Life After MedTech From Human Factors to Preventing Homelessness

Hey, Chris?

Happy Friday, buddy! How you doing?

Yeah, good, how are you?

Just wanted to share some good news with you. There was a woman that was on this A webinar two weeks ago.

You know?

speak out on AI and so forth, and she reached out to request our support. We had a really nice call yesterday. She's in the UK. So I want to say thank you. This works very well.

Oh, you're welcome. I'm glad that we could connect you.

No, it was awesome.

Oh…

She specifically said, yeah, I saw Sean asking you questions on the webinar, and I had some questions for you myself, and I was like. Sean, marry me! This is how it's supposed to work. Everybody supports each other, so, you know, that rising tide raises all ships, so thank you very much.

Yeah, no, I'm glad that we could, get you connected. Hey, Martin, how's it going? You're muted. It's still muted.

Hi there, how you doing?

Yeah, good afternoon, happy Friday in Switzerland. How's the weather?

Very hot.

Very hot.

like… 35 plus Celsius, so I don't know what that is in Fahrenheit. That's hot.

That's in… that's in the 90s.

Yes, basically.

Sure, but it's low 90s. So… Yeah, that's hot. Particularly for Switzerland. I think of Switzerland as being such a hot place, but…

The glasses are melting.

Damn.

So… while we're waiting… To get started, I thought I'd talk about, what's coming up. We have, a number of… new ones lined up that I haven't put on here yet. I think, Compliance Studio is gonna do, July the 10th, and then, I think we're gonna have an FDA presentation about, changes at the FDA, on the 19th, but that one isn't nailed down yet. I might have… promised that to someone else, in which case, I'm wrong, but, this is interesting. So,

Taylor, who, works for iRhythm Technologies, which is a manufacturer, Was at the conference in Boston. And I had met him there last year, and he gave a really interesting presentation. So, we've kind of expanded on that, embellished it, changed it around for a more general audience, and, you know, started talking about the shortcomings of Fishbone and getting to the actual. Where the rubber meets the road with risk.

Root calls. the root cause.

Yeah. Right, which… which doesn't always happen. Even when you do a perfect risk analysis, you don't always arrive At the root cause. So, right, that's an interesting way to put it. Then, webinar on Tuesday, June 30th, QMSR Unpacked. And they're basically gonna present 5 different areas of QMSR. From management review to… recalls, and just all sorts of stuff. So that would be an interesting one. And then on the 3rd, since it's the day before the 4th of July, and I don't really know, if maybe the people in the US want to say whether they're planning on showing up at all on the,

On the third, you know, that would be… sort of good to know, but, I'm planning on, You know, sort of launching this new, Thing, and giving away lots of… Lots of my best tips on how to, stop being overlooked, and it's sort of the synthesis of everything we've learned from the MLV100, and the nominees, and the posts that we do every week. It's like, what… what is it that, you know, you have to offer, and how can you do that without becoming a full-time marketer? Because that's my goal, is to support this community, in… to create a venue and a stage for those conversations.

And, and move things forward. We're at 3 minutes till… And… I… Do not see the speaker. Shoot…

She's invited, everything is good on my end.

Okie doke. Boom. Well… What do we do if the speaker doesn't show up?

Get someone else to speak.

I will do that, and it might be you, and it might be you.

I do.

Hey, Shar.

John, do you think it has anything to do with today being Juneteenth? I mean, I'm in San Diego, and they've closed… the city is shut down for it. It's a holiday. So… Because I get up… I get up early every day, and I was on the freeway, like, I'm used to seeing traffic in my neighborhood, on this freeway, everything, and there was like a… it was like being back in the pandemic. shut down. There was nobody on the road, and I was like, what's going on? And my wife… I had to call her, she's like, it's Juneteenth, it's actually an official holiday in San Diego. So, I don't know if this impacted your viewership, but it might.

Yeah, I don't know.

And I could be completely wrong. It's my Irish luck.

Lent me, try to make a phone call.

I'm here!

Here she is.

Sorry if I stressed you out.

You stressed me out. Okay, I'm recovering. I bounced back quickly. Thank you, Shannon. So… I have, prepared an opening script. Good morning, everyone, and welcome to Friday in Focus. We're gonna keep it a little more conversational today. We may have a smaller group than usual, being a holiday. and the nature of the topic, which is, you know, a little bit off, but I'd love for, as many of you as possible to participate, ask questions, and help us think through this big problem together. A few quick housekeeping notes. The session is recorded. The recording will be shared with registrants. Please use the chat to say hello, tell us where you're joining from, and share reactions as we go. Please use the QA, for questions you want Shannon to answer directly if you put them in the chat, or you can just, you know, raise your hand and talk.

