This was a great conversation with a veteran of the industry. Whether you’ve been in medical technology innovation for decades or you’re just starting you, you can learn from Howard’s experience.

Check out Howard’s company, Nova Insights, if you want to work with him.

If you’re investing in, acquiring or selling a digital health company, get in touch - you need technical due diligence.

London, Ontario probably doesn’t come to mind. But London has a nucleus of people, companies and organizations who are creating the conditions for a level of excellence that rivals those major centres.

Dr. Rob Arntfield of Deep Breathe, Saumik Biswas of Tenomix, Oleksiy Zaika of Vessl Prosthetics, and Arash Samimi of Eliomedica are four such people, and Western Research Parks is one such place.

In cooperation with BioNext (one such organization), they held a panel to discuss what it takes to build the next generation of medtech.

So… what does it take? Here’s what the panel had to say.

Solve a real need

First of all, you need to “get married to a problem, not a solution.”

It’s easy, especially if you’re coming from a tech background, to jump straight into solutions. Throw some AI at it.

That’s a good way to burn through a lot of money and then find out no one actually wants your solution. As Rob put it, “if you’re not solving a clinical need, it’s just a gadget.”

That doesn’t necessarily mean you have to be a physician to innovate in medical technology - Saumik pointed out that clinicians are sometimes so used to their current workflows, they’re not primed to notice how things could be improved.

Medical technology innovation is a partnership between… well, medicine and technology. You obviously can’t have one without the other.

Become an expert in your marketplace

The problem you choose to solve doesn’t start and end with your users. A huge part of the problem space is the marketplace.

This means things like reimbursement, regulatory considerations, and competition.

Competition especially can be intimidating. The development cycle for medical technology is long, and the market can shift multiple times while you’re still hacking away on arduinos or labelling data.

But!

Competition doesn’t have to be a bad thing. Activity in a medical domain can result in more, or better, reimbursement pathways. It can create familiarity in the market with a category of solutions, meaning you don’t have to introduce novel concepts to your buyers.

Your marketplace doesn’t just change based on what happens within the medical technology industry. Innovations in hardware, for example, can create cheaper hardware which can open up new possibilities - faster processing time and new clinical applications.

It’s all very dynamic, and given the sweat, tears and money most founders pour into their projects, it can be overwhelming. The trick is to remain committed to your core market while keeping one eye open to changes and new opportunities.

Involve the right people

“Asking ‘why’ an annoying number of times.”

“Bloodthirsty curiosity.”

“Accountability, transparency and trust.”

Don’t try to go alone. Medical technology is created by teams. The right people are people who are curious and honest. Prioritize temperament, not technical credentials.

Sometimes you have to pay to involve the right people. Sometimes you can tap into networks of successful entrepreneurs and engineers who are now looking to give back.

This is one of the reasons London is poised for excellence. The right people are already there and already pushing the next generation forward.

Even if you don’t live in London, you can benefit from the network here. If you want to get involved, reach out - to Eliomedica, to BioNext, to any of the panelists, or to me - and join the next generation of medtech.

Given time and consistency, the relationship physicians develop with their patients can be a cornerstone in comprehensive, life-long healthcare.

Yet the relationship between a patient and a care provider continues to be under-appreciated. Some technology even aims to replace that relationship altogether.

That’s just one reason why it’s critically important for medtech and digital health companies to have physicians embedded in every aspect of their product and market strategies.

Dr. Keith Thompson is helping commercialize a powerful technology with NuraLogix - but he wants to see that technology used to enhance, rather than replace, those relationships.

He joined me on Magic or Medtech to talk about NuraLogix remote photo plasmography technology, its potential use cases, leveraging technology on a population level before the individual level, the crisis in family medicine, and what physicians should know about entrepreneurship.

—

NuraLogix

Thiv Paramsothy, CEO and co-founder of Hera Fertility, has found a way to do that for a group of people who rarely even talk about their problem… much less take the often awkward steps towards solving it: men experiencing fertility issues.

I had a chance to talk with him about the current state of male fertility testing and treatment, the practical and psychological barriers men have to overcome to seek out treatment, and how he knows he’s on the right track.

Hera Fertility

Faisal Khudud is on a mission to change that for concussion recovery.

