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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
February 2019
We just lost A LOT of money, and boy, is my wife upset!
7 min reading time

No, I’m not kidding.

We made our first investment in August, 2015. It was the first time we invested in a medical device startup.

When selling Beth on the investment, I began, “I know this sounds cliched, but this is a sure thing.” She gave me an appropriately skeptical look.

“I know, there’s no such thing as a sure thing,” I pressed on, “but this comes as close to one as I’ve ever seen. Hear me out.”

The Perfect Medical Device Investment

I first learned about Aqueduct Neurosciences in June 2014 at a then-named Washington Biotechnology and Biomedical Association (WBBA) event. My friend Dennis Kroft asked me to interview the Aqueduct founder, which I did, shortly after a compelling presentation about his “Smart External Drain.”

I learned elevated intracranial pressure (ICP) can be a result of acute hydrocephalus or other acute conditions such as traumatic brain injury, tumors, and infections. Under these circumstances, neurosurgeons will often place an external CSF drain to prevent secondary brain injury or death. The current technology used involves a gravity controlled burette that is raised or lowered to adjust the Cerebral Spinal Fluid (CSF) flow rate.

(All current systems on the market must be maintained by the nursing staff and require continuous attention.)

In the interview, I learned his product was the first and only external CSF drainage system that regulates ICP without the need for manual measurements, adjustments and interventions. The product would allow for greater patient mobility, improve patient safety, and require significantly less staff time.

I wanted to learn more.

Why We Invested

Over the year that followed, I became close with the founder and today consider him a friend. I learned critical insights and begged the ultra-conservative investor I married for funds.

I pitched Beth with my best understanding:

  1. The Competitive Frame. Only three players make external CSF drains: Medtronic, J&J Codman, and Integra Lifesciences. They each hold a third of the market. The product is a cash-cow for them. The product has been around for roughly 60 years and hasn’t seen innovation in decades. I concluded it was an “also” kind of product; that is, Sales might say, “We sell all these things, and also we can sell you this CSF drain when you need them.”

  2. The Innovation. Patients today can’t move – at all – or they’ll affect the pressure on their brains. That’s why nurses have to stay bedside during therapy. The Smart External Drain would significantly improve patient care and comfort and, by freeing up staff, would save the hospital money.

  3. The Price Point. Never explicitly stated, but price wouldn’t be an issue. Either it would be priced at parity or it could command a slight premium for the added benefits.

  4. The Market Share. Aqueduct had spoken with each of the three players. Each expressed interest. Each said they’d consider discontinuing their current product if they had the rights to distribute Aqueduct’s product instead.

    I thought, “I can’t think of another innovation that’s virtually guaranteed a 33 percent market share upon introduction!” I mean, Medtronic? JNJ? Integra? And one of these three would completely adopt Aqueduct technology and have it replace their product??! Unheard of!

  5. Other Investors. Medtronic invested in Aqueduct. Seven figures’ worth.

  6. Solid Leadership. Tom is well-known in the Seattle medical device marketplace and played a significant role in a company that had a successful exit. He included two fellow Seattle medical device CEOs I know and respect on his board.

  7. Intellectual Property. I’m no patent lawyer but came to understand the technology was unassailably protected. Besides, there are only three players, all of whom ceded innovation leadership on this particular item to Aqueduct.

  8. The Need, The Acceptance. There is clearly a need for external CSF drains. The benefit for Aqueduct’s Smart External Drain is obvious, easy to explain and understand. The market already accepts the category and competitors are ready to stand aside – even roll out a red carpet upon its introduction.

Were there more reasons? Yeah, maybe. I don’t remember now.

I was able to find this old page on the web.

Three Rounds

We invested in each of three fund raises. The first 30 percent was for a Series A (Aug, 2015).

The quarterly updates were quite positive.

We invested 50 percent more in a convertible unsecured promissory note (Dec, 2016).

FDA clearance was granted and cash burn was lower than expected. I thought we’d have an exit sometime in 2019, conservatively, for a 2½ times return, minimally.

At my behest, Beth – who already was uncomfortable having so much in one illiquid investment – didn’t fight strenuously enough when I asked for the last tranche of the investment, so I steamrolled past her discomfort.

If she really objected, she would have put her foot down. She didn’t.

Secure and infallible, I wrote that last check in August 2018 for a bridge loan.

And then…

My friend, the CEO was let go by the board in September. I was shocked.

But I thought, “Oh, plenty of times the board decides the guy who got us this far isn’t the guy to lead us into commercialization.” I was disappointed things worked out that way, but my investment would still pay off.

Right?

