23.02.2013 Views

The minimally invasive surgery market, and associated Danish ...

The minimally invasive surgery market, and associated Danish ...

The minimally invasive surgery market, and associated Danish ...

SHOW MORE
SHOW LESS

Create successful ePaper yourself

Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

a brief by aquilo<br />

Copenhagen - January 2012<br />

aquilo I www.aquilo.info


aquilo I www.aquilo.info<br />

1<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

1) INTRODUCTION, PURPOSE AND SCOPE: ......................................................................................................... 2<br />

2) EXECUTIVE SUMMARY: ................................................................................................................................ 2<br />

3) SURGICAL DEVICE INDUSTRY DYNAMICS – THE WAY IT IS/USED TO BE: .............................................................. 3<br />

3.1.1 Opoly: ............................................................................................................................................ 3<br />

3.1.2 Approval: ........................................................................................................................................ 5<br />

3.1.3 Pharma/Biotech: ............................................................................................................................ 5<br />

4) FUTURE SURGICAL DEVICE INDUSTRY DYNAMICS - THE WAY IT IS (POTENTIALLY) GOING TO BE: ............................ 7<br />

4.1.1 Western healthcare systems: ......................................................................................................... 7<br />

4.1.2 Reduced price willingness: ............................................................................................................ 8<br />

4.2 Globalization & commoditization: ..................................................................................................... 9<br />

4.2.1 Expiring patents: .......................................................................................................................... 10<br />

4.2.2 EU approval process & IP prosecution: ....................................................................................... 10<br />

4.2.3 Demographics: ............................................................................................................................. 10<br />

4.2.4 What will globalization look like?: ................................................................................................ 10<br />

4.2.5 What will happen to the multinationals?: ..................................................................................... 11<br />

4.3 Innovation: ...................................................................................................................................... 12<br />

5) MIS INDUSTRY PERSPECTIVE: .................................................................................................................... 13<br />

5.1.1 MIS definition: .............................................................................................................................. 13<br />

5.1.2 MIS capabilities?: ........................................................................................................................ 13<br />

6) VIABLE MIS STRATEGIES: .......................................................................................................................... 14<br />

6.1 Leapfrog innovation: ....................................................................................................................... 14<br />

6.2 Sub-leapfrog (yet far above “face-lifting”) innovation: .................................................................... 14<br />

6.3 Reverse engineering: ...................................................................................................................... 15<br />

6.3.1 R&D cost <strong>and</strong> overhead: .............................................................................................................. 16<br />

6.3.2 Price point: ................................................................................................................................... 16<br />

6.3.3 <strong>The</strong> “made in Switzerl<strong>and</strong>” twist: ................................................................................................. 16<br />

6.4 Emerging <strong>market</strong> strategy: .............................................................................................................. 17<br />

6.5 Niche indication strategy: ............................................................................................................... 19<br />

7) THE DANISH ANGLE: ................................................................................................................................. 19<br />

8) APPENDICIES: .......................................................................................................................................... 21<br />

* Appendix #1: Top-level analysis of <strong>Danish</strong> players ............................................................................ 21<br />

* Appendix #2: Competency fit, surgical disciplines, <strong>Danish</strong> players. .................................................. 28<br />

* Appendix #3: Collaboration matrix, <strong>Danish</strong> players. .......................................................................... 29<br />

* Appendix #4: Global surgical <strong>market</strong> matrix & <strong>Danish</strong> opportunities. ................................................ 30<br />

Appendix #5: Intuitive surgical, “Da Vinci” ........................................................................................... 31<br />

* For insight into these appendicies please contact Medico Innovation


aquilo I www.aquilo.info<br />

2<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

1) INTRODUCTION, PURPOSE AND SCOPE:<br />

Medico Innovation has rewarded aquilo with the task of producing a brief on the surgical device<br />

industry, <strong>and</strong> more specifically the <strong>minimally</strong> <strong>invasive</strong> surgical (MIS) segment of that sector.<br />

<strong>The</strong> purpose of this brief is to provide Medico Innovation with:<br />

a) an overview of the dynamics driving the surgical device industry.<br />

b) an overview of the surgical device industry with a specific focus on the MIS segment.<br />

c) an overview of the future viable strategies a <strong>Danish</strong> based MIS device initiative<br />

or company could pursue.<br />

d) link these global trends <strong>and</strong> strategies to specific <strong>Danish</strong> companies, institutions or initiatives.<br />

Ideally the above overview will enable Medico Innovation to:<br />

e) underst<strong>and</strong> the future trends <strong>and</strong> viable strategies in the MIS segment of the surgical device<br />

industry.<br />

f) match innovative companies with physicians <strong>and</strong>/or researchers in Denmark to develop new,<br />

competitive MIS devices.<br />

It is out of scope for this brief to produce suggestions that are specifically describing new potential<br />

innovations - this is for the parties in (f) to examine. Nor will this brief contain calculations on revenue<br />

potential for the described strategies in (c).<br />

In (d) we shall focus mainly on delivering food for thought on which small to mid-sized <strong>Danish</strong><br />

companies, institutions <strong>and</strong> initiatives that could, single-h<strong>and</strong>edly or in collaboration pursue one or<br />

more of the strategies in (c).<br />

As Medico Innovation has already launched initiatives in the fascinating med-tech areas of “diagnosis &<br />

imaging” this brief shall exclude that part of the industry.<br />

2) EXECUTIVE SUMMARY:<br />

This brief argues that the innovation level in the surgical device industry, including the MIS segment of<br />

the industry, has historically produced rather modest levels of innovation when compared with other<br />

industries. Further, the authors present the case that the industry st<strong>and</strong>s at a crossroad similar to that of<br />

the pharmaceutical industry a decade ago. Regardless of how swiftly the industry reacts, it is expected<br />

to see the industry dynamics change significantly in the coming decade. This change will be driven by:<br />

(a) an increasing cost pressure on western healthcare systems, (b) globalization <strong>and</strong> commoditization,<br />

<strong>and</strong> (c) innovation.<br />

For <strong>Danish</strong> MIS initiatives this could offer opportunities in most of the surgical segments. <strong>The</strong> brief<br />

further identifies five viable MIS strategies.<br />

It is recommended not to apply traditional analysis focusing on <strong>market</strong> size when determining which<br />

<strong>Danish</strong> initiatives could be created, but rather focus on where <strong>Danish</strong> companies, researchers <strong>and</strong><br />

physicians possess know-how, <strong>and</strong> find out in which of the five viable strategies this know-how could<br />

yield maximum impact.


aquilo I www.aquilo.info<br />

3<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

Of the five viable strategies the brief favors: Reverse engineering strategy, Leapfrog strategy <strong>and</strong> Niche<br />

indication strategy.<br />

Finally, 20 <strong>Danish</strong> companies, research institutions <strong>and</strong> initiatives that could potentially contribute in<br />

creating a viable <strong>Danish</strong> MIS initiative is located, top-level research on capabilities is carried out <strong>and</strong><br />

compiled in appendices 1-4.<br />

For insight into these appendicies please contact Medico Innovation.<br />

3) SURGICAL DEVICE INDUSTRY DYNAMICS – THE WAY IT IS/USED TO BE:<br />

When taking a closer look at the innovation that has taken place in the world of surgical devices over<br />

the past decades, one has little reason to be impressed. If this level of innovation (or lack of same) was<br />

to be transferred to the world of cars, most of us would still be driving a face-lifted version of Henry<br />

Ford's famous T-model. Or expressed slightly more diplomatic: One will have to search long <strong>and</strong> hard<br />

to find an industry where the word “innovation” occurs at such high frequency in company logos <strong>and</strong><br />

tag-lines, yet, delivers so modest real innovation as in the surgical device industry.<br />

As a matter of fact the authors of this brief would go even further, <strong>and</strong> state that the only true innovation<br />

that has taken place in many of the surgical device disciplines, over the past decades, is the<br />

development of <strong>minimally</strong> <strong>invasive</strong> techniques <strong>and</strong> devices. Having said this one must also relativize the<br />

term “minimal <strong>invasive</strong>”, as it is also a <strong>market</strong>ing term that has been used <strong>and</strong> misused ever since its<br />

inception by device companies <strong>and</strong> doctors alike. <strong>The</strong> correct term should of course be: “Less <strong>invasive</strong><br />

<strong>and</strong> potentially better for you if your surgeon has passed the point of critical mass on the learning<br />

curve”. We may only speculate why <strong>market</strong>eers <strong>and</strong> doctors have chosen not to call this term by its<br />

correct name.<br />

Now, lets start with taking a closer look at the forces behind the unfolded potential for real innovation in<br />

an otherwise very interesting industry. As with all explanations in life, the full <strong>and</strong> complete explanation<br />

is multifaceted, however, when the wheat is separated from the chaff we are fortunately left with only<br />

three facets:<br />

1) “Opoly”<br />

2) Approval<br />

3) Pharma/Biotech<br />

3.1.1 Opoly:<br />

<strong>The</strong> term “opoly” refers to the ending of the competitive definition known from microeconomics in<br />

<strong>market</strong>s where only few companies compete. As the fast minded reader might have guessed the<br />

explanation “opoly” is applied here to illustrate the fact that players in the surgical device industry are<br />

often competing in what could be classified as duopoly-like environments.