I already showed the slide earlier, for what's coming up. Next Friday, we have fishbone fatigue, risk that actually reaches the patients, or as Martin put it, root cause, with Taylor Derringer, and, from iRhythm Technologies. So, he's from a manufacturer. He gave an interesting presentation, in Boston two weeks ago. And we have, worked on that. On Tuesday, June 30th, we have QMSR Unpacked, the new FDA Playbook for Quality System Readiness, with Michelle and Don. From LeanRocka. And then, on July the 3rd, I decided that I'm gonna hijack this call, because I'm afraid that no one is gonna show up, so if it's just me talking, that will be fine. I'm planning on giving a one-hour presentation on the Silent MedTech Expert, which…

basically is for many of you on this call, which is to say, how do I, as a solo person, or as part of a small consultancy, raise my profile, attract attention without becoming a full-time marketer, without hiring a full-time marketer, and without getting bogged down in everything that I hate about marketing. So, I strongly recommend that you attend that, because I'm gonna give away lots of free Prompts that are gonna make your life a whole lot easier. Now… Today's session is called Life After MidTech, and From Human Factors to Serving Humans, and our guest is Shannon Clark. Shannon is the founder and president of Haven Safe. Before that, she founded UserWise,

medical device human factors consultancy that many of you may remember that was acquired. In 2014, she built that company to roughly 30 people and exited in 2022. That alone would be a full conversation for this group. A lot of people in this community are founders, consultants, operators, and subject matter experts. Many of them are asking some version of the same question Shannon asked after selling her company. What comes next? Shannon's answer was unexpected and deeply connected to the work she's already been doing. She took systems thinking, human factors discipline, and use error mindset from medical device work and applied it to eviction and prevention of homelessness. One of the ideas Shannon shared in our earlier conversation really stayed with me. In human factors, we moved away from

user error, because the phrase places blame on the person. The shift to use error forces us to look at the system around the person. What conditions led to the failure? What information was missing? What resources were unavailable? What did the system make harder than it needed to be? Shannon now applies that same lens to housing instability. ability. Haven Safe focuses on preventing homelessness before it happens. That means helping people cover rent before eviction, connecting them with legal, financial, employment resources, and giving practical guidance at the moment when they have… when they still have options.

So, today is going to be partly a founder's story, partly a human factors conversation, partly a nonprofit case study, and partly open question for the community. What happens when med tech skills are applied to a human problem outside of med tech? Shannon, thank you for being here.

Wow, thanks so much, that was a beautiful introduction. So nice to meet everyone! Hello, I'm Shannon Clark, former CEO of UserWise. Does anyone have any questions before we begin, or, like, burning topics that they definitely want me to cover before I start? Who here has heard of human factors? I think everybody at this point, but when I asked that question in 2014, everyone would be like, I think it's about ergonomics, I think it's about anthropometrics. It really wasn't until… 2016, when the FDA finalized their guidance that human factors really exploded into the common discourse.

The FDA started enforcing human factors in, like, 2000… earlier than 2009. I mean, they had their first guidance in, at the turn of the century. But then they hired their first human factors engineer in around 2008, 2009, and that's when they actually started enforcing, and I was just so lucky to be at Intuitive Surgical, which was at the forefront of innovation, technology, human factors, use error reduction, and FDA enforcement, which was sort of, like, the perfect, collection of all the things to springboard my career into founding, user-wise. So, user-wise, I do have slides that I could get into, I guess, and just share a little bit of background. I thought it might be interesting to share the history of, kind of, me founding a company and the timeline.

When I founded it in 2014, it was not 30 people yet, but I got it to that point, and pretty soon, as of 2022, it was the largest independently owned human factors consultancy in the medical device space in the United States. So that's really set me up, To be a platform company for, a private equity firm. I'm gonna share my screen. Are you able to see my screen?

Alright, so I sort of, like, had this foundation, I studied mechanical engineering at UCLA, worked at Abbott and Intuitive Surgical, worked on a number of different products at Abbott and Intuitive Surgical, as well as working with startups in the Bay Area. I was born in Palo Alto, so I immediately, you know, in high school, started interning at medical device companies. But I kind of wanted to talk through the history of my company that I founded, just for some further background. So, I started consulting in 2014. I was working at Intuitive Surgical in moonlighting. I very carefully reviewed my moonlighting clause of my employment agreement, and it seemed to permit it. So I was able to start this company

while fully, gainfully employed. I call it wing walking, so there was no point where I was worried about losing my home or not having enough money, because I always had two jobs at any given time. So that's one way to do it, but it's also one way to be Pretty, pretty busy, working 80-hour weeks. So I formally incorporated, hired contractors at first, but then hired my first employee, Nantini's now a successful human factors engineer at Intuitive Surgical, after being my patient zero, and I had never managed anyone before, so, wow, she is patient and kind. And but she worked at UserWise for quite some time, and actually, what's so crazy is that her daughter, who's 16 years old, is intern… having her second internship with Haven Safe this summer. So we're keeping it in the family.

So as I grew the company, it sort of hit a tipping point in 2019, where it really started to feel like a real company, and I was the CEO, and there was, basically too many people for me to review every single report that we wrote. So it really was a, year of growth and scaling. And also establishing new business processes to accommodate the scaling. We launched a study facility in 2020 that was part of the plan in 2019, but when the pandemic hit, it was crickets. We lost all of our business. There was nothing. And I was kind of looking at, well, do we need to do a layoff? Or is there some creative way I can get ourselves out of this terrible situation? So, I did apply for the government grants, and we did get them, for, you know, covering people's wages so that I didn't have to do a layoff, but I didn't know that at the time, so I retrained everyone at the company to have expertise in, at-home diagnostics, and we were able to.

start working on emergency, COVID test kits, and became predominant experts in the emergency use authorization pathway. And so that, actually led to extraordinary growth for user-wise. Not only did we get to avoid a layoff, during my entire tenure, but also, we were able to grow in 2020, 2021. And then also became predominant experts in actual use usability testing. So from there, I was able to sell my company. Oh, there's me giving my first presentation at Fogarty Institute for Innovation in 2014, I think? Took a vacation day and did that.

