patients themselves. “Lung patients have difficulty inhaling medication strongly and deeply enough. And they may make mistakes. They get the dose wrong, breathe from an empty inhaler, exhale when they should inhale… That’s why this technology is such an important breakthrough.”
The basic principle
The basic principle of Electrospray is an inhaler that can be adapted for precise administration of different medication formulations (spanning a range of particle sizes), as an aerosol (soft mist).
“This is the inhaler of the future” says Huigen. “Our patented Electrospray technology offers the potential to deliver more advanced pulmonary drugs and formulations with large and small molecules, in a targeted way to patients via inhalation, making treatment more effective.”
In recognition of their breakthrough, the company was named one of the top 10 respiratory device solution providers by MedTech Outlook in 2019.¹
“We chose Philips Engineering Solutions because they could offer us a one-stop-shop for our full development trajectory”
Just four months from lab proof of concept to functional handheld demonstrator
Rather than adapting a current device, Gilbert Technologies is building its new, smart and connected, device from scratch. That enables them to learn from the past, and to create a modular design that addresses requirements for the drug formulations used and design of the device. Combining these two aspects has also posed unique challenges for the project. “We chose Philips Engineering Solutions because they could offer us a one-stop-shop for our full development trajectory,” says Scott Fleming, Chief Technology Officer, Gilbert Technologies. “It’s quite unique to find a partner that can put together such an experienced multi-disciplinary team.”
The first task for Philips Engineering Solutions was developing a handheld, battery-operated demonstrator for this new generation soft mist inhaler. “They recreated our initial proof-of-concept on the lab bench using full scale high voltage generators, a syringe, actuator pump, and a bulky spray nozzle with circuit boards and laptops for software controls.
We had to compress this big lab set-up down to a small and ergonomic handheld device,” says Fleming. “We needed to have a device that demonstrated the concept works and also that it can be packaged in a way that patients can use.”
“Thanks to our huge base of experts, we could meet this project’s broad mix of requirements,” says Alwin Rutjes, Project Manager, Philips Engineering Solutions.
“We pulled in an electrical engineer, with experience in high voltage systems and embedded software, and a mechanical designer specialized in micro fluidics to achieve the precise dosage of fluids to the nozzle. Guided by the system architect, this team came up with an architecture that could be quickly implemented in a practical demonstrator.”
To get the demonstrator done on time and on budget, Philips Engineering Solutions used as many off-the-shelf components as possible. However, specific items, such as the product housing, high voltage parts, and control parts with software, were developed in-house. Fleming says, “With Philips help, we went from proof of concept using a benchtop setup in the lab to a portable and functional handheld demonstrator in just four months.”
Meeting ISO 13485 medical and regulatory requirements
“It’s always exciting to work on a project like this with such an enthusiastic customer,” says Rutjes. “But we are also very conscious of keeping them focused on what’s most realistic and practical within the constraints. That’s why we advised them to use off-the-shelf components to save time. Based on our experience in developing medical devices, we also advised them to start the process of making their development activities compliant with ISO 13485 from the beginning to save headaches in the end.” Philips Engineering Solutions helped the customer team translate their idea into the different layers of requirements within a quality management system to ensure that the eventual clinical device will meet all the ISO 13485 medical and regulatory aspects.
Fleming adds, “Philips has prepared the foundation for meeting medical regulations and future CE marking, that we can build on as we progress towards developing a further miniaturized clinical device ready for clinical studies. It means we’ll have done everything by the book and won’t have to go back and re-do anything. This should lower our risk and save us both time and money going forward.”
To prepare for the development of the clinical device, Philips Engineering Solutions also led a series of Failure Mode and Effects Analysis, or FMEA sessions with clinical expert Professor Dekhuijzen.
He helped the project team uncover potential failure modes and provided insights into useful ways to improve the design to mitigate them.
“Our goal was to make the device as foolproof as possible,” says Dekhuijzen. These patients have difficulty breathing in deeply, and might exhale or cough into the inhaler. Philips Engineering Services was a very experienced and professional partner who helped us consider all those aspects during the in-depth sessions.”
Together we can achieve a truly meaningful advance
“In a project this complex, it’s invaluable to work with one development partner who coordinates all of the disciplines and phases of the process, so you can be sure that the final result will meet all of the end requirements,” says Huigen. “From the very beginning, the belief and enthusiasm for our project that Philips Engineering Solutions showed was key. The synergy has been there from the very beginning, and we are confident that together we can achieve a truly meaningful advance that will make it easier for lung patients to breathe and live their life to the fullest.”
¹ MedTech Outlook, 2019, Top 10 Respiratory Devices Solution Companies, MedTech Outlook, viewed 11 November 2020, https://respiratory-devices.medicaltechoutlook.com/vendors/top-respiratory-devices-solution-companies-rid-58.html
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