In October I learned otherwise on a virtual Shareholder Information Session.

The Shareholder Information Session

The newly-appointed CEO spoke first.

The company’s primary goal for 2018 was to complete development and receive clearance for the product’s third generation. This product would:

  • include features that could support broad commercialization by a large medical device company; and,
  • be capable of being produced in volume at an acceptable cost in outsourced to a contract manufacturer.

He explained both of these were required to enable an acquisition of the company.

Then explained, “it became increasingly apparent that the state of the console design was such that it cannot be produced in volume at an acceptable cost or outsourced to a contract manufacturer.”

We would need to raise more money.

A lot of it.

Like, $8-10 million more.

And I thought, “How am I going to tell Beth?”

Last hope extinguished

I learned the terms of the new raise. They were extraordinary for new investors, at the expense of existing investors like me.

First I thought, “Well, I’m sure the Series A is worthless. But, if the investors come and the company is bought out, my convertible debt and bridge loan are both supposed to convert to at least two times principal (plus six percent interest).

Lose 30 percent, get 140 percent? I’d still be up 40 percent.

But those investors never came.

The CEO wrote us.

“Unfortunately, we have not been able to secure the additional capital necessary to continue operations. Effective January 31, Aqueduct will cease business operations.”

I wrote back, asking, “Is it reasonable at this point for me to write off my investment as a total loss?”

He succinctly responded. “Yes, unfortunately.”

Aftermath

While I held on to that glimmer of hope, Beth wasn’t shocked when I told her about the total loss. She was much angrier when I first alerted her back in October.

We’ll get through this. Beth is the single best thing that’s ever happened to me. But still. I’m sure some of you can relate.

(Side note: We had a planned “date night” that night. I told her at Panera Bread to mitigate the fallout. We saw Bohemian Rhapsody and I wrote about it in my Journey. The film was so good I actually and completely forgot about our troubles for the entire movie length.)

Coda

Aqueduct built something amazing. We just couldn’t get it over the finish line.

Having said that, I’d be delighted if somehow this article brought the attention and investment needed for this life-enhancing, even life-saving technology. Reach me if you can help in some way.

What did I learn from all of this? Nothing I didn’t already kind of know: Investing is risky, investing in medical device innovation is really risky, and even though I thought I had all the boxes checked, there was something else out there for which I hadn’t planned.

Not being able to scale manufacturing? I still don’t completely understand how that came to be but, for me, it doesn’t matter.

Beth will never, ever, ever, ever, ever, ever, ever, ever let us invest in a start-up again.

Like, EVER.

But maybe you can learn from my experience. Or at least nod in appreciation for this story and this article.

And maybe buy a ticket to the 10x Medical Device Conference.

You see, I could use the money. ¯\_(ツ)_/¯

+++

Fast Round

Speaking of flushing your money down the (smart) toilet, this:.

And…

  • Shafi in India wants to know how to select and contact a notified body.
  • Ikennah asks if FDA changes will change reimbursement.
  • Joel seeks a CRO for his startup.
  • Alison predicts a Brexit Catastrophe for medical devices. Are you prepared?

+++

Thank you for being part of our Medical Devices Group community!

If you’re looking for work, check out the newly posted jobs here!

Make it a great week.

Joe Hage signature

Joe Hage
Founding Principal,
Medical Devices Advisory Group

P.S. Please this post if you think your customers would value it.

And if you’re in business development, marketing, or sales, you’ll value my subsequent post, “How Failing is the New Winning,” about how his article was received.

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Asked on February 19, 2019 1:27 pm
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JeanMarie Markham

Joe, if it wasn't for guys like you taking a risk - many of these technologies would never see the light of day. I applaud you for at least trying - despite the bitter pill.

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Having been behind the scenes doing due diligence and constant checks across startup and innovation ecosystems, this unfortunately isn't uncommon. The foundation of a startup fundamental changes upon the blocks it is built on: talent, leadership, technology, software, data, hardware vs. market/industry trends.

That formula changes a lot based on the phase of development the startup is at and directly morphs with market and competitive offerings that may be at different phases. As an investor those variables really need to be understood as the core investment structure controls who, when and why people make money.

Typically the funding round changes the trajectory of the startup and requires later rounds to play risky, dilute holders, or defer return on investment for salary (which kills the startup even faster.)

While a little late... I would extend the general advice: if you are investing in a new area, be prepared to lose it all on the first run. Find lead investors who carry 90% or more of the raise and do not extend yourself pass 100% loss.

