Making a life-saving drug delivery device significantly lighter and easier to use.
Bellerophon partnered with bb7 to develop their next generation INOpulse Mark2 device, an evolution of their Mark1, which was a functional prototype also developed by bb7. The INOpulse Mark2 is a nitric oxide-delivery device which treats pulmonary hypertension, primarily in ambulatory patients. Therefore, the Mark2 had to be portable, while improving ease of use and performance.
Medical devices demand a high level of product development execution, and the INOpulse Mark2 is no exception. Our software and electrical teams developed several critical components, such as audible alarms, a watchdog circuit for the processor, three periphery boards for cannula indication/verification and USB communications on drug sensing. The teams also assisted with firmware development, implementation of the breath detection algorithm, electromagnetic compatibility (EMC) optimization and ESD protection.
At 2.5 pounds and the size of a paperback book, the INOpulse Mark2 epitomizes ease of use and consideration of human factors. The INOpulse Mark2 incorporates an intuitive user interface validated by bb7’s formative and summative usability testing. The industrial design and mechanical design teams improved the interface with features like LED lights which dim for sleeping and improved ergonomics. They simplified the housing, designed a carrying case, eliminated a pinch point on the drug cartridge and ensured manufacturability of all mechanical components. Our material scientists utilized cutting edge advancements in water ingress protection – nanotechnology – to safeguard against water damage.
bb7 submits products to rigorous testing to mitigate risks and ensure delivery of the highest quality products. In the case of INOpulse Mark 2, bb7 was key in the completion of foundational testing responsible for optimizing the quality and reliability of drug therapy delivery. Further, we performed EMC, water ingress and drop tests, which are only a few of the ways we test products’ viability. If we find vulnerabilities, we work until they are eliminated – a streamlined and in-house verification process.
bb7 delivered INOpulse Mark2’s product and design specifications for regulatory compliance. The documentation team also developed the design verification and validation plans and protocols, the design history file, the risk management file, the Instructions for Use (IFU), a Quick Start Guide and the product labeling.
The Mark2 is intuitive for patients to operate independently.
Mark2 is programmed for safe, automatic dosing that a physician can easily monitor.
The INOpulse Mark2 delivers nitric oxide therapy. It is programmed to automatically adjust based on a patient’s breathing pattern to deliver a constant and appropriate dose over time, independent of the patient’s activity level.