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Upcoming tradeshows and conferences 

PDA

Oct 21 - Oct 22, 2025
Vienna, Austria
Hall X2, #150

PODD

Oct 27 -Oct 29, 2025
Boston, MA, USA
#26

CPHI

Oct 28 - Oct 30, 2025
Frankfurt, Germany
Hall 8, #0J92

Don’t miss our presentations at PODD and CPHI!

  • PODD
    • Monday, October 27, 2025 – 05:30 PM - 05:45 PM
      A Novel Approach to Modelling Injector Performance and Break-Loose Extrusion Force Data
      Presenter: Tom Oakley, Springboard, co-presenting with Deep Bhattacharya, Pfizer
  • CPHI
    • Wednesday, October 29, 2025 – 11:35 AM - 12:05 PM
      Rethinking Injector Mechanics – A New Approach to BLEF-Based Modelling
      Speakers: Tom Oakley, Springboard, co-presenting with Jay Sayed, Pfizer
    • Wednesday, October 29, 2025 – 12:05 PM - 12:20 PM
      Modelling to Market – Enabling Smarter, Faster Injector Development
      Speaker: Alex Vasiev, Springboard

Meet our experts at the conferences

Feel free to reach out to our sales representatives to arrange a meeting in advance.
Click on the images to send an email.

Christian Classen-1

Christian Classen
Chief Sales Officer, CSO
PDA, CPHI

Tom Oakley

Tom Oakley
VP Strategic Design & Development Partnerships (Europe)
PODD, CPHI

01-geoff-jones2

Geoff Jones
Vice President Sales, CDMO
PDA, CPHI

Ed Butler

Ed Butler
Business Development Manager
PDA, PODD

03-chuck-crandley

Chuck Crandley
Business Development Manager
PODD

Sven Dasbach

Sven Dasbach
Business Development Manager
CPHI

Paula Dominguez

Paula Domínguez
Business Development Manager
CPHI

Joe Masci

Joe Masci
Business Development Manager
PODD

Cameron Palagruto

Cameron Palagruto
Business Development Manager
PODD

Alex Vasiev

Alex Vasiev
Business Development Manager
CPHI

  

CASE STUDY

PMB logo 2

From Prototype to Production

End to end device development and manufacture for PulmoBiomed

PulmoBioMed are revolutionising the way in which exhaled breath samples can be taken from deep in the lungs.

The PBM-Hale™ is a device that helps researchers, contract research organisations and pharma companies identify and stratify patients with a range of lung conditions, so that the patients can be given the best treatment. Best of all, this is all done non-invasively making it easier to adopt for patients and clinicians alike.

Sanner Inhaler mit Mundstück_print-3
Sanner Inhaler mit Mundstück_print V3-1

Why partner with the Sanner Group?

PulmoBioMed had developed a prototype of their device but needed a partner to refine the design for manufacturability, transition it into production under an ISO 13485-certified Quality Management System, and manufacture it according to industry standards.

With the PulmoBioMed team motivated to get the device to market, they recognised that expert help within the design, development,
regulatory and manufacturing space would support them achieving their goal in a shorter timeframe.

They saw the value of choosing a CDMO partner which could provide all the required services under one organisation.

 

"We were impressed with Sanner’s professionalism from the get go and the quality of workmanship as we saw our 3D printed prototype mature into a robust, high quality injection moulded product. The process handover from design for manufacture to scaled production was smooth and the partnership progressed productively in the context of SME needs vis-a-vis stringent quality and regulatory criteria. We look forward to establishing global supply for PBM-Hale with Sanner GmbH."

Dr. Sterghios A. Moschos, Founder and Chief Executive Officer

Developing the Design

Sanner was ideally positioned to support PulmoBioMed with its design expertise, risk management, and project oversight. With a team of experienced engineers and scientists who quickly grasped the underlying physics of the device, we were able to build on the solid foundation already established by the PulmoBioMed team, by taking the designs through the stringent multi-step product development process. This included conducting a risk analysis for the device and testing the current prototype and design iterations.

