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66. Challenges of Building a Medical Device Startup for Underserved Populations w/ Sona Shah
5th November 2024 • Global Health Pursuit • Hetal Baman
00:00:00 00:46:55

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How does vital signs monitoring address neonatal mortality in low-income countries? What challenges do medical device startups face, especially in regulated healthcare environments?

In this interview, Sona Shah, CEO of Neopenda, walks us through her personal journey from studying chemical engineering at Georgia Tech to creating impactful healthcare solutions while navigating the complexities of medical device development. She shares her experiences teaching in Kenya, working in pharma, and meeting her co-founder Tess at Columbia University. The conversation delves deep into the challenges of launching a healthcare startup, the importance of culturally sensitive design, and critical business decisions such as choosing a for-profit model and restructuring the team during COVID-19. Sona provides valuable advice for aspiring entrepreneurs driven to solve urgent healthcare problems.

Takeaways:

  • Sona Shah's journey from engineering to healthcare highlights the importance of cultural sensitivity in medical device design.
  • Neopenda was founded to address neonatal mortality in low-income countries with innovative monitoring solutions.
  • The challenges of launching a healthcare startup include navigating regulatory hurdles and securing funding.
  • COVID-19 opened opportunities for Neopenda to adapt its device for adult and pediatric patients.
  • Creating a sustainable business model is crucial for balancing profitability with social impact in healthcare.
  • Restructuring during tough times can lead to stronger teams and better company performance in the long run.

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Transcripts

Hetal:

Hey, it's Hetal with the Global Health Pursuit podcast.

Hetal:

Today's episode is all about innovation, resilience and the power of bringing healthcare to the most underserved communities.

Hetal:

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.

Hetal:

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.

Hetal:

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.

Hetal:

This experience sparked the beginning of Neopenda and along the way she met her co founder Tess at Columbia University.

Hetal:

Together they've been navigating the complex world of medical device innovation for emerging markets.

Hetal:

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.

Hetal:

From navigating regulatory hurdles to choosing a for profit model, to restructuring their team.

Hetal:

During COVID 19, Sona shares her insight on the highs and lows of running a healthcare company.

Hetal:

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.

Hetal:

My name is Heathal Bauman 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.

Hetal:

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.

Hetal:

Every listen and every share helps this podcast reach more people who care about global health.

Hetal:

,:

Hetal:

Election day.

Hetal:

Every vote counts, so go out and vote.

Hetal:

Sona, it's so good to finally get you on the podcast.

Hetal:

I have been trying to get you on the podcast for like couple years now.

Hetal:

I know life has been pretty crazy I think for all of us.

Hetal:

This interview is special because I've known you for a little while now.

Hetal:

We both did our graduate school at Columbia University and we met through a design course taught by Dr.

Hetal:

Katie Reuther and she's apparently on your board now at Neaganda.

Hetal:

So that is really, really cool.

Hetal:

I want to start this interview just kind of going back, you know, going back to just the beginnings of what Neopanda was like.

Hetal:

Where did you even get the idea.

Sona Shah:

Yeah, thanks so much for having me.

Sona Shah:

It's an honor to be here.

Sona Shah:

If it's okay, I might actually start from when I graduated with my undergrad degrees, I went to Georgia Tech for chemical engineering.

Sona Shah:

I graduated a semester early and decided why not travel a bit.

Sona Shah:

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.

Sona Shah:

So right after I graduated, I went to Western Kenya, and I was a primary school teacher.

Hetal:

I did not know that.

Sona Shah:

Yeah.

Sona Shah:

Wow.

Hetal:

Okay.

Sona Shah:

That's kind of where international development started for me.

Sona Shah:

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.

Sona Shah:

I taught one day of Swahili, and that didn't end well.

Sona Shah:

No word of Swahili, but, you know, that's fine.

Sona Shah:

Um, kids ended up learning.

Sona Shah:

Uh, but anyway, I was there for several months and just really, really loved it.

Sona Shah:

Everything about the culture and community was incredible, except for the inequities that I was fortunate not to have growing up.

Sona Shah:

And that really stuck with me.

Sona Shah:

I.

Sona Shah:

When I came back to the US I had a job lined up in pharmacy, and so I worked in bioprocess research and development and really loved my time there.

Sona Shah:

I was in engineering.