And then just to kind of… the past couple years, I was able to, transition user-wise, now it's ClaryMed, and then launched Haven Safe. I started volunteering in the encampments. Because I live in… does anyone here live in, California? I notice you are awake quite early, so maybe… oh, I see maybe… oh, I see a Golden Gate Bridge! That's nice. Hello. Yeah, it's kinda early. But yeah.

Great way to start the day, thank you.

No, thanks for being here! Amazing. Yeah, so… So, 40% of the United States homeless population is in California. And I think part of that is that we crank out making homeless people. It's not necessarily a magnet for homeless people, as the news might tell you. I think there is some truth to that, and I have met people where they traveled to California because maybe it was easier to get drugs, or maybe it was easier to live outside because you can't freeze to death in California in most places. But I think most of the problem is our economic prosperity actually leaves behind a lot of people that live here.

And, so anyhow, I live in San Jose, California, and I have two daughters, an 8-year-old, sorry, a 5-year-old and an 8-month-old. And they, we lived about a half mile from the Coleman encampment, so that, I think, was the largest… encampment in Northern California. And had a thousand people living outside with no potable water. or, sanitation, and you see people walking along the street with giant jugs of water from Target, or balancing it on their bikes to try to bring it back to the encampment. And this is, like, right next to my house, and really inspired me to just dig into what is going on. This is crazy.

So I started volunteering in that encampment, handing out food, getting to know people who live there, and trying to understand what's going on. I also joined the board of directors of Recovery Cafe San Jose, which is a loving community center and non-religious place for, people who are homeless or, suffering from deep poverty to come hang out all day and have free meals. be treated with dignity, and have activities to do. I'm on the community chorus, there's also art classes, they're required to attend, circles once a week, and it's a model that's been wildly successful in the United States and Canada. There's over 50 of these.

Throughout, the lands. And it's, it's just, the premise is, embracing people with love, use the carrot rather than the stick to invite them back into society. So, it's a model that I love, and we're also trying to scale it so that we can also add the housing component in with the loving community, though it can be a little tricky, because you have to be sober for 24 hours to participate, and so it's an incentive to… to keep com- to stay sober to keep coming back. And when you're housing someone, it's a little trickier, because you can't just kick them out of their house if they fall back into drugs.

But that's another project I'm working on that's not Haven safe. In 2024, I think I fully had kind of characterized what the problem statement was that I needed to dig into. And what I found through all of the studies and research and books that I read is that the cheapest way to end homelessness is to stop it before it starts. So I have families coming to Haven Safe where they just need $300, and they're panicking, they're gonna just leave their apartment because they can't afford it, and they just need $300, and they're a family of four. And, I mean, any sane person would say, let's just cover their rent for $300, are you kidding me? Like, they should not be living in their car. They just need $300.

to get through this month, and then they'll be able to go back to work after their medical emergency. So, on average, our clients get around, like, $2,200, and that is able to stabilize them as they were about to fall into homelessness, and then we diverted them. We also get a lot of calls from people who are actively unhoused, but it's a stark difference, where if someone's housed, it takes about 2… 2 hours, 2 to 8 hours of case management to keep them housed. When someone's unhoused, they've now, started to… their mental health has started to decay. Maybe even they started drinking a little more. Maybe they lost their job because they didn't…

Oh, I'm talking to one person right now where she's struggling to charge her phone, she works at Uber Eats, and she is really struggling to charge her phone to get enough hours at Uber Eats. And then, inevitably, the downward spiral progresses to the point of the car getting impounded, or repossessed, or towed, because they were parking somewhere illegally, and then it leads to other things. So, it takes 250 hours of case management to dig someone out of that, versus just covering their rent. I also wanted to share… Do-do-do-do-do… Oh, I had it up. I wanted to share this,

Does anyone have any questions, by the way, while I dig up this PDF that was supposed to be right here?

got you in.

What got what?

What motivated you to take on this huge challenge? Which I appreciate you doing this, but I was curious what motivated you.

