Tips for Hardware & Software Med Device Product Development

 


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Today’s guest is Rob Crowder, Head of Product at Nutromics in Australia, which has a booming life science community. Nutromics is a medical device company with a hardware and software component that includes a wearable micro-needle biosensor and software companion. 

Nutromics is focusing on Therapeutic Drug Monitoring for vancomycin. Vancomycin is a vital antibiotic that is used to treat gram positive bacterial infections, including sepsis and MRSA.

1 in 5 patients admitted to hospitals in the US are infused with the antibiotic Vancomycin. However, only 40% of doses are in the therapeutic range. This overdosing causing complications such as Acute Kidney Injury (AKI) in 10% - 20% of patients; or underdosing meaning the underlying infection never gets treated. Both situations result in significant adverse patient outcomes and increased healthcare costs. Each incident of Vancomycin-induced AKI costs the healthcare system an extra $10,000.

Nutromics’s vision is a world with zero preventable deaths due to a lack of timely biological data, and it’s mission is to revolutionize health care through real-time molecular monitoring. 

Maybe one day, everybody will be wearing biosensors and have real time data from a molecular-level information superhighway.

Rob is a former GM of a Medtech product development company and has worked with more than 100 companies on feasibility, design, and commercialization of novel products. 

Key Takeaways:

  • How to approach the challenges of developing hardware and software products
  • How to have the right mindset as a product leader
  • How to balance quality and product development velocity

Show Notes: 

Nutromics

Application to be on the show: From Lab to Launch

Qualio

Music by keldez

 

Transcript

We seek to transcribe the audio as accurately as possible. Please excuse any minor grammatical or misspellings. 

Grant: Hi everybody, welcome to today’s show. I’m Grant and I help produce this podcast. Just a quick note before we dive in here, it’s been amazing to see the listeners across the world. Today’s guest is from Australia where we’re seeing a booming life science community, and a lot of our listeners come from there. I think you’re going to like this episode.

Today’s show, we talk with Rob Crowder, the head of product at Nutromics. Nutromics is a medical device company with a hardware and software component that includes a wearable micro-needle biosensor, and a software companion to that. The Nutromics vision is a world with zero preventable deaths due to a lack of timely biological data.

In this episode, you’ll hear how Rob approaches the challenges of developing the hardware and software products of their medical device. To have the right mindset as a product leader, to balance quality and product development velocity. Who knows, maybe one day we’ll all be wearing biosensors and have real time data from our molecular level information superhighway as Rob calls it. Let’s get into this episode.

Robert: I really appreciate you stopping by for a chat and conversation today. You have an incredibly interesting story and you bring a ton of experience across different roles. What I was hoping to do today is really just kick off with Nutromics and maybe tell us a bit about the biosense. How do you folks do, how does it help the world? After that, I love to dig into a bit of your background and story as to how you got there and any lessons learned.

Rob: Yeah, happy to talk about it. Nutromics, we’re a healthcare technology company. We’d been going for about three years now. We’ve been focused on biosensing. Essentially what we've built is a way to access new information in the human body. We’re using micro-needle patches to access interstitial fluid. It's a compartment in the body that contains—it's basically an information superhighway. It contains a bunch of information at a molecular level which can be really useful.

It's not something that's been accessed before. Typically, it's blood that clinicians use to gain insights into how your body is behaving in particular situations. We feel there’s a real opportunity to just change the paradigm of healthcare by making it really easy and really timely to make good decisions when it's needed at the right time with new information that's never been seen before. I guess a typical example, over the years, many people would be familiar with, would be constant glucose monitors for diabetics.

That's a small little patch. You can wear the monitor is one thing, glucose. It can help you control your food intake for people with prediabetes and obviously with diabetes. It's crucial for them to control their insulin levels. A similar paradigm for us. There are tons of targets that we can look at that can change the way that people look after themselves and clinicians treat people.

Robert: This is an application outside of some of those clinical indications too. There is this wave of quantified self. I know continuous glucose monitoring, but there is, within that community, people are starting to have ports where they can experiment with different—reading their biomarkers overtime. Are these all related but just not an indication you're interested in? I'm curious how you folks have looked at this.

Rob: Yeah, it's a definite trend, absolutely. I mean you can see with the glucose monitors that those companies, levels of healthcare that are growing really fast based on more consumers looking at the ability to use this new data, to make different decisions about their health, exercise regimes, lots of different things. We absolutely see the trend of what our device can do is going to start in the hands of experts, clinicians who can make better informed decisions at the right time. But we absolutely see it moving towards a more intermediate step because of its remote nature.

It’s a wearable patch. You can talk through a phone. This can go anywhere. But then eventually the power of the information can sit with consumers, not just clinicians who are the experts but consumers. They can start to understand this new information and make their own decisions for themselves. That's a long way in the future, I think. But we're not talking about any kind of new paradigm. This has existed previously with wearables and with other types of technology, which is the next wave of attacks molecular monitoring and we’re going to make that happen.