Sona Shah:

I was working with large bioreactors, actually using that engineering background, learning about product process development, regulatory inequality, and the importance of that in the healthcare industry.

Sona Shah:

I got to see quite a few medications coming through the pipeline as all the drugs we were creating were going through clinical trials.

Sona Shah:

A really fun atmosphere, a very comfortable lifestyle.

Sona Shah:

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.

Sona Shah:

That drove me back to graduate school.

Sona Shah:

Columbia, as you mentioned.

Sona Shah:

And I specifically picked it for a couple of different reasons.

Sona Shah:

And I started working in a lab that was creating a point of care diagnostic for HIV and syphilis.

Sona Shah:

Wanted to get more into the realm of biomedical engineering, and more specifically, how can we provide equitable access to healthcare around the world.

Sona Shah:

I also picked it for the access to a ton of nonprofits.

Sona Shah:

In New York.

Sona Shah:

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.

Sona Shah:

And then I took the biodesign course that you mentioned with Dr.

Sona Shah:

Katie Reuther, and that's where we started Neopendis.

Sona Shah:

I have a lot of thanks and a lot of my career journey is thanks to Dr.

Sona Shah:

Reuthers.

Sona Shah:

Thank you for everything that you've done.

Sona Shah:

And I would encourage anybody to go through a bio design course because it really does 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.

Sona Shah:

But a lot of our fundamentals really stemmed from that course.

Hetal:

That is so helpful.

Hetal:

I totally did not know that you spent some time in Kenya.

Hetal:

I mean, it speaks to what you're doing today.

Hetal:

During that time, you mentioned that, you know, while you were working in pharmaceutical, you had this kind of realization that these medicines most likely will not reach the kids that you taught in Kenya.

Hetal:

Where were the other inequities that you saw when you were there?

Sona Shah:

Yeah, while I was in Kenya, there's kind of a whole host of inequities.

Sona Shah:

It was full of this beautiful and warm culture, A life without as many expectations.

Sona Shah:

I think here in the U.S.

Sona Shah:

you know, we don't have hot water in the shower and in the morning, and it's the worst day in the world.

Sona Shah:

And, you know, being there, it just makes you realize what's really important to you.

Sona Shah:

And for a lot of the people there, it was family, Do I have food on my table?

Sona Shah:

The culture in the community, and in many cases, religion for them.

Sona Shah:

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.

Sona Shah:

But that does also contribute to detrimental effects in healthcare.

Sona Shah:

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.

Sona Shah:

And in.

Sona Shah:

In their culture, it was essentially spirits that were taking over her.

Sona Shah:

And so they wouldn't let me take her to a hospital where we knew that she would be able to get better care.

Sona Shah:

And so there was this whole cultural shift that, you know, I.

Sona Shah:

I physically could not take this child to a hospital when she desperately needed that.

Sona Shah:

And so some of it was kind of the education piece of it, how things were taught in the education system.

Sona Shah:

I think there's a lot of reform that is needed.

Sona Shah:

There's a lot of really great things that are taught in schools.

Sona Shah:

In where I was, a lot of the females didn't go past primary school.

Sona Shah:

It was kind of their job, their duty to get married and have children.

Sona Shah:

And that was kind of their goal in life, which is a great goal for many that wasn't my goal growing up.

Sona Shah:

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.

Sona Shah:

I think when I went into this I was a naive American that thought I can change the world.

Sona Shah:

And then I walked away thinking I don't know if I actually did anything.

Sona Shah:

What it did do was open my eyes to an entirely new culture and community and how a lot of the world lives.

Sona Shah:

That just the exposure is really what was fundamental for me.

Hetal:

Yeah, I mean, 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.

Hetal:

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 this stigma around spirits and you know, run away, you're going to catch it.

Hetal:

I actually did a three part episode with Tigo Daniel Joyem on literally this.

Hetal:

So that's episodes 34 to 36.

Hetal:

So if you want to learn more about that, go and listen to that.

Sona Shah:

It's definitely very fascinating and you know, I think highlights a lot of the importance of Western methodologies don't work everywhere.

Sona Shah:

You can't come in with a mindset of what works in one community will definitively work in another community.

Sona Shah:

And you know, as much as I wanted to take the child to the hospital, that's not how it was done there.

Sona Shah:

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 somebody thing.

Sona Shah:

Yeah.

Hetal:

And I mean there's a, there's a line, right.

