On Building a Medical Device Startup for Underserved Populations - from Global Health Pursuit

In today’s episode, we are continuing our “episode swap” series with an episode from the Global Health Pursuit podcast hosted by engineer turned social impact storyteller, Hetal Baman.
On her podcast, Hetal tackles tough questions from the vast field of global health with a beginner's mindset.
In this interview, Hetal speaks with Sona Shah the co-founder of Neopenda. Neopenda's mission is to develop affordable medical devices addressing neonatal mortality, which are tailored to the unique constraints of underserved healthcare environments in low and middle-income countries.
Be sure to visit our podcast website for the full episode transcript.
LINKS:
- Learn more about Sona Shah's company Neopenda at neopenda.com
- Connect with the Global Health Pursuit podcast at https://www.globalhealthpursuit.com
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CHAPTERS:
00:08 - Introducing New Voices
04:47 - The Journey to Neopenda
12:27 - Addressing Healthcare Inequities
18:00 - Becoming an Entrepreneur
31:03 - The Product Market Fit Journey and Growing Neopenda's Team
36:24 - Navigating Challenges During COVID-19 and Restructuring Neopenda
44:18 - Advice From a Startup Entrepreneur
00:00 - None
00:08 - Introducing New Voices
04:47 - The Journey to Neopenda
12:27 - Addressing Healthcare Inequities
18:00 - Becoming an Entrepreneur
31:03 - The Product Market Fit Journey and Growing Neopenda's Team
36:24 - Navigating Challenges During COVID-19 and Restructuring Neopenda
44:16 - Advice From a Startup Entrepreneur
Welcome back to Narratives of Purpose.If you tuned in a couple of weeks ago, you already know that we are doing things slightly differently throughout this month in order to showcase even more unique stories of change makers. You won't be listening to me and my guests.Instead you will hear from fellow podcasters who are creating some amazing content I absolutely want you to listen to. So I will drop you some of the episodes as an introduction to their shows today.The second episode swap of this month's series is with Global Health Pursuit, a podcast hosted by Hetal Baman. Hetal is an engineer turned social impact storyteller. On her podcast, she tackles the tough questions of global health with a beginner's mindset.So these are questions like why are infants still dying from preventable causes or what exactly is voluntourism and can it harm the communities people intend to serve?Now, in this episode I share with you today, Hetal speaks with Sona Shah, an entrepreneur dedicated to transforming healthcare access in low and middle income countries through her venture Neopenda.Neopanda's mission is to develop medical devices that can withstand the unique constraints of these communities which are, for example, unreliable electricity and challenging climates. Take a listen to this inspiring conversation.
Hetal BamanHey, it's Hetal with the Global Health Pursuit podcast. Today's episode is all about innovation, resilience and the power of bringing healthcare to the most underserved communities.For this episode I spoke with Sona Shah, CEO of Neopenda, a medical device company that's transforming healthcare access in low income countries with affordable life saving technology. So if you're an aspiring entrepreneur or just passionate about solving urgent healthcare problems, Sona's story and advice are going to be pure gold.Her journey started at Georgia Tech, studying chemical engineering and took her across the world to Kenya where she saw firsthand the gaps in healthcare. This experience sparked the beginning of Neopenda and along the way she met her co founder Tess at Columbia University.Together they've been navigating the complex world of medical device innovation for emerging markets.In this episode we get to dive into real world challenges of launching a healthcare startup, especially one focused on life saving devices for infants. From navigating regulatory hurdles to choosing a for profit model to restructuring their team.During COVID 19, Sona shares her insight on the highs and lows of running a healthcare company.She also opens up about how culturally sensitive design plays a huge role in creating solutions that truly fit the needs of the communities Neopenda serves.My name is Hetal Baman and welcome to the Global Health Pursuit, a podcast for those curious about public health, global impact, and inspiring people who are making a difference. So make sure you're subscribed, leave a 5 star review if you're enjoying the show and share this episode with someone who might find it valuable.Every listen and every share helps this podcast reach more people who care about global health.Also, just a reminder, if you're in the US and if you're listening when this episode is being dropped November 5, 2024, you probably know what day it is. Election Day. Every vote counts, so go out and vote. Sona, it's so good to finally get you on the podcast.I have been trying to get you on the podcast for like a couple years now. I know life has been pretty crazy, I think for all of us. This interview is special because I've known you for a little while now.We both did our graduate school at Columbia University, and we met through a design course taught by Dr. Katie Reuther, and she's apparently on your board now at Neopenda. So that is really, really cool.I want to start this interview just kind of going back, you know, going back to just the beginnings of what Neopenda was like. Where did you even get the idea?
