Commercializing Med Tech Innovations: When Scaling Sales Makes Sense

Commercializing Med Tech Innovations: When Scaling Sales Makes Sense

Mark Andreessen, the founder of Netscape and regarded investor/entrepreneur, coined the term “Product/Market (P/M) Fit”, which simply means “…being in a good market with a product that can satisfy that market."  According to Andreessen, this state of commercial Nirvana is achieved by iterating on your product, messaging, and targeting until something really clicks.  Then, and only then, do you flip the switch to “Scale”.  In med tech (vs. tech), there are usually two or more markets to satisfy, namely users of the technology (e.g. doctors, nurses, patients) and those paying for it (e.g. hospitals, health insurers, maybe patients again).  There are often two products, too – the gizmo, app or service being sold, and the evidence demonstrating that the product is worth the payers' money or the users' effort. You could say that in med tech a “Product/Evidence/Markets (P/E/M) fit is the gateway to scalable commerce.  

In our industry, we have become very creative in hitting that all-important “on market” milestone as quickly as possible, making good on long-standing promises to investors (often longer than planned) and sparking celebration among long-suffering employees. For PMA devices we go to Europe, we pursue humanitarian device exemptions, and find first applications with the fastest clinical pathway no matter how small the opportunity or insignificant the benefit.  For 510(k) devices, the possibilities for fast-tracking to launch are even more plentiful. But this cleverness and scrambling increases the likelihood P/E/M fit has been bypassed, delayed, or just ignored.  This can lead to the Commercialization Doom Loop:

Here are four steps emerging med tech companies can take to find their P/E/M and avoid market purgatory:

1.     Gain P/E/M insight as early as possible - learn what you can about product performance and evidence requirements for both user and payer market majorities well before submitting that FDA or CE filing. This early feedback could affect everything if you listen carefully: clinical study plans, product designs, regulatory pathways, financing requirements, even what talent you need.  While engaging S2N to help gather all this data is great (shameless plug), most critical is sending all the company leaders into the field to interact with target customers and opinion leaders. This gets everyone on the same page, and helps the company build loyal future customers who will bear with you through early mistakes.  In our experience these first accounts are often your best ones for many years to come.

2.     Clearly set investor expectations that regulatory approvals and clearances don’t translate into immediate hockey stick sales growth.  Initial launch is not the time to hire the seasoned commercial CEO and replace all of your engineers with glossy reps. Use different language to describe your first 6-18 months post approval – deploy terms like “limited launch” and make an overt distinction between that and “full launch”.  While not the ticket to instant riches, the first regulatory approvals do drive value in that they reduce the cost of evidence development and provide irreplaceable real-world use experience. Product and study iterations are challenging in our regulated industry, but a window of relative efficiency can open after regulatory approval and before locking down scaled manufacturing.

3.     Once “on market”, start small. Limit the size of your initial sales and marketing organization so that you can iterate on messaging and targeting, and ultimately find that repeatable, scalable sales process (assuming you have P/E/M fit). Starting small has a number of benefits – you learn from the market while managing not just your commercial spend, but also containing the costs for your clunky, sub-scale first-gen devices, and minimizing the likelihood and scope of any initial safety or performance issues.  If you make the most of the limited launch period, and don't exit it prematurely, you will be much better positioned for success at commercial scale up (look for our next blog on sales metrics and knowing when to hit the gas).

4.     Consider a longer, more meaningful regulatory path. Heresy, right?  Regulatory approvals are so seductive and satisfying, but no matter how much you try to contain investor expectations, or how ready your team may feel to progress to the next chapter, the shortest path to market may not be the wisest.  Consider alternative regulatory strategies that may take longer initially but provide you with more claims or “E” at launch, such as a de Novo 510(k) vs. a traditional 510(k).  The timeframe to meaningful sales could end up being no longer, and even shorter, than Plan A, and the additional market risk reduction could be attractive to commercial stage investors or acquirers.

The road to P/E/M fit is never clear, easy or short in med tech, but the destination can be well worth the trip.

Five Tall Tales Emerging Med Tech Companies Tell Investors

Five Tall Tales Emerging Med Tech Companies Tell Investors

Honesty is a virtue to which we all aspire, but in the game of funding an emerging med tech company sometimes the straight story and a nickel won’t buy you a cup of coffee.  Most entrepreneurs, particularly the engineering types who tend to invent medical devices, aren’t deliberate fib-tellers. They are passionate about their innovations, confident of their capabilities, and eager to make an impact on healthcare and the market.  Their visionary tales are often compelling and credible, and may be just that - tales, unsullied by the current realities of our industry.   Here are five works of fiction commonly heard on the med tech fundraising trail:

1. The device works – we’ve tested it in our lab / in pigs / in China

Achieving market-ready performance for a new medical device, which includes not just safety and efficacy but also reliability, acceptable user pain-in-the-ass factor, and viable COGS at market pricing, is all about design iterations.  For engineers, this is fun; for investors, not so much. Not only do devices interact with a wide variety of patients in the real world, they are also going to be handled by an array of human care providers in many different settings.  Until we get into clinical trials, or even early market launch, we don’t know what we don’t know about how the device will work, or whether it really meets customer requirements. 