Hetal:

There's the white saviorism kind of.

Hetal:

I mean we're Indian, but still there's like concept.

Hetal:

Yeah, the concept works in that sense too.

Hetal:

It's just how do you do things intentionally and sensitively in a country like that?

Hetal:

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 Shah:

So when we originally started the biodesign course, Dr.

Sona Shah:

Aaron Kyle, who's another professor actually on our advisory board as well, challenged us to think about during this course.

Sona Shah:

Why is newborn mortality so much higher in low and middle income countries than in the us?

Sona Shah:

There truly are about A million problems that contribute to this.

Sona Shah:

But that was kind of the starting point.

Sona Shah:

We were tasked with thinking about this.

Sona Shah:

We were drawn towards kind of vital signs.

Sona Shah:

Monitoring it has been something that many teams had worked on for a while and identified as a need.

Sona Shah:

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.

Sona Shah:

And so, you know, we fast forward a little bit and then I'll get back to the biodesign course.

Sona Shah:

But after the course, we actually entered into the Columbia Venture competition.

Sona Shah:

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.

Sona Shah:

And that was really kind of the initial seed funding.

Sona Shah:

And that was when Tess and I decided there's only so much we could do from a lab in New York.

Sona Shah:

We really needed to get out there and understand what are these issues.

Sona Shah:

So we used that funding, went to Uganda and we did a more proper needs assessment.

Sona Shah:

And this was kind of post course.

Sona Shah:

And so we had done a lot of the biodesign elements.

Sona Shah:

But again, I think truly understanding the problem didn't really happen until a little bit later.

Sona Shah:

When we were in country and when we were in Uganda.

Sona Shah:

What we had seen is a couple of different things.

Sona Shah:

The first is we kind of toured different public and private facilities across the country trying to understand what are the most pressing issues.

Sona Shah:

And the biggest thing that we had seen was that these hospitals didn't have functioning medical equipment.

Sona Shah:

They had rooms or fields that nurses literally call the equipment graveyard.

Sona Shah:

It's exactly kind of what you're picturing or exactly what it sounds like.

Sona Shah:

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.

Sona Shah:

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.

Sona Shah:

And so that's really when we committed ourselves to Neopenda and, you know, spinning it out of the university and into a fully fledged startup to design medtech that functions anywhere in the world.

Sona Shah:

Our roots were and still are in neonatal mortality and trying to understand what those big issues are.

Sona Shah:

And so most of our time was spent in the neonatal wards trying to understand what are the biggest problems that these nurses have.

Sona Shah:

It's quite a daunting thing because you go into the hospitals and hospitals need medical equipment.

Sona Shah:

Clinicians need devices to be able to deliver the highest levels of care that are needed for these patients.

Sona Shah:

Um, it's just a detriment that these patients don't have access to that.

Sona Shah:

The clinicians don't have access to that.

Sona Shah:

And so they're the ones that are really suffering from this strain.

Sona Shah:

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.

Sona Shah:

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.

Sona Shah:

Some were on tables, there was an open drawer of a desk and there was a baby inside.

Sona Shah:

And so there.

Sona Shah:

It's just a massive ward with too many patients.

Sona Shah:

And there were two nurses.

Sona Shah:

Two.

Sona Shah:

How are they supposed to know which babies actually need their attention?

Sona Shah:

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.

Sona Shah:

The hospital that I mentioned is kind of on the extreme.

Sona Shah:

It's more of a government facility.

Sona Shah:

So there's a lot more patients there.

Sona Shah:

But you get the picture, not enough nurses.

Sona Shah:

They don't have the tools to really identify patients in distress.

Sona Shah:

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.

Sona Shah:

And that is kind of the root of the problem that we wanted to help solve.

Sona Shah:

That lent itself well to a vital signs monitoring, which is what we created as our first product.

Hetal:

Yeah, I mean, you touched on a lot of things there, especially the equipment.

Hetal:

Graveyard.

Hetal:

Right.

Hetal:

I think it was like 85% of medical devices are designed for high income countries.

Hetal:

I think that's what the stat was.

Hetal:

And you worked at a pharmaceutical company, I worked at a medical device company.

Hetal:

And what happens is once we have a new generation of a device, we'll donate or throw out whatever we had.

Hetal:

It's almost like you're wiping your hands clean.

Hetal:

Like, okay, we just donated a bunch of stuff.