To illustrate this point we have constructed the below Q&A:<br />

Q1: Who are dominating the world of orthopedic implants?<br />

A1: Stryker, Depuy, Zimmer.<br />

Q2: Who are dominating the world of interventional cardiology?<br />

A2: Boston Scientific, St. Jude, Cordis.<br />

Q3: Who are dominating the world of abdominal <strong>surgery</strong>?<br />

A3: Covidien, Ethicon Endo-Surgery.<br />

Q4: Who are dominating the world of sutures (needed for almost any kind of<br />

surgical intervention)?<br />

A4: Ethicon, (Covidien).<br />

aquilo I www.aquilo.info<br />

4<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

Q5: How big is the actual clinical difference between e.g. a Boston Scientific stent <strong>and</strong><br />

a Cordis stent? And between Covidien stapler <strong>and</strong> an Ethicon Endo-Surgery stapler?<br />

A5: Small to insignificant.<br />

Q6: How many of the above listed companies are legally related?<br />

A6: Of the nine multinationals listed in the above, four are children of the same parents<br />

- Johnson & Johnson Medical.<br />

Now, you might have already figured it out, but lets spell it out now that we are at it: When looking at<br />

four of the major surgical/interventional disciplines (including suturing) each discipline is dominated by<br />

two to three multinationals, hence, the “opoly” reference. This is as close as one gets to a duopoly in a<br />

globalized <strong>market</strong> economy comprised of democracies with antitrust laws <strong>and</strong> cross-border<br />

competition authorities, who hold the honorable m<strong>and</strong>ate of serving <strong>and</strong> protecting their citizens against<br />

big businesses becoming too big, which in-turn leads to limited innovation <strong>and</strong> high prices . . . .<br />

“Limited innovation <strong>and</strong> high prices”, what does that remind you of?<br />

When one builds on, this 21 st century duopoly-like <strong>market</strong> situation, the fact that in our little quiz above<br />

four of the nine listed multinationals are basically one company <strong>and</strong> further adds that the clinical<br />

difference between the few dominating players is insignificant, how would you think that might affect<br />

innovation?<br />

<strong>The</strong> critical reader might object that the above quiz is overly simplified <strong>and</strong> does not include all players<br />

<strong>and</strong> sub-specialties etc. - a criticism that is perfectly correct. One should, however, bear in mind that<br />

this section is not about the “full <strong>and</strong> complete industry picture”, but about the main factors driving the<br />

perplexing combination of modest innovation <strong>and</strong> high prices in a very profitable industry.<br />

Nevertheless, to add some global <strong>market</strong> statistics, that should silence potential critics of the above<br />

Q&A. See Figure 1 <strong>and</strong> please consider that of total global medical devices revenue in 2009, the top-30<br />

multinationals covered 80% of revenue generated. When isolating the top-ten multinationals, we see<br />

that their overall dominance equals 50%. And by further narrowing that down to the top-five, the<br />

dominance amounts to 33% of all medical device revenue generated worldwide 1 . Further, it is worth<br />

noticing that if the top-five device companies control 33% of the global device <strong>market</strong> their <strong>market</strong><br />

1 Medical Markets Fact Book, 2009 <strong>and</strong> aquilo analysis


aquilo I www.aquilo.info<br />

5<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

share, in the surgical specialties where they are active (none of the top-five cover all specialties), must<br />

for simple mathematical reasons on average exceed 33% by far.<br />

Figure 1: Global top 30 medtech companies 2<br />

3.1.2 Approval:<br />

So how does the approval process affect the level of innovation? Well, the US has in the past been <strong>and</strong><br />

still is the largest device <strong>market</strong> in the world making up 41% of global revenue 3 . So if you are going to<br />

make it big you better make it there. Obtaining a FDA approval for a surgical device can, hence, result in<br />

that device's revenue curve taking on exponential proportions. It is, however, even for multinationals<br />

with deep pockets an extremely costly <strong>and</strong> time consuming exercise to obtain the much sought after<br />

FDA approval.<br />

<strong>The</strong> argument here is that tapping into the largest <strong>and</strong> most profitable <strong>market</strong> in the world, is highly<br />

correlated with making or breaking it as a business. <strong>The</strong> question is, whether one can procure the cash<br />

<strong>and</strong> time to “sit it out”, answering question after question, going through round after round with FDA<br />

reviewers, hence, prolonging the process by 90 days between each round. In the world of business<br />

school linger this is labeled “entry barriers”. This is the second reason why we have seen a lack of<br />

innovation in this industry.<br />

To avoid any misinterpretation of the above it might be appropriate to stress that a governmental<br />

approval body for surgical devices naturally has it place. However, when a surgical device that has<br />

obtained approval by the European authorities, is required to go through a second approval process<br />

(FDA), that is very costly <strong>and</strong> time intensive in order to obtain access to the world's largest <strong>and</strong> most<br />

profitable <strong>market</strong> (the US), one has to accept that this significantly reduces the investment into new <strong>and</strong><br />

innovative surgical device companies, which in turn has a negative effect on the long term innovation<br />

level for the entire industry.<br />

This leads us to the third main explanation - pharma <strong>and</strong>/or biotech.<br />

3.1.3 Pharma/Biotech:<br />

Let's start by looking at what <strong>surgery</strong> really is - with a humorist simplified twist It could be expressed as:<br />

Cutting bad stuff out of people with the aid of various instruments or putting some sort of functional<br />

implant into them so that they may live better <strong>and</strong>/or longer post operatively.<br />

2 Frost & Sullivan, ”Medical Device Industry: Recovering from Recession”, 2011<br />

3 Frost & Sullivan, ”Medical Device Industry: Recovering from Recession”, 2011


aquilo I www.aquilo.info<br />

6<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

Immediately following the above humorously twisted simplification one must on a more serious note<br />

express the greatest respect for the various surgical disciplines, <strong>and</strong> the men <strong>and</strong> women dedicating<br />

their lives to mastering them.<br />

<strong>The</strong> somewhat camouflaged point from the above is that due to the very nature of <strong>surgery</strong> i.e. it being a<br />

highly specialized craft it remains exactly that – a craft. This in turn renders <strong>surgery</strong> <strong>and</strong> thereby the<br />

devices used for <strong>surgery</strong> subject to a set of “natural limitations”. By “natural limitations" we underst<strong>and</strong><br />

the laws of mechanical physics <strong>and</strong> gravity. Now, one could argue that we are all subject to the laws of<br />

physics <strong>and</strong> gravity <strong>and</strong> certainly all medical treatments <strong>and</strong> natural sciences must respect these laws.<br />

A claim that is correct, however, this is why we specify the limitation as mechanical physics <strong>and</strong> gravity<br />

– a definition <strong>and</strong> limitation that is not as predominant/need not be respected in other fields like<br />

electronics, computing <strong>and</strong> pharmaceutics.<br />

Surgery has always been a mechanically driven craft <strong>and</strong> it is, hence, subject to the fact that there is<br />

only x number of ways in which a liver can be resected, a knee or hip can be replaced. <strong>The</strong>refore, when<br />

true extraordinary innovation in the surgical field takes place one of two events often unfold:<br />

1) a disease that previously had no successful treatment path can now be treated surgically. Examples<br />

of this could cover teeth implantology, knee <strong>and</strong> hip replacements. Please note that the first generation<br />

of the mentioned therapies all dates decades or more back. A more recent example could be illustrated<br />

by <strong>Danish</strong> based Sonion Medical, who has recently developed a surgical device to treat cancer in the<br />

brain (human trials is currently ongoing).<br />

2) a disease that was previously treated surgically is now treated pharmaceutically. Examples of this<br />

could be schizophrenia <strong>and</strong> other mental illnesses, which were still surgical indications in the first<br />

quarter of the 20 th century. Other examples include GERD (Gastro-Esophageal Reflux Disease), a<br />

disease that was surgically treated <strong>and</strong> increased significantly throughout the 80-90's. However, in this<br />

day <strong>and</strong> age surgically treated GERD is facing a sharp decline, as an increasing number of GERD<br />

patients are treated pharmaceutically.<br />

As a residual of duopoly-like <strong>market</strong><br />

environments, a costly path of access<br />

to the world's largest <strong>market</strong> <strong>and</strong> the<br />

role of pharmaceuticals reducing<br />

surgical indications, the surgical<br />

device <strong>market</strong> has been characterized<br />

by marginal innovation at the cost of<br />

real game-changing innovations.<br />

By taking “baby steps” in terms of<br />

innovation, the industry has actually<br />

been able to reshape the traditional<br />

Figure 2: PLC curve, with med-tech reshape 4 Product Life Cycle (PLC) as<br />

graphically illustrated in figure 2.<br />

When developing modestly improved versions of existing devices a product line is kept alive for much<br />

longer than it would otherwise be possible in a truly competitive <strong>market</strong> like that of cell phones, where<br />

product lines become obsolete in 12- 24 months.<br />

4 aquilo


aquilo I www.aquilo.info<br />

7<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

<strong>The</strong> effect on the PLC curve is a quite flat decline after a device has reached maturity. This represents<br />

the main explanation why this industry has been able to maintain gross margins of over 80% for<br />

decades - many devices simply turn into true cash cows through marginal innovations, thus, moving<br />

along the reshaped PLC curve.<br />

Enough about the past <strong>and</strong> present - what will the future bring?<br />