2. We’ll be on the market in X years [+/- in Europe]

Those timelines we put in our pitch decks to potential investors are, understandably, reflective of the most optimistically smooth sequence of events- when stars and moon align, and a gentle tailwind blows from the north.  Some glaring falsehoods include omission of crucial and time intensive steps like V&V, ordering custom tooling, contracting with clinical sites, creating a regulatory package, and so on. One of my favorites is showing full market launch virtually on the same day as regulatory approval – I have yet to see this happen.  And while Europe is still a good place to seek a faster regulatory milestone for PMA devices, many of the same time sinks apply on that side of the Atlantic (and then some).

3. We will get acquired before expensive US IDE trials / commercial launch

While a few large med tech acquisitions have occurred prior to pivotal data or commercialization, in reality they are pretty rare.  The large med tech companies are most hungry for quickly accretive transactions, and may place some cheap technology bets (Medtronic claims to be on the hunt for early tech acquisitions). Development-stage deals are increasingly heavily back-ended to account for regulatory and commercial (mainly reimbursement) risk.  Without strategic exit possibilities during development, the amount of capital and time required for a meaningful payday for investors is often well beyond what most companies estimate.  The modest opening in the med tech IPO window somewhat tempers this whopper, but the companies that went public in the last year had each raised $50-$150M+ prior to their IPOs, and most were commercial in the US or very close to it.

4. We will capture X% (e.g. >40%) of the addressable market in <5 years

The biggest hurdle to adoption for a new medical technology is getting someone to pay for it, unless it simply replaces an existing device at a similar or lower cost.  Even then, competitor contracts and bundling leverage may delay adoption. Whether it’s a battle for payer reimbursement or hand-to-hand combat with clinicians and budget-conscious administrators, market penetration takes time.  Most new medical devices, whether 510(k) or PMA regulatory path, are launched without the killer data needed to win the reimbursement battle, and that is assuming they’ve gotten the technology right on the first pass (see #1). 

5. The addressable market [or worse, revenue] opportunity is $1B+

Let us count on the fingers of one hand, other hand not required, the number of medical device product categories, much less products, to have achieved annual revenue greater than $1B.  Drug eluting stents, pacemakers, surgical robotic systems, orthopedic implants, hearing aids, someone help me here…  Sad as it is, medical devices have a rough time even breaking through the $100M revenue sound barrier- not that it isn’t possible, but it’s damned hard.  If you have anything but a therapeutic technology, it’s even harder.  Yet there is something magical about that $1B+ addressable market number, and it appears in almost every pitch deck to investors.

To some degree, this tale-telling between entrepreneurs and investors is negotiation 101; those seeking funding must be hyperbolic, knowing potential funders will haircut whatever they say. Unfortunately, our industry is missing the irrational exuberance of tech and biotech that makes fairy tales come true (Uber is worth $50B as I write this). Despite our sector's current reality, med tech investors still want and need to feel that magical high return potential, and so we liberally sprinkle the pixie dust.   The truth: there are plenty of good ROI opportunities for med tech investors if we stop telling each other stories and work together to get creative in how we finance and develop new technologies.

 

Skin in the Game: Can Risk Sharing Energize Med Tech?

Skin in the Game: Can Risk Sharing Energize Med Tech?

Everyone wants advances in medical technology, but getting paid for innovation is tough even with the most convincing story about improving care and saving costs. Hospitals are understandably skeptical; can these magical benefits be realized in our institution, or will we just get stuck with the bill?  Better to keep doing what we do now, right?  As advisors to companies attempting to create and grow markets for new medical technologies, usually without killer data or labeling out the gate, S2N is keenly aware of the current economic realities in healthcare. But we also believe there is measurable value in many med tech innovations.  So how do innovators persuade customers, particularly early ones, to take that leap of faith to gain a foothold, or even a toehold, in the market?  Overstating claims is generally frowned upon by the authorities (sorry Acclarent executives), so maybe the answer lies in risk sharing - putting some skin in the game against the demonstration of realized benefits with actual use of new technology.

If it sounds a bit scary, it is. The conditions are perfect, though, for risk sharing to emerge as standard course of business between health care providers or payers and technology companies: increasing availability of data related to every facet of healthcare delivery, intense budget pressure from the facility to the national level, and a growing demand for more value per healthcare dollar spent. Seeing these forces in the market, big med tech companies are starting to explore various risk-sharing arrangements, although the specifics are a bit murky.