Well, I feel like I've been so, so fortunate in my life. I can't believe that I've really won the lottery of my life, and I think… I owe it to civilization, society, my community, to, give back and make sure that I'm uplifting everyone else. And I'm confused that if someone is, you know, so blessed, like, wouldn't anyone just want to spend the rest of their lives giving back? Like. I mean, I think Elon Musk, like, he can be a trillionaire if he wants to, but… I mean, I guess his thing is he wants to go to outer space and look forward, and he's, like, given up on… people in poverty, I guess, but, I just don't think we're ready for that until we treat everyone in our society with dignity, and what speaks to me the most is just how, I think the way you measure a society is how you treat, like, the worst of that society. I think that was from Nelson Mandela. I just butchered that quote, but it's like, how do we treat people who are in

Are they mistreated? And I'd say, yeah, right now they are mistreated. They're not really given the resources to turn their lives around. And there's a lot of dehumanization happening, I think. So, I think we need to sort through those societal issues, and I want to be a part of moving the needle there. And… I think there's just so much to be done. As I enter this space and look around, I'm a little bit bothered that I'm the most technical person I've met in this space. I met one other guy who works at Apple who's kind of volunteering and does some things. But, I'm actually not that technical. Human factors engineers are more, like, empathetic and, like, logical and evaluate things, but I don't code. I'm learning to vibe code, but, so I'm like, oh man, I'm the most technical person in this entire field. Everyone's still using paper forms, they're really not… I've noticed executive directors tend to not operate their organizations with keys

performance indicators. So, to be honest, like, they don't really know what's going on or what their output is, because since there's no capitalism, there's no economic feedback loop, they're just sort of blind leading the blind, and they're not organizing these things towards a certain goal with measurable outputs. So that's… that's ultimately my wish and what I'm working towards. I think Haven Safe starts as a model, and I kind of did this with UserWise, too, where Haven Safe, it's an example where we are highly metric-focused, and we measure, the outcomes of every single person. I've talked to other agencies, and they're like, oh, wow, how do you have the resources to measure the outcomes of every single person? And I'm like, well, we have to do it. If we don't do it, then what's the point of doing anything we're doing?

So, I think medical devices were related, were governed by quality systems, QSRs. And it, I honestly think we need something like that in the social services space, especially in homelessness, where it holds people accountable and, ensures continuous improvement, and most importantly, gives people in poverty a voice to complain and offer that feedback loop, because right now they're shouting into echo chambers And ignored, because, nonprofits will just want to look good more so than continuously improving.

So, I mean… I generally am not the type of person that wants more and more regulation. I think it can lead to unforeseen consequences, but I would like to use the carrot versus the stick for nonprofit organizations and, foundations and donors, and just try to align everyone on, hey, we need to… Make sure that what these agencies are doing, they're using your money to actually have the outcomes that they're saying that they have. And the first… the first step there is data collection. So we've been able to keep 96% of all of our clients who engage with us, keep them housed. It's been very effective, a very effective model. The 3% that fall into homelessness

They tend to have severe mental health issues, and they're just not the demographic that is helpable through this model. They need something other than money. This was a study done by, the UCSF Benioff group, they, they did a study in 2023. And… They found that 49% of all homelessness in the Bay Area, California, is easily preventable. So, 12% were someone just lost their job, and they're looking for another job. 9%, maybe people went to live with family, and then there was a conflict, they got kicked out, or wrongfully evicted. maybe they had a conflict with the property owner. There's a lot of, slumlord landlords, that might,

try, like… I saw, what was the word? I think one landlord recently put bedbugs in my client's home to try to drive them out, because he wants to sell it, and he doesn't want to comply with the laws. For giving 60-day notice, offering them monetary compensation to move, so it just got really hostile. And, so conflict with property owner, it tends to start with an eviction that's maybe a shady, illegal eviction, or bullying, or threatening. And so we'll help, help through those situations, too. Does someone have a question? And then another… there's a lot of people here in the Bay Area where they're doubled up. They might be staying on someone's couch.

Or in a space not meant for human habitation, or maybe they're sharing… many people sharing a room. I met one person where she was running a space to live in a communal kitchen in a house, so she would just roll out a bed in the kitchen and sleep there. And then they were charging her rent for doing that. Also, poor housing conditions, again, like the bed bugs or mold leading to severe sickness. I've seen a lot of that. And then commonly, if there's maybe some adult kids living with their elderly mom, and then she passes away, the family no longer has that Social Security income, so their income drops significantly, and maybe they didn't plan for it.

So they might become homeless. And so, for some of these situations, we want to find them new housing as quickly as possible and cover their deposit. None of our callers have the money available to cover a deposit to move into a new place. And then, also, we want to make sure that no one gets an eviction on their record, if avoidable, because then it just makes it impossible to get rehoused in the future. So, these are all the use cases that, Haven Safe is addressing. The other use cases in the 51%, by the way, are, Let's see, leaving the area for job or family, programs ending, so, transferring to a different institution, violence or abuse in the household, breakup between residents, and participant substance use.

And then other. So those… there's… there's 51% that Haven Safe is not addressing right now, but, there's other… other agencies working on that. Going back here… So, what does this have to do with human factors? Well, this is a slide from back in the day when I would give human factors talks. The premise… when I'm working on a medical device, I want to make sure that I'm giving the users what they need, not necessarily what they say they want, because what people say they want isn't necessarily what they need, so you want to use tacit observation to uncover truths about user interaction. So I want to use data and collect,

feedback and information, but ultimately analyze that data and give the users what they need. So, for example. 60%… for 58% of our callers, at Haven Safe, we have a highly responsive call center, which is… really novel in this space. When you call these other agencies, they do not pick up the phone, and their favorite terms are, we are at capacity, or we don't do that, and then they hang up. What Haven Safe does is we have a software that triages them to bring them exactly where it is they need to go, no matter who they are. Even if we don't do that, we are gonna make sure someone else does that. And then we don't let go of their hand until they let go of our hand, no matter who they are.

