Before We Welcome Open-Source Ventilators With Open Arms, We Need to Talk About IP

With the global COVID-19 crisis, medical manufacturing companies have pushed ventilator productions to its limits. But still, it hasn't been enough. These medical device manufacturers cannot produce ventilators as quickly as hospitals need them. As the race for medical equipment continues, certain medical device providers have made their ventilator designs public for third parties to help increase output. 

But welcoming these third parties into ventilator production may pose Intellectual Property (IP) issues down the line. In particular, these issues may arise because the medical industry has specific guidelines and protocols for making health care devices—despite the government relaxing some of those regulations to speed up production.

 

MPS' open-source ventilator was inspired by MIT's E-Vent project. Image used courtesy of MPS

 

Some companies, in spite of the IP question, have open-sourced their ventilator designs to the public, allowing virtually anyone with the appropriate resources and knowledge to use their designs to build ventilators.  

The problem with that, according to Patrick Keane, an IP attorney who works with ventilator and hospital manufacturers, is that third parties who do choose build with manufacturers' ventilator IP will have to exercise extra caution after the COVID-19 pandemic passes. These third parties must be aware of the limitations on these open-source designs to avoid patent infringement when the medical device industry stabilizes and certain permissive licenses expire.

Who is liable if a patient is harmed because of a third-party-built ventilator? And are there limitations on this open-source ventilator movement?

In this article, we'll examine three open-sourced ventilator designs from Medtronic, Renesas, and Monolithic Power Systems and explore what IP issues come into play.

 

Comparing the IP of Three Ventilator Designs

Before diving into the specifics of each ventilator IP, it's first important to establish the key specifications for successful ventilators. They include:

• Inspiratory/expiratory ratio (I/E ratio): 1:1–1:4
• The respiratory rate (RR) in breaths per minute (BPM): 8-40
• Tidal volume (TV): 200mL–800 mL
• PEEP (positive end expiratory pressure)
• HEPA filtration
• Failure alarms
• Power converters
• Backup power sources 

 

Medtronic, a Leader in Ventilator Design

Medtronic is an industry leader in researching, designing, and manufacturing medical devices. So, it came as a surprise when they released their open-source Puritan Bennett (PB) 560 ventilator system design and specs in late March of this year. After all, as Debbie Wang (Morningstar analyst for Medtronic) notes, the medical device industry has "historically been extremely sensitive about protecting its intellectual property." 

Due to their deep roots in the medical industry, the PB560 is an older (2010) and more complex design. The device is compact, mobile, and lightweight. Medtronic has a permissive license in place, protecting their IP while allowing third parties to use their design. However, Medtronic clearly states they are not responsible for the process, design, testing, and manufacturing of any ventilators inspired by their design.

 

The PB560 is available for public download but is protected under a permissive license. Image used courtesy of Medtronic

 

The permissive license also states that third parties are not allowed to use the Medtronic brand or trademarks. The license is in effect from the time a party downloads the designs until October 2024. Medtronic has not released where they source their many components for the PB560. The lack of resource knowledge and the age of the PB560 may make it difficult for a third party to source components needed to quickly build this design.   

 

Renesas

Renesas, typically known for its semiconductor solutions, has a three-board, ready-to-assemble ventilator design inspired by other open-sourced designs, including the Medtronic PB560. It monitors patient status while delivering and controlling the amount of tidal volume and gas the patient receives. The Renesas design uses Bluetooth connectivity, allowing nurses and doctors to monitor a patient’s status via a mobile device.

Additionally, the Renesas design can be connected to a humidifier to relieve the patients’ lungs. Renesas’ module consists of two microcontrollers monitoring the oxygen ratio and the exhale pressure. Datasheets and the recommended components are linked on their website, making it easier to source products and replicate their ventilator.

 

Renesas' block diagram for a ventilator design. Image used courtesy of Renesas

 

Renesas does not explicitly mention an agreement or specific protocol for using their design. They do mention that their data sheets can change. A third party can legally use their design; however, if the ventilator fails, it would be unclear who would be held responsible. 

 

Monolithic Power Systems

Monolithic Power Systems (MPS) specializes in semiconductors and uses their expertise in motor controls to automate the bag valve mask (BVM) resuscitator. Their MPS open-source ventilator model was inspired by MIT's E-VENT project. This MPS ventilator can be built rather quickly at a low cost with off-the-shelf components that are listed on their open-sourced model page.

It is no surprise that the MPS ventilator model contains battery backup and power loss alarms since MPS specializes in high-performance power solutions. These systems ensure continuous breathing assistance for COVID-19-affected patients.

 

Monolithic Power Systems' open-source ventilator design. Image used courtesy of MPS

 

The MPS ventilator is also mobile, making the transport of patients feasible. Like Renesas, MPS, does not display a contract or liability for replicating its open-source design. While the Monolithic model is a prototype, they make it known on their site that they need assistance finding device qualification and usage recommendations from medical professionals, manufacturing partners, and component suppliers.

 

Treading Lightly With Open-Source Ventilators

It's no secret that open-source ventilator projects have been on the rise in the past several weeks. But what happens when its reputable medical device manufacturers releasing the designs?

All three of these open-source ventilator projects include the core tenets of a successful ventilator design: microcontrollers assisting with the function and monitoring of PEEP (positive end expiratory pressure), BPM, filtration, tidal volume, and inspiratory pressure—all critical measurements for a patient’s recovery.

Many of the issues of IP come into play with the execution of these designs. While there is a pressing need for ventilators to combat the COVID-19 virus, issues with IP can complicate the process.