“[We are] ...transforming ourselves from a device business to a healthcare solutions business around our therapies by starting to make partnerships and alliances with our hospital customers around specific disease areas or big departments, which we can manage together, with some levels of risk sharing.” -Omar Ishrak, Goldman Sachs Conference, 2013

There are three basic approaches to risk sharing path that emerged from the pioneering experiences of pharmaceutical companies over the last 10-15 years; many of these early risk sharing deals were between pharma companies and payers, and primarily in Europe where governments are the primary healthcare payers and providers. For med tech, the negotiating counter-party is more likely to be a hospital, healthcare system or ACO (looking forward), but despite these differences, the structures of risk-sharing arrangements come in three basic flavors:

  1. Conditional use:  This is similar to the concept of "Coverage with Evidence Development" which CMS has embraced for everything from paying for devices in clinical trials to pulling reimbursement for budget-busting products or applications lacking sufficient evidence of efficacy. In the positive med tech case, though, the goal of conditional use would be to receive "provisional" payment for innovative products from customers or payers while the benefits are being validated with real-world use.The goal of conditional use risk sharing arrangements is to receive "provisional" payment for innovative products while the benefits are being validated with real-world use. One could say that med tech companies engage in this form of risk-sharing routinely, otherwise known as the “eval”. However, current medical device evals are often conducted in a non-rigorous fashion – if the evaluation site likes the technology, finds it easy to use, helpful and economical, they agree to continue to buy it or buy more; if not, it goes back. With conditional use under a risk-sharing agreement, the hospital or health system agrees to purchase if clinical benefits or cost savings hit certain pre-determined performance benchmarks during the assessment period. Success here is all about how to define and measure performance, which is likely to require more extensive use of the technology than a typical eval process (one benefit of risk-sharing for the company).  
  2. Warranties/rebates: This type of risk-sharing agreement, which offers downside protection for hospitals if specified performance expectations are not met, can be linked to device-related disappointments or non-delivery of anticipated clinical or cost-saving benefits.  The latter has already made an appearance in med tech, for example St. Jude Medical is currently offering to pay hospitals a 45% rebate on the price for cardiac resynchronization therapies if a lead revision is needed within the first year. Offering rebates or warrantees for failure to meet clinical or economic benefit benchmarks is a space where med tech has yet to play in a meaningful way, but pharmaceutical companies have been trying to make this work with mixed success. The pharma side of J&J cut a deal with UK’s NICE for a cancer drug called Velcade, offering to rebate the cost for patients who didn’t experience clinical benefit defined as a 25%+ reduction in serum M protein, a validated biomarker of treatment response.  In actuality, it turned out to be quite difficult to track treatment response as proposed, and the analysis of the data was delayed year after year.
  3. Upside sharing: Going into business with healthcare customers and "splitting the profits" generated by new technologies is certainly a radical departure from current med tech business practices, and is fraught with regulatory peril, but this type of risk sharing may ultimately be the way forward if we believe our own cost-effectiveness stories. As big med tech companies add services to their device offerings to provide customers with turn-key solutions (see the timely news of Boston Scientific adding value-based offerings to its Cardiovascular line), the stage is being set for sharing the financial gains from quality and cost improvements.  For upside sharing to work, however, there must be strong compliance with use of the products and services involved, particularly if the gains are to be quantified at a systems or population level. Timeframes need to work for both parties, too, requiring some balance between upfront and back end payments.  

While risk sharing is still in its infancy, particularly in med tech, it could represent a significant source of competitive differentiation and revenue growth in the future. In a recent Ernst & Young survey of 162 healthcare institution purchasers in the US and Europe, risk sharing, along with related factors such as demonstrating value and outcomes, are emerging as critical decision factors beyond straight-up price. How to structure and implement risk sharing – especially in the US legal context – still needs to be sorted out, but conceptually risk sharing should be a win for manufacturers, providers, patients and payers.

The Pfizer-Hospira Deal: Do Pharma and Device Companies Need Each Other?

The Pfizer-Hospira Deal: Do Pharma and Device Companies Need Each Other?

Having been at the flag-raising ceremony for Hospira when it spun out of Abbott back in 2004, the news of Pfizer’s acquisition was a bit emotional for me.  I didn’t cry or anything, but I did feel a little sad, and a little proud, and maybe a little hopeful at the end of the day.

The pride part first.  My presence at Hospira on “Spin Day” was a function of the strategy work I was doing with the newly forming entity, trying to create a cohesive plan around the bits and pieces cast off by Abbott – a mishmash of commodity products (e.g. saline bags), mid-tech stuff like drug pumps, and then there was this generic IV drug business.  No matter how we sliced and diced the market opportunity, profit, and growth potential of all these product lines, the IV drug business always came out on top (made me wonder whether Abbott overlooked that one in the spin). So I found myself posing the leading question to Hospira management, “How many more of these drugs could you add, and how fast?”  I am sure many consultants have given Hospira similar advice in the intervening decade, and apparently Hospira got the message, culminating in the recently announced Pfizer takeover.