So that's probably the most important, like, tenet of Haven Safe, and why we're really successful, and why we are able to build trust with our clients really quickly. A trust that has been actually lost by this current ecosystem of homelessness. So, anyhow, as I'm developing a medical device, I want to give people what they need, not necessarily what they say they want. And people call, they say, I need a job. 58%, they say, I lost my job, I need a job. That's a lot of people that need jobs. But what we give… what this ecosystem has been giving them is they pay their landlords. So… that's great, I'm so glad that we were able to stabilize them, but they weren't asking us to pay their landlords. They were asking us to…

give them a job. So that is kind of what I've been focused on this year, as Haven Safe has now, helped 1,280 people avoid homelessness last year by just covering their rent. Now I want to give them what they need, which is a job. And I'll talk a little bit more about that, but I'll get through this slide first. So, two is making the user experience invisible. When I got started, people were taking 250 hours of their time calling agencies in hopes of getting a meeting for an intake. And, I had some clients where every morning they would wake up and make the phone calls, calling 19 different agencies in hopes of getting help, for weeks. And maybe they would get, finally, an appointment. But then, for that particular program.

They would find out, oh, only 29% of applicants are actually eligible to apply. And so, based on my advocacy and rolling up my sleeves and really putting pressure on the system, at least at this point, they've consolidated that particular program, it's a public program, to one phone number instead of 19. And, they now do, eligibility assessments within 48 hours instead of 6 weeks. So that was probably our wildest success last year of, like, really changing the system in a big way, but… that user experience was not invisible, and it continues to not be invisible. But the invisible user experience that I am seeking with Haven Safe, ultimately, is to

Know who is about to become homeless next month, through… A system, a government system, and then reach out to them proactively. Because no one… what I found is no one in this community realizes that there's $30 million available to cover people's rent, to prevent homelessness. No one I talked to in the encampments had ever heard anything about that, but there's $30 million, theoretically. And then also, people get really panicked when they get the 3-day notices. I'm not sure what it's like in other states. But the California template for letting someone know that you might start the eviction process, it says you must leave within 3 days.

So, a lot of people will panic and just leave, but what they don't realize is that there was no court case filed yet, and it's just a piece of paper. Like, I know it's really scary, but don't panic and leave, because that's the worst thing you can do. Then you aren't eligible for rent assistance. So we help de-escalate those situations. But this is a long roundabout way of saying I want to call people before they even are thinking about self-evicting, and the way I'm doing that is partnering with the City of San Jose, where they already have a city ordinance passed. requiring landlords to report 3-day eviction… 3-day notices, 10-day notices, 30-day notices to the city. And this is the only city that I know of in my region that has that city ordinance. So right now, my city is sitting on a list of the 2,000 people that will become homeless next.

month, and so I've been begging them for two and a half years now to please sign a data sharing agreement with me, so that Haven Safe can call each and every one of these people and say, like, hey, like, did you just forget to pay rent, or is there something more going on here? And then if there is something more going on here, can we tell you a little bit about your tenants' rights and, tell you about the fact that there's $30 million in our community to cover rent? And I think that that truly closes the systems engineering loop in making the user experience invisible, because right now they have to kind of imagine or have heard about rent assistance, think to type it into a Google and then see our website.

Or meet us at an outreach fair. Any questions about that?

Yeah, I had no idea that rent assistance was even a thing.

No one knows, yeah. It's a… yeah, it's a secret. And the… and what I found is the government wanted it to be a secret. I… and I'm still grappling with that. I'm like, I'm confused why… why are we trying to keep secrets? maybe money laundering? I don't know. I mean, I'm not directly accusing anyone of anything, but I… my clients aren't getting… a lot of my clients aren't getting money.

Who's… who's support… who's providing that? Is that federal, state? Where's that $30 million come from?

Well, I know $8 million of homelessness prevention money comes directly from the city of San Jose, and then a lot of other money comes from the county, and I believe some private foundations also contribute. But the funds that I specifically rely upon, because first I thought, I need to build a $3 million fund, because that seems to be the gap as I do the math on how many people are becoming homeless and what's going on. So I think we need $3 million more dollars. And then I started working and realized that there's these funds that caseworkers can just apply to, so people in the community can't apply, but caseworkers can. So, we will serve as the agents for our clients to access those funds, and those funds have fully served all of our clients. One is called Chronicle Season of Sharing, it was set up by the San Francisco Chronicle newspaper, and they have $3 million a year.

And then, there's one about a million dollars with this other private fund called, Housing Industry Foundation. And so by partnering with those existing funds, we're actually able to keep everyone housed. Except for people who, like, really are in a… A non-stable situation, and they're still in a downward spiral, and just, like, covering their rent for a month or two months isn't gonna help them. So those situations we still haven't really figured out, but I do think having an emergency job will help stop the downward spiral for those… for those clients, and will help us help more people. So,

finally, when I am designing a medical device, I definitely want to minimize and eliminate the need for training where possible, and, because I am always talking to software engineers, they're like, we're making a capital equipment diagnostic product, and they're like, oh, well, I know your users made that mistake in your usability city, but we can just add it to the training. But are they really gonna remember that key point in the training? Why can't we just bake something into the design to guide them to the right place, and to do the right thing, or guard them against making that error? That's always the best solution, if at all possible, and training is spotty at best in any organization.

