Download 2016 European Minimally - Invasive Structural Heart Devices

2016 European Minimally - Invasive
Structural Heart Devices
Product Line Strategy Leadership Award
2016
BEST PRACTICES RESEARCH
Contents
Background and Company Performance ........................................................................ 3
Industry Challenges .............................................................................................. 3
Product Line Strength and Customer Impact of Occlutech .......................................... 3
Conclusion........................................................................................................... 6
Significance of Product Line Strategy ............................................................................ 7
Understanding Product Line Strategy Leadership ............................................................ 7
Key Benchmarking Criteria .................................................................................... 8
The Intersection between 360-Degree Research and Best Practices Awards ....................... 8
Research Methodology .......................................................................................... 8
Best Practices Recognition: 10 Steps to Researching, Identifying, and Recognizing Best
Practices ................................................................................................................... 9
About Frost & Sullivan .............................................................................................. 10
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Background and Company Performance
Industry Challenges
Structural heart disease commonly refers to heart defects or abnormalities present at
birth—congenital—but may also include abnormalities that develop later in life due to the
normal wear and tear of aging; infections such as rheumatic fever and endocarditis; or
injury resulting from heart attacks, medications, or other underlying conditions such as
high blood pressure. The term structural heart disease encompasses an array of disorders
associated with congestive heart failure (CHF) and embolic stroke, including:
•
Atrial septal defect (ASD): A hole
Spectrum of Structural Heart Disease
in the wall (septum) between the
top two chambers of the heart
(atria); one of the most common
congenital
heart
defects
still
present in adulthood
•
Ventricular septal defect (VSD): A
hole in the septum between the
lower two chambers of the heart
(ventricles)
•
Patent foramen ovale (PFO): A
tunnel between the atria
•
Left
atrial
appendix
(LAA):
A
Source: European Heart Journal
http://eurheartjsupp.oxfordjournals.org/content/ehjsupp/12/suppl
_E/E2.full.pdf
small pouch in the wall of the left
atrium and site of thrombus formation
Until recently, open heart surgery was the first line of treatment for structural heart
disorders. Presently, technological advances in catheterization techniques, medical
imaging, as well as devices over the last decade provide effective, minimally-invasive
alternatives to open heart surgery. Minimally-invasive techniques reduce the physical
trauma and are associated with improved patient outcomes, shorter hospital stays, and
reduced hospital costs.
As a result, interventional cardiology procedures are now the standard of care to treat
ASD and PFO. Driven by a growing demand for minimally-invasive procedures, new
product
launches,
percutaneous
increasing
(catheter-based
fibrillation—structural
heart
applications,
interventions)
interventions
are
and
LAA
expanding
occlusion
growing
in
rapidly
indications—such
patients
within
with
the
as
atrial
broader
interventional cardiology segment.
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New technologies, the range of structural heart disease, and the inherent differences
within each disease process impact the level of skill, expertise, and understanding
required to implant the right product for individual structural defects. While different
diseases may require similar devices and implantation techniques like in ASD and PFO, all
devices are different and processes cannot be interchanged. Moreover, even within one
disorder, one device does not fit every lesion. Device manufacturers that recognize each
procedure nuance and physician struggles while providing flexible and broad solutions and
specialized, dedicated physician training with support personnel will capture market share.
Product Line Strength and Customer Impact of Occlutech
Established in 2003 in Jena, Germany, Occlutech is a private company that develops,
manufactures, and sells innovative, premium structural heart occluders, including
accessories, in over 85 countries worldwide. To date, over 50,000 structural heart
procedures have been performed using the company’s occluders. Since inception, the
company’s focus and key mission is to “help physicians treat structural heart diseases
better, easier, and safer.”
Occlutech: Better, Safer Structural Heart Occluders
Cardiac catheterization is a minimally-invasive procedure for treating some heart
conditions including ASD, VSD, and PFO. Using imaging to guide the surgery, the
physician makes a small incision in the leg or arm and inserts a catheter to access the
heart. A special sizing balloon measures the defect’s stretched diameter, enabling the
physician to select the appropriate device size. An introducer sheath then delivers the
occlusion device to the defect site, the physician positions the occluder, pushes the device
out of the catheter, and the device expands plugging the hole, preventing the need for
open heart surgery.