Faisal is the founder of neuroapp.ai, a tool that helps people get the information they need to educate themselves and advocate for themselves.

We talk about the current state of concussion treatment, the difference between providing information and making claims, how to find good people for fractional roles, and the unique challenges of being a solopreneur.

—

neuroapp.ai

That’s what Jim Closs is doing with CareTech Solutions. He takes existing research and technology to assess fall risk in seniors using biomarkers like gait and strength.

I had a chance to talk with Jim about the severity and prevalence of falls, the impact they have on the healthcare system, what providing value actually means, and why he’s the general contractor of fall prevention.

CareTech/CareFall

That’s why Shawn Mondoux is on a mission to moneyball healthcare. Shawn is the founder and CEO of Prognostiq Health, where he is creating a system that informs physicians on their own patient outcomes.

We talk about the current state of insight into clinical outcomes, the incentive structures of Canadian hospitals, what it takes to start a digital health company, and the path Canadian medtech companies often take through the American healthcare system.

You’ll learn about her experience as a military physician, how complex care works in Canada, why she thinks physicians make great founders, and how to find the right people to talk to in large institutions like hospitals and healthcare networks.

That’s all for this week. Thanks for listening.

- Clark

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POMMe Health: https://pomme-health.com

We talk about her personal experience finding birth control and why she started her company, how to start a digital health company without a technical or medical background, how to build a team, femtech and the importance of women's health, and her work with StartOut Canada and LGBTQ entrepreneurs.

Thanks for listening.

- Clark

I want to elaborate, but first here is the full post for context:

It seems like everyone thinks the medical technology market in Canada is broken.

I talked to dozens of people at Impact Health this week - founders, scientists, investors, and even government representatives. All of them said some variation of "there's a reason people focus on getting FDA approved rather than Health Canada approved."

Medical device founders almost universally target the American market. Digital health founders get a haunted look in their eyes when you ask them about getting their software into Canadian hospitals.

Why?

No one really agrees. Here are some of the reasons I heard:

- People aren't used to paying for things in Canada.
- People aren't allowed to pay for things in Canada.
- Canadians are risk-averse.
- The Canadian market is anti-competitive and prone to oligopolies.
- Canadian hospital IT is too old and compartmentalized to adopt new technology.
- Lack of funding because investors know American companies have better access to the American market.
- It's a federal/provincial clarity of responsibility problem.
- It's a "Canadian governments start tasks forces to assemble committees to make recommendations" problem.
- Canadian privacy regulations don't make any sense for modern workflows.

I do know it's not for a lack of talent and ideas. There's plenty of that here. It's really inspiring to see startups succeeding despite the obstacles.

There are also plenty of people trying their best to help founders and innovators succeed... it's just that the most direct way to do that is to help them access the American market.

And there are people in the healthcare system itself trying to accelerate adoption of medical technology - I heard about one hospital defying the odds and creating a technology intake system. It doesn't sound like much, but for a time-strapped founder trying to get a foothold, that sort of clear process can be a game changer.

To me, it sounds like the foundational problem isn't really any of the ones I listed above. The underlying problem is that we don't actually agree on what success looks like.

It's easy to point out problems, but talking about solutions requires some really uncomfortable conversations.

If you think the problem is Canadians being unwilling or unable to pay out of pocket - well, that kind of cuts to the core of the public/private healthcare debate.

If you think it's a risk aversion and health system IT issue - who is paying for the monumental undertaking of updating our critical digital healthcare infrastructure?

If you think it's an anti-competitive oligopoly problem - you're not wrong and the uncomfortable part of this is pointing fingers.

So what does success look like? How do we incentivize people to try to get there? How do we make Canada an attractive place for Canadian medtech companies to do business?

Let me know what you think.

I… don’t know enough. Every time I think I’m starting to get a handle on the Canadian healthcare system, I fall through a hole in the floor and there’s another layer of tangled, rusting infrastructure underneath.

I want to say, just before we get too far into this - I’m an optimist about this. The more people I meet in Canadian medical technology, the more I think we have a real shot at being legitimately world class.

I’m going to talk to people and learn as much as I can. There’s a good chance the next few newsletters will be on this topic, so…

Subscribe now

… so you don’t miss anything!