Sona ShahYeah, thanks so much for having me. It's an honor to be here.If it's okay, I might actually start from when I graduated with my undergrad degree, I went to Georgia Tech for chemical engineering. I graduated a semester early and decided why not travel a bit.I was always drawn towards kind of volunteering and helping people, but didn't really know what I wanted to do with that beyond, you know, clubs at school. School. So right after I graduated, I went to Western Kenya and I was a primary school teacher.
Hetal BamanI did not know that.
Sona ShahYeah. Wow. Okay. That's kind of where international development started for me.I just randomly ended up in a small town in western Kenya, and I was walking 40 minutes a day to get to the school and I was teaching math and science and English mostly. I taught one day of Swahili, and that didn't end well because I didn't know a word of Swahili. Swahili. But, you know, that's fine.Kids ended up learning. Uh, but anyway, I was there for several months and just really, really loved it.Everything about the culture and community was incredible, except for the inequities that I was fortunate not to have growing up. And that really stuck with me. I.When I came back to the us, I had a job lined up in pharma, and so I worked in Bioprocess research and development and really loved my time there. I was in engineering.I was working with large bioreactors, actually using that engineering background, learning about product process development, regulatory and quality, and the importance of that in the healthcare industry. I got to see quite a few medications coming through the pipeline as all the drugs we are creating were going through clinical trials.A really fun atmosphere, a very comfortable lifestyle. But at some point I realized that the kids that I taught in Kenya would maybe never see the medications that I was helping make.That drove me back to graduate school. Columbia, as you mentioned, and I specifically picked it for a couple of different reasons.I started working in a lab that was creating a point of care diagnostic for HIV and syphilis.Wanted to get more into the realm of biomedical engineering and more specifically, how can we provide equitable access to healthcare around the world. Also picked it for the access to a ton of nonprofits in New York.So I interned at the TB alliance, both in community engagement, which was totally outside of my expertise, but loved expanding my horizons there, and also in drug discoveries. And then I took the biodesign course that you mentioned with Dr. Katie Reuther, and that's where we started Neopendis.I have a lot of thanks and a lot of my career journey is thanks to Dr. Reuthers. Thank you for everything that you've done. And I would encourage anybody to go through a biodesign course because it really does start.Start the fundamentals of biodesign and how to, you know, what seems intuitive of start with a problem and then create cool tech to help solve the problem, opposed to vice versa. But a lot of our fundamentals really stemmed from that course. That is so helpful.
Hetal BamanI totally did not know that you spent some time in Kenya. I mean, it speaks to what you're doing today.During that time, you mentioned that, you know, while you were working in pharma, you had this kind of realization that these medicines most likely will not reach the kids that you taught in Kenya. Where were the other inequities that you saw when you were there?
Sona ShahYeah, while I was in Kenya, there's kind of a whole host of inequities. It was full of this beautiful and warm culture, a life without as many expectations. I think here in the U.S.you know, we don't have hot water in the shower and in the morning, and it's the worst day in the world. And, you know, being there, it just makes you realize what's really important to you.And for a lot of the people there, it was family Do I have food on my table? The culture in the community and in many cases religion for them.So there were a lot of basic necessities that I think they focused a lot more on, which I think is not an inequity that is far advanced than, you know, what most of us, including myself, grew up with. But that does also contribute to detrimental effects in healthcare.For example, one of my kids while I was there had a seizure and she fell to the ground and she was foaming at the mouth. And in, in their culture, it was essentially spirits that were taking over her.And so they wouldn't let me take her to a hospital where we knew that she would be able to get better care. And so there was this whole cultural shift that, you know, I, I physically could not take this child to a hospital when she desperately needed that.And so some of it was kind of the education piece of it, how things were taught in the education system. I think there's a lot of reform that is needed. There's a lot of really great things that are taught in schools.In where I was, a lot of the females didn't go past primary school. It was kind of their job, their duty to get married and have children. And that was kind of their goal in life, which is a great goal for many.That wasn't my goal growing up. And so I think just even the presence of being there as a female kind of getting out there and doing something different was the impact that I made.I think when I went into this, I was a naive American that thought, I can change the world. And then I walked away thinking, I don't know if I actually did anything.What it did do was open my eyes to an entirely new culture and community and how a lot of the world lives. That just the exposure is really what was fundamental for me.