4) FUTURE SURGICAL DEVICE INDUSTRY DYNAMICS - THE WAY IT IS (POTENTIALLY) GOING TO BE:<br />

<strong>The</strong> good news for patients, healthcare systems <strong>and</strong> in the long run probably also for the surgical<br />

device industry is that the future need not be an extrapolation of the past.<br />

When looking ahead in the surgical device industry, a few important factors seem to determine the<br />

future drivers in this industry:<br />

1) Western healthcare systems<br />

2) Globalization & commoditization<br />

3) Innovation<br />

4.1.1 Western healthcare systems:<br />

When analyzing the Western World economies, one will as expected find that dating back to the end of<br />

the Second World War these economies have experienced significant GDP growth decade upon<br />

decade 5 . Despite the fact that the Western World has become richer in real terms, we are now at a point<br />

where the social benefits hereunder the public healthcare systems are about to “break the bank”.<br />

Though this “casino terminology” might at first seem slightly inappropriate, it is nevertheless quite<br />

telling of the forces currently at play in all the “Old” European Countries <strong>and</strong> the Euro Zone as such.<br />

Admittedly, there are differences in the degree of severity in a country-by-country comparison;<br />

nevertheless, we are merely discussing the “degree of severity”. <strong>The</strong> variation in severity does not alter<br />

the fact that all the economies of the “Old” European countries are facing the challenge on how to avoid<br />

their social <strong>and</strong> healthcare systems becoming the “player” that “breaks the bank”.<br />

On a more humorous note, one could<br />

squeeze in that considering the current<br />

financial mess <strong>and</strong> bail-out issues the Euro<br />

Zone is facing, if it is not the social- <strong>and</strong><br />

healthcare systems that “breaks the bank”,<br />

it will be because the private <strong>and</strong> central<br />

banking system will “break the bank” first.<br />

<strong>The</strong> “breaking the bank” issue, in the former<br />

Figure 3: Demographic development, Western World 6 _ ___ perspective, is indeed a two-sided coin – the<br />

cost side <strong>and</strong> the income side. From a cost<br />

perspective more people in the “Old World” will be tapping into services that are currently publicly<br />

funded, as the generations aged 50 <strong>and</strong> above, currently represent as much as 40% of the population<br />

5 OECD, National accounts of OECD countries, 2010.<br />

6 aquilo


aquilo I www.aquilo.info<br />

8<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

in e.g. Germany 7 . Whereas on the income side fewer people are left to fund the publicly financed social-<br />

<strong>and</strong> healthcare systems. <strong>The</strong> macroeconomists label this “the challenge of the inverted demographic<br />

pyramid” as visualized in illustration 3. This in turn leaves the “Old World” with three main options if the<br />

level of publicly funded healthcare is to be maintained:<br />

a) Do more with less:<br />

<strong>The</strong> explanation lies in the heading. This option means year-on-year increases in public sector<br />

healthcare output combined with decreasing real budgets – not a cocktail likely to go down well with<br />

healthcare systems <strong>and</strong> citizens alike.<br />

b) Increase factor input or factor output:<br />

Create a biotope for new jobs creation, preferably in the private sector. This will affect the income side<br />

of the equation positively as more private sector employment will help fund the publicly financed<br />

systems via corporate <strong>and</strong> personal taxes. This will naturally not just benefit the healthcare system, but<br />

the entire economy in nations that are successful in navigating this path.<br />

or<br />

By replacing tasks that in today’s healthcare systems are carried out by humans with robots. This will<br />

potentially have a positive effect on the cost side of the healthcare system equation i.e. increase factor<br />

output significantly. Anecdotal evidence of such a model comes from Japan, where nurses have been<br />

relieved from feeding patients as this is h<strong>and</strong>led by machines/robots, <strong>and</strong> overseen by a nurse 8 .<br />

c) Privatize:<br />

Finally the countries “diagnosed” with an inverted demographic pyramid will have to privatize large<br />

parts of their healthcare systems to achieve the much sought after efficiencies through an absolute<br />

advantage selection process.<br />

So which is it going to be?<br />

Well, though the way nations are likely to deal with the challenge of the inverted demographic pyramid<br />

in the decades to come, will include measures from all three options described above, the specific mix<br />

of the above measures is difficult to estimate precisely.<br />

<strong>The</strong> only thing we know with a high degree of certainty is that the “do more with less strategy” will be<br />

central to all developed countries' healthcare systems going forward, as this is the option that for<br />

politicians <strong>and</strong> hospital executives dem<strong>and</strong>s the least amount of effort <strong>and</strong> creativity to dictate<br />

implemented.<br />

4.1.2 Reduced price willingness:<br />

We believe that in an environment where the “do more with less strategy” dominates the scenery, the<br />

main challenge facing existing device companies will be what we refer to as price willingness. Price<br />

willingness is a measure for how much a surgeon or purchaser is willing to pay for the combination of<br />

device capability <strong>and</strong> perceived device innovation.<br />

<strong>The</strong> first sign surgical device companies come across when encountering the “do more with less<br />

strategy”, is the shift in power from surgeon to purchaser. Though the surgeon still has influence her/his<br />

power is significantly diluted, as the surgeon now has to justify her/his preference in terms of clinical<br />

7 OECD, Statistics Directory extract <strong>and</strong> aquilo analysis.<br />

8 Institut for Fremtidsforskning, Copenhagen, Denmark


aquilo I www.aquilo.info<br />

9<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

outcome to the purchaser. In a competitive environment where the real clinical difference between<br />

competing devices is minimal to nonexistent, such justification might prove challenging. Thus, in a<br />

duopoly-like environment with modest device differentiation <strong>and</strong> where the subjectivity of surgeon<br />

relationship <strong>and</strong> history with a specific company is taken out of the equation, or at least strongly<br />

reduced, which decision factor is left?<br />

If you whispered “price” when reading the end of the previous paragraph, you are perfectly right. Due to<br />

the low level of real product differentiation among the few companies dominating each surgical<br />

specialty, one will, in a hospital system where purchasing has been centralized <strong>and</strong> empowered, expect<br />

to see price becoming the main factor determining which company wins the business.<br />

With the combination of increased price sensitivity <strong>and</strong> centralized hospital purchasing we will also see<br />

more frequent tender rounds where purchasers will have the “duopoly” companies fight the price war<br />

against each other to win tenders that continuously become less <strong>and</strong> less profitable. As a derivative of<br />

the shift in decision power from surgeon to purchaser we also expect to see little or no allowance for<br />

price premiums on “face-lifted” devices.<br />

<strong>The</strong>re are two main factors that have allowed the industry to stay as profitable <strong>and</strong> generate as many<br />

cash cows as it has:<br />

1) Price increases<br />

2) “Face-lifting” or line extensions<br />

It is important to underst<strong>and</strong> that price increases have had a double role in generating profit to device<br />

companies. One is the year-on-year upward price correction to reflect or compensate for the general<br />

inflation in society at large. <strong>The</strong> other is the price increase that companies have been able to impose on<br />

what we classify as “face-lifted” devices (marginal device changes, where basic device concept is<br />

unchanged <strong>and</strong> clinical benefit versus original concept is statistically undocumented). In the later<br />

example, device companies have been able to impose “innovation” price increases of as much as 25%<br />

on what is, clinically seen, the same device.<br />

As hospitals are swiftly moving towards centralized purchasing <strong>and</strong> no longer allowing surgeons to<br />

decide independently on device, <strong>and</strong> thereby device company, these two important profit-drivers will<br />

erode <strong>and</strong> potentially disappear completely.<br />

4.2 Globalization & commoditization:<br />

<strong>The</strong> second mega trend in surgical devices is globalization. One might argue that globalization is taking<br />

place <strong>and</strong> based on facts from other industries already yesterday's news. This is correct when looking<br />

towards many consumer goods such as electronics or cars, where not only production but also<br />

innovation is coming out of China. However, in the surgical device industry this development has hardly<br />

begun yet. Some surgical device companies have invested in production facilities in China, however,<br />

globalization has not reached the level where a majority of devices are no longer developed <strong>and</strong><br />

produced by US-based multinationals but by Chinese companies.<br />

Hence, the question remains: When will the surgical device industry get hit at full force by globalization,<br />