Hetal:

And for you to create a medical device that is designed around the limitations and constraints that a hospital ward in Uganda have.

Hetal:

Like, you know, humidity.

Hetal:

Humidity is a big thing.

Sona Shah:

Yeah.

Hetal:

Dust, insects, all of that kind of stuff.

Hetal:

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.

Hetal:

And it's like, okay, have you thought about that?

Hetal:

So what I wanted to go next is, okay, you decided that you wanted to start Neopenda.

Hetal:

Was that always your goal to, like, become an entrepreneur?

Hetal:

Like, what.

Hetal:

What did you think?

Hetal:

Going to Columbia University, doing your master's.

Hetal:

What did you think you were going to end up doing?

Sona Shah:

Honestly, I had no idea.

Sona Shah:

I think working in pharma right after undergrad was such an amazing experience.

Sona Shah:

I learned a lot about what I loved.

Sona Shah:

Engineering, healthcare, you know, all of the elements of that.

Sona Shah:

But I also learned a lot about what I didn't love.

Sona Shah:

I don't like being one person in a big corporation.

Sona Shah:

I don't have the impact that I think I can have.

Sona Shah:

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.

Sona Shah:

That is where I thrive a lot more.

Sona Shah:

I didn't know exactly what I wanted, but I knew that I wanted a change.

Sona Shah:

And it is really difficult to give up a really comfortable lifestyle in corporate America where you.

Sona Shah:

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.

Sona Shah:

And there's, you know, there's a drastic differences in kind of why I did what I did.

Sona Shah:

And maybe it was a little bit of craziness, but I think every entrepreneur has a little bit of craziness in them.

Sona Shah:

But going into Columbia, I didn't know.

Sona Shah:

And that was a lot of the reason why I wanted to go there is because I wanted to work in this lab.

Sona Shah:

I wanted access to the nonprofits.

Sona Shah:

I wanted to be in such an international community to figure out what I wanted to do.

Sona Shah:

I think I've always had inspiration for an entrepreneurial journey.

Sona Shah:

My dad started his own company before I was born, and it's an environmental consulting company.

Sona Shah:

So totally different from what I'm doing.

Sona Shah:

But I have so much more respect now for the work that he's done and being able to.

Sona Shah:

To really help it thrive and survive.

Sona Shah:

Over the past several decades, that spirit has always been built in me.

Sona Shah:

I just didn't know it until I started the company.

Sona Shah:

When you go to these communities and you see the gaps and you see the problems and the needs, you can't forget them.

Sona Shah:

There isn't an easy solution to join a company that is working to solve this.

Sona Shah:

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.

Sona Shah:

That's not okay.

Sona Shah:

We need to do better.

Sona Shah:

Me starting the company alongside Tess.

Sona Shah:

I wouldn't have been able to do this without Tess right by my side.

Sona Shah:

Um, but just having that is a lot of the reason why we started it.

Sona Shah:

It just didn't exist.

Sona Shah:

So we created our own.

Hetal:

Did you know Tess before?

Hetal:

Nope.

Sona Shah:

We met in grad school.

Sona Shah:

We met basically in the biodesign course.

Sona Shah:

Biodesign is kind of where we really met each other.

Hetal:

And I feel like that's really serendipitous, right.

Hetal:

To meet somebody who is equally as passionate about this cause and make this company an actual thing.

Hetal:

That's so.

Hetal:

Yeah.

Hetal:

Interesting.

Sona Shah:

Yeah, it's wild.

Sona Shah:

And I think you hear a lot of horror stories about founders, you know, falling out or having difference of opinion.

Sona Shah:

And I can truly say that, you know, I.

Sona Shah:

I've never felt that with Tess.

Sona Shah:

I think we are such complimentary people in every sense of the word.

Sona Shah:

I think our skill sets are very diverse, but complementary.

Sona Shah:

The way that we think, the way that we approach things is in many cases quite opposite.

Sona Shah:

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.

Sona Shah:

And so that's been strong since day one.

Hetal:

Amazing.

Hetal:

I want to talk about the model of Neopenda.

Hetal:

So when you think about social impact, a lot of times that comes alongside nonprofits, right?

Hetal:

And when you first thought about, okay, what is the model of Neopenda going to be?

Hetal:

What went through your guys mind?

Hetal:

Because I'm sure you thought about the model of being a nonprofit medical advice company.

