Wearable Bolus Injectors: Balancing Stakeholder Needs and Overcoming Barriers to Entry

Until now, biologics and immuno-oncology drugs have tended to fall into two very different delivery modalities: 1 ml to 2 ml self-administered injection using devices such as autoinjectors and 10ml+ infusion delivery typically administered by healthcare professionals in a hospital or outpatient setting. More and more, pharmaceutical companies are formulating (or re-formulating) drugs that fall into the gap between these modalities, in the drive to move the delivery of higher-volume biologics away from the clinic and towards a home-based, self-administered environment. This creates opportunities for subcutaneous injection devices that can deliver volumes beyond the reach of current autoinjectors and those of current infusion devices.

Although the number of commercially available on-body delivery systems remains low, several companies have devices in development to help fill this gap, including the recent collaboration announced between Phillips-Medisize and Subcuject. However, the market for such devices remains in its infancy and faces persistent challenges from well-established autoinjectors and a new cohort of larger payload, more sustainable autoinjector variants.

Launched devices and those in development range from simple piston-based systems to sophisticated electromechanical devices, employing drug containers ranging from fill at point-of-use custom-designed reservoirs to industry-standard primary containers. With uncertainty over the patient acceptance of wearable devices and no precedent for a wearable device to be prefilled, preloaded, or assembled by the user, defining a clear path for these devices is challenging – but also potentially rewarding.

Register for this webinar, where the speaker will discuss some of the challenges involved in developing a wearable bolus injector. To successfully achieve this, the needs of patients, drug formulators, pharmaceutical manufacturing commercial teams, and the environment must all be carefully balanced, whilst employing established and trusted processes to minimize the barriers to entry for these devices. The speaker will also demonstrate how Phillips-Medisize and Subcuject are engaged to address these challenges with a novel, cost-effective device that requires no battery, motor or electronics.

Speaker

Tony Bedford, Director, Front-End Innovation, Phillips-Medisize, a Molex company

Tony Bedford is Director, Front-End Innovation at Phillips-Medisize, a Molex company based in Cambridge, UK and has been involved in the design and development of medical devices for over 25 years. With a background in product design, his broad experience covers everything from innovation and market strategy to clinical research and product launch, focusing on understanding market, stakeholder, and user needs. Before joining Phillips-Medisize, he held project management and business development roles in the consulting industry, working on various device programs. He has been specializing in drug delivery devices for many years. His primary focus at Phillips-Medisize is on the large volume and on-body injector markets.

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