John M. York
Pooja Shah
Farah Pragga
Michael Toscani



Most vaccines have a similar method of delivery, utilizing a needle-based system to administer vaccines. Moreover, many require the maintenance of a “cold chain” to preserve its integrity and usability. While these options are feasible in developed parts of the world, delivering these vaccines to underdeveloped areas becomes difficult. Many vaccines go to waste due to breakages in the “cold chain,” leaving many people without vaccinations. Furthermore, with the recent COVID-19 crisis, needs are emerging around strategies to deliver products that do not require extreme temperatures for storage and allow for efficient vaccine delivery on a mass scale. Many companies, including Pfizer, Moderna, and Johnson & Johnson, have brought to market COVID-19 vaccines. Pfizer and Moderna have found development success and profitability from their vaccine technology, both now and potentially in the future. Still, storage, administration, and waste challenges exist with these current options, creating opportunities for alternative delivery mechanisms. With these vaccines being essential for the current global situation, other administration strategies, such as Bioneedle™, could provide a valuable alternative and help mitigate the associated cold chain and sustainability issues seen with currently available options.

Bioneedle™ Drug Delivery B.V. (BDD), a European biotechnology company, is developing a needleless vaccine-device combination product, the Bioneedle™. This technology value proposition focuses on solving the logistics issues associated with many vaccine products.  These include eliminating cold-chain requirements, increasing the speed of vaccination, and reducing non-recyclable, medical waste (e.g., plastic syringes). It employs a reusable delivery system that administers multiple vaccines using biodegradable mini-implants to aid mass immunization efforts. This approach could significantly reduce plastic waste from syringes, translating to a significant sustainability benefit consistent with the United Nation’s Initiatives. Accordingly, BDD seeks support from a venture, corporate, government, or foundation for developing this novel delivery platform.

This case aims to achieve two objectives.  First, it seeks to provide an in-depth overview of the value proposition of Bioneedle™, sparking discussion around its feasibility in a real-world setting.  The second involves creating dialog regarding improvements to the Bioneedle™ system and other innovations that may help mitigate cold chain issues while still providing needleless delivery of vaccines.

This case discussion highlights the potential of a new vaccine delivery system that various healthcare settings can use. This approach may pose a cost-effective solution to the loss of vaccines in the cold chain and address the growing concerns around plastic waste and the environment. In closing, this narrative allows for an open-forum discussion around the opportunity of introducing a new medical device in a thriving vaccine market. It is a learning experience that requires strategic decision-making in response to questions posed for new startups and the new vaccine technology.