Sona Shah:

That definitely crossed our mind.

Sona Shah:

And if we go back to our biodesign roots, the first question we asked is, what is a business model?

Sona Shah:

And so thankfully, the course helped us, you know, understand what that actually means.

Sona Shah:

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.

Sona Shah:

Otherwise it's a meaningless technology, even if that business model is a nonprofit structure.

Sona Shah:

And so we certainly thought about nonprofit, we thought about for profit, we thought about hybrid structure.

Sona Shah:

So there's many different ways that companies can structure their entity.

Sona Shah:

For us, sustainability is really important.

Sona Shah:

We care equally about the profitability as the impact that we can have with our systems, because those go hand in hand.

Sona Shah:

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.

Sona Shah:

So that's what lent itself was well to a for profit structure.

Sona Shah:

I think there are a lot of great organizations that are nonprofits.

Sona Shah:

Many of our partners are nonprofits.

Sona Shah:

For the medical industry in particular, I see no reason to compromise profitability and impact.

Sona Shah:

Both of those truly do go hand in hand.

Sona Shah:

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.

Sona Shah:

There's a lot of gray area between what are you using grant funding for versus investment dollars.

Sona Shah:

And you have to have kind of a larger organization with clear lines of what's the difference between the two.

Sona Shah:

And it just often gets blurred.

Sona Shah:

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.

Sona Shah:

So we went more towards the for profit realm.

Sona Shah:

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.

Sona Shah:

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.

Sona Shah:

But it's human nature that you're not going to take care of something that was free for you.

Sona Shah:

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.

Sona Shah:

One of the biggest constraints that we have is affordability.

Sona Shah:

Um, 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.

Sona Shah:

And for us, that is essential for success of the company.

Sona Shah:

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.

Sona Shah:

But in our model, the sustainability aspect, profitability is really important for us and is a way to drive more impact.

Hetal:

That reminds me of the book Toxic Charity talks about.

Hetal:

I would read it.

Hetal:

That sense of accountability that people have.

Hetal:

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 Shah:

Yep.

Hetal:

So 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.

Hetal:

And there's something to say about that for sure.

Hetal:

Yeah.

Hetal:

So talk about developing your first product that's called NeoGuard and then selling it.

Sona Shah:

Yeah.

Sona Shah:

So the development process took longer than you expect.

Sona Shah:

I think this is true for any startup.

Sona Shah:

Double the time, double the money.

Sona Shah:

In our case it was maybe triple the time and triple the money, but that's fine.

Sona Shah:

We learn and now we're a lot smarter about it.

Sona Shah:

But early on there is a lot that comes with medical devices which is very different.

Sona Shah:

Healthcare in general is quite different than many other industries because it's so regulated for good reason.

Sona Shah:

And so when we were developing the NeoGuard system, we didn't just have to create a system for NeoGuard, we had to create a design and development process for all future products as well.

Sona Shah:

And so when we spent six years to get our first product to market, it wasn't just to get NeoGuard to market, it was to create an actual system that allows us to replicate it for future products as well.

Sona Shah:

You know, if you are interested in healthcare and medical devices, quality management systems and getting that set up early on is so essential.

Sona Shah:

It is way too much money, but it is well worth it.

Sona Shah:

You should spend your money on developing a quality management system.

Sona Shah:

We didn't do that until maybe a couple years into our design and development process.

Sona Shah:

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.

Sona Shah:

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.

Sona Shah:

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.

Sona Shah:

We didn't have the capacity to do it then, but we knew eventually we would want to.

Sona Shah:

And so why create a one product company when you can have multiple products?

Sona Shah:

And so that was kind of part of the reason why it took us so long.

Sona Shah:

Understanding how to get regulatory clearance and what is the process for that, conducting clinical trials.

Sona Shah:

There were just a lot of elements of it and you know, some of it was funding related.

Sona Shah:

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.

Sona Shah:

Most investors don't understand at least one of those three.

Sona Shah:

So a lot of our job had to be education of investors or grant funders.

Sona Shah:

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.

Sona Shah:

But you know, it is pretty capital intensive for med devices.

Sona Shah:

of FDA clearance, that was in:

Sona Shah:

,:

Sona Shah:

There are certainly distinct points in Neopenda's journey where I've.

Sona Shah:

I'm reminded that this isn't just a classroom project.