Defining the problem and defining success

To start off, this week I want to break the problem down a little further.

There are a few (well… more than a few) major categories of concern in the Canadian medtech market:

• Lack of funding

• Brain drain

• Fear and risk aversion

• Lack of commercialization options

• Reluctant adoption of new technologies and workflows

• Bad healthcare system incentives

• Competition between federal and provincial priorities

• Lack of associated services and infrastructure

• American competition

• The Canadian competitive" environment and oligopolies

• Regulatory capture

• Cultural issues

Yeah, it’s a long list. That’s not even close to exhaustive.

Here’s another one from someone in the industry:

There is no financial incentive for hospitals here to adopt technology or even improve on healthcare.

The risk adverse/ maintaining status quo/ valuing pedigree nature of Canadian culture is whole other topic but that requires a cultural shift.

But before we can even begin to solve anything, we need to know what we actually want. What does success look like? What does a healthy Canadian medtech and digital health industry need from itself, from the healthcare system, and Canadians in general?

And how can we tell if we’re on the right track?

Here are a few indicators I personally would look for in a successful Canadian medtech ecosystem.

There are more medtech and digital health startups

This isn’t as obviously “a good thing” as it appears, but I still think it’s important.

So startups are great. I love startups. They are a core reason I started this newsletter (and the sole reason I started the podcast).

But having lots of startups is not the same thing as having good startups.

Medtech is a not a “throw things and see what puts a hole through the drywall” kind of industry. Not everyone is capable of starting a medtech company - and that’s fine. It takes education and a deep understanding of clinical workflows (or at least the ability to gain that understanding).

But for now, more is better… because it would indicate that the people capable of starting a medtech company aren’t moving to the United States.

Canadian brain drain is a huge, huge, massive problem and the reasons are not hard to understand. Housing cost, everything else cost, terrible long term economic projections, the impending retirement tax burden… most people my age agree with some variation of the statement “if I didn’t have family and friends here, I would try to move to the States.”

Having the potential to exit a successful medtech company circumvents those issues to a degree. Knowing that you could build a company (here in Canada) and achieve a life changing exit (again, here in Canada)… that changes the math for talented young people. It means you can be financially successful without having to move far from everything you know.

There are more Canadian health system commercialization and Health Canada regulatory consultants

Startups are the foundation species of the medtech ecosystem.

The health of the ecosystem is directly tied to the number and quality of startups that thrive in it.

The better startups are doing, the more they will spend on service providers - but for our purposes, the most interesting ones are those that specialize directly in Canadian regulations and institutions.

More companies choose to remain CCPC

Canadian controlled private corporation is the designation given to companies that are, essentially, owned by a Canadian (or Canadians) headquartered in Canada.

Medtech companies - device companies especially - tend to start out as CCPCs. Once they start making gains in the American market though… that changes.

If we are succeeding in making Canada an attractive place to do business as a medtech or digital health company, companies will decide being a CCPC is more of a benefit than a burden.

There are other generic indicators of a healthy industry of course, but those are the most informative Canada-specific indicators I could think of.

I’m obviously very focused on startups, just since that’s what I know. I intend to get a better handle on the issues from the care delivery side.

If you can think of more indications, I’d love to hear them.

So what is the goal here?

I don’t know that I’ve really defined success yet. Let me try:

Our goal should be to create the conditions for Canadian startups to have a reasonable chance of commercializing and selling their products to Canadian institutions as well as the American market.

Working definition. “Reasonable chance” is carrying a lot of water there. It doesn’t say much about funding.

I’m open to suggestions.

Another interesting take I saw gave me some pause, and I’m not sure I’ve fully incorporated it into my thinking yet - but I want to:

We should offer to the world what makes us unique without thinking that we should be like Bay Area.

Good point. We can’t be America. But we have a highly educated population, specialized institutions, and proximity to America. There has to be a way to exploit the niche we find ourselves in.

So what is it?

I’m going to try to figure that out.

What’s next?

I’m going to dive into this. I think it will lead to some interesting places - clinical workflows, regulations, investor sentiment, culture, and who knows where else.

If you think you have something to say about it, let me know. I’d love to chat.