<strong>and</strong> what <strong>and</strong> how will that affect the <strong>market</strong> situation?<br />

A quite interesting question, as globalization alone would have had less of an impact on this profitable<br />

industry had the social <strong>and</strong> healthcare systems of the “Old World” not been under such pressure. Or<br />

put differently: Were we looking at a demographic situation in Europe equal to that of the 1960's,


aquilo I www.aquilo.info<br />

10<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

globalization would not be playing first violin in the symphony that depicts the future of the surgical<br />

industry.<br />

As it is not the demographic situation of the 1960’s, which prevails today, we will instead see Chinese<br />

low-cost versions of the surgical devices used today, flood the “Old World”. This will happen for the<br />

following reasons:<br />

1) Expiring patents<br />

2) EU approval process & IP prosecution<br />

3) Demographics<br />

4.2.1 Expiring patents:<br />

First of all, many surgical devices in the duopoly-like environments described earlier, are based on<br />

patents that have expired or will soon expire. This fact alone should justify our relative harsh<br />

introductory comments on the innovation level in the surgical device industry. This is, however, not the<br />

point – the point is that the combination of expiring patents <strong>and</strong> globalization most likely will spearhead<br />

the influx of “copy & paste” devices from China over the next decade.<br />

4.2.2 EU approval process & IP prosecution:<br />

Secondly the ease of approval for surgical devices in the EU, relatively to the US, will further assist the<br />

influx of Chinese “copy & paste” devices.<br />

<strong>The</strong> ability of European nations to follow through an effective IP prosecution towards Chinese “copy &<br />

paste” device manufactures who might not be eager to “sit-it-out” for 20 years is questionable, <strong>and</strong> that<br />

for two reasons. One being that though the EU represents a significant geographic area <strong>and</strong> economic<br />

power; it is comprised of 27 independent nations whose individual determination to push for change in<br />

China is questionable. Even as a collective (European Union) the maneuverability seems subject to<br />

many conflicting interests <strong>and</strong> agendas, <strong>and</strong> though on paper more powerful than the individual nations<br />

in the end probably also challenged in carrying through change in China.<br />

4.2.3 Demographics:<br />

Finally, the demographic reality bites again - as it is the above factors in combination with the<br />

demographic situation in Europe that will leave politicians <strong>and</strong> hospital executives with the dilemma of<br />

acting against the low-cost “copy & paste” Chinese manufactures, thus, protecting big business' (often<br />

US based) IP - or accepting the much needed extended h<strong>and</strong> that the “copy & paste” solutions offer in<br />

the battle against exploding healthcare costs. <strong>The</strong> authors of this brief are betting on the latter.<br />

4.2.4 What will globalization look like?:<br />

We believe that with globalization entering on the surgical device <strong>market</strong> at full force over the next<br />

decade or so we will see many of today's technologies that are non-novel, yet, still “alive <strong>and</strong> kicking”<br />

<strong>and</strong> attached with labels as: “highly innovative, premium devices, preferred by surgeons, best in-class<br />

outcomes” etc., become commodities.<br />

How that exactly will unfold is not easy to predict, yet, our estimate is that premium priced devices like<br />

DES (drug eluted stents) for interventional cardiology, stapling devices for laparoscopic <strong>surgery</strong>,<br />

mobility implants (knee, hip, spine) <strong>and</strong> many more will become low priced technologies developed,<br />

produced <strong>and</strong> <strong>market</strong>ed from China or another low cost production region.


aquilo I www.aquilo.info<br />

11<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

Today most US, Japanese <strong>and</strong> European (top three medical device <strong>market</strong>s) cardiologists would<br />

probably find it inconceivable to work with a DES developed <strong>and</strong> produced by a Chinese low cost<br />

manufacturer <strong>and</strong> back this with the importance of patient safety, company track record etc. All very<br />

reasonable objections, however, when looking closer at what a DES really is, then one could claim that<br />

it is nothing more than a stent, which by the way was invented decades ago, coated with a drug that<br />

further reduces the probability of narrowing of the blood stream. Admittedly, this feature represents a<br />

significant benefit in terms of improved patient outcomes. However, with the current <strong>and</strong> especially<br />

future sophistication level of Chinese manufacturing, <strong>and</strong> reverse engineering, is this really a device that<br />

we cannot trust the Chinese to manufacture? Must such an important <strong>and</strong> life saving device be<br />

<strong>market</strong>ed by a US multinational, who has its own production sites in China, for doctors, healthcare<br />

systems <strong>and</strong> patients to trust in it? Today yes. But in five to ten years the answer will probably be no, if<br />

having a low-cost Chinese manufacturer produce <strong>and</strong> <strong>market</strong> a DES, translates into price reductions of<br />

50% or more.<br />

In short, globalization will lead to a commoditization of what we today consider highly specialized <strong>and</strong><br />

premium prized “technologies”, which in turn will affect the current multinationals' portfolios by turning<br />

many of their highly profitable cash cows into dogs.<br />

<strong>The</strong> reason why it is a relatively simple task for a cash rich investor (or country) to commoditize the<br />

surgical device industry is not only globalization, it is naturally also a residual of the strategy chosen by<br />

the industry decades ago. <strong>The</strong> decision we are referring to, is the choice to follow the very profitable<br />

“marginal innovation strategy”. As with all profitable strategies, this one will eventually outlive itself,<br />

which is probably what the industry will experience over the coming decade.<br />

4.2.5 What will happen to the multinationals?:<br />

An interesting question indeed. Interesting as the combination of globalization <strong>and</strong> commoditization will<br />

lead to a range of different outcomes for today's leaders in the surgical device industry. Some will come<br />

out stronger than ever before, others will be marginalized compared to their current position in the<br />

<strong>market</strong> <strong>and</strong> some might fold completely.<br />

Those who will take the legal path against the low cost “copy & paste” device companies, will most<br />

likely be fighting a battle already lost, <strong>and</strong> hence be the companies that will benefit the least from these<br />

new <strong>market</strong> dynamics. And even if they win a legal case or via an army of lobbyists succeed in having<br />

the US Congress <strong>and</strong>/or the European Parliament impose sanctions against the “copy & paste”<br />

companies or countries harboring these “profit busters”, they will most likely loose the battle of the<br />

public opinion in their traditional <strong>market</strong>s, leaving behind an image of profit-hungering multinationals<br />

that prevent tax payers access to affordable <strong>surgery</strong>.<br />

<strong>The</strong> other group, who has already read <strong>and</strong> understood the writing on the wall, will be re-inventing their<br />

innovation strategy <strong>and</strong> in some cases find their way back to what they originally were – truly innovative<br />

surgical device companies.<br />

In between these two scenarios lies a variety of strategies <strong>and</strong> outcomes of which the most interesting<br />

probably is the strategy of “cannibalization in due time”. This strategy builds on current <strong>market</strong> leaders<br />

tapping into a commoditized <strong>market</strong> by producing their own low-cost versions of their existing product<br />

lines or alternatively entering into some sort of legal relationship with the “copy & paste” companies<br />

(joint venture, majority or minority stakes etc.) <strong>and</strong> thereby gaining a foothold in this strong future<br />

segment.


aquilo I www.aquilo.info<br />

12<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

4.3 Innovation:<br />

As briefly mentioned the third <strong>and</strong> final derived dynamic from the combination of inverted demographic<br />

pyramid <strong>and</strong> the following cost pressure on healthcare systems, globalization <strong>and</strong> commoditization, is<br />

innovation.<br />

How does an industry that has been globalized <strong>and</strong> commoditized develop further? Well the answer is<br />

simple: Through real <strong>and</strong> significant innovation.<br />

Critics might object that after an industry has been commoditized follows a period with no or limited<br />

innovation. This might be correct for commodities like coffee - originally a luxury <strong>and</strong> premium priced<br />

product that after hundreds of years of premium status, became a commodity during the 20th century.<br />

Yet, one must not forget that the commodity status was not maintained for long as true innovators<br />

marched in <strong>and</strong> re-invented the coffee industry both in terms of machines <strong>and</strong> end products (drinks<br />

containing coffee). When looking at the history <strong>and</strong> development of coffee, it seems fair to state that it<br />

went from being a pure luxury product to being a pure commodity product. Yet, revived into the 21st<br />

century with two main product lines: a commodity- <strong>and</strong> a luxury line to the benefit of a broader range of<br />

consumers.<br />

<strong>The</strong> mindful reader will recall that, we earlier on stated that the change in <strong>market</strong> dynamics which we<br />

st<strong>and</strong> before embodies the good news for patients, healthcare professionals, public healthcare systems<br />