So what I've done is I have operationalized case ma- casework. So, I do think that there is varying, levels of… capability among all caseworkers. A lot… a lot of frontline caseworkers are actually paid, like, $20 an hour, and they were just homeless last year, and then employed by their agency, which I think is great, but they may not have, like, the training and experience to really offer really good advice to the people they're serving. So I developed a software where it helps them walk through the crisis step-by-step, and then it gives an automated case management plan. So that way we're able to offer, like, a really high level of case management to everyone in my community without having to train each and every caseworker.

And the way that Haven Safe, like, manage… manages our clients right now, is that we have, a call center that's volunteer-run. So, If you have an extra 4 hours a month, please volunteer with us. We… you can work remotely from the comfort of your own home. You cover the phones from, 9 to 1, or 1 to 5. We also have a volunteer program for callbacks on off hours, because we really pride ourselves on being highly responsive. And so, any empathetic community member can roll up their sleeves and use our software to offer really good quality initial intake and case management. At the end of your 20-minute phone call with our caller, it automatically emails the software-generated case management plan to their email. And then, in some cases, it automatically sends a referral to their health insurance.

A really cool thing that's happening in California is that there's billions of dollars through Medi-Cal, where like, when you're about to get surgery, you get a pre-authorization for that surgery. Well now, if you have a client living in poverty, and they're about to become homeless, or they are homeless. You can now send a pre-authorization to get case management paid for by the health insurance, so Anthem, Kaiser, and Cure Santa Clara Family Health Plan. And that is revolutionary, because now you're aligning incentives. Where, like, Kaiser doesn't want their people to be homeless, because they're going to become very expensive patients, so they will pay the caseworkers to get them out of homelessness.

And, so I'm really excited about that, and we have some new partnerships with some of the providers through Kaiser and Anthem and all the local health insurances. And then, so now we set up this, like, software automatic referral. Again, make the… make the… User experience invisible. So they call us, and then they're immediately talking to a caseworker that's gonna actually solve their problems. Yeah, so I'm excited about our software solution. I haven't really seen… Anything similar? this quote just really stood out to me from Mark Twain, that humility is strong opinions weakly held. As I've gone through this process of starting Haven Safe, I've learned a lot, and I think Human Factors has really created a context where I have an open mind, and I'm… I'm very happy to change my opinions.

And have discourse about other ways of doing things. What's one example where we pivoted? I think… There was… oh, yeah. When I got started, we found the county's screener online in their operator's manual for how they were screening people. You know, I told you, like, the 250 hours of calling, and then the screening appointment, 6… weeks later, and then only 29% of people can actually be eligible to apply. Well, I found their whole operations manual online, and… the questionnaire. And so what we started doing was coaching people, because the questionnaire was highly subjective. It's nothing I would ever let my employees at UserWise write.

Like, depending on the day, or the time, or how you're feeling that day, you're gonna get a different score on it, and then if you score low, you don't get help. So what we started off doing was coaching people, explaining, okay, well, the whole premise is that you want to score higher in order to get help. Like, that's, like, a helpful thing for them to know, because they're asked questions like, do you have poor credit? And then they're like, well, I mean, you could argue that this number is good or bad, like, it's so subjective. And so if they know that they need to get more points in order to get help.

And, you know, I tell them, don't lie, but, you know, you could decide that a 600 is a poor credit score if that's what you think. So, we were coaching them, and then, I guess I got a spanking from the county, and they said, you can't coach people, that's unfair. So, kind of, that's where we're at. But ultimately, there's more work to be done here to make it less subjective, and… Offer easy, equitable, and visible access to rent assistance for homelessness avoidance. So Humility is Strong Opinions Weekly Held. I agreed to move away from coaching people, but I think that there's some other solutions that we're hoping to collaborate with them on.

Yeah, we already talked about how user error, is no longer a thing, and that is really the premise of Haven Safe, that if we can defer Blame away from… people, then it opens up the opportunity to actually change a system, and that basically summarizes what Human Factors is. And I think that's why they changed it from the term homeless people to the unhoused. And it's totally the same exact shift, where we don't want to blame the user by saying user error. we want to say it's a use error, it's something that's sort of happening to them, and that it's caused by something. And so then you can actually start coming up with solutions, because if you just blame, then it's, game over.

Another thing that that brings up for me is when I'm operating a company, as the CEO, everything is my fault. So, if someone at my company makes a mistake, and this goes for, like, if I'm a manager as well, if someone makes a mistake, that is my fault. Because either I didn't… give them the right training, or I didn't have the right business process in place to make them successful. And then in some very rare circumstances, I hired the wrong person, but everything is… Basically, the fault of the company itself, or me. Not…

the… not the employee. Once you start blaming employees, your company's gonna start sucking. And so… I think this is also why IDO, which is just, like, user-wise, IDO is, like, the user-wise of, like, earlier times. They pivoted into management consulting, and that makes so much sense to me, because if you just apply human factors to organizational design, You can, you know, probably get more money as a management consultant, rather than a manufacturers engineer.

