Services & Support

With a long history of providing a range of devices to our pharmaceutical industry customers, innovation and technical expertise are key to our success. Our research and development department provide the critical expertise for creating the products which help patients to improve their day to day disease management. The process starts by acquiring an in depth understanding of patient and healthcare practitioners’ needs and the challenges they face during drug administration. This is combined with obtaining a deep understanding of the drug formulation, characteristics and delivery requirements. This detailed knowledge helps our design engineers to identify & formalise the requirements for successful product design. Our Design Engineering teams have a wealth of experience in numerous engineering disciplines, employing the latest approaches in areas such as CAD, FEA, tooling & materials, testing methodologies, design documentation and risk management. These approaches ensure our products fully function to the user requirements throughout the lifecycle of the device.

HF is key to success throughout our product development & design process. Our principal objective is to ensure that the final injection device is safe and effective for use by a diverse range of users – including patients, caregivers and healthcare professionals. Establishing product requirements starts early in the concept phase of product development by using HF best practice, and insights from formative testing and customer research to deeply understand and influence the user-interface. Iterative HF studies are conducted to explore all elements of user interaction during device development to ensure that any potential use error can be identified and controlled to minimise use risk. Owen Mumford’s human factors process is fully aligned with regulatory requirements, and our user evaluation planning is conducted to provide comprehensive study data to support your product registration process.

In addition, we can provide advice and information to help you develop successful HF strategies for all points of interaction between the user and the device including packaging, labelling, instructions for use and patient training materials.

IP is a key element in bringing new devices to market and we understand that having Freedom to Operate (FTO) is a critical part of a successful new product launch. At Owen Mumford we take our approach to intellectual property seriously, keeping up to date with the ever-evolving patent landscape. A key part of our customer relationship is providing you with confidence that there is no risk of infringing third party patents during the product commercialisation process.

Our R&D team are continually looking at new ways to create innovative patient-centric injection devices. Protecting this work is fundamental to our success. We therefore file to protect our device designs on a regular basis.

With a wide variety of inspection equipment at our disposal, we have the capability to conduct precise measurement of the component parts of our injection devices. All contact measurement machines (CMMs) and vision systems are placed in a 24-hour monitored temperature-controlled environment. Our diversity of equipment and capacity allows us to offer a tailored solution to all our clients. CMMs and vision systems are serviced and calibrated regularly and fully traceable to international standards. This detailed analysis is part of our product development process starting with early concept models and continuing through the design verification process where reproducibility is paramount.

All our Inspection CMMs and Vision System Metrology Engineers are fully trained and certified by the by the equipment manufacturers and through our in-house training and development programme.

With manufacturing and packaging operations in the UK, US and Asia, we produce billions of components and assemble hundreds of millions of life changing devices each year.

We accommodate our customers’ needs with our capabilities on manual and semi-automatic assembly, flexible manufacturing and fully automated production. Our clean room facilities can be utilised for manufacturing, processing and packaging when required.

To ensure high quality, consistent product performance and patient safety, we incorporate a range of in-line, ongoing performance control and assessment systems, for example: automatic vision systems that inspect and measure components and assemblies during our production processes.

Working closely with leading global regulatory bodies such as FDA, MHRA and SGS, we aim to continuously improve our facilities and practices. By following GMP compliance regulations, we continue to meet and strive to exceed the high standards and criteria required within medical devices and pharmaceutical industries.

We have MHRA medicinal product licences for the manufacture of both commercial products plus investigational product for clinical trials and have over 12 years of experience in certified assembly of drug device products with the necessary personnel, cold storage facilities and security required.

Our quality ethos across the organisation helps ensure all our devices meet the rigorous standards that apply to the device, pharmaceutical and biotech industries. As such our management system is set up to ensure we are fully compliant with medical device regulations such as 21 CFR 820, ISO 13485:2016 and EU Medical Device Directive 93/42/EEC as well as ensuring adherence to GMP (Good Manufacturing Practise).

This systematic approach applies throughout product development process starting at the beginning where a comprehensive record is kept in the Design History Files for each development. We continue to work employing best practice to ensure that our products are consistently manufactured to the highest standards by employing quality assurance & risk management practises across all functions. Our Quality Policy drives the whole business to create devices that might one day need to be used by our own families, so must be safe and effective with quality built into the design. Our facilities are regularly audited by key biotech and pharmaceutical partners and scrutinised to maintain our certification by worldwide regulatory authorities.

With over 50 successful product registrations to date, we have experience in dealing with the FDA, EMA and other regulatory bodies across the world. In addition, over a period of many years, we have gained expertise in the regulatory complexities associated with combination products.

Using this knowledge, we can help you in your own regulatory application processes by providing the necessary data, documentation & guidance to help achieve a positive outcome.