<strong>and</strong> the surgical industry at large. No doubt cheaper mobility implants <strong>and</strong> stents are beneficial to<br />

public healthcare systems <strong>and</strong> privately funded patients, but how can this change be beneficial to the<br />

surgical industry? Is it not, from a purely financial perspective, the almost beautiful symphony of high<br />

unit prices, marginal innovation strategy <strong>and</strong> thus extended PLC-curves, spiced up with a natural <strong>and</strong><br />

anti-cyclical procedure growth averaging 3-5% per year that have led to significant wealth creation<br />

among the top-10 device companies?<br />

<strong>The</strong> reason why we argue that this change can be beneficial to the industry is that the “survivors” will<br />

come out leaner, meaner <strong>and</strong> more innovative, which in it self is positive. On top of this the survivors will<br />

also avoid going through the unfortunate mix of public embarrassment <strong>and</strong> self torture that the<br />

pharmaceutical industry has/is going through. <strong>The</strong> pharmaceutical industry had for years been at the<br />

stage where the surgical device industry is today. Incapable of underst<strong>and</strong>ing, embracing <strong>and</strong> acting on<br />

the fact that it had become complacent <strong>and</strong> thought to have earned a right to maintain abnormally high<br />

profit levels. H<strong>and</strong>-in-h<strong>and</strong> with this lack of underst<strong>and</strong>ing came a lack in capabilities to address this<br />

matter with appropriate measures, resulting in an embarrassing fight to cling on to “the way it used to<br />

be” through various lobbyists, infomercials etc. – a battle that was clearly lost on several fronts <strong>and</strong> if<br />

nothing else it was certainly lost to the public opinion, <strong>and</strong> more importantly to the producers of generic<br />

pharmaceuticals.<br />

If you feel like countering that statement then think about what springs to mind when thinking about the<br />

pharmaceutical industry. Or even better ask a h<strong>and</strong>ful of people that same question. Answers will, if<br />

your “sample group” is not biased, most likely contain vocabulary like: ”greedy, un-trustworthy, i am<br />

skeptical of stuffing myself with chemicals, they are pushing indications to sell more”.<br />

One may also want to consider how the, by Danes perceived, best behaved kid in class – Novo Nordisk<br />

– has recently been questioned in relation to allegations of pushing off-label usage of its Novo-Seven<br />

product. Another recent <strong>Danish</strong> case is Lundbeck's anti-depressive – Cipramil – which was allegedly<br />

prescribed to teenagers with fatal results.


aquilo I www.aquilo.info<br />

13<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

<strong>The</strong> point is that if no change were to come to the surgical device industry it would travel down the<br />

same torturous road as the pharmaceutical industry did. <strong>The</strong> surgical device industry now st<strong>and</strong>s at a<br />

crossroad, which depending on which path is chosen has the potential to revive an entire industry. Even<br />

if the entire industry should choose to go down the “pharmaceutical” path, significant change in the<br />

industry can be expected – the much needed change will, however, be longer on its way <strong>and</strong> instead of<br />

a swift, deliberate <strong>and</strong> profitable change, look more like that of the commoditization <strong>and</strong> later<br />

rejuvenation of coffee.<br />

Having discussed the main trends in the surgical device industry, we can now add the discussion of<br />

how these mega trends will influence the <strong>market</strong> for MIS devices.<br />

5) MIS INDUSTRY PERSPECTIVE:<br />

Most MIS devices are developed <strong>and</strong> produced by the very companies also producing non-MIS surgical<br />

devices, hence, the MIS innovation trends are, to a large extend, victims of the same limitations <strong>and</strong><br />

trends described above.<br />

5.1.1 MIS definition:<br />

Lets first look at the definition of the term MIS. As mentioned in the introduction the MIS definition has<br />

been used <strong>and</strong> mis-used by companies <strong>and</strong> doctors alike. In this brief we shall however work with a<br />

definition as follows: Minimally Invasive Surgery are devices or methods leading to significantly:<br />

- Reduced pain levels<br />

- Reduced hospital stay<br />

- Reduced healthcare cost<br />

- Improved patient outcome<br />

- Improved patient quality of life<br />

One could object that this is a somewhat wide definition - which it is. Nevertheless, we deem it<br />

reasonable to look at MIS in a broad perspective, in order not to corner Medico Innovation's efforts this<br />

early in the process.<br />

5.1.2 MIS capabilities?:<br />

Having settled this, lets get practical about what this means by starting out with looking at a MIS<br />

technology which is not directly related to the “old” multinationals, yet, potentially offers MIS<br />

capabilities across a wide range of surgical interventions: Robotic Surgery embodied in Intuitive<br />

Surgical's Da Vinci Robot (appendix 5) - a great piece of technology that allows for precise dissection,<br />

3D capabilities, remote <strong>surgery</strong> <strong>and</strong> much more. When examining Intuitive Surgical's list of areas <strong>and</strong><br />

procedures where the Da Vinci Robot's MIS capabilities can be utilized, it is difficult to imagine a MIS<br />

technology available today that surpasses the Da Vinci Robot.<br />

Does this technological wonder fall under the above interpretation of MIS? <strong>The</strong> answer to this simple<br />

question is less simple, wherefore; this discussion is carried out in appendix 5 (a), where we share two<br />

anecdotes.<br />

We hope that these two anecdotes <strong>and</strong> discussion around the Da Vinci Robot, in appendix 5 (b),<br />

illustrates well the challenges in evaluating true MIS capabilities <strong>and</strong>, thus, the challenges of developing<br />

true MIS devices.<br />

Regardless of the authors critical, yet, hopefully objective assessment of Da Vinci as a true MIS<br />

technology across a broad range of procedures, it remains clear that with this technology <strong>surgery</strong> has


aquilo I www.aquilo.info<br />

14<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

taken a step towards a potential revolutionizing future. It remains to be seen if it will be in the form of a<br />

robotic console or whether some of these new features developed by Intuitive Surgical, will be further<br />

enhanced <strong>and</strong> applied in the traditional laparoscopic devices, <strong>and</strong> to which extend Intuitive Surgical will<br />

be able to financially benefit long-term from the innovations it has become a first mover within.<br />

6) VIABLE MIS STRATEGIES:<br />

It is in these difficult <strong>and</strong> stormy waters of expiring patents, questionable IP protection, inverted<br />

demographics, globalization <strong>and</strong> challenges of documenting real MIS capabilities, we must define the<br />

strategies of the new MIS initiatives Denmark is to produce <strong>and</strong> thereby decide which battle fields we<br />

want our MIS companies to conquer. Underst<strong>and</strong>ing the main trends <strong>and</strong> triggers in the surgical device<br />

<strong>market</strong> we can now start defining the strategies most likely to be successful over the next decades.<br />

Lets begin with confirming that the MIS <strong>market</strong> looks attractive - from abdominal <strong>surgery</strong> we know that<br />

this <strong>market</strong> is growing at 10-15% annually where as the non-MIS abdominal surgical <strong>market</strong> averages<br />

3-5% annual growth 9 . It seems fair to assume a similar growth pattern in the other surgical specialties.<br />

6.1 Leapfrog innovation:<br />

At this level of innovation one needs not worry about the degree of surgical <strong>invasive</strong>ness – because<br />

here we are talking about surgical innovation that makes the blind see, the deaf hear or the paraplegic<br />

walk. This level of innovation is what everyone be it nurses, doctors, engineers or business people in the<br />

surgical industry dares only dream about in a quiet <strong>and</strong> private moment, before we are brutally taken<br />

back to reality by our own common sense. This is a shame - not only would a (partial) reconstruction of<br />

a broken spinal cord or reconnection of nerves represent an unimaginable positive to patients affected<br />

by paralyzation. It also makes sense that the described impairments could be improved through<br />

electromechanical innovation, as they are all results of damages that lead to some sort of<br />

“electromechanical circuit shutdown”. To cure or improve these impairments, it is probable that one will<br />

have to look towards sophisticated electromechanical techniques <strong>and</strong> devices. Further down this line of<br />

thinking we find the “joker” of stem cell research, where one day some human “spare parts” might be<br />

available in an injectable substance that will regenerate damaged tissue <strong>and</strong> organs. It could prove<br />

“less of a challenge” or “faster” to produce improved outcomes via electromechanical<br />

techniques/devices/implants, than via stem cell research.<br />

Needless, to say that if one can produce innovation that makes the blind see, the deaf hear or the<br />

paraplegic walk - one has a pretty strong concept by all measures. At these only too rare levels of<br />

innovation one would even expect to see a swift FDA approval process.<br />

6.2 Sub-leapfrog (yet far above “face-lifting”) innovation:<br />

This strategy involves significant improvements in terms of one or more of the MIS definitions above<br />