Occlutech’s patented nitinol braiding technology allows the company to develop highquality occlusion devices with unique properties that provide significant advantages over
competing products. The company’s special braiding process results in more flexible
occluders than any other product currently on the market. With the memory effect of
nitinol (shape-memory alloy) and the occluders’ flexibility, the devices enable unparalleled
versatility for adjusting to very difficult geometries. Occlutech also has patents on its
surface treatment technology and delivery systems, which support the implants’
biocompatibility as well as increased maneuverability for better product placement under
various challenging conditions and defects.
The company’s occluders are also safer than competitor offerings. The devices’ superior
technology and design coupled with the unique delivery systems minimize the risk of fatal
complications, including erosion. Unlike competing products to date, after 50,000
interventions no cases have been reported where the occluder implanted erodes the tissue
around it.
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Dedicated Expertise, Expanded Access, Valuable Support
Structural Heart Occluders, Occlutech
ASD
Occlutech is a structural heart disease expert with
a
full
product
paravalvular
arteriosus
line—including
leak
(PDA).
configurations,
(PLD),
The
and
devices
specific
to
ASD,
patent
PFO,
ductus
have
different
individual
disease
abnormalities, and are available in multiple sizes,
to address a range of morphologies as well as
PFO
anatomies.
PDA
The
company’s
broad,
flexible,
and
versatile
solutions enable physicians to treat many patients
PLD
that
were
not
previously
minimally-invasive
Courtesy of Occlutech
eligible
structural
heart
to
undergo
procedures,
reducing the number of patients that ultimately
require surgery.
To ensure the best value for its customers and successful clinical outcomes, Occlutech
trains its sales force as well as its global distribution network to support physicians in all
aspects—selecting the right product for each indication in a particular case. Furthermore,
the company assists all its clients through a global network of specialized physicians that
advice the interventional physician during the procedure for better treatment.
Leveraging Customer-driven Innovation with Global Ambitions
The company understands its customers’ needs and responds with fast innovation.
Occlutech works closely with key opinion leaders and physicians worldwide. Depending on
the market needs/gaps, the company develops both novel products for new indications as
well as better products for rapidly growing areas, keeping Occlutech at the innovation
forefront while earning customer trust and capturing share from its larger counterparts.
The company responds quicker to the market’s innovation demands than its competitors
due to its smaller size, dedicated research and development resources, and regional
manufacturing plants in Germany, Turkey, and Sweden.
Occlutech’s latest product, muscular VSD, received CE approval in late 2015. The company
plans to seek European approval for its perimembraneous VSD and LAA occluders in 2016
and has an additional 8 products in its pipeline. Furthermore, Occlutech is expanding its
geographical access and availability. The company’s ASD closure device gained approval in
Japan in early 2016, with its next stop being China. The company is growing in all the
markets where it is present and projects a 20% annual increase over the next 5 years.
Occlutech’s short-term strategy is to strengthen its position in the international market
before entering the United States market in the next 2 to 3 years.
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With over a decade of product innovation and development experience, Occlutech is
uniquely positioned to grow sales and gain market share globally. Frost & Sullivan believes
that the company brings the expertise, flexibility, and versatility needed to support the
emerging and diverse needs in the structural heart disease market.
Conclusion
With technological advances in catheterization techniques, structural heart disease is an
emerging sector within the broader interventional cardiology segment. Occlutech’s efforts
to advancing high-quality, flexible, and versatile structural heart occluders coupled with
specialized physician support ensures better, easier, and safer treatments to a broader
patient population. Frost & Sullivan anticipates that these strategies will support the shift
from open heart surgery to more minimally-invasive options as the standard of care for
many patients with structural heart disease.
With its commitment to customer-driven innovation, broad product offering, and strong
overall performance, Occlutech earns Frost & Sullivan’s 2016 European Product Line
Strategy Award in the minimally-invasive structural heart device industry.
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Significance of Product Line Strategy
Ultimately, growth in any organization depends upon customers purchasing from your
company, and then making the decision to return time and again. A full, comprehensive
product line that addresses numerous customer needs and preferences is therefore a
critical ingredient to any company’s long-term retention efforts. To achieve these dual
goals (customer value and product line strength), an organization must be best-in-class in
three key areas: understanding demand, nurturing the brand, and differentiating from the
competition.
Understanding Product Line Strategy Leadership
As discussed above, driving demand, brand strength, and competitive differentiation all
play a critical role in delivering unique value to customers. This three-fold focus, however,
must ideally be complemented by an equally rigorous focus on building a superior and
comprehensive product line.
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Key Benchmarking Criteria
For the Product Line Strategy Leadership Award, Frost & Sullivan analysts independently
evaluated two key factors—Product Line Strength and Customer Impact—according to the
criteria identified below.
