Design for Manufacture
At Owen Mumford, we understand the complexities of creating medical devices for new customer requirements and international markets.
We have over six decades of experience in developing medical device solutions for our own brand and for the world’s leading pharmaceutical and diagnostic innovators. For companies such as Alliance Healthcare, Johnson and Johnson, Janssen, Chemo, NHS, Novartis, MSD Animal Health, Lincoln Medical, Bayer, US World Meds, Merck Sorono, Bioprojet and countless others.
Our approach to custom-made devices reduces the risks associated with new product development so that pioneering solutions can be brought to market on-time and on-budget.
We do this by being able to offer advanced concept to supply services, which combine our world-class in-house research and design expertise with in-house engineering and manufacturing excellence.
World-class research and engineering design
- We have invested in creating one of the largest research and design team focused on generating a wide IP portfolio encompassing autoinjectors, injection pens and devices, needles and capillary blood sampling solutions.
- Our human factors engineering and usability engineering expertise ensures that products are designed with patients and healthcare professionals in mind, to make it as easy as possible for the end-user to adhere to a treatment regime.
- With extensive experience in mechanical and industrial design we ensure devices are designed and manufactured to the highest specifications and have full IP protection.
State of the art manufacturing and in-process inspection including:
- Advanced 3D printing capabilities for rapid prototyping enabling real-world feedback to be gathered on new devices and modifications to be made early in development.
- Testing and validation facilities including a full environmental chamber to test to ISO standards.
- Manual and automatic assembly capabilities for high quality, high volume production (which is approved by the MHRA to support full assembly processes including the insertion of the final drug into the completed device).
- Category 4, world-class edge-to-edge clean room production facilities.
- Moulding capacity from 35 to over 250 tonnes.
- Single to 105 cavity tooling.
- Extensive needle handling capabilities.
- High-speed indexing and continuous motion technology.
- Polymer, glue and lubrication expertise.
Project management from concept to after-sales support includes:
- Regulatory teams that provide assistance with strategy and technical filings.
- Final packaging and labeling capabilities.
- Over 10 years experience of MHRA certified assembly of drug delivery devices. We are certified to handle controlled drugs on our premises, with the personnel and building security that this requires.
- Post market surveillance services.
- Extensive accreditation and standards.
- Continuous product testing and regular, stringent auditing. We assess 800 million finished devices every year. With product registrations in over 50 countries, our devices are inspected and/or certified by third parties such as FDA, MHRA and SGS. We also operate an independent Corporate Quality Assurance Group that views all operations with 100% objectivity.
- Regional Hubs supporting an international sales organisation providing local support to our customers and gathering feedback on local market requirements for product needs and marketing materials
To find out more about our custom device solutions click here to explore our dedicated website.