Now the sadness part.  As someone who makes a livelihood in the device industry, who believes devices are an underestimated part of the solution to our healthcare woes, the transformation of Hospira into more or less a pharma company feels like a declaration of defeat.  Maybe the way to be successful in the device industry is to exit it, or minimize it in your portfolio, and start making drugs.  As a business consultant I have to tip my hat to Hospira’s strategy.  As a medical device professional I can’t help feeling a bit betrayed. 

Finally, the ray of hope.  Hospira didn’t abandoned devices completely on their path to the Pfizer exit; they shut down aging and failing infusion pump product lines and acquired new ones to follow the market out of the hospital and into the home.  While bio-similars are what drove most of Hospira’s valuation, their technology and know-how of drug delivery devices was attractive to Pfizer as well, particularly considering Pfizer’s avalanche of patent expirations.  Devices have the potential to breathe new life into drug IP, and often with far less investment in R&D and time.  The biopharma business may be more profitable and sexier on Wall Street right now, but some devices tucked into the portfolio might be a worthwhile insurance policy for drug companies to consider purchasing. Maybe drug and device companies need each other more than they think.

MedTech M&A Tips from the Front Lines

MedTech M&A Tips from the Front Lines

S2N recently hosted an informal gathering of emerging med tech CEOs, a sort of group therapy session for people suffering from a form of temporary insanity that makes one want to be a healthcare entrepreneur. Two of the participating CEOs, Christopher von Jako, Ph.D. and Edward Kerslake, had sold their companies in 2014 for a combined $500M+. Chris and Ed kicked off a lively discussion of lessons learned from the M&A trail.  Without getting into too much detail (what happens at S2N stays at S2N), the group offered some sharable wisdom on approaching, enduring, and succeeding in the medical device M&A game.

Run a tight ship

Companies that buy emerging med techs are usually quite experienced at due diligence, and know all the rocks to look under for valuation busters.  If you see a strategic exit in your future, pay special attention to regulatory and quality documentation, as well as contracts with customers, distributors, suppliers, and so on.  You may also consider having a litigator ‘attack’ your patents so you can uncover and patch holes in your IP early on. “Everything imaginable will get scrutinized during diligence.”

Always keep your pitch book fresh

Smallco pitch decks tends to get dusted off and revised when management is gearing up for a fundraise. The exit experts recommended keeping that PowerPoint updated at all times, and taking every opportunity to practice delivering the pitch along the way.  “You might not have a lot of time to pull this together when opportunity knocks.”

Build relationships with investment banks

Even if you aren’t in selling mode, it’s good to know the who’s who of investment banks, particularly which i-banks are working with which strategics.  The experts suggested getting an investment bank involved about 6 months before you want to sell.  “A good investment bank will do a lot of work to earn the business, and their involvement can help validate the credibility of your company.”

Have a selling price in mind

While the investment banks are very motivated to do deals, they aren’t necessarily incentivized to get the best price.  Small-co’s should develop and maintain a rigorous pro forma justifying their desired acquisition price; key valuation drivers in the pro forma include revenue growth rates and synergy value for the acquirer.  “It’s best to go in a little high and get talked down.”

Keep the M&A inner circle small

It’s hard enough to run an emerging med tech company – harder still if half the employees are distracted with diligence or rumors of an acquisition.  To protect on-going operations, the experts suggest limiting the number of employees pulled into diligence activities, and keeping interactions with potential buyers low profile, e.g. hosting them at the company only after 6:30pm. “The fewer people that know and are involved, the less chance of a leak and distraction.”

Maintain the momentum

Any successful exit requires a champion (at least one) at the acquiring company who will push for the transaction and make things happen; companies don’t make acquisitions, people do. Identifying and nurturing those advocates is critical, and so is making sure the deal closes on their watch. “A key champion can move on from the company and then you are stuck.”

The meeting wrapped up with someone offering the old axiom, “Companies are bought, not sold.” Honestly not everyone in the room was nodding in vigorous agreement to that one. However, whether you think you have the power to push a sale or not, playing it cool with the strategics can be a wise bet.  “Position your interactions with them as updates, but always stay in touch.”

The Importance of Being Scrappy: Tips from a Med Tech Entrepreneur

The Importance of Being Scrappy: Tips from a Med Tech Entrepreneur

One thing medical device investors love to see in their portfolio companies is “capital efficiency”, or getting from point A to value-creating milestone B with the least dilutive dollars possible.  To achieve capital efficiency, entrepreneurs need to be a little bit "scrappy" in how they develop their innovative technologies. Certainly increased regulatory and evidence requirements have upped the scrappiness benchmarks in the last few years, but globalization and technological advances are providing new avenues for getting things done cheaper and faster.  In any case, we’ve observed a wide range of performance on the “scrappy scale” among emerging med tech companies, so we decided to seek out some best practices from one of the most capital efficient entrepreneurs we know: Amar Sawhney, President & CEO of Ocular Therapeutix.