That’s it for this week. Thanks for reading.

- Clark

You’ll learn how to build credibility, market your early stage medical device, and network with important early stakeholders.

Thanks for listening!

- Clark

That said, it’s also subject to limitations. Funding in particular.

After the hop, I’ll summarize how Arash Samimi of Eliomedica and Oleksiy Zaika of Vessl Prosthetics recommend you build your vision… without running out of money.

R&D for you and me

My instinct when I’m starting a new project is to open up my text editor and start typing. Just get started and see what happens.

That is not a good approach to medical device R&D.

You need to have a plan. The FDA is a show-your-work organization. You don’t have infinite funding (probably… if you do, consider investing in Magic or Medtech). You might not even know what you need to build yet.

Here are a few practical tips for approaching R&D:

1. Buy a hat rack

You need to be able to switch from wearing your dreamer hat to wearing your business hat.

If you’re like most founders, you have a finite runway and finite resources. You need to know when to play the chips you have.

Set explicit parameters for yourself based on the resources you have available to yourself. Put a structure in place. Then put the dreamer hat back on.

Often, limitations encourage innovation.

2. Understand what you need in a prototype

A prototype isn’t a solution. Its job isn’t to pass FDA and go to market. Its job is to convince potential customers to try it and give you feedback.

You need feedback as early as possible. Feedback is a resource just like your funding, time and materials. You can use it to set the parameters from #1.

But you need a prototype in order to get feedback. Focus your earliest R&D efforts on convincing stakeholders to give you feedback.

3. Develop to a funding schedule

Say you have 8 months of runway. What do you need to prove by month 3 and to whom? What about month 5? Do you need to demonstrate product/market fit or find it?

What technical challenges can you reasonably expect to overcome by month 3 and month 5? What might be unrealistic?

Can you segment your market and develop around that segment?

Emile Maamary of Steadiwear told me his company had to focus on just one subgroup of their customers in order to develop their first iteration with the resources they had. Steadiwear makes gloves that reduce hand tremors for people with Parkinson’s and essential hand tremors.

At first, their product had to exclude people with Parkinson’s due to technical constraints. Focusing on what they could actually achieve instead of trying to solve the whole problem at once allowed them to find customers and build a successful company - and then fund further development to expand to their whole market.

Subscribe so you don’t miss the Magic or Medtech podcast with Emile next week!

In case you missed it, this week’s podcast was with Lisa Voronkova of Ova Solutions.

She had some great things to say about R&D, like how to balance innovation and limitations and how to keep your skills up to date.

The week in medtech and digital health

Spit-take

The Institute of Cancer Research has announced positive results from a study utilizing spit tests to detect prostate cancer risk.

The test was more accurate than the standard blood test.

For the men with the highest genetic risk, the test falsely identified fewer people with prostate cancer than the PSA test, picked up people with cancer who would have been missed by the PSA test alone, and picked up a higher proportion of the aggressive cancers than the PSA test. The test also accurately identified men with prostate cancer that was missed by an MRI scan.  

I love this. Making screening more convenient is the lowest hanging fruit of preventative medicine, especially for men.

Get your pancreas from Google Play

CamDiab, an offshoot of the Cambridge University focused on diabetes software, just got FDA clearance for an Android app insulin pump controller - the “world’s first artificial pancreas app.”

The app allows a compatible insulin pump and a compatible continuous glucose monitor to ‘talk to each other’, creating an artificial pancreas.

The app has been cleared to manage blood sugar levels for people over the age of 2 with Type 1 diabetes, including pregnant women.

It will be interesting to see if these kinds of "device data proxy” apps become more common and if that will lead to more technical standardization across medical devices.

Don’t Deny the Lyme

En Carta has raised 1.5m pounds to develop an early diagnosis test kit for lyme disease.

Current tests rely on antibodies which can take weeks to develop to detectable levels, making the disease harder to cure.

I am terrified of Lyme disease. Early detection is crucial to prevent the worst outcomes of the poorly-understood disease. Some physicians are still skeptical that it’s a disease at all, so more point of care testing options can only help.

Luckily, there are also some vaccine candidates in phase 3 trials.

Maybe one day we can live in a world where ticks are just gross.

