VentLife WHW

Many people have asked what VentLife is, what my involvement with it is, why ventilators, etc… So, I’m summarizing most of it here. The why, how, what. Please keep in mind that this is my experience through this start-up project, and does not necessarily reflect what the entities, VentLife or CoreVent, or the team members in them, would say.

Everyone is aware of how quickly, and to what extent, COVID was sweeping the world, so I won’t go into detail about numbers. That said, if you would like to see numbers from the extensive research we (and others) have done, please see our presentation below. I did want to say that because of this, I was seeking ways to contribute to helping the situation however I could… That leads me in:

In early February, I got a phone call from a friend I made in college, Sarma Singam. We studied biomedical engineering together and led the student BME Society in Cincinnati, then he went on to med-school, residency, and fellowship. Along the way, he got patents, worked in start-ups, and has done a plethora of cool and valuable things for humanity – overall awesome guy. Anywho, on this phone call, he asked me if I knew of any ISO13485 (medical grade) manufacturing shops. I asked him what he was up to, because he’s always doing something cool, and he told me about the group that was forming to create low-cost, clinically viable, ventilators to help with COVID – I said, I WANT TO BE PART OF THIS. Two things of note here: 1) I’ll define “low cost” and “clinically viable” a bit better later, and 2) time was of the essence. Sarma introduced me to Glen Meyerowitz – the leader of the team. Glen, a super smart, empathetically driven, and pioneering leader, is a Yale physics graduate, former Space X and autonomous-driver engineer, and current UCLA biodesign fellow. He sent me an agreement form, and I joined the team.

Time was of the essence for multiple reasons. First off, when the virus started popping off in the US, the initial treatment for critical patients included intubation with ventilators, and there were a LOT of people needing them. Second, LOTS of teams were forming to work on the problem of short-supply of ventilators around the world (which was cool in itself). There was so much media attention around the shortage it caused quite a stir in medical and governmental circles; lot’s of public pressure to be ready to combat this respiratory virus…. and frankly, there still it that pressure to be better prepared in the future. If you’re not familiar, a SIGNIFICANT portion of the national stockpile of ventilators (which wasn’t that much to begin with) had to be thrown out because they were not meant to be stored the way they were, weren’t maintained properly, and there were all sorts of logistical issues with them being delivered where they needed to be. In short, it was a mess. Hospitals, doctors, administrators, and politicians were frustrated, and some were very scared.

Enter the big three

Because of this fear and pressure, the big three moved quickly with their massive resources: Ford, Tesla, and NASA. They all pivoted quickly to help on the ventilator shortage front – prototyping, testing, and getting the emergency use authorization (EUA) from the FDA – unprecedented speed. Once again, the media covered extensively these companies’ progress (PR budgets can be great tools!). The US government spent something like $3.2B on re-upping their ventilator stockpile. Unfortunately, more than half the devices they pledged to purchase are not very useful in an acute critical-care respiratory situation (more on that in a bit). The point here is that through the media, most people believed that the issue was taken (or being taken) care of.

With all the media coverage of the big three and SO many industries, companies, friends, and family asking for monetary help, we observed two HUGE mountains to overcome early-on: 1) raising money while everyone was (or felt like they were) tapped out (otherwise known as Donor Fatigue), and 2) showing the value of our device in spite of the general population believing the problem was taken care of.

So let’s get into some of the details. There are a few different types of ventilators, but the big two that most people are hearing about are clinical care ventilators and hand operated bag valve masks. The latter is sometimes referred to as an ambu-bag, and some companies have built mechanical compressors around the bags to make a cheap version of a mechanical ventilator. These ambu-bags are what the US government pledged to make more than half of their stockpile composed of. Ironically, we spoke with one of the authors of the 2017 Pandemic Plan for the CDC (if I remember correctly), who may have been having a bad day that day, but who was VERY upset about the decision of the government to purchase these products – stating that they are almost worthless in an acute-care pandemic emergency. LET ME BE CLEAR – WE ARE NOT BUILDING AN AMBU-BAG TYPE DEVICE. These types of devices are what are considered the low-cost ventilators and are typically sold under $5k. The high-end, computerized microprocessor-controlled mechanical ventilators typically used in intensive-care, home care, emergency medicine, and as a component in anesthesia medicine have a WIDE range of features and functions – they’re difficult to make, produce, source, use, and repair. Also, before the pandemic they typically cost between $25k-50k per unit.

https://www.fiercebiotech.com/medtech/medtronic-deploys-remote-controlled-ventilators-to-lessen-coronavirus-exposure
https://news.mit.edu/2020/ventilator-covid-deployment-open-source-low-cost-0326

So, with Glen’s provisional patented design, we’re encouraged that we can treat 75-80% of adult patients who need to be on a ventilator for under $7k per unit. Like I said – we’re on a mission to provide access to a low-cost, clinically viable ventilator. They use a principle in fluid dynamics that allows a more simple design – therefore, they are easier to source, use, and repair. If my sources are correct, we would also be the 4th company to receive an EUA by the FDA for a clinical mechanical ventilator – after Ford, Tesla, and NASA.

A rendering of our ventilator design.