Robert: Well, I'm wearing, I guess a single lead ECG monitor on my wrist like millions of other people. It’s becoming normalized and I think this consumerization of healthcare is really exciting as a trend that's coinciding with this democratization of what it is to start a company in the broader healthcare life sciences arenas. I think all these trends are coalescing together to create opportunities like what you folks are doing.

Now, the product itself I believe has two different parts. There's a software component and hardware components. I'm going to say, as a software company ourselves and knowing people in hardware companies, often people in hardware companies, it brings its own challenge between hardware and software, it is really common in the medical devices, diagnostics arena. I can see your face. Tell me, let’s start with the bad news. Let’s talk about some of the challenges in bringing this combination product to fruition. As the head of product, of course, you're well aware.

Rob: Yeah. Well, the product as a whole has obviously three elements. It has to be valuable and useful for the people who use it. It has to be successful commercially, to make sense. Technically, it has to work. We start with that premise. But then when you add into the mix that is made up of a hardware part and a software part, generally the path of development for those three elements do not play nicely together if we were to look at them in isolation.

With software, there are amazing tools now where you can do continuous testing, agile development. All of those things have really matured into a way to develop software ready quickly and make it powerful. But with hardware, it's more of a process driven exercise. It has to be. It’s a physical object where one change in it cascades into a bunch of other things including the software that may need to change. You have to balance the equation between the speeds you could go at with the software versus the practical speed you can go at with the hardware. That's a challenge.

Getting the planning right across that is hard. I guess the way I've gone about it in the past really is to use the product principles as the linchpin between it. What are we actually aiming for? The specification, the needs we’re trying to fulfill, the utility we want to get. I suppose in that role as product owner, that's what you have to maintain, the vision. That can often help in the way you plan out. The work that happens across hardware and software. I think in life sciences particularly, you have to consider the system as a whole.

You have to consider the hardware and software, do you have to work together? They all have to sit under the umbrella of the design inputs that the product needs to meet and the regulatory requirements that you also have to meet along the way. For me, I used to see it as a horrible challenge. But I've actually enjoyed it now, to be honest.

Robert: Awesome. It is a unique thing, because you have the different velocities that hardware and software typically move at natively. You have this, if you go to inputs, standardization process and data and information. One thing that we've seen is that, one of the challenges industries had as a result of bringing in this quality assurance, focuses, of course, the goal of quality, making sure products are safe or effective, to work consistently. It’s the promise of quality that you folks make that allows you to sell your products. The concept of this quality velocity is acting as these opposing forces that tend to be there.

Often, they act against each other, whereas in reality, being able to get it right quickly with really good data feedback loops, that's how you build your products. How have you solved that, or how have you tackled that challenge?

Rob: It's a really interesting question. I believe, actually it's a matter of perception to start, more than anything. I know that's a high level. To me, if you start with the perception that it is going to be hard and difficult because quality and speed do not go together, then that's not a great place to begin thinking about what you're doing. I consider it differently. I think if we start with clarity, the purpose of what we're doing and why we're doing it and we know what that is, and we document properly, we know what the point is we want to start controlling our design inputs and overlying quality.

We know at which point we can still play around with things, get the feasibility studies done. Work through key risks and questions. I believe that it's actually quite straightforward to get quality and speed working together. It's a matter of timing more than anything. Working really hard at the outset and all the assumptions that you've got leading into the point of which you do want to start controlling things. I don’t think people focus on this enough. They have assumptions about how their product will work and why it will work and think they got the answer. They don't break it down early on into risks.

Again, that's where quality frameworks can help because there's loads of them about risk that you can use at the start to say I have this assumption, I haven't got any evidence to support the fact I've mitigated. If you go into design with that, that's not going to end well and you are going to feel those opposing forces. I'd start, I think, as an opportunity to just think differently and work hard. Then when you get to the point where you can put the quality frame over top of it, it should be reasonably straightforward to get velocity happening together. That's my view anyway.

Robert: I think that's really insightful because it's something that we see all the time when we speak to customers, particular companies that have software components or companies that are, I guess, think in a more—looking to the future and the demands of these products is and the speed matters, like velocity matters. I think the past year of lockdowns and pandemics has been a great exercise. You can move quickly if you need to. I think that's going to become the default expectation and competitive advantage for companies that don't assume that we can move real slow, we have to move quickly and build a great product. I applaud how you’ve described that, Rob.

Thinking about the biosensors themselves, I think smart patch biosensors might be like a way to talk about the category. Is that how you would describe the product category? How would you describe it?

Rob: Yeah. I think the word smart, we might want to replace at some point. Biosense is the key really. It’s the technology that we want to harness and use. The fact that it's in a patch is just a way to access the compartment of interest. There's two parts to the technology really. There are micro needles, which allow us to virtually painlessly enter that compartment. Then there’s the sensor component that sits at the end of those micro needles that senses the various molecules we might be interested in.