Remote, salary-included medtech jobs

Alright.

I tried.

I don’t have unlimited time, but I searched for a full hour and I found zero new remote, salary-included job postings in medtech or digital health. A few startups in the Bay area, but most were either hybrid or required you to be located in California.

I guess maybe that says something… either about the job market, or my ability to find job postings.

So. If you have any favourite sources of job postings, or you are hiring, let me know by clicking the button below or leaving a comment.

Sorry!

That’s all for this week. Thanks for reading!

- Clark

We talked about how she balances innovation and limitations, the opportunities she sees in the wearables market, her mindset advice for medical device founders, why she uses TikTok to stay up to date, and how she ended up owning a chain of coffee shops in Chile.

If you enjoyed the episode, please leave a rating and share it with anyone you think might be interested!

- Clark

We talked about how she balances innovation and limitations, the opportunities she sees in the wearables market, her mindset advice for medical device founders, why she uses TikTok to stay up to date, and how she ended up owning a chain of coffee shops in Chile.

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Magic or Medtech newsletter: https://magicormedtech.substack.com 

Talk to me about software development: https://calendly.com/clark-t4cb/30min

Follow me on LinkedIn: https://www.linkedin.com/in/clark-teeple

😱

Scared yet?

You don’t have to be. As promised last week, I have more to say about Arash Samimi and Oleksiy Zaika’s panel discussion.

This week, we’re talking regulations. Or rather, they already talked. I’m just writing down what they said.

Safe and Effective

FDA compliance is a confusing, comprehensive, and stressful process that exists to ensure exactly two things:

1. That your product works the way you say it does.

2. That your product is safe.

Sounds like something you should do even if there was no FDA, eh?

Of course it’s more complicated than that. It’s always more complicated than that. But you can do it. Here’s how:

Avoid it if you can

This should go without saying, but if you have a valuable product without making any condition or diagnostic claims, find your product/market fit first and then consider wading into regulated water.

Even if you think you’ll ultimately have to be regulated, it’s never a bad idea to run your product through some strict parameters and see what comes out the other side.

Work with the process, don’t fight it

FDA requirements don’t have to be an extra pile of work you keep putting off. You can use them to make your life easier.

Quality Management Systems (QMS) can identify serious issues early on, before you have to perform surgery on your product. Risk Management Systems (RMS) can identify architectural flaws in your software.

Your product will have to meet the requirements eventually. Use them to guide your process from the start… it might feel like they’re slowing you down, but they can also dramatically reduce the distance you have to go.

Include regulatory milestones in your fundraising roadmap

Use presubmissions and submissions as checkpoints in your product development and fundraising cycle.

Where can you get with the runway you have?

Use classification as a competitive advantage

If you’re the only Class II medical device in a niche full of Class I devices, you have access to billing and reimbursement codes no one else does. You have access to indications and conditions no one else does. You are almost by definition ahead of the pack.

This is especially true you’re keeping on top of regulatory trends in your market. Are there new regulations coming? You should know if there are. Being Class II might set you apart in a new regulatory regime.

Bonus advice from the author

Get help. Seriously, don’t do this by yourself. People like Arash can save you months of wasted time and money. Talk to experts.

That being said - by the end of the process, you should be an expert too.

Alright, that’s probably enough for you to think about this week. Next week, we’ll cover what Arash and Oleksiy had to say about R&D.

Everything EHR integrations

This week on the podcast, I spoke with Alex Goel of Topology Health about EHR integrations.

It was a great conversation that I’ll cover in depth in the newsletter two weeks from now (blame Arash and Oleksiy for frontloading my writing schedule).

If you can’t wait that long, you can listen here or wherever you listen to podcasts.

The week in medtech

Epic makes a surprise move, Oracle makes a surprise move, Colorado makes a surprise move, and openEHR and HL7 work together to make a surprise move.

Epic goes open source

Epic has released a free and open source AI validation engine called Seismometer.

The software will allow Epic users to validate the models integrated to their EMR, including models developed by Epic itself.

The package includes templates to analyze model statistical performance, fairness across different cohorts, and the application and impact of interventions on outcomes for commonly used model types within healthcare.