Before the, call started, I was talking with Martin King about, root cause, and that's, you know, gonna be a large part of the discussion next week, is getting, getting to root cause. doing risk analysis, fishbone analysis, or, you know, 5Ys, or 6, or whatever it is. And, you know, so I'd be curious to know how, you know… I mean, obviously this is, this is all you know, I would almost call this proximate cause, which is a legal term for what was the proximate cause of somebody's death or injury, and this is the proximate cause of their home… of their unhoused state, you know? So, this is a very interesting discussion to me. Does anybody else have any other comments or questions? I saw that Nidra had put a question in here about, for both your companies, what strategies do you use for scaling your business? Also, your slide mentioned an FDA grant. Could you please speak more about that?

Oh, thank you. Yeah, so we were the only consultancy to that point to ever get, like, half a million dollar contract with the FDA to run a multi-year study examining the effects of training decay on, human factors validation. Training decay is the idea that, at least the original guidance has said you have to have at least an hour between when you train a surgeon on using a surgical robot And when they come back and use it. And then you have to justify the length of training decay you select. Before the guidance got so specific on the one hour, we were doing, accelerated decays. We would have participants, playing with Lumosity, it was like a brain teaser math game on the phone, to distract them, or, doing a reading comprehension test that had nothing to do with

the medical space, to try to expedite losing information, forgetting. So, I conducted, a literature review of basically all the literature done to date on memory loss. Most studies At the time, we're done on skills acquisition and speed of skills acquisition, but that's not what we're interested in when we're talking about expedited training decays in the medical device space. But you can imagine that sending a surgeon home for a night, and then bringing them back the next day to do a simulated surgical case. That is expensive. That is really expensive. So I think the FDA needs to really justify this request for longer decay periods, especially in the pharmaceutical space. I mean, we're seeing, like, real-time decays, where,

People will go home for a whole month, because it's injected once a month, and then they come back, and then you have a high attrition rate for your participants, so you have to recruit more participants, so pretty soon you're looking at a $2 million human factor study. I mean, luckily, pharmaceutical companies have, the money to do that, but… they don't like having a month-long delay in their development, and all the medical device companies absolutely cannot afford that. So, the premise of our grant was to examine the effects of shorter and longer training decays on different types of tasks.

And so it was a collaboration between UserWise and the FDA, and we had some pretty interesting insights that, I would have to ask user-wise if I'm allowed to speak about that. I don't know whether they technically own the data. So, Yeah, happy to talk more about training decay. What was the other question?

The other question was, for both your companies, what strategies do you use for scaling your business?

I think just knowing that… think you're gonna fail. Fail early and often, as with… everything about me is human factors. Fail early and often. I hired Nandini, my first employee, and I was a terrible manager, and I learned a lot, and then I became a little better manager, so she stuck with me, it was great. I also… you know, you make a lot of mistakes, and you just have to… Learn from the mistakes and quickly pivot and address them. I think perfectionism does not work when you're founding a company, or, you know, writing a business plan and then revising it every time you want to pivot. I never wrote a business plan, I just kind of did, and then…

changed what I was doing. When I first got started in 2014, they're like, a lot of people said, you're too young, like, that doesn't make any sense that you're gonna start a consultancy. that's not gonna work. No one wants to do human factors. There's no market for human factors. You're gonna have to do regulatory human factors and quality. Why don't you… why don't you work longer at Intuitive Surgical and become a manager so you can at least become a manager on their dime? Well, I'm glad that I ignored all of, those recommendations and listened to my intuition, and also, I'm the only person that's gone through everything that I had gone through up to…

At that point, I was the person that apprenticed Ed Izrowski, who is the chairman of the Standards Committee. He invited me to contribute, and it was super inspiring to work with him and see everything with a front row seat that was about to happen, with Human Factors back in 2011. And seeing the FDA guidance get, released, and, see the FDA, like, enforcement at Intuitive and Abbott in those early days. So I knew… I knew in my heart, like, human factors is gonna blow up, and my bet was right in the end. So, not listening to people, and just listening to your own intuition, I think is so important. And then being not… avoiding perfectionism. At Haven Safe, I knew going in that I had no experience hiring, caseworkers.

And that I was gonna make mistakes, and then I did, unsurprisingly, and then I was not surprised by that, because I had this experience of knowing that, yeah, there's just some research and development and trial and error, and then… and then once you learn from those mistakes, you know not to make them again. So I do want to mention, put in some plugs for my emergency job program. So, what I'm trying to do now is launch an emergency job program where people call us, they say, I want a job, and then they get a job. They can show up the next day and be a, art studio… assistant in our marbling art studio. This is an AI rendition of it. It looks even cooler now, because these, high school kids just painted a mural on that brick wall, and it looks gorgeous. They're not done yet, but I'll send an in-progress picture out. So yeah, we're gonna be, it's like tie-dye, but way cooler.