(significantly reduced: pain, hospital stay, costs, <strong>and</strong>/or improved: patient outcomes, patient quality of<br />

life) but does not necessarily change the intervention as such. A good example of this would be<br />

prostatectomy by laparoscopic Da Vinci technique, here the surgical procedure is not really changed,<br />

yet, the application of enhanced vision capabilities <strong>and</strong> thus more precise dissection capabilities lead to<br />

better outcomes. <strong>The</strong> previously discussed DES (Drug Eluted Stent), would likewise be an example of<br />

what we would label as “sub-leapfrog” innovation.<br />

<strong>The</strong> main challenge with this kind of innovation, apart from developing the idea, is to actually finance<br />

the clinical study that proves the concept: (a) safe <strong>and</strong> (b) significantly beneficial to patients.<br />

9 aquilo analysis based on industry interviews


aquilo I www.aquilo.info<br />

15<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

6.3 Reverse engineering:<br />

This strategy carries a low degree of real innovation <strong>and</strong> is rather a question of being innovative or<br />

creative in manufacturing <strong>and</strong> sales force excellence, thereby beating the multinationals in the coming<br />

tenders <strong>and</strong> thus becoming a profit- <strong>and</strong> “opoly” buster.<br />

Though, one has to acknowledge that this strategy is neither glorious nor honorable in terms of<br />

innovation, we will argue that this strategy from an investor perspective is quite exciting indeed. <strong>The</strong><br />

answer to this somewhat counterintuitive argument lies in recalling that it is the stormy waters depicted<br />

above on which western healthcare systems are to navigate in the coming decades. Hence, by<br />

identifying the highly profitable existing MIS devices where the core of the technology has not evolved<br />

significantly over the past decades, <strong>and</strong> bringing “copy & paste” versions of these devices to <strong>market</strong>,<br />

one can cater to a new <strong>and</strong> upcoming dem<strong>and</strong> pattern. A dem<strong>and</strong> pattern that is dominated by publicly<br />

financed hospital executives that need to deliver more treatments with reduced real term budgets.<br />

Some readers might produce a slight frowning when reading about this strategy, thinking, “well is that<br />

not what some Chinese companies are already doing – so why would we go down that path”?<br />

Yes, there are some Chinese manufactures that have gone down this path with mixed results. Much of<br />

the reverse engineering that is established, is based around the segment where unit prices could be<br />

described as low to medium. What we have seen in the “copy & paste” MIS segment are devices like<br />

the laparoscopic access ports, which from a <strong>market</strong> leader like Johnson & Johnson are priced around<br />

USD 80-150 per unit (average usage per procedure = approximately USD 300). What we are still to see<br />

are “copy & paste” versions of the Zimmer knee implant, the Covidien endoscopic stapler or the Boston<br />

Scientific drug eluted stent – where each of these implants or MIS devices are priced in thous<strong>and</strong>s of<br />

dollars per procedure.<br />

<strong>The</strong> explanation why these higher priced devices have not yet seen much competition from the Far East<br />

is probably multifaceted. However, one reasonable <strong>and</strong> significant explanation would appear to be a<br />

reluctance among surgeons <strong>and</strong> healthcare professionals towards using Chinese produced devices that<br />

are to last for 20 years or more. Whether this reluctancy is justified or not is of less interest for this<br />

strategy - as with many other aspects of the 21st century we have to accept the fact that “perception is<br />

reality”.<br />

What we are proposing is indeed to create “copy & paste” devices in the segment where a combination<br />

of high unit prices <strong>and</strong> high volumes are flourishing <strong>and</strong> where the core technology patent protection<br />

has expired or dates a decade back.<br />

How would a <strong>Danish</strong> based initiative be able to take up the “copy & paste” battle with all mighty China?<br />

And how should one go about the challenge of delivering devices that offer significant cost reductions<br />

yet a similar quality to that of the established multinationals? Naturally, beating the Chinese at their own<br />

game requires a certain degree of savvy. Lets begin by looking at why a <strong>Danish</strong> based initiative could<br />

fair better than a Chinese based solution.<br />

In today's world we possess equal portions of admiration <strong>and</strong> fear for the Chinese industrial <strong>and</strong><br />

technological express train coming at us. We appreciate the cheap consumer products coming out of<br />

China, yet, we are less appreciative of the jobs that “has gone <strong>and</strong> will continue to go east”. But we are<br />

outright fearsome of what the Chinese are going to do with all that excess cash – a pile of cash that<br />

seems only to increase by the hour. Will they “buy” your country or a country close to you next year?<br />

This “fear factor” combined with the quality perception of “made in China” comprises two important<br />

pillars in beating the Chinese at their own game so to speak.


aquilo I www.aquilo.info<br />

16<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

We are thus arguing that there exists an increasing animosity towards Chinese produced goods, an<br />

animosity that is unlikely to decrease over the next decade, as the European recession is likely to<br />

worsen <strong>and</strong> potentially lead to a breakup or reduction of the Euro Zone, which in turn will increase<br />

national debt levels to China. Should this situation progress it is probable that even 7th grade school<br />

kids will underst<strong>and</strong> that what drove European nations into Chinese “ownership” was the combination<br />

of (a) fiscal negligence <strong>and</strong> (b) an artificially maintained low Yuan which has fueled the Chinese export<br />

Eldorado – or expressed with an extra portion of sarcasm: <strong>The</strong> artificially maintained low Yuan is the<br />

reason China can “buy your country with your money”.<br />

In order to be successful at this strategy, one would have to apply consumer look-a-like <strong>market</strong>ing<br />

techniques towards hospital executives playing the “based in <strong>and</strong> produced in Europe card”.<br />

If a <strong>Danish</strong> based company cannot produce its “copy & paste” MIS devices in China, how is one to run<br />

a profitable business? <strong>The</strong>re are many reasons why such a solution might be as profitable or even more<br />

profitable than the multinationals currently <strong>market</strong>ing such MIS devices <strong>and</strong> also more successful than<br />

the Chinese based devices. We shall discuss the top two reasons in the below <strong>and</strong> add a little twist as a<br />

third option:<br />

1) R&D cost <strong>and</strong> overhead<br />

2) Price point<br />

3) <strong>The</strong> “made in Switzerl<strong>and</strong>” twist<br />

6.3.1 R&D cost <strong>and</strong> overhead:<br />

First of all when one implements a “copy & paste” strategy the R&D cost should by definition represent<br />

only a fraction of the original R&D cost (carried by the multinationals). Secondly, when competing<br />

against the multinationals with copies of their own portfolio in a hospital environment as described<br />

above, one needs less sales people trying to sell marginal <strong>and</strong> insignificant device differentiation. In this<br />

kind of environment quality relative to price will, ceteris paribus, be the main sales driver.<br />

6.3.2 Price point:<br />

What this also translates into is that the “copy & paste” MIS device need not be of the exact same<br />

quality as the original – it merely needs to be “close enough”. Likewise the price point need not be one<br />

tenth of the originals - a 25-40% price reduction will suffice as long as the quality is “close enough”. To<br />

draw an analogy from the world of European commercial airliners, one could state that to be successful<br />

with this strategy one need not become the Easy Jet or Ryan Air of MIS companies – becoming the Air<br />

Berlin will not only do – it might be the more successful strategy.<br />

A real life example of a company that has successfully implemented this strategy could be represented<br />

by UK based Purple Surgical, founded in year 2000, it has taken basic MIS devices (low to medium unit<br />

priced devices) in the field of laparoscopy, applied the “reverse engineering” or “copy & paste” strategy<br />

into a new, less expensive, yet, good enough quality product range.<br />

A US-based example that has gone down that same route is Applied Medical, which allegedly, has<br />

surpassed Covidien in terms of <strong>market</strong> share for laparoscopic access ports in the US.<br />

6.3.3 <strong>The</strong> “made in Switzerl<strong>and</strong>” twist:<br />

Having covered the basics of R&D, overhead <strong>and</strong> quality versus price point, we are left with the last<br />

interesting factor – we call it the “made in Switzerl<strong>and</strong>” twist. It is hard to think of a label that by<br />

consumers across the globe is regarded as highly as the “made in Switzerl<strong>and</strong>” label. If “made in


aquilo I www.aquilo.info<br />

17<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

China” is attached with a certain association, the “made in Switzerl<strong>and</strong>” automatically provokes the<br />

exact opposite association in our minds. Though “made in Germany” also scores high on the quality<br />

perception score it does not match that of the Swiss. Now, this is truly peculiar as we all know that<br />

German build “stuff” embodies “best in class” quality <strong>and</strong> engineering precision second to none. In fact,<br />

Swiss manufacturing DNA is based on German engineering. Hence, the “made in Switzerl<strong>and</strong>” label is<br />

certainly among one of the largest <strong>market</strong>ing victories carried out by a single nation (consisting of only<br />

seven million people).<br />

<strong>The</strong> interesting point is that nowadays an increasing number of Swiss made consumer goods are<br />

produced in China, so the “made in Switzerl<strong>and</strong>” would now at best relate to “designed by a Swiss<br />

based company”. Obviously this is not as quality catchy as “made in Switzerl<strong>and</strong>”. So, how do some<br />

consumer goods companies get around this? <strong>The</strong>y leave the little legally obliged label “made in China”,<br />

however, they put the good old Swiss flag on the product – which is probably even stronger than the<br />