Hetal BamanYeah, I mean, I.I also talk about this reverse culture shock that we kind of experience when we come back from an experience like that, because we tend to have our perspectives kind of opened up and then we start asking questions about like, why is it that we live this way and they live that way.Another thing that I wanted to mention, I know you touched on that little girl having a seizure and how epilepsy in a lot of countries have the stigma around spirits and, you know, run away, you're gonna catch it. I actually did a three part episode with Tigo Daniel jum on literally this. So that's episodes 34 to 36.So if you want to learn more about that, go and listen to that.
Sona ShahIt's definitely very fascinating and you know, I think highlights a lot of the importance of Western methodologies don't work everywhere. You can't come in with a mindset of what works in one community will definitively work in another community.And you know, as much as I wanted to take the child to the hospital, that's not how it was done there.And but at the same time you have to be culturally sensitive and appropriate and know where your limits are and to know how can you design and develop something that actually works within a community and not imposing your own personal beliefs on something.
Hetal BamanYeah, and I mean there's a, there's a line, right. There's the white saviorism kind of. I mean we're Indian, but still there's.
Sona ShahLike a similar concept.
Hetal BamanYeah, the concept works in that sense too. It's just how do you do things intentionally and sensitively in a country like that?Now going back to the design course, where did the idea stem for Neopenda and what was the need that you were trying to tackle?
Sona ShahSo when we originally started the biodesign course, Dr.Aaron Kyle, who's another professor actually on our advisory board as well, challenged us to think about during this course, why is newborn mortality so much higher in low and middle income countries than in the us? There truly are about a million problems that contribute to this. But that was kind of the starting point. We were tasked with thinking about this.We were drawn towards kind of vital signs. Monitoring. It has been something that many teams had worked on for a while and identified as a need.But we didn't truly understand what problem are we addressing until we actually went out to Uganda and did more of a needs assessment. And so, you know, we fast forward a little bit and then I'll get back to the biodesign course.But after the course we actually entered into the Columbia Venture competition.And it's really fun to go back to that pitch deck because at least now I know we've come a really long way since the deck, but it was at least good enough to be able to get $10,000 from the university. And that was really kind of the initial seed funding. And that was when Tess and I decided there's only so much we could do from a lab in New York.We really needed to get out there and understand what are these issues. So we used that funding, went to Uganda and we did a more proper needs assessment.And this was kind of post course and so we had done a lot of the biodesign elements, but again, I think truly understanding the problem didn't really happen until a little bit later when we were in country and when we were in Uganda. What we had seen is a couple of different things.The first is we kind of toured different public and private facilities across the country trying to understand what are the most pressing issues. And the biggest thing that we had seen was that these hospitals didn't have functioning medical equipment.They had rooms or fields that nurses literally call the equipment graveyard. It's exactly kind of what you're picturing, or exactly what it sounds like.It's just mounds of devices that are sitting there broken because nobody has really thought about the constraints of 85% of the world's population.And we just design medical devices for countries like the US where power instability or dust getting into our devices or humidity constraints aren't really as much of an issue.And so that's really when we committed ourselves to Neopenda and, you know, spinning it out at the university and into a fully fledged startup to design med tech that functions anywhere in the world. Our roots were and still are in neonatal mortality and trying to understand what those big issues are.And so most of our time was spent in the neonatal wards trying to understand what are the biggest problems that these nurses have.It's, it's quite a daunting thing because you go into the hospitals and hospitals need medical equipment, clinicians need devices to be able to deliver the highest levels of, of care that are needed for these patients. It's just a detriment that these patients don't have access to that, the clinicians don't have access to that.And so they're the ones that are really suffering from this strain. So one of the biggest issues that we saw was that there were just too many critically ill patients and not enough nurses to care for them.I think the first ward that we had gone to, I just remember this gut wrenching feeling walking out of the ward because there were 150 babies in this ward. Some were on tables, there was an open drawer of a desk and there was a baby inside.And so there, it's just a massive ward with too many patients and there were two nurses. Two. How are they supposed to know which babies actually need their attention?Compare that to your NICUS here in the US where maybe it's a ratio of two babies, three babies at most for one nurse. The hospital that I mentioned is kind of on the extreme. It's more of a government facility.So there's a lot more patients there, but you get the picture, not enough nurses. They don't have the tools to really identify patients in distress.That is really the problem that we wanted to help solve is how do we leverage technology to alert clinicians when a patient needs their attention so now they can provide more timely and appropriate treatment to the patients that really need it. And that is kind of the root of the problem that we wanted to help solve.That lent itself well to a vital signs monitor, which is what we created as our first product.
Hetal BamanYeah, I mean, you touched on a lot of things there, especially the equipment. Graveyard.
Sona ShahRight.
