Ventilator R&D Post COVID-19 – What’s Next?
- Posted by Emily Stripling and Chris Justice
- On July 10, 2020
Ventilation R&D leaders are facing challenging days: everyone on the planet has lit a fire under them to produce ventilators as quickly as possible for the common good. This sense of urgency has been fueled, in part, by the unknown impact of this pandemic and potential scarcity of ventilators based upon infection rate trajectories. However, the rapid increase in ventilator production could mean market saturation for years to come. This article discusses long-term considerations for ventilator research and development, post-COVID-19.
In hindsight, perhaps lives would have been spared if humanity was better prepared for a mass outbreak such as the one we confront today with COVID-19. Should more have been done to follow through on efforts to stockpile low-cost emergency ventilators (among many other items)? As we feared the exhaustion of the world’s ventilator supply, we witnessed automotive factories converted to ventilator production, and new factories come online quickly while existing production capacity also expanded. Many are rising to the challenge, and we applaud efforts by Dyson, Tesla, NASA, volunteer groups, universities, and others who are quickly designing and building simple emergency ventilators. But fast-forward to the day where an effective COVID-19 vaccine is available (or there is a pivot in standard-of-care); what happens next in ventilation?
What’s Next for the Ventilator Market?
Non-Medical Device Companies
While many have pivoted to meet the new market demand, we predict that most of these companies will return to their previous focus – if they haven’t already. For instance, despite the 20M euros invested in developing an entirely new ventilator, Dyson’s ventilator project was abandoned due to its lack of regulatory approval. In fact, Dyson’s is the second project to be abandoned by the National Health Service in the UK. In the coming months, we foresee others will return to their core business.
We predict that many of the hastily-designed ventilators will and become unavailable for future use in our market. When the world is not in a fervor, we will rightly demand ventilators that are both safe and effective – with established requirements, verified and validated designs, and controlled production with known-good outputs.
We are hopeful that these emergency-use ventilators might be repurposed for emerging markets instead of scrapped. Though there are many challenges in exporting and supporting these ventilators, organizations like World Medical Mission are already providing such equipment to hospitals in need, where the alternative is going without ventilation equipment.
Regardless of the fate of these hastily designed ventilators, any fear of US, EU and other established market saturation due to these rapidly produced vents is unlikely.
Sophisticated ventilators like the Medtronic PB980 and others are being manufactured at accelerated rates and are selling as fast as production allows. Medtronic reports targeting more than 1,000 ventilators per week by the end of June, representing an approximate five-fold increase in production versus pre-pandemic levels. It seems hard to escape the implication that the increased production of state-of-the-art vents today will cool demand for these advanced vents in the coming months and years.
Despite the predicted potential for a shortage, the United States ventilator supply was still 2.1 times higher than demand during the anticipated peak time in April 2020. This is good news!
Accordingly, we anticipate that future ventilator demand will include new segments for basic models with a lower price tag that are available for emergency use.
Increased Demand for Basic Ventilators
The basic, existing ventilator designs from medical device companies placed into mass production are safe and effective. We predict these ventilators will continue to face higher demand even through the post-pandemic years. Basic units will be good candidates for a national strategic stockpile of emergency ventilators, which may be a priority in the coming years.
Many of the simple ventilators won’t have the advanced features of high-end ventilators, such as the ability to communicate with remote monitoring systems. This will signal a change for ventilator manufacturers that have rallied around the more complex, state-of-the-art ventilators (that command higher price tags) in years past. We project a new market segment for basic emergency ventilation, especially when coupled with remote monitoring and control that keeps respiratory therapists safe while also multiplying the capacity of our trained and experienced respiratory therapists.
The Strategic National Stockpile
Research shows that the US Department of Health and Human Services has finalized contracts to produce or acquire over 187,000 ventilators by the end of the year. We predict that in the coming months and years, the US will continue efforts to replenish the Strategic National Stockpile. “We do want to make sure we have an adequate supply for future new waves or recurrences of the disease, without having to do all the improvising that was done in the last couple months,” Eric Toner, a senior scholar with the Johns Hopkins Center for Health Security, told the Wall Street Journal.  While the number of vents required is still uncertain, there are key features that we would add to the list of top priorities.
Below we have listed some of our top considerations for the national stockpile of ventilators.
- Domestically sourced supply chain, or a risk-managed supply chain
- Design licenses pre-negotiated so that production can scale domestically
- Verified, validated, FDA approved, and clinically proven design
- Portable manufacturing instructions and tooling specifications that can be shared for scale production
- Remote monitoring and control to make use of limited respiratory therapy (RT) resources
- Important features should include: AC power, O2 mix, pressure and volume control, full invasive ventilation support
- Comprehensive understanding of use cases and resulting user needs – including new use cases
COVID-19 demonstrated our highly optimized global system can be fragile, and supply chain disruptions can be catastrophic for critical medical devices. We predict the federal government will review supply chains and domestic production capabilities to secure the availability of critical medical supplies for when needs arise in the future. Will there be legislative pressure to source certain medical devices domestically? We think so.
As the world recovers from this pandemic and settles back into a more comfortable equilibrium, we will see an evolution of ventilator R&D as the use cases change and market demand shifts. The rush to mass-produce ventilators has lit many fires over the last several months; many will need to be extinguished. The fires to stoke are the easier-to-produce, state-of-the-art ventilators at normal market demand levels, as well as, the basic, well-regulated ventilators that could contribute to the national stockpile.
As specialists in pneumatic systems, ventilator and medical device design, Engenious Design will be closely engaged with our industry partners at the forefront of these efforts as we, the medical device industry, seek to advance technologies that will improve lives.
ABOUT THE AUTHOR(S)
Emily is a skilled project coordinator with nearly six years of experience leading and executing complex projects. As a previous project manager in health care technology, her broad experience is a natural fit for medical device development. She is an excellent communicator with the innate ability to build relationships and connect the right people leading to the successful execution of sophisticated project plans.
Chris has accumulated many lessons-learned from 22 years of medical device design. Chris is principal and co-founder of Engenious Design, a medical device design firm that works with complex electro-mechanical & embedded software systems that are developed from scratch, acquired, and multi-generation products.