Product Line Strength
Criterion 1: Breadth
Criterion 2: Scalability
Criterion 3: Technology Leverage
Criterion 4: Features
Criterion 5: Supply Chain Reliability
Customer Impact
Criterion 1: Price/Performance Value
Criterion 2: Customer Purchase Experience
Criterion 3: Customer Ownership Experience
Criterion 4: Customer Service Experience
Criterion 5: Brand Equity
The Intersection between 360-Degree Research and Best
Practices Awards
Research Methodology
Frost & Sullivan’s 360-degree research
methodology
represents
the
360-DEGREE RESEARCH: SEEING ORDER IN
THE CHAOS
analytical
rigor of our research process. It offers a
Emerging
Technologies
360-degree-view of industry challenges,
Industry
Evolution
Smart Cities
trends, and issues by integrating all 7 of
Technology
Obsolescence
New Business
Cultures
Demographics
Frost & Sullivan's research methodologies.
Too
often,
growth
companies
decisions
understanding
of
make
based
on
their
important
a
Crowd
Sourcing
Career
Development
Industry
Expansion
Country
Risk
Competitive
Benchmarking
Buying
Behavior
New Vertical
Markets
Capital
Investments
narrow
Competitive
Strategy
environment,
leading to errors of both omission and
commission. Successful growth strategies
are founded on a thorough understanding
of market, technical, economic, financial,
customer, best practices, and demographic
CEO
Availability
of
Capital
Emerging
Competition
New
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Economic
Trends
Growth
Strategies
Growth
Implementation
Branding
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Positioning
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Perceptions
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Industry
Convergence
Disruptive
Technologies
analyses. The integration of these research
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Best Practices Recognition: 10 Steps to Researching,
Identifying, and Recognizing Best Practices
Frost & Sullivan Awards follow a 10-step process to evaluate award candidates and assess
their fit with select best practice criteria. The reputation and integrity of the Awards are
based on close adherence to this process.
STEP
Monitor,
1 target, and
screen
OBJECTIVE
KEY ACTIVITIES
OUTPUT
Identify award recipient
candidates from around the
globe
• Conduct in-depth industry
research
• Identify emerging sectors
• Scan multiple geographies
Pipeline of candidates who
potentially meet all bestpractice criteria
Perform comprehensive,
360-degree research on all
candidates in the pipeline
• Interview thought leaders
and industry practitioners
• Assess candidates’ fit with
best-practice criteria
• Rank all candidates
Matrix positioning all
candidates’ performance
relative to one another
2
Perform
360-degree
research
Perform in-depth
examination of all candidates
• Confirm best-practice criteria
• Examine eligibility of all
candidates
• Identify any information gaps
Detailed profiles of all
ranked candidates
3
Invite
thought
leadership in
best
practices
Initiate
research
Conduct an unbiased
evaluation of all candidate
profiles
• Brainstorm ranking options
• Invite multiple perspectives
on candidates’ performance
• Update candidate profiles
Final prioritization of all
eligible candidates and
companion best-practice
positioning paper
5
Assemble
panel of
industry
experts
Present findings to an expert
panel of industry thought
leaders
• Share findings
• Strengthen cases for
candidate eligibility
• Prioritize candidates
Refined list of prioritized
award candidates
6
Conduct
global
industry
review
Build consensus on award
candidates’ eligibility
• Hold global team meeting to
review all candidates
• Pressure-test fit with criteria
• Confirm inclusion of all
eligible candidates
Final list of eligible award
candidates, representing
success stories worldwide
7
Perform
quality check
Develop official award
consideration materials
• Perform final performance
benchmarking activities
• Write nominations
• Perform quality review
High-quality, accurate, and
creative presentation of
nominees’ successes
8
Reconnect
with panel of
industry
experts
Finalize the selection of the
best-practice award recipient
• Review analysis with panel
• Build consensus
• Select winner
Decision on which company
performs best against all
best-practice criteria
Inform award recipient of
award recognition
9
Communicate
recognition
• Present award to the CEO
• Inspire the organization for
continued success
• Celebrate the recipient’s
performance
Announcement of award
and plan for how recipient
can use the award to
enhance the brand
Upon licensing, company
may share award news with
stakeholders and customers
• Coordinate media outreach
• Design a marketing plan
• Assess award’s role in future
strategic planning
Widespread awareness of
recipient’s award status
among investors, media
personnel, and employees
4 director
review
10
Take
strategic
action
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About Frost & Sullivan
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