Hetal BamanI think it was like 85% of medical devices are designed for high income countries. I think that's what the stat was. And you worked at a pharmaceutical company. I worked at a medical device company.And what happens is once we have a new generation of a device, well, donate or throw out whatever we had. It's almost like you're wiping your hands clean, like, okay, we just donated a bunch of stuff.And for you to create a medical device that is designed around the limitations and constraints that a hospital ward in Uganda have, like, you know, humidity. Humidity is a big thing.
Sona ShahYeah.
Hetal BamanDust, insects, all of that kind of stuff.I even, I did an interview with somebody who told me that the doctor that they worked with would wash his gloves and then hang them up to dry for the next day. And it's like, okay, have you thought about that? So what I wanted to go next is, okay, you decided that you wanted to start Neopenda.Was that always your goal to like become an entrepreneur? Like what, what did you think going to Columbia University, doing your master's, what did you think you were going to end up doing?
Sona ShahHonestly, I had no idea. I think working in pharma right after undergrad was such an amazing experience. I learned a lot about what I loved.Engineering, healthcare, you know, all of the, the elements of that. But I also learned a lot about what I didn't love. I don't like being one person in a big corporation. I don't have the impact that I think I can have.I thrive in a much smaller environment where I have a lot more autonomy and I have a lot more of the ability to shape and change the course. That is where I thrive a lot more. I didn't know exactly what I wanted, but I knew that I wanted a change.And it is really diffic to give up a really comfortable lifestyle in corporate America where you. I, you know, had a very active social circle and I had my evenings and weekends and all of the things that we take for granted.You know, now working at a startup and it's a totally different lifestyle. And there's, you know, there's a drastic differences in kind of why I did what I did.And maybe it was a little bit of craziness, but I think every entrepreneur has a little bit of craziness in them. But going into Columbia, I didn't know. And that was a lot of the reason why I wanted to go there is because I wanted to work in this lab.I wanted access to the nonprofits. I wanted to be in such an international community to figure out what I wanted to do.I think I've always had inspiration for an entrepreneurial journey. My dad started his own company before I was born and it's an environmental consulting company. So totally different from what I'm doing.But I have so much more respect now for the work that he's done and being able to, to really help it thrive and survive. Over the past several decades, that spirit has always been built in me. I just didn't know it until I started the company.When you go to these communities and you see the gaps and you see the problems and the needs, you can't forget them. There isn't an easy solution. To join a company that is working to solve this.I could probably count on one hand the number of medical device companies that are truly investing in Africa or low and middle income countries more broadly. That's not okay. We need to do better. Me starting the company alongside Tess. I wouldn't have been able to do this without Tess right by my side.But just having that is a lot of the reason why we started it. It just didn't exist. So we created our own.
Hetal BamanDid you know Tess before?
Sona ShahNope. We met in grad school. We met basically in the biodesign course. Biodesign is kind of where we really met each other.
Hetal BamanAnd I feel like that's really serendipitous, right? To meet somebody who is equally as passionate about this cause and make this company an actual thing. That's so.
Sona ShahYeah.
Hetal BamanInteresting.
Sona ShahYeah, it's wild. And I think you hear a lot of horror stories about founders, you know, falling out or having difference of opinion.And I can truly say that, you know, I. I've never felt that with Tess. I think we are such complimentary people in every sense of the word.I think our skill sets are very diverse, but complimentary. The way that we think, the way that we approach things is in many cases quite opposite.And that's what makes us such a good pair, is that we're able to bring different perspectives and bring them together. To come up with something cohesive. And so that's been strong since day one.
Hetal BamanAmazing. I want to talk about the model of Neopenda. So when you think about social impact, a lot of times that comes alongside nonprofits, right?And when you first thought about, okay, what is the model of Neopenda going to be, what went through your guys's mind? Because I'm sure you thought about the model of being a nonprofit medical advice company.
