Sanner and PulmoBioMed: Innovation for lung sample collection receives CE marking

Design specialist for medical technology products and CDMO Sanner, together with the medical device company PulmoBioMed Ltd, have jointly achieved CE marking for PBM-HaleTM. The technology for collecting breath samples is approved as the first solution for non-invasive, saliva-free samples from deep lung areas for clinical and research purposes throughout Europe and the USA. Together, Sanner and PulmoBioMed developed the groundbreaking device from prototype to market launch, which is now ready for series production.

Obtaining representative samples from the deep lung today involves invasive, costly, and risky procedures that are only intended for severely ill patients and are unsuitable for routine or repeated testing. As a result, causes of lung diseases often remain untreated, while their symptoms are instead addressed therapeutically.

The British medical technology company PulmoBioMed aims to challenge invasive clinical diagnostic procedures and advance respiratory research and the development of future methods. This led to PBM-HaleTM, a non-invasive device for collecting breath samples from the deep lung. By collecting saliva-free breath condensate from the distal lung, it minimizes contamination from the mouth, upper airways, and the environment. Additionally, the solution is designed to integrate into standard diagnostic workflows.

Development expertise from prototype to production

To develop the prototype into a market-ready product while receiving regulatory support and cleanroom manufacturing capacity from a single source, PulmoBioMed partnered with Sanner. Under the leadership of development experts from Sanner UK, the design underwent a rigorous product development process: risk analyses, prototype and iterative design testing, as well as tolerance analyses within a ISO 13485-certified quality management system, verified the reliable functionality.

The team also involved experts early on for design transfer. Using 3D data and injection molding simulations, the design of the 17 parts was optimized for subsequent manufacturing via injection molding and for serial assembly. Meanwhile, the manufacturing teams ensured that material selection and tool design met functional, regulatory, and assembly requirements.

Cleanroom manufacturing to the highest standards

After verification, installation, and functional qualification (IQ/OQ), Sanner produced the first 3,500 units in a Class 7 cleanroom. "We were impressed from the very beginning by Sanner's professionalism and the quality of execution as we witnessed our 3D-printed prototype evolve into a robust, high-quality injection-molded product," says Dr. Sterghios A. Moschos, founder and CEO of PulmoBioMed. In addition to the device itself, Sanner also developed the concept for primary packaging, the secondary cartons bearing the brand logo, and the tertiary multipacks necessary for shipping PBM-HaleTM.

Successful development partnership for increased device accessibility

Sanner's integrated full-service CDMO approach proved crucial in enabling PulmoBioMed to transition efficiently from development to commercialization and to bring PBM-HaleTM to market. "The process transfer from design to manufacture for scaled production went smoothly, and the partnership took into account our needs regarding strict quality and regulatory criteria," emphasizes Dr. Moschus. With the CE marking now secured, PulmoBioMed plans to introduce PBM-Hale™ in clinical studies and in collaborations with diagnostic manufacturers, as well as pharmaceutical and biotechnology companies in the USA and Europe. The company’s long-term goal is to make lung disease diagnostics safer and accessible to a broader patient population. "We look forward to conquering the market together with Sanner and establishing a worldwide supply of PBM-HaleTM," concludes Dr. Moschos.