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Hi Joe. When you thought you "had all of the boxes checked", you may have missed the one that was on the due diligence form to approve you as an investor in a high-risk early state medical device startup. It's the standard one that asked you "Can you afford to lose part or ALL of your investment?" It would not be ethical to take your investment without ensuring that you could tolerate the loss by asking you this question. The lesson learned here is to take this question very very seriously when you consider making such an investment.
Best Regards and Sympathy, Warren

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Bummer. I made an investment in an oil project and lost it all. My wife was not happy about it like yours. It would have been interesting to have brought in to look at the challenges they were facing to see if I could have brainstormed with them to come up with an idea to avert the closure. I have started my own company called Problem Busters LLC primarily for project management consulting, but because of the breadth of my background, I could take on other problems if they needed busted.

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Dave Sheppard, CMAA

Hi Joe - sorry about your losses! Not that it will help you with a full recovery - however - is someone looking at selling the IP ? If MDT invested, one of the "Big 3" you mentioned may be interested in the IP. Obviously, it won't bring the same result as an exit with a commercial product but it could bring some minimal "help" for the stakeholders. Just a thought. Cheers - Dave Sheppard

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It's well known that the biggest gains are made by those initial and continuing angel investors. You took a shot with a compelling story with a compelling person. It sounds like the demise was due to either a boatload of corporate mismanagement. As an investor, aren't there certain assets like patents that could be sold and split? Huge investor losses occur not just investing in startups but post-IPO too or even later just before stock share prices crash and reverse splits become the norm. Nexeon Medsystems and ReShape Lifescences are perfect examples. Buyer beware.

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Joe Hage

Thanks for your comments, everyone. Dave Sheppard, I'll follow up with you directly.

Somewhat unsurprisingly, I received many personal messages today; many including sentiments like Barry's and Warren's, citing the hazards of investing more than you can afford to lose.

We didn't. We'll be fine. We don't need to sell the house, our retirement plan is intact, we have savings toward the kids' schools. But losing 100 percent of anything, no matter the size, stings.

I wrote this piece for five reasons.
1. I love to write. The piece was cathartic to write and the story was worth telling.
2. The piece may inform someone considering their own first-time medtech investment.
3. The piece may comfort others who've sailed the same boat I have.
4. The piece may bring a buyer and a seller together. The technology deserves commercialization.
5. I think the story is compelling and worthy of your time. Heck you may even share it. I know one author who would deeply appreciate if you did this article.

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Hey Joe,
Thanks for the post, always a joy to read, but sorry for your loss. I think it is natural to experience the "never again" feeling when you have one, but I do hope you get back in as there is nothing better than helping lifesaving / improving companies get out of the lab and into the market - especially when you run programs like you and I do and you see so many every year. When you are ready to get back in, or if you just want to see how we do it, drop me a line.
-Alex

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My deepest condolences for your loss Joe 😔. I feel your pain (deeply). Despite the movie + date night, I feel like you may have a few more months of groveling ahead of you just to get Beth to forgive you 😐. Hang in there.

This definitely seems like it was (and could still be) a great product. The issue was production costs. I am sure that if a couple of brilliant engineers can get back to the drawing board and redesign the console, they can figure how to mass produce this thing at a reasonable cost. I hope you + original team don’t just ride this off. There is a serious unmet need here that needs to be addressed.

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Overseeing a medical technology business incubator, our investors hold to a hard rule when it comes to investing in startups. We never accept more than 10% of anyone's investment portfolio. If the company takes off, that 10% can outperform the other 90%, but if not, you don't end up divorced or under a bridge.

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Joe Hage

@Alex, no, I'm quite certain. We have one other medical device investment. Let's see if we do better this time.

@Robert, I do believe it will see the light of day. I certainly hope it will.

@Shara, no divorce, no bridge. On the other hand, college is expensive!

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Michael Tar

Hi Joe, thank you for the sad-but-educational story. Whether this company can be salvaged or not is a valid question, and I would reach out to Brett Naglreiter (954) 205-4787 http://nmddo.com for an opinion. Brett is a device engineering veteran with a unique type of service (and company) designed to get device concepts ready for quality at scale. It's as important to de-risk the "buildability" early in the process just as with any other risk category like regulatory, clinical, commercial, etc.

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Joe,

I read your heart-broken story about your recent investment loss. I am so sorry. I
understand this on several levels because I have been through a very similar
situation myself. I have many things to share about Start-Ups and product launches,
and hopefully some of them will be helpful & hopeful during your remorse. Please,
you must read on.