Sona ShahThat definitely crossed our mind. And if we go back to our biodesign roots, the first question we asked is, what is a business model?And so thankfully, the course helped us, you know, understand what that actually means. And, you know, I think as engineers, even though we had a problem and we had a great solution, you have to have a business model to go alongside it.Otherwise it's a meaningless technology, even if that business model is a nonprofit structure. And so we certainly thought about nonprofit, we thought about for profit, we thought about hybrid structure.So there's many different ways that companies can structure their entity. For us, sustainability is really important.We care equally about the profitability as the impact that we can have with our systems, because those go hand in hand.The more devices we can sell, the more patients we can improve quality of care for, and the more profitable we are as a company that can then feed back into future products as well. So that's what lent itself well to a for profit structure. I think there are a lot of great organizations that are nonprofits.Many of our partners are nonprofits. For the medical industry in particular, I see no reason to compromise profitability and impact. Both of those truly do go hand in hand.So when we were thinking about the business model, we had gotten advice from a lot of other startups that the hybrid structure of nonprofit and for profit, it's great because you can attract both grant funding and investment dollars, but it's a really difficult structure to manage. There's a lot of gray area between what are you using grant funding for versus investment dollars?And you have to have kind of a larger organization with clear lines of what's the difference between the two? And it just often gets blurred.We didn't have the capacity as a two person team with engineering background, not business backgrounds, to really be able to kind of structure it that way. So we went more towards the for profit realm.I think one of the key elements for us is the nonprofit model often lends itself to donation of equipment, and that doesn't seem to be quite as sustainable. We've seen this shift in a lot of hospitals that we work with that. They used to attract a lot of, you know, medical devices that were donated.But it's human nature that you're not going to take care of something that was free for you. And so for us, even if we can subsidize or even if we can, you know, design affordable technologies, that was really the key for us.One of the biggest constraints that we have is affordability. But even if they can pay something for it, there is a different sense of ownership, there is a different sense of excitement over a technology.And for us, that is essential for success of the company. That's not to say that other companies that are nonprofits aren't doing great and aren't able to kind of sustain themselves that way.But in our model, the sustainability aspect, profitability is really important for us and is a way to drive more impact.
Hetal BamanThat reminds me of the book Toxic Charity talks about.
Sona ShahI read it.
Hetal BamanThat sense of accountability that people have.I think there was a story in there where there was a group that wanted to donate clothes, but instead what they did was they set up a little shop and they discounted all of the items by like 90%.
Sona ShahYep.
Hetal BamanSo that people came in and they were actually able to afford something like a gift or whatever it was, so that they could feel proud that they actually bought it. And there's something to say about that for sure.
Sona ShahYeah.
Hetal BamanSo talk about developing your first product that's called Neogard and then selling it.
Sona ShahYeah. So the development process took longer than you expect. I think this is true for any startup. Double the time, double the money.In our case, it was maybe triple the time and triple the money, but that's fine. We learn and now we're a lot smarter about it. But early on, there is a lot that comes with medical devices, which is very different.Healthcare in general is quite different than many other industries because it's so regulated for good reason.So when we were developing the Neogard system, we didn't just have to create a system for Neogard, we had to create a design and development process for all future products as well. And so when we spent six years to get our first product to market, it wasn't just to get Neogard to market.It was to create an actual system that allows us to replicate it for future products as well. You know, if you are interested in healthcare and medical devices, quality management systems and getting that set up early on is so essential.It is way too much money, but it is well worth it. You should spend your money on developing a quality management system.We didn't do that until maybe a couple years into our design and development process.We of course had design controls and other kind of basic elements of it, but actually creating our QMS didn't happen until a couple years in and we had to kind of backtrack a bit and really create all of our records and structures around that.But really creating a product that is risk based and understanding what are the potential failure modes and harms, all of that should really be built in from day one.And so I think that was a lot of what we did for the first six years is iteratively designing our solution with and for our users and in the process also creating kind of a robust mechanism to look at future products as well. We didn't have the capacity to do it then, but we knew eventually we would want to.And so why create a one product company when you can have multiple products?And so that was kind of part of the reason why it took us so long understanding how to get regulatory clearance and what is the process for that, conducting clinical trials. There was just a lot of elements of it and you know, some of it was funding related.We had to go through multiple cycles of funding because medical device development is capital intensive upfront and many investors are risk averse for a variety of reasons, including you're a regulated industry, you're working in hardware, you're working in Africa. Most investors don't understand at least one of those three. So a lot of our job had to be education of investors or grant funders.We were, you know, quite successful with getting grant funding early on for the idea of the company and the solution that we were creating despite, you know, it is pretty capital intensive for med devices. And so that was the first six years when we finally got CE Mark, which is the European version of FDA clearance, that was in 2021.And that led to our formal launch in Kenya in Q3, Q4, 2021. There are certainly distinct points in Neopenda's journey where I've, I'm reminded that this isn't just a classroom project. This is real.This is a device that is going on patients and has the potential to improve their life, potential to save their life in many cases. And getting CE Mark was one of them. That this is our stamp of approval that we can go out there and put devices in the hands of our users.And of course that was a longer journey than we anticipated as well. We spent more time in product market fit than I had certainly anticipated.And I think that's an area that I would highly Recommend other entrepreneurs to just spend a lot of time thinking about. We had a beautiful go to market plan. We had this robust idea of what everything would look like.But commercial use of product is always different than clinical trials.The more patients you're on, the more things you're going to see, the more user feedback you're going to get, the more you'll have to evaluate what is the target customer and actually build a proper sales organization.So we spent maybe a year and a half after commercial launch, we, you know, attracted some customers, we brought in a few customers, we had devices on patients, but we spent the better of a year and a half really focusing on product market fit, which spanned from the product side and making improvements based on customer feedback all the way through customer side.And what does our business model look like and how do we actually sell to organizations and then once we get it there, how do we make sure that they're using it and using it correctly and having the impact that the system can actually have? So it wasn't until about Q3 last year that we really kind of turned a corner with our sales.And now I can very confidently say, like, we have a robust sales organization that is continuing to sell products not just in Kenya, but in, in Uganda and Ghana and then two more countries later this year. So it was definitely a journey. And I think the year and a half that we spent on product market fit was a really crucial year and a half.But it was full of trials and tribulation.