“made in Switzerl<strong>and</strong>” tag as the flag represents a visualization, a symbol of “made in Switzerl<strong>and</strong>”.<br />

How does this little consumer anecdote relate to our business-to-business reality of MIS devices? Well,<br />

one can indeed be a European based MIS “copy & paste” device company <strong>and</strong> outsource device<br />

production to China – one must, however, assure to use the “flag” appropriately in the <strong>market</strong>ing of the<br />

company <strong>and</strong> the company's product line.<br />

Should one decide to go down this path it is important to recall that there are also low cost production<br />

countries inside the EU. Admittedly China is still outperforming low cost European countries by a factor<br />

of about 1:5-8. However, this does not include the “cultural” challenges of outsourcing production to<br />

China, increased transportation cost etc.<br />

<strong>The</strong> authors of this brief strongly believes in this strategy <strong>and</strong> have little doubt that a decade from now<br />

we will see quite a few “opoly” & “profit-buster” MIS companies thriving, creating employment <strong>and</strong><br />

becoming an integral <strong>and</strong> respected part of the industry. <strong>The</strong> question that remains is who in Denmark<br />

will have the guts to go down this path? If <strong>Danish</strong> device companies can muster the courage to follow<br />

through on this strategy, we could see some relative quick wins <strong>and</strong> fast growing companies to the<br />

benefit of Denmark, healthcare systems, patients <strong>and</strong> eventually also to the benefit of the industry as<br />

this will force the multinationals to reinvent themselves.<br />

6.4 Emerging <strong>market</strong> strategy:<br />

This strategy shares many traits with the “reverse engineering strategy”. One could argue that the two<br />

strategies are indeed siblings - not twins, just siblings.<br />

Whereas the “reverse engineering strategy” focuses on producing “copy & paste” versions of top of the<br />

line MIS devices <strong>and</strong> <strong>market</strong> these at more reasonable prices than currently, the “emerging <strong>market</strong><br />

strategy” focuses on producing outright inexpensive devices.<br />

<strong>The</strong> rationale supporting this strategy naturally has its offspring in the growth rates of countries like<br />

Brazil, Russia, India, <strong>and</strong> China (BRIC). Countries that on a GDP per capita basis might be considered<br />

relatively under privileged when compared with the “Old World”, nevertheless, these countries <strong>and</strong> this<br />

category of countries have undergone significant economic development over the past decade. This<br />

development has also led to an increase in healthcare availability in these countries.<br />

As it is common knowledge that several emerging <strong>market</strong>s have enjoyed impressive GDP growth rates<br />

<strong>and</strong> are likely to continue to present GDP growth above the six percent mark in the coming years, we


aquilo I www.aquilo.info<br />

18<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

shall not dwell further in justifying the attractiveness of these <strong>market</strong>s 10 . Instead we shall discuss further<br />

the factors driving the need for inexpensive MIS solutions <strong>and</strong> the potential reward to companies that<br />

can deliver such solutions.<br />

<strong>The</strong> combination of relatively modest GDP per capita levels <strong>and</strong> the variability in healthcare systems in<br />

emerging <strong>market</strong>s are the factors driving the need for inexpensive MIS devices. <strong>The</strong> word “variability” in<br />

this context could be replaced with “creative payment models”. First of all, <strong>surgery</strong> is rarely hundred<br />

percent publicly funded – not even in publicly run hospitals. As a minimum some kind of unofficial<br />

payment to the surgeon <strong>and</strong> often also to the anesthesiologist has to take place prior to <strong>surgery</strong>. In<br />

some emerging <strong>market</strong>s, it is even common practice that patients wishing to have their procedure<br />

carried out by MIS-technique are equipped with a “shopping list” of which devices to buy directly from<br />

the company/distributor <strong>and</strong> asked to bring the devices to the hospital on the day of <strong>surgery</strong>.<br />

When considering the current price level of MIS devices <strong>and</strong> especially the scenario above it is no<br />

wonder that the penetration rate of MIS techniques is faltering in emerging <strong>market</strong>s. However, the low<br />

penetration rate of existing MIS techniques in emerging <strong>market</strong>s <strong>and</strong> the GDP growth rates, see figure<br />

4, are also the factors fertilizing the future possible success for companies that can produce<br />

inexpensive MIS devices.<br />

To further illustrate this point, a Chinese university hospital or regional hospital carries out as many<br />

surgical procedures within one specialty as is carried out by all surgical units in Denmark in one year.<br />

Any MIS device company might very well be content having established a <strong>market</strong> share of say 50% in<br />

Denmark for a specific procedure, which in turn would translate into a range of surgeons working with<br />

the specific device in about ten of the country's largest hospitals. <strong>The</strong> point is that, could the same<br />

company produce an inexpensive version of an existing MIS device, it could by getting this into one<br />

Chinese hospital sell twice as many devices as it sells in the <strong>Danish</strong> <strong>market</strong>.<br />

China<br />

India<br />

Russia<br />

Brazil<br />

GDP, projection vs. actual, USD trn<br />

0 1 2 3 4 5 6<br />

USD trn<br />

Figure 4: 2010 GDP projections vs. actual 11<br />

In the last section we used Air<br />

Berlin as a consumer product that<br />

could well reflect the “reverse<br />

engineering strategy”, if we were to<br />

apply a similar consumer analogy<br />

in summarizing the “emerging<br />

<strong>market</strong> strategy” it would be to<br />

develop MIS devices, reflecting the<br />

cost level <strong>and</strong> philosophy of the<br />

Nano Car from Indian based TATA,<br />

a USD 3.000 modern city car.<br />

From figure 5 one should be able to derive one simple message: Forget about importing cheep “stuff”<br />

from India <strong>and</strong> China, if one can sell “stuff” to the Chinese <strong>and</strong>/or Indians, one need not worry much<br />

about the US. Hence, Mr. Sinatra's “if I can make it there, I can make it anywhere” might relate better to<br />

Shanghai or Delhi than New York.<br />

10 Medical Markets Fact Book, 2009<br />

11 Goldman Sachs, Economist, December 2011<br />

2010 actual<br />

2010 projection (2003)


USD m<br />

aquilo I www.aquilo.info<br />

12000<br />

10000<br />

8000<br />

6000<br />

4000<br />

2000<br />

Figure 5: BRIC medical <strong>market</strong> value forecast 12<br />

19<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

6.5 Niche indication strategy:<br />

This strategy is, as indicated by the headline, a rather narrow strategy both in terms of volume <strong>and</strong><br />

geography. <strong>The</strong> multinationals is of course mostly interested in developing devices for indications that<br />

are characterized by being crucial <strong>and</strong> frequent. <strong>The</strong> “niche indication strategy” aims at a different<br />

combination: Crucial indication but low volume. <strong>The</strong> main business reason why <strong>Danish</strong> MIS companies<br />

should consider such a strategy is that the competition in this field in most cases will be modest to<br />

nonexistent, which in turn is explained by low incident rates. Such a dynamic can be extremely<br />

profitable for a, seen in a global perspective, small device company.<br />

An example of a <strong>Danish</strong> based company that has pursued this strategy is Aalborg based Neurodan,<br />

who produces a, compared to other technologies, <strong>minimally</strong> <strong>invasive</strong> implant treating the relatively low<br />

incident disease “foot drop syndrome”.<br />

Companies that pursue this strategy might find themselves in a monopoly-like <strong>market</strong> situation, due to<br />

the combination of addressing crucial indications <strong>and</strong> low incident rates, which in turn is a warranty for<br />

abnormal price <strong>and</strong> profitability levels 13 .<br />

7) THE DANISH ANGLE:<br />

Having thoroughly discussed viable future strategies <strong>and</strong> trends, this final section can be sliced sharply.<br />

Traditional analysis would start out by determining which therapeutic area that should be addressed.<br />

When glancing at appendix 4 it is evident that the largest therapeutic area is cardiology <strong>and</strong> thoracic<br />

<strong>surgery</strong> which, with an annual global revenue of USD 56bn, comprises about one fifth of the global<br />

medical device <strong>market</strong>. Taking a closer look at this huge <strong>market</strong> might be relevant for multinationals,<br />

however, considering that this brief is meant as food for thought for existing <strong>and</strong> up <strong>and</strong> coming <strong>Danish</strong><br />

device companies, applying <strong>market</strong> size as the main selection criteria seems to make little sense.<br />