First, you cannot fault the technology or your belief in the purpose. From an
Electronics & Instrumentation point of view, it is quite easy to actively regulate a
“gravity drip” with a micro-pressure sensor, a mass flow meter, and a stainless
solenoid valve. Whether your inventor used these exact components or not, what is
required for this device can be priced out at about $1800-$2400 a set, plus
packaging and medical grade components, ~about $3200-$3400max per each manufactured prototype.

A product like this would be very easy to mass produce, which would definitely cut
your O.E.M. product costs in half with volume pricing of the main components. As a
product engineer, that part is a no-brainer from my point of view, and it validates
your original belief in a solid product investment.

Given an average starting production launch of 100 units per month, the unit cost
could easily be kept under $2200 each, leaving a workable profit margin in the
medical market. There is no way this product could not be profitable from a simple
engineering and marketing analysis.

The real problem was not with the technology or the ability to manufacture it cost
effectively. The real problem lies in Human Dynamics and “sharing”
with the existing Market Sharers.

There is a fine line in any product launch as to how much you share about the
product before it becomes a product. Obviously every product developer has to share
some amount of info to get interest and investments, but to whom and how much are
completely different considerations. These “considerations of confidence”, or
selective NDA offers, are critical in developing the business plan from the
beginning.

There’s an old adage, “Never tell your competition what you are planning to do.”
-and I might add, “~especially when you have the technology that can obsolete them
all….”

By attempting to leverage off the only 3 existing competitors in the marketplace, as
to who would sign up first for this new product & market share, -playing three
against each other… -that approach may have inadvertently opened the door to a
fourth, unforeseen possibility; -that all three would team up and obsolete you
first, keeping their status quo intact, and avoiding a “market upset” for them.

There definitely seems to be some level of corporate sabotage going on here,
arranged behind closed doors with lawyers acting somewhat fraudulently to ruin a
valid business Start-Up. Had you&company come up with the extra $8-10M as suggested, they would have sucked that dry too, just on legal expenses alone. No, you have a right to get your money back, not from the inventor, but from the people who sold you out and cancelled the project. You didn’t lose your investment because the
inventor or technology failed; you lost because someone else stole the whole
operation from you.

While advice in hindsight is always a bit late, I can only suggest that when a
company has a new technology that can obsolete the rest of the marketplace, -do not
tell the rest of the market place about it until the product is on the shelves.
-then they get broadsided, not you. Only then do they have to react by “catching up”
to your advanced product; -anytime before that, and they will dig their heels in
hard and stall that Start-Up completely.

There are dozens upon dozens of real life stories, -just in the automotive industry
alone, about people who invented new fuel-saving engines that just “disappeared”.
The Medical Industry is no different; in fact, probably worse, considering the
massive investments made in new biotech & anti-resistant pharmaceuticals these days.

What this really means, is that your Start-Up hit the ‘big-time’; your Start-Up it
hit a nerve with the ‘Big Boys’ and it pissed them off. That means your Start-Up did
something right, and it scared them. If you look at it sideways, this validates your
threat level in that market place, suggesting you can take over all three and
replace the market entirely.

This is one of the first indications that you have a truly “disruptive technology”,
when someone goes out of their way to disrupt you first. It’s not the best of
affirmations, -but does suggest that you’re on the right track. There is no reason
to give up this effort after the first flushing.

This situation would be worth an additional legal investment. Should you be able to
prove a level of illicit, fraudulent, and/or criminal behavior from the “other
investment group” (with the help of SEC & others…), winning the case would be worth
the original investment capital, plus treble damages after that. (-that’s a
four-fold return on your original investment, for all investors and inventors
involved, minus court fees and such… -there will be a lot of time preparing for
court. Try to find a lawyer that will work on contingency, for a higher percentage
of course.)

An outside engineering consultant, such as myself, could review the original
invention documents; and as an Expert Witness, could testify that this ‘brain-drain’
device could indeed be mass produced at an economical price for the medical
marketplace. From there, it is much easier to show & prove that the reasons for
shutting down the product by the “newly installed” CEO were completely fraudulent,
and were possibly pre-arranged behind the scenes without the knowledge of the
stakeholders, the investors, or the originators.

You deserve to get your money back, plus treble damages; and there is a lawyer out
there who can help you do that.

Nonetheless, I completely understand your wife’s viewpoint, which is very valid
indeed. BUT! Given the unique position you have in promoting the development of
useful medical devices & products, You Cannot! give up on the premise of Start-Ups.
You are a Star and a Beacon to many medical product developers and inspired
inventors, myself included, who are looking for advice, contacts, resources, and
experience to help them bring a better device, a better solution, or a better
product to the market for the better health and wellbeing for us all. You have been
doing a most excellent job of being that inspirational resource for medical product
developers across the world.