Sounds great. The more companies spending actual money on developing AI monitoring and evaluation tools in general, the better. The risk surface with AI is enormous. IMO it encompasses literally “all of society.”

That said, I’m not sure what the motivation is for Epic here? This will be another gatekeeper in their integration process, but why open source it?

My best guess is this just gives hospitals and health systems an Epic-branded point of reference for model validation for any software they’re considering - not just Epic integrations.

Also this:

If you have any better ideas, I’d love to hear in the comments.

Oracle isn’t having any of it

One open source project doesn’t make an organization open.

Oracle Executive VP Ken Glueck wrote a blog post this week calling Epic CEO Judy Faulkner the “single biggest obstacle to EHR interoperability.”

Epic’s contracts expressly appropriate all patient EHR data as Epic’s own, stretching HIPAA beyond recognition, while Oracle/Cerner’s explicitly state medical centers must opt-in to any data sharing.

Oracle acquired Cerner, arguably Epic’s biggest competitor, in 2022.

I’m a software developer, so I’m instinctively predisposed to not believe anything anyone at Oracle says. That being said… fair point, Ken.

Colorado regulates healthcare AI

Colorado became the first US state to regulate AI in healthcare.

The legislation will bolster consumer protections when key health care-related decisions are made via AI, and require developers and deployers to address algorithmic bias based on reproductive health, genetic information and other data. Developers must also make disclosures about AI systems that make high-risk decisions.

The new legislation doesn’t kick in until 2026. Plenty of time for GPT-5 to make it all either totally insufficient or just irrelevant.

I don’t think anyone knows how to regulate AI. At best, you can set up requirements around the margins - set parameters around training data, create technical standards around interfacing with the model - but it’s hard to regulate fundamentally indeterministic systems.

Underneath every assertion of capability, there’s an unstated caveat:

"This seems to work at least as well as a human physician, but we don’t actually know why.”

I guess that’s fine?

Everyone is getting along

openEHR and HL7 announced their intention to cooperate and align their respective standards.

I’m not up to speed on the areas of friction between the two organizations, but cooperation in technical standards is always a good thing.

Competition is great for most categories of progress - open standards for highly technical interoperability is not one of them. Everyone here wants the same thing. The best ideas will come from discussion and collaboration between motivated communities.

Remote jobs with salaries

Medtronic is hiring a Director of Market Access, Business Development and Remote Sales for $176K - $264K CAD

Garner Health is hiring a Director of Product Design for $175K - $195k USD

Thirty Madison is hiring a Principle Product Manager for $185 - $278K USD

Big Health is hiring an Engineering Manager for $190K – $245K USD

If you’re looking for a job in medtech or digital health, let me know. I’m here to connect people!

That’s it for this week. Have a great weekend!

- Clark

Alex is the CEO of Topology Health, a company that specializes in custom EMR/EHR integrations and interoperability tools.

Here’s what you’ll learn:

• The integration process

• Integration opportunities for digital health and medtech startups

• The future of EMRs and interoperability

• How AI fits into the picture

• The EMR landscape in Canada vs the US

• Interoperability standards like HL7, FHIR, and DICOM

• What software developers need to understand about integrated systems

• How to get a foot in the door for your integration

If you enjoyed the episode, please leave a rating and share it with anyone you think might be interested!

- Clark

Here’s what you’ll learn:

• The integration process

• Integration opportunities for digital health and medtech startups

• The future of EMRs and interoperability

• How AI fits into the picture

• The EMR landscape in Canada vs the US

• Interoperability standards like HL7, FHIR, and DICOM

• What software developers need to understand about integrated systems

• How to get a foot in the door for your integration

Even though I've designed and coded a fair number of EMR integrations myself, I learned a lot by talking to Alex. I hope you learn something from him too!

If you like the Magic or Medtech podcast, check out our newsletter. Advice and how-to's for medtech and digital health founders, industry trends, health technology news, and the best remote job opportunities in the field - every Friday.

And if you like the episode, please leave a rating and share it with anyone you think might be interested!

Arash Samimi (founder of Eliomedica) and Oleksiy Zaika (co-founder and CTO of Vessl Prosthetics) held a panel discussion in the upstart medtech hub of London, Ontario. I’ll be writing about what they had to say for weeks, because I think their conversation was the best encapsulation of what you need to know before starting a medtech company I’ve ever heard.