Sona Shah:

This is real.

Sona Shah:

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.

Sona Shah:

And getting CE Mark was one of them.

Sona Shah:

That this is our stamp of approval that we can go out there and put devices in the hands of our users.

Sona Shah:

And of course that was a longer journey than we anticipated as well.

Sona Shah:

We spent more time in product market fit than I had certainly anticipated.

Sona Shah:

And I think that's an area that I would highly recommend other entrepreneurs to just spend a lot of time thinking about.

Sona Shah:

We had a beautiful go to market plan.

Sona Shah:

We had this robust idea of what everything would look like.

Sona Shah:

But commercial use of product is always different than clinical trials.

Sona Shah:

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.

Sona Shah:

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.

Sona Shah:

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.

Sona Shah:

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.

Sona Shah:

So it wasn't until about Q3 last year that we really kind of turned a corner with our sales.

Sona Shah:

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.

Sona Shah:

So it was definitely a journey.

Sona Shah:

And I think the year and a half that we spent on product market fit was a really crucial year and a half.

Sona Shah:

But it was full of trials and tribulation.

Hetal:

Can you explain what that term means?

Hetal:

Product market fit?

Sona Shah:

Yeah, means something different to everybody.

Sona Shah:

And so does investor rounds.

Sona Shah:

Everybody has a different definition.

Sona Shah:

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.

Sona Shah:

So take this with a grain of salt, but in our mind, product market fit is understanding.

Sona Shah:

One, who are the customers that really need the product?

Sona Shah:

Two, what value does our product actually serve them?

Sona Shah:

And three, is the product actually serving that value?

Sona Shah:

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.

Sona Shah:

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?

Sona Shah:

And then there will be a whole product market fit phase again.

Sona Shah:

So it's a continuous journey.

Sona Shah:

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, you know, stamp for us that we've achieved product market fit.

Hetal:

So 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?

Hetal:

You know, because now you have a whole team behind Neopenda when, like, where was the turning point there?

Sona Shah:

Pretty 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.

Sona Shah:

So our very first hire was in Uganda.

Sona Shah:

That's where we had done a lot of our, you know, early clinical trials, our early research in general.

Sona Shah:

And so very early on, we brought on a team member and she was great.

Sona Shah:

She was incredible for what we needed at the time.

Sona Shah:

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.

Sona Shah:

So some of our longest standing team members are really on the R and D front.

Sona Shah:

You don't need a full sales team when we're still in R and D in the product.

Sona Shah:

And so there was kind of that balance between it.

Sona Shah:

I was doing a lot of the business side of things alongside Product development.

Sona Shah:

And so those are essential to go hand in hand.

Sona Shah:

But we didn't need a full team behind that.

Sona Shah:

So yeah, we brought on a lot of our R and D and research clinical trial team early on.

Sona Shah:

Just kind of the general day to day operational aspects of things.

Sona Shah:

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.

Sona Shah:

It's not one person that can do everything, but you don't have the money for everything.

Sona Shah:

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.

Sona Shah:

So that was the model that we had used.

Sona Shah:

Bringing on consultants comes with its own complexities that we probably don't have enough time for to talk about all the complexities.

Sona Shah:

But I think it's a great way to build your team.

Sona Shah:

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.

Sona Shah:

So that's a natural course of things.

Sona Shah:

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:

Do you think that was maybe the most difficult thing to handle in the very beginning of the first few years?

Sona Shah:

Yeah, I think there were a number of difficult things to go through.

Sona Shah:

I think just the funding cycles were difficult and managing that, having to balance, you know, creating an entire company while focusing on the first product.

Sona Shah:

There's just a lot of things to figure out and a lot of things that you don't know.

Sona Shah:

We still don't know a lot of things.

Sona Shah:

We're a lot smarter than we were, you know, seven years ago, but there's still a lot that we don't know.

Sona Shah:

I have the ability now to hire experts in the space and I can bring on people that have expertise.

Sona Shah:

But early on, Tess and I had to figure it out.

Sona Shah:

We had to figure out what does it mean to have a quality management system?

Sona Shah:

What does it mean to do voice of customer informative testing?

Sona Shah:

What does it mean to do all of these things that we had no idea how to do?

Sona Shah:

And I think our conviction and our mission was so strong that we figured it out and we moved mountains to make it work.