Let's see if I have a picture. It's like tie-dye, but way cooler. Has anyone here marbled before? like, stationery or shirts. So you drop paint on a viscous fluid, and then you swirl it around with a comb. It's very therapeutic. And then you place a garment, or cloth, or paper, and then you lift up the pigment and dry it out. And it's just… I'm excited to do it all the time, and… we're gonna… hopefully, sell things on Etsy, and then cover the wages of the people who we are offering emergency jobs to.

And the idea of this emergency job is that they work here for about, maybe even 2 days, but up to 60 days, maybe, if they really need to. And then while they're there, we offer them intensive case management and help finding a longer-term job. So, just 2 weeks ago, I launched our emergency job software, where it… our col… our software before would triage them, like, okay, of the hundred different rent assistance programs that exist, which one is gonna meet your needs? And then now we have the job version of that, where it's like, okay, well, you need to become an in-home supportive services worker. You need to… let's find you daycare for your kids so that you can… free daycare so that you can get a job.

Let's, you can work at DoorDash, because your car was done… was created more than, earlier than 2013. Yeah, so you can't drive Uber, but you can drive DoorDash. So we're triaging everyone, to give them extremely, like, what job can they get tomorrow? So, if someone can't get a job tomorrow, they can come to our art studio, and that way we can uplift everyone in our community and make sure everyone who's saying, I need a job, I'm at risk of homelessness now, please help me, we help them immediately. And so, if y'all have any ideas, any other ideas of how we can connect people with emergency jobs, or how to engage your own companies in offering work, or, you know, even gig work, because I would love to scale this program.

And then, to offer sustainable revenue, we are doing team-building events, so while we will sell things on Etsy and hopefully get some revenue there, that's more focused on job skill building, for the participants. The way that we're really gonna bring in enough money to cover this operation on an ongoing basis is to do team-building events. So, this summer, we're gonna do 3, like, precursor team-building events before our launch in September. By the way, everyone is invited to our launch, please come, it's in September. But we're gonna offer 3 team-building events to practice and, like, learn how to give these

team-building events. So, if anyone is interested in coming and doing some art, for the good of reducing homelessness, let me know. And then we're also gonna be opening an art, showroom. So, the only reason I'm doing this is because I got this space for free, so, otherwise it would not pencil out, and I'd be way more stressed about it. But yeah, we're gonna do art shows where our, clients who are artists, they can show their work and sell it, and then 50% would go to charity, to Haven Safe, and covering emergency job wages. And then 50% would go, to the client. And then I'm also hopeful that we can get some big-name artists in here to, like, really draw a lot of attention. So if you have any connections there, let me know. But yeah, if you're interested, or if you have any friends who want to give back to the community, we need volunteers for our call center.

it's a very volunteer, kind of scrappy organization, and I like it that way. I don't want to spend any dime before it's time, or just be another $100 million fat cat nonprofit, like… Just sucking up government funds.

That was inspiring! And, I would like, I would like to thank you. for bringing that and sharing all of it with us. I would encourage the people on the call to scratch their brains a little bit and think about, what you've heard today. Has it changed your view of homelessness? I mean, I know it's… it's done wonders for mine. you know, I had a lot of preconceived ideas coming into this call that were… that were… that were dispelled, but I think the most interesting angle to this is… is about the idea of transferability of human factors skills, or, med tech experience generally.

to problem solving, risk management, any other area of your life that you're trying to affect change. And I think that's ultimately what we're talking about here, is how do we affect change? And so, going back to the root cause, going back to the proximate causes, going back to the structure of the system, and then saying, where are the flaws in the system that are causing use error, you know? And I think that is, remarkable, and I, and I love… to see, creativity, ingenuity, thoughtfulness applied in ways other than just strictly, you know, let's make more medical devices, let's make more money.

not that there's anything wrong with making money, but, I think that, that, yeah, I think this is, this is wonderful. Any closing remarks, comments from Shannon or anyone else?

Well, I would invite each and every one of you to reach out, to me on LinkedIn, or at info at havensafe.org, I don't know if I could display that. But I… I do wanna… I do wanna collaborate. I need as much, you know, support from everyone, both monetarily, emotional, and volunteering. But one thing that I would like to do out of this, if anyone's interested, is, maybe a webinar on doing a use-related risk analysis or a risk analysis for homelessness. I started it, or maybe I could, like, share With all of you. But that's the way my mind works. Like, you want to work on the design issues that could lead to the most harm to users, and so right now, this space is not structured with that prioritization. They're like, oh, you need, a free bus pass just to get around and see the sights? Like, let me spend time on that. It's like, no, no, you shouldn't be spending time with that guy with that aim. You need to spend time with this guy.

who's literally about to become homeless. And so, risk analysis would be really helpful for this space.

That's fantastic. Yeah, reach out to me, reach out to her. I'm happy to, help in any way that I can, and Let's… let's keep the door open for future conversations. Anyone else? Have any closing words?

Thanks for doing this, Shannon, it's amazing.

Agreed.

You're welcome, I'm trying!

we're doing.

Okay, well, thank you everyone for your time. I know this was a little bit off our beaten path. Come back next week for fishbone fatigue, with, Taylor. And, talk soon. Cheers.

Nice to meet you, thanks for your time!

Thank you. Bye.