It's the marrying of those two technologies really and it would appear to be the most relevant format is a patch. The word smart is in there just because the data can stream to a phone or the cloud or whatever we need to, to then be processed by a lovely data lake somewhere. We can produce new insights and whatever that dashboard might need to look like for a clinician for that particular indication. It's an encompassing term.

Robert: That comes in default. Everything's becoming connected now. To the point of maybe we don't even need to call that out as a differentiator. You’ve spoken incredibly articulately about the challenges of this hardware-software in this emerging field really. That's still pretty new, I think, in terms of being applied at scale. How did you get into this? Because I looked at your background, you started off, you were in PWC at the time.

You’ve gone into wearables and then into this path into health care. Maybe you could tell that narrative because I believe there's a lot of product people now who are probably looking at applying these product skills into the actual act of helping, save and improve lives and treat disease. I think it's a noble cause. I'm curious to see how you got there.

Rob: Yeah. Where to start? I think I've always been a product person even before it was a term. I don't have a mode where I'm at home and I'm different, I'm at work I'm different. I just think. I wanted to develop a wearable device for tennis because I was really into tennis at the time and I loved it, a real first world problem, I must be honest. My forehand sucked, so I thought why not make a device to make it better. I went on that journey. I mean I have a physics background.

I've always had a love of technology and I think I was just looking at what was going on, particularly in my game and realizing that there's a bunch of problems other people are experiencing too that I could help solve. I built a device. I run a Kickstarter campaign and did all these wonderful things that product people to try and put together a story that's compelling and convincing. I made some headway with it and had some investor interest in things. But eventually, I had to put my critical hat on as a product person, which you have to do and say, does the world actually need this product right now? Is it the most burning issue out there that I could be solving?

It just never felt quite right. At the time, I was working at PWC as well. Once that job is good, there's always this nagging feeling that I could be applying my thinking and my skills in a field that really mattered. I always wanted to be in healthcare. I was working at a product developing company called Procept. That's where I got the chance to work with a bunch of companies who are developing really incredible novel devices in healthcare and other spaces. It really lit the fire for me for wanting to do this and Nutromics was a client. I met the founders Peter and Hitesh. They’re incredibly passionate about the mission of Nutromics.

We want to make sure that we're preventing deaths where possible by using our device and there are so many areas we can go into, but anyway they convinced me. I'm on board officially just over a year ago, but I was working with them as a client probably for 18 months before that. I came on board. I feel incredibly fortunate to work in life sciences. I think any product person that's out there that they're using their skills and their thinking I love what I'm doing but there’s just maybe a little gap. Health is the one that really ignites you because of the impacts on people.

Generally, those people are going to be someone you know when you wake up in the morning—exactly, you never fail to think, I need to do this.

Robert: Yeah. Like I said, I'm curious for other product managers who are interested in the space or interested in getting in there, what advice would you have for them?

Rob: That's tricky. It's a burgeoning space. It's got so much interest. I would just encourage you to get yourself involved. I know it's difficult at the minute to actually go to physical meetups and things. I got a lot of value from doing that in the early days where there will be little communities around biohacking or something similar looking at health problems. There will be loads of different people that like software people, hardware people, clinicians and all sorts. As a product person, that's fertile ground. You're in the middle of all the stakeholders you want to work with.

Going to those things was really key to building relationships with people, talking about the work you’ve been doing, making connections and perhaps just having a go. There are so many courses out there as well about being a product manager that use live fire exercises. Just go and do it.

Robert: Well, I think that that's awesome. I know that we're coming to the end here, Rob. I'm curious—our sign off question is if you can leave a voicemail that everyone in your industry would hear, what would you say?

Rob: I was going to joke and say get a different job.

Robert: That's a bit fatalistic, Rob.

Rob: Just this lockdown, it really gets to you.

Robert: One more week you said, one more week.

Rob: One more week. I think the message I would like to leave is just to retain the joy in being wrong. There's nothing better than when you have an assumption about something and you've identified a possible solution to that but then you go and do the work where you speak to people and you try and test that assumption and you actually end up being wrong. I think over time, you can get a little bit jaded with that because as a product person, you're wrong most of the time.

If I was to leave a voicemail, I’d say be comfortable with that feeling. Try and revel in the joy of finding a different avenue to solve the problem. The final thing will be active listening. When you're speaking to stakeholders, no matter what role, they could play on a product. Have your ears open and always listen out for those little nuggets which are often the key to unlock how something can be really valuable.

Robert: I like that you stated that, Rob. Thank you for sharing. I really enjoyed having you on the show today.

Rob: Yeah, thank you. Likewise.

Robert: I know you're morning, wishing you a productive day. Please do keep in touch and I'm really excited to go and watch your folks and your progress. Thank you very much.

Rob: Yeah. Thank you for that. I love what you guys are doing. Yes, thank you.