Nypro Healthcare is a recognised leader in the development and contract manufacture of complex drug delivery and diagnostic devices. It is headquartered in the US and has sites in 11 countries. In 2013 Nypro Healthcare became part of Jabil, a US based Fortune 200 global manufacturing services company.
Established in 1980, the company has sites in Bray and Waterford in Ireland. It employs 450 staff and offers a variety of solutions to customers in healthcare. Devices developed and manufactured include a variety of inhalers, auto-injectors and drug delivery devices. Irish activity forms an important part of the wider group, with responsibility for both design and manufacturing activity. It provides customers with a comprehensive process for early stage design and development, clinical build supply and final large scale manufacture of medical devices. It works closely with the world’s leading pharmaceutical companies in both the design and development stages and its products are primarily developed for the export market.
Nypro Healthcare’s activities in Ireland have developed from pure contract manufacturing to the inclusion of an integrated design and development function. As a result, it has developed a Design and Development Centre at its plant in Bray supporting Nypro Healthcare’s manufacturing function in Ireland and in Europe.
Design activity in Ireland
Design is embedded in Nypro Healthcare’s strategy and operational processes. The Design and Development Centre currently employs 16 members of staff, with specialist skills in areas such as product design, injection moulding and tooling, project management, design engineering and electronic engineering. Its facilities include modelling, electronic and prototyping labs (including 3D printing), and a CT scanning room. According to the company, these facilities have “been developed to facilitate internal design activities, thus reducing development time”. However, the facilities also illustrate a statement of intent for Nypro’s design capacity which is providing advanced lab space and an environment that encourages design thinking and collaboration.
External design expertise is sought by the company in specialist areas such as regulatory support and specialised human factors research. Nypro Healthcare also collaborates with external design houses to prepare their concepts or prototypes for manufacturing. Therefore, a typical project may see the company work with a design house contracted to a pharmaceutical company. Such companies approach Nypro Healthcare for ‘industrialisation assistance’ to reduce risk and prepare the product for high volume manufacture. Alternatively, pharmaceutical companies approach Nypro Healthcare directly for design and manufacturing support. This latter model has become more important following the creation of the Design and Development Centre.
The Design Centre was primarily introduced to allow the company to expand its manufacturing offering with added value services. This helps customers reduce risk by getting involved earlier in the product development process. In this respect, Nypro Healthcare’s objective is the “Early involvement in the design and development process to define inputs and outputs in accordance with recognised quality standards (21CFR820 and EN ISO 13485)”.
Contributing to the competitiveness of the company, the Design and Development Centre enabled it to move up the value chain, and establish itself as a key partner in the design, development and manufacturing process. The company is now better able to reduce development and manufacturing risk for customers, ultimately leading to a smoother introduction to high volume supply. It has also responded to the needs of its customers for a more integrated service, allowing them to simplify their supply chain relationships.
The strength of the Irish med-tech sector, particularly in the West of Ireland, has increased competition for medical device skills. The company identifies the lack of ‘system engineering’ skills as the main challenge to its design activities. These are central to its ability to address opportunities associated with the ‘internet of things’ and smart devices. As the company stated:
“In Ireland there is nationwide competition for medical device related skills. The trend towards increased complexity and connectivity in medical devices will increase the need for multi-disciplinary, systems engineers to manage the development of the complex systems integrating mechanical, electrical and software systems. This is an area of weakness in the current academic and industrial skill set.”
Design in focus
In 2014, Nypro partnered with UK-based Glide Technologies to design a novel auto-injector device which could deliver a solid drug dosage. This needle free drug delivery concept represents an important area of technology and market development, offering the advantages of expanded immunisation coverage, decreased healthcare costs, and increased patient compliance.
The Glide SDI® is intended to open up novel therapeutic formulation and delivery options for new and existing treatments. Nypro Healthcare was subcontracted to develop an initial design to a point where it was suitable for large scale production, and optimised for patient use. Nypro Healthcare’s design input focused on the repeatability of the device manufacturing and usage. It was led by staff from the Design Centre, and included a structured programme of analysis including mechanical design analysis, design for manufacture and tolerance analysis, and finite element analysis as well as the development of final prototypes.
Nypro’s work on the Glide SDI® was completed in 2014 and the device is now ready for clinical trial. Nypro Healthcare believe that the partnership with Glide Pharma was very successful, and it anticipates further growth in the area.
Impacts from design
The development with Glide Pharma illustrates the role of Nypro Healthcare’s Design Centre in supporting early stage design for manufacture and assembly of products. By supporting the pathway to manufacturing, Nypro’s design expertise allows it to secure revenue at an earlier stage in the product development process, while building ongoing relationships with customers.
The Glide Pharma collaboration also illustrates that the timeline between early stage design support and manufacturing can be long, especially with the requirements for clinical trials and regulatory approval. Nypro Healthcare believe that without the development of its Design Centre and expertise it is unlikely it would have been able to maintain its competitiveness and expand its wider operations in Ireland.
This continued evolution was recognized nationally in 2014 when Nypro Healthcare won the Irish Medical Devices Association’s Medical Technology Company of the Year.