First let’s establish Amar’s scrappiness street cred.  In 2006, Amar sold Confluent Surgical to Covidien (then Tyco Healthcare) for $245M, having raised only $60M to gain PMA approval on its lead DuraSeal product (CE mark was achieved earlier with about $10M). Amar’s current company, Ocular Therapeutix, a biopharmaceutical company focused on opthalmics, turned $66M of venture money into compelling clinical data on four exciting sustained drug delivery programs and PMA approval on its ocular sealant, enabling a $75M IPO in Q3 2014.  His other company, Augmenix, launched two CE marked products and a US 510(k) cleared one with less than $30M in strategic and venture funds.  Contrast these numbers with the average of ~$94M to get to PMA approval - very scrappy, indeed.

Amar offered many words of advice for emerging med tech companies looking to minimize venture financing and dilution on their way to success, but three struck me as particularly wise and possibly counter-intuitive:   

1. Pursue mastery first: Focus is an importance concept for would-be scrappy med tech entrepreneurs (S2N is practically a missionary of it), however Amar has a very specific sense of what it means to focus. “You have to go deep and master one thing,” advises Amar. “If your solution doesn’t get it right 99% of the time, you won’t be successful commercially.”  Once you hone your capabilities in that first product, then consider where else the technology might have relevance, but don’t spread yourself too thin too early.  Amar would also prioritize mastery over market size. “Don’t worry that the first market you go after isn’t the biggest” counsels Amar, “Just be the best solution for that particular problem.”  

2. Hire carefully: Amar’s hiring philosophy is to do it only when nearing the point of pain. “There should be a very clear mandate for every new hire, and no idle hands around,” says Amar.  Augmenix launched its first CE marked product with a full-time staff of 11 people, and that included some in-house manufacturing - way leaner than many emerging companies we’ve seen. Amar’s hiring advice runs counter to conventional wisdom that you should hire good people when you can get them; Amar is not so concerned with finding the right people when he needs them (but then again his companies are in Boston). I’ve also noticed that Amar has worked with many of his senior people for many years and across multiple companies, which must help communication and efficiency.

3. File IP intelligently:  Really a subset of point #1, unfocused pursuit of IP is a rabbit hole that Amar sees companies falling down all the time.  According to Amar's philosophy, IP should only be filed when something truly novel has been identified and needs to be protected. As we all know, IP-related expenses grow exponentially with number of filings, adding up to a significant line item for small med tech companies. In Amar’s view, “The real protection comes from having the best product on the market.” Focus not only saves IP costs, but can also breed more discovery.  “One of the benefits of going deep in one area is that you uncover more novel, patentable inventions the deeper you go,” concludes Amar.  

Staying lean and mean in emerging med tech is really about survival in the current investment and healthcare climate. Even the smallest bit of bloat can mean not hitting promised milestones with dollars raised, or not having the financial flexibility to iterate and pivot along the predictably unpredictable development pathway. Worst of all, over-spending can force financing under terms that create a "preference stack" penalizing common stockholders (employees and founders), even in some winning exits.  A little scrappiness today can buy entrepreneurs a little happiness tomorrow.

Realizing the Value of Med Tech Innovations

Realizing the Value of Med Tech Innovations

I recently attended a workshop hosted by the National Institute for Health and Care Excellence (NICE), the UK agency that reigns over new technology assessment and drives reimbursement decisions within and sometimes beyond its jurisdictional borders.  Having girded myself for a sermon on British-style healthcare frugality, I was surprised to learn that Solvadi, Gilead’s $94,500 per course Hepatitis C drug, has been recommended by NICE for use in the UK. While Solvadi’s high price tag is controversial to say the least, NICE’s thumbs up got me thinking that medical technology companies are probably too timid when it comes to pricing breakthrough innovations. By leaving too much money on the table, are we crippling the whole med tech innovation ecosystem and dooming ourselves to commoditization and mega-mergers?

There are many examples of medical devices that arguably are priced well below their value.  One of my favorites is Mirena, the levonorgestrel-releasing intra-uterine device from Bayer. Mirena provides 5 years of reversible birth control without many of the risks of dual-hormone oral contraceptives, including the risk of not remembering to take them. So why was it priced lower than the 5-year cost of market-leading birth control pills? The humble pacemaker is another good example; pacemakers can vastly increase the length and quality of life, sometimes for decades, yet they cost less than $5,000.  The list goes on of truly game-changing technologies whose sticker price — even factoring in procedures, tests and device-related complications — doesn’t come close to accounting for the quantifiable direct savings much less the gain in Quality-Adjusted Life years (QALYs) that the health economist wonks at NICE used to justify Solvadi.