Hetal BamanCan you explain what that term means? Product market fit?
Sona ShahYeah, means something different to everybody. And so does investor rounds. Everybody has a different definition.Early stage could be you're a $30 million company and you know, that in my mind is not early stage, but people have different definitions. So take this with a grain of salt. But in our mind, product market fit is understanding one, who are the customers that really need the product?Two, what value does our product actually serve them? And three, is the product actually serving that value?So really understanding and making sure that we can get products into the hands of users and they're utilizing product in the way that we intend for it to be used. And it's having the impact that we intend for it to have.You know, as we continue in our journey, there will be another phase of product market fit as we expand into new geographies and understand, okay, now we've got our first set of customers and how do we scale this to a broader set of customers? And then there will be a whole product market fit phase again. So it's a continuous journey. It's never truly done.But for us, really getting kind of those initial customers, making those product improvements, that was kind of the biggest stamp for us that we've achieved product market fit.
Hetal BamanSo I wanted to ask, you know, in the very beginning it was you and Tess and when did you see the need to grow staff? You know, because now you have a whole team behind Neopenda. When, like where was the turning point there?
Sona ShahPretty early on, I think, especially because Tess and I are still based in the US we knew that we needed to bring on local team members. So our very first hire was in Uganda. That's where we had done a lot of our, you know, early clinical trials, our early research in general.And so very early on we brought on a team member and she was great, she was incredible for what we needed at the time.And as we continued to evolve as a company, we brought on various team members, primarily on the R and D side to begin with or the research and clinical trial side. So some of our longest standing team members are really on the R and D front.You don't need a full sales team when we're still in R and D and the product. And so there was kind of that balance between it.I was doing a lot of the business side of things alongside product development and so those are essential to go hand in hand. But we didn't need a full team behind that. So yeah, we brought on a lot of our R and D and research clinical trial team early on.Just kind of the general day to day operational aspects of things.I think bringing on the R and D team is a tricky thing to evaluate because creating a medical device that has hardware and electronics and plastics and software and firmware and everything in between, that requires many different types of engineers. It's not one person that can do everything, but you don't have the money for everything.And so we brought on a lot of consultants early on as well to help with the heavy lifting as we kind of built our R and D team. So that was the model that we had used.Bringing on consultants comes with its own complexities that we probably don't have enough time for to talk about all the complexities. But I think it's a great way to build your team.There are just nuances around managing consultants and managing expectations of what consultants can deliver and then realizing that you might need to backtrack to really understand how something was built or how can we make improvements to something. So that's a natural course of things.But we did work with a lot of partners early on just to help make sure that we could advance without having to bring on too many full time team members.
Hetal BamanDo you think that was maybe the most difficult thing to handle in the very beginning of the first few years?
Sona ShahYeah, I think there were a number of difficult things to, to go through. I think just the funding cycles were difficult in managing that.Having to balance, you know, creating an entire company while focusing on the first product. There's just a lot of things to figure out and a lot of things that you don't know. We still don't know a lot of things.We're a lot smarter than we were, you know, seven years ago, but there's still a lot that we don't know. I have the ability now to hire experts in the space and I can bring on people that have expertise. But early on Tess and I had to figure it out.We had to figure out what does it mean to have a quality management system? What does it mean to do voice of customer, informative testing? What does it mean to do all of these things that we had no idea how to do.And I think our conviction and our mission was so strong that we figured it out and we moved mountains to make it work. But it is really difficult to do everything when you don't know any of it. Yeah, I've.