Through the work of Elliot Kotek (a fascinating and kind super-creative and connector is an award winning producer and entrepreneur), we formed a non-profit, VentLife, as an avenue to raise money. VentLife is housed under the umbrella of the Giving Back Fund – a non-profit that hosts HUGE non-profit orgs like players associations. Believing that it might be the fastest way to raise money. We also set up a GoFundMe and worked very hard to promote it – in the end we considered it a failure, and chalked it up to mostly donor fatigue, people’s perceptions of the situation being handled, and lack of knowledge/timing on the campaign. That said, we maintain VentLife to rapidly raise and distribute much needed funds for the research and development of clinically effective Low Cost Ventilators – tax deductible donations can be made here.

https://www.ventlife.org/

We also formed a for-profit, CoreVent, (through the work of Glen) as another avenue to raise funds. In the end, we weren’t sure what the best avenue was in this climate, so we did both.

In the early stages (February/March), we had several of us focusing on the GoFundMe/marketing, while others were looking into the real scope of the market, working on partnerships for funding and/or prototyping, looking for grant and competition opportunities, getting the benchtop model built and tested (which included a lot of clinician feedback), and building internal business ‘products’ and processes. Building companies is no small feat, let alone the product on top of that, and even more so, a regulated medical product. There were a TON of hours put in by a lot of people for this effort; an inspiring group of doctors, engineers, executives, and entrepreneurs. Because of that, I want to share most of the team here.

Speaking of some of the internal business products… what the hell are those? Here’s an example: I built a poor-mans quality management service (QMS), which I like to call a knowledgebank; where all the information anyone inside the company would ever need is easily sorted and managed. It turned out to be almost a catastrophe as I accidentally deleted team member’s hidden files (which we were able to recover), so it was a good learning moment – plan/schedule big moves. Others were things like flow diagrams for the ventilator, user’s interface, functional block diagrams that describe the operation of the ventilator, simple company paperwork and naming conventions, meeting notes, one-pagers, etc. The list is endless. Glen took on massive loads of work. Hell, he even got a provisional patent on the novel approach to mechanical ventilation during this time.

We decided to start looking at other ways to get exposure and funding. Because Glen is associated with UCLA, we were able to get into and finish two regional nodes of the I-Corps program hosted by the National Science Foundation (NY and LA). These programs had us develop and refine a business model canvas (BMC) by interviewing TONS of people in the ecosystem of our product (a ventilator). So that meant interviewing doctors, hospital administrators, hospital purchasers, FDA regulators, medical device manufacturers, researchers, etc. From all these interviews we were constantly updating our target market/users, value propositions, segments, partners, etc.

While a small group of our team was working through the I-Corps programs, I led another small group of us through a pre-incubator program at the University of Cincinnati Innovation Center‘s 1819 Innovation Hub– in their 10th Cohort. There were a lot of similarities between the programs, so it made it nice to get resources and feedback from both and share the info across the teams. At the end of the program we did a virtual pitch – asking for partnerships in manufacturing and using language eluding to money. Unfortunately, there were technical issues with the link provided for the virtual pitch so many people weren’t able to see it live. Here’s a link to our presentation for that program.

Also, at the early stages of going through the I-Corps programs, we participated in a couple hackathons – Pradnya got us into the Hack for Hope competition put on by USC and UCLA, where we won a bronze medal (even with our benchtop model), and Varun got us into a European hackathon.

Through all of this, Glen and some of the team out in LA have been updating the prototypes and testing them at the UCLA Simulation Center where we’ve gotten really great results. Our prototypes have been run through more than 100 tests on state of the art artificial lungs.

We applied for an EUA from the FDA, brought in more team members to work on the electronics, design, a more robust QMS, and kept chugging along. We had LOTS of meetings as a team and as smaller groups, because medical devices are almost NEVER built this quickly – let alone building a company and non-profit at the same time.

We weren’t accepted into the national I-Corps program as our device was deemed too far ahead of what the funds for that program are designated for, so we pivoted to continue applying for grants (such as the SBIR). We realized early in the project that because we set out to create a high-value (low-cost / high-quality) medical device without intention to make much money, we would never be attractive to venture capital funding. So, grants, donations, and partnerships are likely our only source of money to get through the final stages of prototyping and FDA testing such as the 510(K).

Because of these reasons for the lack of funding, we decided to create an alternative revenue stream – I’ve created an online store to sell our merchandise. Every product is high-quality, and every dollar helps us meet our mission. We’re currently selling hand sanitizer, masks, and t-shirts – you can visit our store here.

Also, a few weeks ago we pitched through UC’s Venture Lab to the Likes of Cincy Tech and Queen City Angels. We’re still waiting on their determination – if you’d like to see the slide deck, please reach out.

I hope this post sheds light on our motivations for this start-up project, the struggles we’re facing, and inspires you contribute to our work. It truly is a passion project for everyone on the team – we’ve put in months and months of hard work for no money… just to do good for the world.

Once again, thank you for reading. More importantly, thank you for considering helping us with this project. If you’d like to learn more, please feel free to reach out. We would love to chat.

Stay well. Stay powerfull.

Best,

Jason

Important Links:

CDC

VentLife Home

VentLife – Donate

VentLife – Store

The Giving Back Fund

FDA -501(k) Testing

NSF I-Corps

UC Office of Innovation

UC 1819 Innovation Hub

UCLA Simulation Center

Published by Jason Kleinhenz

Why: I’m passionate about family, friends, community, helping people, rugby, and drumming. How: I’m involved in cultivating culture, philanthropy, startups and new ventures, young professionals, mentors and mentoring, biomedical engineering, cross functional and cross disciplined teams, sharing, and love. What: I’m an engineer, business owner, drummer, rugby player, philanthropist, community lover, and passionate beach bum. More info: You can see my other pages for more information, and please feel free to contact me if you think we could have a mutually beneficial discussion. If you’d like to get in touch, please feel free to say hello through any of the social links below.

4,016 thoughts on “VentLife WHW”

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