Why have med tech innovators been hesitant to bust through conventional device price ceilings and really go after the money they are worth? And more importantly, what can be done to change the paradigm?

Overcoming incrementalism

Most med tech innovations represent incremental advances, building off of existing technology that was revolutionary in its day.  The first coronary stents were unequivocally a breakthrough because they offered a therapy for coronary artery disease without requiring hugely invasive and dangerous open-heart surgery. Drug-eluting stents came along and finished the job, achieving sufficient efficacy to convert a large share of the surgery market (with the help of aggressive interventional cardiologists), and became a rare $4B+ device category. Since then, new stent iterations have made unexciting gains, and both stent prices and reimbursement have come down.  Many other device categories, from orthopedics to vascular to ophthalmics, have also seen a parade of line extensions focused on defending shares and justifying modest price increases to health system purchasers. Incremental medical device advances are crucial to the engineered solutions we develop, and appropriately supported by the FDA 510(k) regulatory pathway, but they rarely change the conversation from the purchaser or payer perspective.

Generating the evidence

Even when a medical technology represents a revolutionary step forward in treatment, device companies often don’t spend the money and time that biopharma does to demonstrate the efficacy and cost-effectiveness of their solutions. Asthmatx received US regulatory approval for their severe asthma treatment Alair with a 300 patient study, and many payors still consider it investigational over four years later.  By contrast, when NICE reviewed Xolair, a leading drug for severe asthma, the agency could draw from 11 randomized trials with data from more than 2,300 patients. Ultimately NICE gave its blessing to Xolair, which can cost up to $40,000 per year and generates $1.3B in revenue for Roche and Novartis. Granted, it can be tough to conduct randomized controlled trials with many devices (creating sham controls for devices is truly an art form), but payers don’t really make that distinction. The clinical development necessary to achieve clinical acceptance and additional reimbursement can be too much for traditional med tech companies and their VCs to stomach, but it’s precisely this evidence that enables pricing to value vs. pricing to existing competition.

Fighting the good fight

Even if we had the evidence we need to justify new reimbursement and get fair value for our innovations, it is just way easier to find a way to fit into current reimbursement than confront the hellish slog to new code. Short-term focused investors even insist on it, having grown allergic to both regulatory and reimbursement risk.  To put medical devices on par with drugs in monetizing demonstrated value, some companies will have to step up and get into the ring with CMS. The manufacturers of transcutaneous aortic valves are going for it, having developed a technology that can avoid major open-heart surgery as stents once succeeded in doing.  Edwards et al are charging more than $30,000 per device, and are building the evidence to demonstrate not just efficacy but also cost effectiveness and yes, QALY gains.  CMS is slowly coming along with a National Coverage Determination that has more conditions than a Hollywood pre-nup, but it’s a start.

Clearly not all new medical devices will, or should be, disruptive innovations that warrant significant allocation of scarce healthcare dollars, and plenty of new drugs are incremental, too (how many erectile dysfunction drugs do we really need?).  However, we med tech people have to resist our inherent urge to endlessly tinker and make some big bets.  We, too, know how to modify disease, though we may not call it that enough, or aim that high often enough. 

Note: Amy Siegel from S2N will be hosting a panel on these topics this Friday, November 7th at the MassMedic MedTech Showcase, featuring Medtech-Biotech crossover executives and investors.

Top 5 Reasons Why Med Tech is Still Cool

Top 5 Reasons Why Med Tech is Still Cool

In S2N’s very first blog, back when we founded our company in 2011, we shared our top 5 reasons why we like the med tech industry. Times have been challenging for emerging med tech companies, though, and the bad days can make you start to doubt your career choices. Maybe it’s time to do something sexier, like develop an app for $0.99 that 100 million people want, or a biotech drug for a really bad disease that 12 people have.

Yet we continue to soldier on, humbly confident that medical devices are still important, and in fact things are looking up for med tech in 2014. It’s been a good year for S2N as well, so we got bold and added some youthful talent to our team. When we offered Andy the job, we weren’t sure we could compete with the glitz and glamour of biotech. Why would anyone with a million possibilities want to get into med tech now, much less work with us?

To lay our bewilderment to rest, and shamelessly fish for compliments from our vulnerable new hire, we asked Andy to refresh our top 5 List with his reasons for entering the med tech field. What attracts a young buck like Andy to join us rapidly aging folk in the pursuit of med tech nirvana?