Do Not Stop! Do Not Lose Faith. Endure for the sake of us all. Halleluiah!
Can I get an Amen!

I’m not saying you should invest again yourself, I’m just saying you are in a unique
position to keep encouraging others to invest in new & viable medical products
–while avoiding certain fraudulent pitfalls, and knowing what actions to take to get
one’s rightful money back after corporate sabotage.

While I have a bit of experience in this area, my resources are still somewhat
limited. Nonetheless, learning to mitigate this level of corruption in Start-Ups and
finding legal avenues for recovering lost investments due to fraudulent activities
of competitors, -could be a vibrant topic of conversation with MDG for the
foreseeable future. With enough public interest, our network could flush those salty
dogs out to sea, and get your money back in triplicate.

Again, I am sorry for your loss, I have felt that much myself. Just remember, the
people you originally invested are still your friends, & they are still right,
decent, and valid. They weren’t the ones that short-changed you out of your
collective investments. They are still a valid, solid group. And as this group,
collectively you are much stronger in challenging the one infiltrate who stole all
your money. Do not mistake this difference and lose your class action legal
advantage.

Re-Group and re-take your market position back. Don’t sit back and say, “Oh, that’s
what the newly appointed money-man said we had to do…” as the con-man walks out the front door with your life’s savings.

You still have a viable product that can still obsolete that entire market. You do
not need their permission to make money for yourselves. Without any patents or IP contracts as of yet, no one can stop you from making these devices for yourselves, -just find a different source of funding other than trying to license to your competitors. But do it sooner, because there’s nothing stopping them from building it either.

Your group is the first to make the product and thus has the most ‘tribal knowledge’
on the subject, and about a 2 year head-start. This timing advantage won’t last for
long if they start development work of their own, and you sit on it and wait.

There are many design firms, including myself, that can help make this product cost
effective enough to sell directly to clinics and hospitals.
If there is one last gasp of internal private funding, it is still possible to get
this viable product into a short production run.

I know how hard it is to get back up and keep pushing on with something you believe
in after you’ve been kicked in the gut by the powers that be; -but this is still a
viable product, and a worthwhile opportunity. Take a deep breath, re-group, and come up with a different strategy that shortcuts these three competitors from the start, without their prior knowledge or permissions. Like I said, you’re playing with the
big boys now, -start with the knee-caps and work your way up from there.

-and, as always watch each other’s backs.

Again, your group did something right, and there’s no reason to stop there. Give
them a run for your money, and don’t look back until they are flat on their face in
jail.

God Bless and God Speed, -let me know if I can help,

Greg Bender
Inventor of MetalliCure*, a range of Super-Oxygenated Metallic Compounds, SOMC’s, that can replace the failing Penicillin family, solve the antibiotic resistance of MRSA, and possibly obsolete one third of the Pharmaceutical Industry. Depending on which side of the AMA, the Consumer Advocate, or the big PharmaCo one sits on, I am either a villain or a Super-Hero. All I know is that I can save a lot of lives, and if any of those folks object to that, well, -that fault lies with them.

*Trademark, 2016, G. Bender & Future-Spark R&D

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Joe,
Thanks for sharing this story. After 4 to 5 startups its been my experience that follow through and company evolution is not always addressed. Early stage companies are often focused on technology and regulatory, as well they should be in most cases. It turns out that this focus is often at the expense of production planning and risk management for commercialization. I have seen several instance where the leaders and investors in med tech startups assume that once they achieve regulatory clearance that the production setup is only an after thought. Its understandable due to the high technology and regulatory risk encountered in early stage med tech startups. Often the minimal of focus on revenue commercialization results in long delays due to production scale up and validation or even longer delays if design for manufacturing is left to the last minute. It is certainly a big ask for management to raise money for production design, manufacturing tooling, logistics infrastructure and customer support organization and other investments related to true commercialization. The need to invest in these resources before it's needed instead of after it's needed important but often overlooked.
At this point, I would consider finding out if its possible to commercialize the existing IP as it lays and what the true cost of putting a fully supported revenue product on the market. There may be opportunities to put together a deal to take the cleared device to market with other investors.

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Very tough story, and I loved the Aquaduct idea. My son has a VP shunt and had 4 revisions in 2000-2001 and another 4 revisions in 2006. When they have to go to an external shunt due to infection (takes 2 weeks to treat with Vancomycin) or because the implantable shunts are not working, it is really tough on the child and parents. One detail missing in your explanation – what kind of evolution occurred operationally regarding COGS. Did a previous design not work? How did they miss so badly regarding COGS projections?

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