Tolerance analyses were performed to predict performance and ensure reliability. The existing 3D data was checked under clear and stringent design for manufacturing principles. The design was also adapted in such a way that it is optimised for the production of the parts by injection moulding.

The early involvement of the Design Transfer teams within Sanner shows a clear benefit of a full-service CDMO with agile and connected, collaborative units. To ensure performance and reliability, mould flow simulations were conducted to guide the mould design for production. These analyses help identify potential weak points early on, allowing both the components and the mould to be optimised for large-scale manufacturing. The device includes a total of 17 injection-moulded parts, along with two additional purchased components that must also be integrated into the manufacturing and assembly process.

Material selection is a vital component to the function, manufacturability, approvals, and cost of the device. Therefore, manufacturing colleagues within Sanner Group were involved early on to ensure that the materials chosen would comply with the requirements for production

PMB stats-1

Seamless Transfer to Manufacture

As the last step, the team at Sanner compiled all the documentation needed to transfer the designs to manufacture. Sanner has decades of experience injection moulding and packaging development.

Tooling experts are available to support at any time and their understanding of moulds and injection moulding behaviour forms the perfect basis for transferring the device to the commercial
manufacturing process.

The Sanner Group manufactures the PBM-HaleTM in an ISO Class 7cleanroom to meet the product requirements set.

Sanner’s advanced change mould system where the tool inserts are mild steel which reduces the overall tooling time and has been a
very cost-effective approach for PulmoBioMed. 

The medical device consists of 17 pieces, so it is essential to develop excellent Design for Assembly concepts allowing secure handling in pilot builds as well as in later manufacturing. Verification, IQ (Installation Qualification) and OQ (Operational Qualification) was conducted within the Sanner Group to get the device ready for the first builds. We initially produced 3500 units to meet the customer needs.

Additionally, the team at Sanner has been instrumental in developing the primary packaging concepts for the device and the
branded secondary cartons and subsequent tertiary multi packs that the devices will ship in. The Sanner team have decades of experience developing packaging for devices and were therefore well-placed to advise the PulmoBioMed team.

Worldwide production capacity and device development services

Sanner operates a global manufacturing network with a total production space of 28,500 sqm, including 11,000 sqm of cleanroom space (Class 7/8). Our Design Centers of Excellence, Springboard and Gilero, are strategically located in the UK and across the US. Our manufacturing facilities are based in the US, Asia and Europe.

Sanner locations

 
How we can help you

  • Capacity for small-batch prototypes and scaling to full production. Our facilities are equipped to handle a wide range of production needs:
    • High precision fully electric thermoplastic injection molding capable of handling small shot weights (around 0.1g) up to 64-cavity molds (max. 350T), including 2K molding with thermoplastic elastomers (TPE). 
    • Manual assembly up to fully automated assembly processes, incorporating mechatronic components for enhanced efficiency and precision.
    • End of line packaging for sub-assemblies or finished goods
    • Sterilization through trusted external partners, utilizing validated processes to ensure compliance with industry standards.
  • Our experience in successfully transferring innovations to production across the EU, US, and China speaks to our ability to bring cutting-edge technologies to global markets. All phases of device development can be supported from our Design and Development Centers of Excellence in both the US and EU. 
  • Our design transfer processes enable the smoother path to market. We offer end-to-end thinking from development to manufacturing all under one roof to de-risk your project and for a better time to market.
  • Our reliability and collaborative working attitude support you in any stage of your project.

 

Quality control processes and compliance with ISO 13485

Sanner Group facilities are ISO 13485 certified for Design & Development and Manufacturing respectively. Over 250 ISO, AAMI/ANSI standards are used routinely. Our streamlined quality system satisfies the FDA requirements for both the device quality system regulations and the part 210/211 cGMP regulations.

 

Talk to an expert
Talk to us today about your next device development project.