Here’s what Andy had to say:

  1. Have you ever heard of Facebook? Yeah, me too. Like most of my generation, I was raised by the Internet. We worshipped Mark Cuban and Mark Zuckerberg, now household names; Silicon Valley is the new Hollywood. What I see in med tech is a potential to rekindle a forgotten industry. While many of my peers flew out West like moths to a bright light, I trekked up to the land of miserable winters and unhealthy Red Sox obsessions (also known as Boston). I knew I wanted to work in an industry that was a little less glitz and a little more grit. Call me naïve, but I see med tech taking front stage in the next tech boom. I’m just getting in while it’s still under everyone else’s radar.
  2. From day one of college I knew I wanted to get into biomedical engineering. In my years of lab research I grew to love the concept of manipulating the mechanics of biological systems to create whole new technologies. But sometimes it felt like my scientific papers were just landing in the great academic abyss. Blame it on me, or blame it on the short attention span of my entire generation, but I knew I needed a little more instant gratification. Wait, what was my point again? Oh right: I wanted to work in an industry that lets you see the hard work of lab research put to use in the real world, and in real people.
  3. Biology is all about revealing the fundamental mechanism behind a process. As a biologist (-ish), I wanted to understand the process of taking knowledge learned at the lab bench and spinning it into a company. After so many years focusing on the science behind medical devices, I became increasingly curious about the businesses behind them, too. Based on my experience, the majority of scientists have only a hazy concept of everything that must happen to translate a science project into a revenue-generating product. The way I see it, this is my new mission: to reveal the mechanisms of turning science into business.
  4. I really should have put this at #1, but here it is: the problems that medical devices take on are the problems worth solving. As much as I love sharing pictures of what I had for dinner with all my Internet friends, the gains for humanity made by these trendy apps are lost on me. With med tech though, every new product launch has the potential to improve or extend a patient’s life. This business might not be the most glamorous, or the best for hitting a jackpot product, but at least the medical device industry strives to tackle real problems. And that makes going to work every day worthwhile.
  5. Deep down, everyone is a salesman, whether you are trying to sell a device, some old speakers on Craigslist, or even just sell yourself as a talented, competent professional. Growing up, I always seemed to be meddling in some “make a quick buck” scheme. Maybe it was this unquenched entrepreneurial spirit that finally drove me to the scrappy space of med tech startups. I wouldn’t be surprised if the thrill of teetering between boom and bust brought you all to this space as well. Whatever the outcome, you know that you are taking action, trying to do something that matters.

There you have it – why I chose to go into the med tech industry in 700 words or less. Now I get to peer into the black boxes of a dozen different med tech companies, all of which are at the forefront of their space. Who knows which one is going to be the next household name?

IPO or Bust for Emerging Med Techs

IPO or Bust for Emerging Med Techs

The recent receptivity of public equity markets to early stage biotech has encouraged more than a few emerging med tech companies to consider IPOs. The allure of the IPO, if successful, is obvious. More capital can potentially be raised on better terms from public investors than private ones to fund expensive commercialization efforts. More to the point, though, tired venture investors and management teams can achieve liquidity and returns sooner than waiting for an attractive M&A exit, which in med tech may require years of slogging it out on market for a multiple of sales deal.

A glance at the five emerging med tech companies to go public in the last 6 months reveals reasonable success in raising money with their dazzling stories of large and growing market opportunities. Notably, all of the companies have a product on the US market, or within sniffing distance of it; contrast this with biotech where promising pipelines alone can drive successful IPOs and high market caps. Also notable is that fundraising expectations were a bit more bullish than the IPO market reality, with all five companies pricing below or at the low end of their target ranges.

If tapping the public markets is something you are considering for that next round of capital, certainly the first step is determining whether public investors are likely to come to the table. Do you have, or are you close to, US revenues? Check. Is your product chasing large markets with big growth potential? Check. Are your VC investors tired and cranky? Check!

An IPO, however, is not just about the day you get listed on the NASDAQ and pocket the cash. As a wise sage told me when I was pregnant with my first child, “Don’t worry about childbirth, worry about everything that comes after.” To gain some perspective on life as a public emerging medical device company, I spoke with Nassib Chamoun, former President, CEO and Founder of Aspect Medical Systems (ASPM), a brain monitoring company that went public in 2000, raising $52M in the IPO that funded the company to >$100M in sales, profitability and acquisition by Covidien in 2009.

According to Nassib, being a public med tech company has certain advantages. “You are a somewhat more legitimate entity, especially when dealing with corporate partners,” says Nassib. Having that ticker next to your company name also raises your prestige with current and potential employees (I’m nominating T2 for the cutest ticker of 2014, by the way). Nassib also recalls fondly many of his interactions with sell-side and buy-side analysts. “They were like an outside Board – I often got more from them than they got from me.”

The leadership of the IPO-ing emerging med tech company needs to prepare for some of new unique challenges, though, that come with being a publicly traded entity. Here are a few you can expect to encounter:

1. The distraction factor: As we all know, being a CXO of a start-up med tech company equates to two full time jobs at a minimum. Add an IPO to the mix and you are now 300% employed. This burden repeats itself, albeit on a smaller scale, at least every quarter once you are public. Employee fixation on the company share price also adds to the distraction factor, especially when there are big swings (a common situation for emerging med techs – see point 4).