Sona Shah:

But it is really difficult to do everything when you don't know any of it.

Sona Shah:

Yeah, I've.

Hetal:

It's a completely new space.

Hetal:

You can take some things that you've learned at your previous job or a company, but like you said, so many nuances.

Hetal:

I want to talk about when Covid hit, what went on in your mind?

Hetal:

What was happening with Neopenda at the time?

Hetal:

And obviously it threw all of us off the rails, but what had happened throughout those couple years?

Sona Shah:

So, I mean, like many other startups had Covid.

Sona Shah:

When Covid hit, that was kind of a near death experience for Neopenda.

Sona Shah:

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.

Sona Shah:

It was.

Sona Shah:

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.

Sona Shah:

On the flip side of that, I think it really opened a lot of potential opportunity for Neapunda as a healthcare medical device company that is creating a vital signs monitor.

Sona Shah:

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.

Sona Shah:

So, you know, again, I think it opened up a lot of opportunities, opportunities for us.

Sona Shah:

I no longer had to necessarily explain what is a pulse oximeter to people.

Sona Shah:

That was kind of a little bit more common knowledge, or at least what is the importance of vital signs monitoring?

Sona Shah:

That was more common knowledge.

Sona Shah:

I think our team, myself certainly included, felt a responsibility to support because we had a solution.

Sona Shah:

You know, my family had Covid and we put our devices on them to make sure that they were okay.

Sona Shah:

And, um, so there were, from the very basic levels all the way through.

Sona Shah:

How can we help the city of Chicago?

Sona Shah:

We didn't ultimately do.

Sona Shah:

But is there a responsibility for us to reach out to nursing homes where we need to put these devices on patients?

Sona Shah:

And it's a much more appropriate solution than your traditional patient monitors.

Sona Shah:

Um, 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.

Sona Shah:

Um, so there were a comp.

Sona Shah:

A number of different opportunities that we were trying to support and to try to just help navigate a really complex environment.

Sona Shah:

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.

Sona Shah:

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.

Sona Shah:

Um, but I think it did set the stage for important conversations and discussions both internally within our team for, you know, what.

Sona Shah:

What is our responsibility to support in a situation like this and gave us motivation to really push harder and harder.

Sona Shah:

And then two, what are the opportunities for us to kind of expand beyond what we know?

Sona Shah:

How does our team have the ability to do so?

Sona Shah:

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.

Sona Shah:

lly kind of strenuous time of:

Hetal:

I know you mentioned to me in a previous conversation that you had to restructure the organization at Neopanda, and that ultimately led to layoffs.

Sona Shah:

Yeah.

Hetal:

And how did that feel for you?

Hetal:

You know, as a entrepreneur, as this leader at Neopando?

Hetal:

Like, how did that feel for you?

Sona Shah:

It 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.

Sona Shah:

It's a really, really tough thing that any leader has to go through, but it's those decisions that are super important.

Sona Shah:

This happened more, you know, in the past couple years.

Sona Shah:

Restructuring, I think it makes a team and a company stronger.

Sona Shah:

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.

Sona Shah:

Unfortunately for us, the restructuring happened when I delivered my first baby.

Sona Shah:

And so the timing probably couldn't have been worse.

Sona Shah:

But I guess it also gave me the ability to make decisions that were meaningful and impactful.

Sona Shah:

There wasn't a lot of fluff.

Sona Shah:

There just wasn't room for fluff.

Sona Shah:

And so I think at the time, as a leader, you have to think about the entire organization.

Sona Shah:

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?

Sona Shah:

They're really tough decisions because everybody on our team has been incredibly hardworking and dedicated.

Sona Shah:

That doesn't always mean that we're seeing the results that we need to be seeing.

Sona Shah:

And so you do have to make those really tough decisions about who to lay off.

Sona Shah:

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.

Sona Shah:

So, you know, providing resources or connections or introductions to other companies that might be looking for it.

Sona Shah:

It doesn't always end up that way.

Sona Shah:

You might burn some bridges in the process, but you do what you have to do.

Sona Shah:

And I'm very proud of the restructuring.

Sona Shah:

It sucked, and I hope that we never have to go through something like that again.

Sona Shah:

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.

Sona Shah:

And that's now our best quarter yet.

Sona Shah:

And we're on track for Q1 this year, becoming the same thing.

Sona Shah:

So tough decisions.

