Expediting Device Development
As the expert that understands the intricacies of the self-injection process and the complexities of the combination product development timelines, a device developer is often contracted to help pharma/biotech companies maximize investments and minimize potential delays to commercial launch. Combining this knowledge and experience with a strong set of in-house capabilities, the development process can often be expedited, ultimately ensuring the successful commercialization of the combination product in a timely manner.
SHL Group details its approach to the challenges of emerging formulations
Once the design of the device is determined, the combination product is put through a series of testing and handling studies to ensure that the product is able to serve the intended patient market as defined by the pharma/biotech partner. As a regulated medical product, these reviews need to adhere to the FDA Design Controls guidelines to ensure that each iteration is thoroughly vetted for safety and efficacy throughout the entire development process, from design input through to mass production.
During these cycles, the device may undergo multiple verification and validation challenges requiring design modifications – all of which call for manufacturing review and input as each of these iterations may impact scale up and commercial manufacturing operations. With a device developer that designs, develops and also houses core manufacturing capabilities in-house, communications are streamlined and the timelines are reduced in comparison to outsourcing some or all of the key manufacturing capabilities. Key manufacturing capabilities that can be hosted in-house include:
- CNC machining
In addition to offering streamlined communications and enhanced quality control, possessing in-house capabilities also allows the device developer to design the device and build manufacturing processes in parallel. For example, once a device developer has been contracted to design, develop and also assemble an auto injector, the tooling, automation and final assembly teams integrate with the device’s project team to ensure knowledge transfer from development into commercialization. Each team works together to build specific equipment and processes needed per the device’s characteristics.
At the same time, product engineers and program managers dedicated to creating an integrated supply chain alliance provide design and tech transfer services to ensure the device program is followed by seamless commercialization.
A comprehensive device developer that has an established process development system is in the unique position to provide insights that are difficult to be made by outside sources. By keeping all operations under one roof, the development process is simplified and significant time can be saved. As a result, the commercialization of critical medicinal products can be expedited, helping the pharma or biotech company stay ahead in the race to market.
SHL is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery devices such as auto injectors and pen injectors. With locations in Taiwan, Sweden, Switzerland, China and the US, our experienced engineers and designers develop product enhancements and breakthrough drug delivery solutions for pharma and biotech clients globally. Significant investment in R&D has enhanced our broad pipeline of next-generation drug delivery systems. These innovative devices include a range of disposable and reusable injectors with fixed or variable dosing and the ability to accommodate high viscosities.
With over 4,000 staff worldwide, our organization consists of several distinct group companies:
SHL Medical designs, develops and manufactures advanced drug delivery devices, as well as provides final assembly, labeling and packaging services for leading pharmaceutical and biotech companies across the globe.
SHL Healthcare develops and manufactures equipment solutions for home, hospital and long term care use.
SHL Technologies provides contract manufacturing and engineering services for the production of complex medtech and industrial products.
For additional information, visit www.shl.group
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