Instead we would argue that it would, as a first step, make more sense to estimate which <strong>Danish</strong><br />

companies could independently or in collaboration successfully pursue one or more of the future viable<br />

strategies discussed above.<br />

This has been summarized in appendices 1 - 4.<br />

0<br />

BRIC, medical <strong>market</strong> value forecast<br />

2009 2010 2011 2012 2013 2014<br />

For insight into these appendicies please contact Medico Innovation.<br />

12 Medical Market Fact Book 2009<br />

13 Neurodan charges EUR 20.000 per implant, which is 3-5 times that of a knee implant.<br />

China<br />

Russia<br />

Brazil<br />

India


aquilo I www.aquilo.info<br />

20<br />

<strong>The</strong> <strong>minimally</strong> <strong>invasive</strong> <strong>surgery</strong> <strong>market</strong>,<br />

<strong>and</strong> <strong>associated</strong> <strong>Danish</strong> opportunities<br />

In these appendices we have identified companies, institutions <strong>and</strong> initiatives in Denmark, ranging from<br />

current MIS manufacturers over stem cell technology to non-medical device material experts, that<br />

include one or more of the following characteristics:<br />

a) poses technology that if commercialized into a MIS device would match one or more of the<br />

___five viable strategies, discussed above.<br />

b) poses capabilities that if paired with other <strong>Danish</strong> companies, institutions or initiatives could<br />

___develop MIS devices that would fall into one or more of the five viable strategies, discussed<br />

___above.<br />

Based on our top-level research of the current <strong>Danish</strong> capabilities, appendix 1-3, It is our preliminary<br />

recommendation that Denmark should focus on bringing companies <strong>and</strong> researchers together to create<br />

initiatives that can pursue opportunites with in the:<br />

1) Reverse engineering strategy<br />

2) Leap frog strategy<br />

3) Niche indication strategy<br />

It is with in these strategies that we believe Denmark will be able to create significant results <strong>and</strong><br />

position itself in the world economy of MIS devices.<br />

<strong>The</strong> in-dept discussion of why exactly these three strategies are most likely to deliver export successes,<br />

new jobs <strong>and</strong> help improve health economic outcomes for health care systems across the globe, we<br />

shall be pleased to discuss during a personal meeting.


Appendix #5:<br />

Intui/ve Surgical, “Da Vinci” (a)<br />

Appendix MIS capabili/es?:<br />

Does this technological wonder fall under the above interpreta6on of MIS? Well, yes <strong>and</strong> no – no doubt that this MIS technology has, a?er<br />

more than ten years in the <strong>market</strong>, finally found some true jus6fica6on. Based on surgeon interviews conducted by aquilo there seem to exist<br />

consensus among surgeons that beHer pa6ent outcomes are achieved for e.g. prostatectomy due to the possibility of more precise dissec6on,<br />

hence significantly reducing trauma to vital structures.<br />

But that is about it. From here there seem to be as many opinions about the technology as there are surgeons. Hence Intui6ve Surgical's claim<br />

that the Da Vinci Robot is also fantas6c for: Bariatric, colorectal, cardiac <strong>and</strong> many more procedures, could not be supported through the<br />

interviews carried out with different surgeons.<br />

Bariatric <strong>surgery</strong> (also known as obesity <strong>surgery</strong>) is at the top of Intui6ve Surgical's “General Surgery” list of interven6ons where the device<br />

offers significant benefits. This might be, if your surgeon has passed the learning curve <strong>and</strong> one is not among the pa6ents that are included in<br />

the learning curve. Well, the learning curve aspect is always present when implemen6ng a new technique, should technologies like the Da Vinci<br />

Robot not be allowed to have that learning curve?<br />

Indeed it should.<br />

However, through the below anecdotes we will illustrate the challenges of dis6nguishing between true MIS <strong>and</strong> marke6ng or perceived MIS:<br />

In the first anecdote a bariatric clinic was adver6sing for “the safest <strong>surgery</strong> in town” as the clinic was offering Robo6c Surgical Implanta6on of<br />

a gastric b<strong>and</strong> to obese pa6ents – so what? Is it wrong to adver6se for Da Vinci <strong>surgery</strong>? Well, in an experienced bariatric surgeon's h<strong>and</strong>s an<br />

implanted gastric b<strong>and</strong> by tradi6onal laparoscopy, also a MIS technique, will take on average 30 minutes (the really experienced o?en go as low<br />

as 20 minutes). Because of the complexity of opera6ng the Da Vinci robot <strong>and</strong> changing instrumenta6on during <strong>surgery</strong>, gastric b<strong>and</strong><br />

implementa6on in this clinic averaged three (3) hours. Even an unexperienced bariatric surgeon will be able to implant a gastric b<strong>and</strong><br />

laparoscopically in about one <strong>and</strong> half (1,5) hours.<br />

Another Da Vinci case related to the more <strong>invasive</strong> bariatric procedure, gastric bypass, paints a similar picture. In this case a clinic decided, for<br />

scien6fic <strong>and</strong> research purposes, to operate with the Da Vinci Robot. <strong>The</strong> average opera6ng 6me for this group of surgeons by tradi6onal<br />

laparoscopic technique was around two <strong>and</strong> a half hours. When first switching to perform the gastric bypass with Da Vinci, the opera6ng 6me<br />

exploded to around five to six hours. It was only a?er more than three years of experience <strong>and</strong> 300 Da Vinci gastric bypass procedures that this<br />

team managed to get the average opera6ng 6me down to a level that mirrored that of their tradi6onal laparoscopic gastric bypass procedures.<br />

And so what? Well, 6me is always a factor <strong>and</strong> especially in pa6ents undergoing bariatric <strong>surgery</strong>. One should consider that these pa6ents are<br />

high risk pa6ents, due to their complex disease paHern. Though bariatric pa6ents are operated for extreme overweight (one medical<br />

condi6on), many of these pa6ents also show up with a variety of co-­‐morbidi6es (mul6ple medical condi6ons) further complica6ng <strong>surgery</strong>. To<br />

give the reader, who might not be familiar with the disease picture of bariatric pa6ents, a quick overview of what we are talking about one<br />

should note that apart from extreme overweight, bariatric pa6ents o?en suffer from hypertension, diabetes, damaged/warn down joints,<br />

sleep-­‐apnoea <strong>and</strong> more.<br />

On top of this, one must add that during a tradi6onal laparoscopic or Da Vinci laparoscopic opera6on the pa6ent is on her/his back,<br />

anesthe6zed, ven6lated <strong>and</strong> “tossed around” from side to side – from extreme an6-­‐trendenelburg to extreme trendenelburg posi6ons (from<br />

siang upright to having the upper-­‐body in 35 degree ver6cally inversed angel). How do you think opera6ng 6me maHers to this kind of<br />

pa6ents? Well, some bariatric surgeons' rule of thumb is that if a laparoscopic procedure in bariatric pa6ents cannot be carried out in less than<br />

three hours conver6on to open technique should be st<strong>and</strong>ard opera6ng procedure, hence assuring that the opera6on is terminated within the<br />

3,5-­‐4,0 hour mark.<br />

Knowing this, how would you appreciate being among the first 300 pa6ents in the above anecdote? And we have not even discussed the<br />

monetary cost factor yet.<br />

<strong>The</strong> monetary part of the anecdote comes in two parts: First there is the extra 6me consump6on where the same team of surgeons,<br />

anesthesiologists, nurses etc. could have carried out more opera6ons, then there is the amor6za6on of the DKK 10-­‐12 million Da Vinci Robot<br />

price-­‐tag (instrumenta6on excluded).<br />

<strong>The</strong> authors of this brief hold conflic6ng views on technologies like Da Vinci in rela6on to MIS capabili6es. On one side it is inarguably a great<br />

piece of technology that in e.g. prostatectomy procedures offers MIS capabili6es beyond what is achieved by tradi6onal laparoscopy. However,<br />

considering the examples of gastric bypass or the horrendous example of gastric b<strong>and</strong>ing one must ques6on the true <strong>and</strong> broad level MIS<br />

capabili6es of this technology.<br />

Regardless of the authors cri6cal, yet, hopefully objec6ve assessment of Da Vinci as a true MIS technology across a broad range of procedures,<br />

it remains clear that with this technology <strong>surgery</strong> has taken a step towards a poten6al revolu6onizing future. It remains to be seen if it will be in<br />

the form of a robo6c console or whether some of these new features developed by Intui6ve Surgical, will be further enhanced <strong>and</strong> applied in<br />

the tradi6onal laparoscopic devices, <strong>and</strong> to which extend Intui6ve Surgical will be able to financially benefit longterm from the innova6ons it<br />

has become a first mover within.<br />

We hope that these two anecdotes <strong>and</strong> discussion around the Da Vinci Robot illustrates well the challenges in evalua6ng true MIS capabili6es<br />

<strong>and</strong>, thus, the challenges of developing true MIS devices.<br />

aquilo Ι www.aquilo.info 31


Appendix #5:<br />

Intui/ve Surgical, “Da Vinci” (b)<br />

Source: Intui-ve Surgical<br />

aquilo Ι www.aquilo.info 32

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!