Hetal BamanIt's a completely new space. You can take some things that you've learned at your previous job or a company, but like you said, so many nuances.I want to talk about when Covid hit, what went on in your mind, what was happening with Neopenda at the time and obviously it threw all of us off the rails, but what had happened throughout those couple years?
Sona ShahSo I, I mean like many other startups, Covid, when Covid hit, that was kind of a near death experience for Neopendia. We've had a couple in our journey and thankfully we're not in one right now, but we've had a couple and Covid was one of them.It was, there were a lot of people, we had funding committed and it got pulled because of COVID So there's a lot of kind of external factors, a lot of panic that was happening.On the flip side of that, I think it really opened a lot of potential opportunity for Neopenta as a healthcare medical device company that is creating a vital signs monitor.I think the importance of vital signs monitoring was much more pronounced during COVID So much so that we actually adapted our neonatal monitor for use in adult and pediatric patients. So, you know, Again, I think it opened up a lot of opportunities, opportunities for us.I no longer had to necessarily explain what is a pulse oximeter to people. That was kind of a little bit more common knowledge, or at least what is the importance of vital signs monitoring? That was more common knowledge.I think our team, myself certainly included, felt a responsibility to support because we had a solution. You know, my family had Covid, and we put our devices on them to make sure that they were okay.And, um, so there are, from the very basic levels all the way through, how can we help the city of Chicago? We didn't ultimately do so, but is there a responsibility for us to reach out to nursing homes where we need to put these devices on patients?And it's a much more appropriate solution than your traditional patient monitors. And we supported a facility in Hawaii that procured devices for use in remote patient monitoring, which is a totally different arena for us.But pretty much overnight, we created a smartphone application that allowed us to monitor patients from home. So there were a number of different opportunities that we were trying to support and to try to just help navigate a really complex environment.We didn't yet have CE Mark at the beginning of COVID so the regulatory clearance side of it sort of hamstringed us a little bit. We weren't able to really have the impact that I think we could have had if it were a year later or two years later.But I think it did set the stage for important conversations and discussions both internally within our team for, you know, what. What is our responsibility to support in a situation like this? And gave us motivation to really push harder and harder.And then two, what are the opportunities for us to kind of expand beyond what we know? How does our team have the ability to do so?And I'm just very proud of all of the efforts that our team had gone through during COVID and that, of course, lasted for quite some time, still ongoing. But hopefully there's some level of normalcy now.But I think just the teamwork and the dedication that we had during the really kind of strenuous time of 2020, that is something that I'm very proud of our team for.
Hetal BamanI know you mentioned to me in a previous conversation that you had to restructure the organization at Neopenda, and that ultimately led to layoffs.
Sona ShahYep.
Hetal BamanAnd how did that feel for you? You know, as a entrepreneur, as this leader at Neopendo? Like, how did that feel for you?
Sona ShahIt is the worst part of my job is having to make those really tough decisions.And looking at you know the whole picture and letting go friends and colleagues, especially in the communities that we're working in, where, you know, we're offering a really sustainable job for people, and now we're taking that away. It's a really, really tough thing that any leader has to go through, but it's those decisions that are super important.This happened more, you know, in the past couple years. Restructuring, I think it makes a team and a company stronger.If you can figure out how to restructure and most importantly when to restructure, then there's a lot of incredible things that can come out of it. Unfortunately for us, the restructuring happened when I delivered my first baby. And so the timing probably couldn't have been worse.But I guess it also gave me the ability to make decisions that were meaningful and impactful. There wasn't a lot of fluff. There just wasn't room for fluff.And so I think at the time, as a leader, you have to think about the entire organization.And the choice at that time was, am I going to lose 10 people's jobs or can I cut a couple of people that are incredible people and really hardworking and dedicated and then save eight people's jobs? They're really tough decisions because everybody on our team has been incredibly hardworking and dedicated.That doesn't always mean that we're seeing the results that we need to be seeing. And so you do have to make those really tough decisions about who to lay off.And the most you can do as a leader is to do it with empathy and to try to help support as much as you can. So, you know, providing resources or connections or introductions to other companies that might be looking for it. It doesn't always end up that way.You might burn some bridges in the process, but you do what you have to do. And I'm very proud of the restructuring. It sucked, and I hope that we never have to go through something like that again.But I think strategies that came out of it and the reality checks that came out of it are really what helped us have the best quarter yet in Q3 until we got to Q4. And that's now our best quarter yet. And we're on track for Q1 this year, becoming the same thing. So tough decisions.It's tough, but in retrospect, if you have results to show for it, then it's worth it.