2. The cost: According to a PWC survey, in addition to underwriting fees paid to the bank(s) taking you public, which can total as much as 5-7% of gross proceeds, companies spend an average of ~$1 million on IPO-related legal, accounting and other one-time costs, and ~$1.5M in annual recurring costs for extra staffing, legal, HR, technology and the like. These sums may not seem like much for larger companies, but for small med techs these additional expenses can have a real impact.

3. The Full Monty every quarter: If you ever listen to a JNJ earnings call, you soon realize that you are learning absolutely nothing. Contrast that with the single product med tech company, where basically every aspect of your business, from your COGS to your installed base to your clinical trial progress, is discussed in intimate detail for the analysts plugging assumptions into their 1,000 line models so they can decide what box to put you in. You might as well send your competitors and every employee in your company your weekly management report. “One of our early competitors was also public and we knew everything about each other – it was a running joke,” said Nassib.

4. The rollercoaster ride: Most public emerging med techs are thinly traded, which makes dramatic share price swings more likely. These swings may have little to do with your company’s results, though plenty of unanticipated things happen in early commercialization that can affect your share price. “The highs are higher and the low are lower,” recalls Nassib. “The volatility brought our organization closer together as we celebrated the successes and managed through the failures.” Small public companies are also more vulnerable to activist investors since it is easier to acquire a controlling share. “You can be forced to liquidate and give up significant future value for much smaller short-term gains,” warned Nassib.

When I asked Nassib about Aspect’s decision to IPO, he emphasized that going public is rarely a choice. “With the amount of money and time required to develop and commercialize a novel medical device, you exhaust your angels, your VCs, your Mezzanine investors, and you still aren’t done. The exhausted investors, and employees, want some liquidity, and an IPO becomes your only option.” If it had been a choice, Aspect might have stayed a private company, though “going public is on the evolutionary path toward becoming a successful company – so live it up and enjoy the journey,” advised Nassib.

MDT + COV - Good or Bad for Medtech Innovation?

MDT + COV - Good or Bad for Medtech Innovation?

Let’s be honest – the headlining acquisition of Covidien by Medtronic may go down as the most boring deal of 2014, unless of course you are an international tax accountant. The swirling buzzwords are inversion, offshore cash, G&A, and hospital contracts. Please wake me up when it’s over. Yet it may be the unintended consequences of this deal that are the real story, in particular the implications for med tech innovators. The real story won’t really be known for months or even years, despite Omar Ishrak’s reassuring pronouncements that the merger will “accelerate” investments in R&D.

We at S2N decided an old-fashioned pro-con debate was in order. Question: Is the big fat marriage of MDT and COV good for Innovation? Tim took the Con position and Amy the Pro stance. Here’s blow by blow:

Cash for innovation or cash for shareholders?

Amy: You need a lot of cash to invest in disruptive innovation, and the combined “Medvidien” will be swimming in it. It’s a perfect match for gaining efficiencies in mature product categories to free up cash for real technological advances.

Tim: This deal is a perfect example of how the big companies are throwing in the towel on innovation and focusing on the bottom line. The extra cash will all go back to shareholders, which is great for them but I’m not sure how that helps innovation.

Temporary deal disruption or big investment hiatus?

Tim: Good luck getting anything done with any division of MDT or COV for the next 3 years while management is completely focused on realizing those promised “synergies”. They will have a good, long run of earnings growth that will take pressure off top-line growth for a while.

Amy: Really Tim, do you think they can afford to turn off the growth-oriented deal flow for that long? Sure, there might be a short-term disruption to early stage investments from the distraction of the merger, but pretty quickly they are going to have to put that cash to work to grow sales. Can’t cost cut your way to success forever!

Spawning of new start-ups or lifestyles of the rich and famous?

Amy: Think of all the med-tech superstars who will make big coin on the deal and then be released to the wild. Some of that money and expertise will start finding it’s way back into the emerging med-tech ecosystem.

Tim: Wishful thinking, Amy. Med-tech veterans don’t have a rich history of aggressive angel funding. Mostly likely the deal will help the yacht and island markets more than med tech start-ups.

One less acquirer in the pool or just fatter acquirers?

Tim: The number of big-time med tech acquirers is pretty small as it is, and it just got one smaller. Negotiations with the new entity will be tougher, too, because there will be less deal competition.

Amy: There is so little overlap in the business units of the two companies, except for endovascular, that it really doesn’t change the picture for most emerging med techs. The acquirer just got a bigger wallet.

Helpful scale or focus elsewhere?

Tim: After tax minimization, the other main drivers of this deal are negotiating power with hospitals and scale to sell in emerging markets. That’s where they see their growth coming from in the next couple of years. Innovation is on the back burner.

Amy: Those more effective hospital and emerging markets sales channels will benefit innovative technologies, not just mature ones, and they will need more products to pull through those channels.