Sona Shah:

It's tough, but in retrospect, if you have results to show for it, then it's worth it.

Hetal:

What did you learn about yourself during that time?

Sona Shah:

Oh, what did I learn about myself?

Sona Shah:

Quite a lot.

Sona Shah:

And it was certainly an interesting experience.

Sona Shah:

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.

Sona Shah:

The most important thing in my life.

Sona Shah:

And if I put 100% of my time and effort for my baby, which is what it should have been, then the company would have died.

Sona Shah:

And so I wasn't going to let that happen either.

Sona Shah:

Neopenda is also, you know, I am reluctant to call it my baby because I think you.

Hetal:

That's a part of you, right?

Sona Shah:

It's a part of me.

Sona Shah:

Yeah.

Sona Shah:

It is an important part of me.

Sona Shah:

And I didn't want that to die because I think there is a sense of responsibility that we have.

Sona Shah:

But balancing the two was really tough.

Sona Shah:

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 things that are most important, but also really devote the time to my baby that we need as a family.

Sona Shah:

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.

Sona Shah:

It's the really, you know, the big strategic decisions that are important.

Sona Shah:

And that's what I focused my time and energy on.

Sona Shah:

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.

Sona Shah:

But I don't think anybody likes letting other people go.

Sona Shah:

So that's not a huge reality.

Hetal:

Yeah, I mean, especially in an organization that has such a bold mission, it can't be easy.

Hetal:

I can't even imagine doing any of that.

Hetal:

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.

Hetal:

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 Shah:

First, I would encourage you to do it because we need more entrepreneurs that are interested in this space.

Sona Shah:

The biggest thing I would say is find a problem worth solving.

Sona Shah:

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.

Sona Shah:

But I think particularly in this space, you will get told to know and that your company sucks and your vision sucks and everything sucks about a million times a day.

Sona Shah:

Use that as fuel, use that as, you know, take the good out of it and understand why are people telling you that.

Sona Shah:

Use that to help make your company better, make your vision stronger and keep going.

Sona Shah:

You know, just keep your head above water, one step at a time.

Sona Shah:

But if you don't have a problem that's worth solving, then, you know, don't bother.

Sona Shah:

That's kind of really the root of why we do what we do.

Sona Shah:

It can be very daunting to get into this space and there isn't a playbook.

Sona Shah:

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.

Sona Shah:

Biodesign courses are really great to help teach you that.

Sona Shah:

But when you actually get to commercializing and launching in a country, there's no playbook.

Sona Shah:

You are figuring it out as the first person to go through this.

Sona Shah:

And that is really hard, but also really exciting.

Sona Shah:

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.

Sona Shah:

And that's what my hope is, is that it.

Sona Shah:

This isn't just, you know, a product that we've put out there.

Sona Shah:

We can encourage other people to come into the space and there's more than enough problems for us to be solving.

Sona Shah:

Let's work together to figure out how we can really provide more equitable access to healthcare around the world.

Sona Shah:

There's a lot of really amazing people.

Sona Shah:

People just get started, find the problem and just get started.

Sona Shah:

One day at a time.

Hetal:

One day at a time.

Sona Shah:

So we started Neopenda in:

Sona Shah:

rted breaking on the appendix:

Hetal:

So it took a number of years, right, to get that first product out.

Hetal:

And that just speaks to the resilience and the motivation that you guys had as a team.

Hetal:

Sona, thank you so much for coming onto the podcast.

Sona Shah:

Thanks so much for having me.

Sona Shah:

It was a really fun discussion and I'm looking forward to many more.

Hetal:

The 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 Shah:

Yeah, neopenda.com is the easiest way.

Sona Shah:

We've got a contact form on the website.

Sona Shah:

You can also feel free to reach out to me as well.

Sona Shah:

My email I'm sure is out there somewhere, so feel free to email me or contact me at any time.

Sona Shah:

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.

Sona Shah:

So thanks so much again.

Hetal:

Amazing.

Hetal:

Thank you for listening to this episode.

Hetal:

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.

Hetal:

There you can get access to resources, links and ways you can get involved in the pursuit for global health.

Hetal:

And if you loved this episode, don't forget to write me a review on Apple Podcasts and rate the podcast on Spotify.

Hetal:

It helps me get in front of more people just like you and continues to elevate the causes we are so passionate about.

Hetal:

I'll see you in the next one.

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