Hetal BamanWhat did you learn about yourself during that time?
Sona ShahOh, what did I learn about myself? Quite a lot. And it was certainly an interesting experience. I mean, I think because of the timing with my Baby.I think there I learned a lot about how to balance, you know, my baby was my, the most important thing in my life. And if I put a hundred percent of my time and effort for my baby, which is what it should have been, then the company would have died.And so I wasn't going to let that happen either. Neopenda is also, you know, am reluctant to call it my baby because I think you.
Hetal BamanThat's a part of you, right?
Sona ShahIt's a part of me. Yeah, it is an important part of me and I didn't want that to die because I think there is a sense of responsibility that we have.But balancing the two was really tough and I had to figure out how can I parse out time for me to really focus on work and figure out how to get us back on track and really only do the, the things that are most important, but also really devote the time to my baby that we need as a family.And you know, I certainly didn't get it 100% but being a new mom helped me realize what the priorities are and not worry about the little things because the little things will sort themselves out. It's the really, you know, the big strategic decisions that are important and that's what I focused my time and energy on.I also realized that I don't like letting go of people, especially you know, colleagues that were our friends and you know, we've met families and we've had dinners together and that's. But I don't think anybody likes letting other people go. So that's not a huge reality.
Hetal BamanYeah, I mean, especially in an organization that has such a bold mission, it can't be easy. I can't even imagine doing any of that.One of the big purposes I wanted to have you on the podcast was not just to talk about Neopenda and the work that you're doing, but also shed some light on entrepreneurship.As a first time startup entrepreneur and leader, I wanted to ask you what kind of advice would you have for any new entrepreneurs that may be looking to do something in a similar space?
Sona ShahFirst, I would encourage you to do it because we need more entrepreneurs that are interested in this space. The biggest thing I would say is find a problem worth solution solving.You will figure out how to navigate all of the complexities if you have a problem that is worth solving and I think just have a level of dedication and resilience that is absolutely essential for any startup founder.But I think particularly in this space, you will get told no and that your company sucks and your Vision sucks, and everything sucks about a million times a day. Use that as fuel. Use that as, you know, take the good out of it and understand why are people telling you that.Use that to help make your company better, make your vision stronger and keep going. You know, just keep your head above water, one step at a time. But if you don't have a problem that's worth solving, then, you know, don't bother.That's kind of really the root of why we do what we do. It can be very daunting to get into this space and there isn't a playbook.You know, maybe there's a playbook for how to create medical devices that's, you know, well known, how to create a quality system, how to go through a design and development process. Biodesign courses are really great to help teach you that.But when you actually get to commercializing and launching in a country, there's no playbook. You are figuring it out as the first person to go through this. And that is really hard, but also really exciting.If you get to that stage, be proud of all of the other impacts that you're having on other entrepreneurs and in this space because you're paving the way for other people to start doing this. And that's what my hope is, is that this isn't just, you know, a product that we've put out there.We can encourage other people to come into the space and there's more than enough problems for us to be solving. Let's work together to figure out how we can really provide more equitable access to healthcare around the world.There's a lot of really amazing people. Just get started, find the problem and just get started. One day at a time.
Hetal BamanOne day at a time.
Sona ShahSo we started Neopenda in 2015, at least, you know, legal entity. And then full time we started working on Neopenda 2016.
Hetal BamanSo it took a number of years, right, to get that first product out. And that just speaks to the resilience and the motivation that you guys had as a team. Sona, thank you so much for coming onto the podcast.
Sona ShahThanks so much for having me. It was a really fun discussion and I'm looking forward to many more.
Hetal BamanThe last thing I'll ask you is how can people learn more about Neopenda and how can people get in contact with you guys?
Sona ShahYeah, neopenda.com is the easiest way. We've got a contact form on the website. You can also feel free to reach out to me as well. My email, I'm sure, is out there.Somewhere, so feel free to email me or contact me at any time. If you're interested in learning more.We've got a monthly newsletter that goes out to share updates on what we're up to, share jobs that we are hiring. We'd love to partner, we'd love to have you on the team or just to have a chat about what you're interested in. So thanks so much again.
Hetal BamanAmazing. Thank you for listening to this episode.If you'd like to learn more about today's topic and guest, head over to the show notes linked in the description of this episode. There you can get access to resources, links and ways you can get involved in the pursuit for global health.And if you loved this episode, don't forget to write me a review on Apple Podcasts and rate the podcasts on Spotify. It helps me get in front of more people just like you and continues to elevate the causes we are so passionate about. I'll see you in the next one.