This week, we’ll start with the big one: product/market fit.

I’m not going to say something pithy like “the secret is that there is no secret.” There is a secret. There are many. There are things you just kind of have to do right.

Here’s five of them, courtesy of Arash and Oleksiy:

1. Realize - and internalize - that product/market fit is a moving target.

Customer needs and expectations change. Regulations and reimbursements change. Technology improves. Understand right from the beginning that you can never stop pursuing product/market fit.

Lodge this concept in your brain - you haven’t “found” product market fit. You’ve just caught up to it for now.

2. Stay aware of changes in your market.

Network like crazy, otherwise you might get left behind. Don’t rely on public information to learn about changes to your regulatory or reimbursement regime. Meet the people who understand and influence the landscape you’re building in.

You also need to understand the context around your market. Oleksiy - who has designed an automatically-adjusting leg prosthetic socket - observed that his end users are overwhelmingly diabetic.

Changes in diabetes treatment can have a significant influence on his market. Knowing about advancements in treatment and prevention, as well as changes to regulations around prosthetic sockets, has helped him project more accurately and even revealed a new competitive advantage.

3. Provide value to all of your stakeholders, not just your end users.

In medtech, your customers are almost never actually your end users. Your customers are their care providers and, in many ways, insurance companies. You can have a device that patients would do anything to get their hands on - but if their care providers lose money on it, you don’t have a business.

Optimize for care providers. Optimize for reimbursement. Figure out as many use cases or conditions for use of your device as possible. Cast a broad net. Your market might be bigger than you think it is, and your original plan for commercialization might not be the best one available.

Consider how your product fits in your market. Look upstream and downstream, find where the money actually comes from, and provide value to everyone you see.

4. Be ready to pivot.

There are stories of companies who pivoted and successfully found product/market fit. There are stories of companies who persisted and were ultimately vindicated.

Knowing when, and how, to pivot is a judgement call. Here’s how you can evaluate your options:

1. Not all pivots are hard pivots. Sometimes you just need to adjust a bit.

2. Think about the problem at a high level. Is your solution heavy handed? Is it incomplete?

3. Do you need to revisit your market? Have you really understood all your stakeholders?

4. Have you received feedback that you didn’t really listen to?

5. Know what your other options are, and why you aren’t pursuing them.

This ties in to the previous piece of advice, but deserves its own section.

You’ve probably gone through multiple iterations of your product. You’ve probably scoped out multiple business models and distribution channels.

Can you point to each one and explain why you didn’t choose it?

Keep track of the decisions you make, and make them intentionally. At worst, it reinforces the lessons you’re learning. At best, it gives you a set of vetted options for pivots.

Bonus advice from the author

It can sometimes feel like you don’t have time to network. Maybe you just don’t like it.

I encourage you to do it anyways. Go to events like Arash and Oleksiy’s panel. Walk up to a few people, make eye contact, and hold out your hand. That’s enough to start a conversation and you never know where those conversations will lead.

If you want to succeed in this industry, you can’t know too many people.

Madness or Medtech - Founder’s Tip #2

Finding product/market fit often requires adapting your vision.

Julia Slanina - founder and CEO of Treehouse - shared her story of how she adapted her vision with me in the latest episode of the Magic or Medtech podcast.

It was genuinely hard to pick just one piece of advice from Julia, but ultimately I think this is the most important - and hardest to internalize: Your vision doesn’t matter if it doesn’t overlap perfectly with the problem you’re trying to solve.

A lot of entrepreneurs start with a vision. A few start with a problem to solve. The successful ones start with both and shape the vision to fit the problem.

If you find yourself reacting defensively to feedback from customers, consider taking a step back and asking yourself if you’re building the right thing.

The week in medtech

Neuralink bounces back, women fight back, and Apple wants to read your mind.

🧠 Neuralink’s big week (again)

Neuralink is bouncing back from the news that their first patient had begun to experience a decline in functionality.

First, they reported they managed to not only fix, but improve Noland Arbaugh’s link. And now the FDA has given them the go-ahead to implant their technology in a second patient.

Elon Musk is… polarizing. At best. But I think we can all agree that Neuralink, more than most medical technology, epitomizes the namesake of this newsletter:

Any sufficiently advanced technology is indistinguishable from magic.

- Arthur C. Clarke

Say what you will about Musk (and I have a lot to say about him), Neuralink is pretty damn awesome.

Keep going.

🎧 Apple’s earworm

Apple recently filed a patent for earbuds containing biosignal sensors:

The biosignals measured by the wearable electronic device may include, but are not limited to, an electroencephalography (EEG). In some embodiments, other biosignals may be measured, such as an electromyography (EMG), electrooculography (EOG), an electrocardiogram (ECG), a galvanic skin response (GSR), a blood volume pulse (BVP), etc.

Basically everything your smartwatch, headband, wristband, or chest monitor might have - all in one earbud.

It appears to be intended to monitor brain activity:

Measuring of the brain activity using electrodes placed in or around the outer ear may be preferred due to benefits such as reduced device mobility and decreased visibility of the electrodes when compared to other devices that require electrodes to be placed on visible areas around the scalp of the user.

So far there is no indication about what the accompanying software might look like. There’s nothing in the patent regarding diagnostics or anything else requiring regulatory approval.

Part of me wonders if this is how Apple expects your AI chatbot will interface with your emotions and mental state.

Creepy? Awesome? I’m beginning to realize that in many regards, the future is looking both pretty awesome… and pretty creepy.

👩‍💻 Telemedicine vs Texas (et al)

Thousands of women are using telemedicine to access abortions in restricted states.

According to the #WeCount survey, approximately 8000 women are using telemedicine to receive abortion medication in the mail from states where practitioners are protected from prosecution.

Fantastic. Usually when I write a sentence that contains only the word “fantastic” followed a period, I’m being sarcastic.

I’m not being sarcastic. I’m not going to comment on the politics of abortion other than to say that this and this and this and this and this are unacceptable and I’m glad people are finding a workaround.

But.

This doesn’t seem sustainable to me. There are crusaders in every single one of the restricted state legislatures and courts who will bang on until this reaches SCOTUS.

I don’t know where it goes from there.

🦠 Pandemic preparedness has great ROI

The Canadian Pandemic Preparedness Hub (CP2H), a joint effort by McMaster University and the University of Ottawa, has received 115m in federal funding.

We can’t spend enough on pandemic preparedness. At the extreme end, the ROI is literally our GDP in perpetuity. Pandemics can bring down societies.

The CP2H will use the funding to build expand both universities’ biomanufacturing capabilities. That’s a great use of 115m. I’m all for it.

I wish we would spend that much on repairing the damage Covid did to our collective understanding of pandemics. Covid was a trial run for the real thing. We tripped over our own feet.

Jobs for you, maybe

Nova Scotia Health is hiring a Senior Director Research in Halifax. Salary is $132,455 - $165,569 CAD.

The City of Toronto is hiring a Superintendent Pharmaceuticals in Toronto. Salary is $102,155 - $135,815 CAD.

The Children’s Hospital of Eastern Ontario is hiring an Executive Director, Knowledge Institute.

Imagen Technologies is hiring a Clinical Services Manager for a remote position. Salary is $110,000 - $130,000 USD.

Hinge Health is hiring a Regulatory Affairs Manager ($144k – $216k USD) and a Medical Director, Commercial ($272k – $408k USD) in San Fransisco.

Kindbody is hiring an FDA Compliance Coordinator in New York. Salary is $80k – $90k USD.

Alto Pharmacy is hiring a Head of Compliance in Washington, California, Nevada, Colorado, Texas, or New York. Salary is $146,400 - $183,000 USD.

Arine is hiring a Health Outcomes Data Scientist for a remote position. Salary is $130K - $150K USD.

The Mayo Clinic School of Health Sciences is hiring a Chief Digital Officer in Rochester, Minnesota.

That’s it for this week. Thanks for reading.

- Clark

Listen to the full episode here or wherever you listen to podcasts.

Thanks for listening!

- Clark

We talk about the importance of reverse engineering the problem you’re trying to solve, seeking feedback (and more importantly actually listening to it), applying well-meaning advice to your own situation, and networking… even if you don’t want to.