2018 APAC Fluorescence Surgical Imaging for Breast Cancer
New Product Innovation Award

2018
APAC FLUORESCENCE SURGICALIMAGING FOR BREAST CANCERNEW PRODUCT INNOVATION AWARD

2018

BEST PRACTICES RESEARCH

Background and Company Performance
Industry Challenges
Breast cancer is the most common cancer among women globally, with more than 2
million new cases diagnosed in 2016 alone. Although various screening programs havesignificantly reduced the mortality rate over the last 10 years, breast cancer remains thefifth leading cause of cancer-related death among women in the Asia-Pacific (APAC)
region. During its early stages, breast cancer is often impalpable and does not exhibit any
signs or symptoms. However, identifying and treating the disease as early as possible iscritical for preventing it from metastasizing to the lymph nodes or other parts of the body;thus greatly improving a patient’s chance of survival. When compared to all other cancer
morbidity rates in women (e.g., cervical, uterine, ovarian), breast cancer has some of thehighest morbidity levels.
When diagnosing the metastasis of cancer cells in breast cancer patients, identifying theposition of the sentinel lymph nodes while excising them to diagnose the pathology
remains a crucial part of the diagnosis protocol. If the cancer has not metastasized to thesentinel lymph node, then the axillary lymph node excision can be omitted to prevent
lymphedema and help in maintaining the patient's quality of life after surgery. For thisreason, surgeons need to accurately determine the position of lymph nodes and quickly
proceed with surgery. As such, Frost & Sullivan points out that the industry is in dire needof a system designed to support breast cancer treatment through the visualization oflymph node, thereby allowing the surgeon to perform procedures while monitoring theposition of lymph nodes being excised.
New Product Attributes and Customer Impact
Product Matched to Needs: The Imperative for Clinical Change
Over the last decade, Shimadzu has made considerable advances in optical control andbiological tissue fluorescence imaging technologies; the company has played a key role inbringing fluorescence technology to the medical imaging industry. Driven by acommitment to research and development efforts, the company launched new nearinfrared fluorescence (NIRF) imaging system, known as LIGHTVISION, in August 2016.
The NIRF LIGHTVISION system stands out as a combination of extensive R&D efforts
coupled with key opinion leaders’ input to deliver a breakthrough image-guided
stereotactic solution with several unique value-adding capabilities. For example, it
supports breast cancer treatment through the visualization of lymph vessels and bloodvessels based on the detection of NIRF light emitted from an indocyanine green (ICG) dye.
Further, the unique additional clinical strengths of NIRF LIGHTVISION in breast cancer
treatment lie in:© Frost & Sullivan 2018

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Sentinel lymph node mapping: Its ability to assist in sentinel lymph node mapping for aquick and easy trace of the flow of lymph which is extending far from the primary cancer
lesion.
Perfusion assessment in breast reconstruction: In plastic and reconstructive surgicalprocedures, the NIRF LIGHVISION system provides a 10x zoom usefulness to a wide
target area of substantial abdominal flap. This 10x enlarger is utilized for top quality
representation of blood vessels to evaluate patency after anastomosis and to perform flap
perfusion, consequently giving a superior clinical investigation of breast reconstruction
assessment of flap perfusion.
Lymphatic vessel mapping on lymphedema: The NIRF LIGHTVISION can bolster theaffirmation of the progression of lymphedema by visualizing the movement throughlymphatic vessels. Amidst the lymphovenous anastomosis (LVA) procedure, the nearinfrared and visualization of lymphatic vessels can be of more noteworthy reference toeasily decide the progression of lymphatic vessels.
The demand for precise surgical navigation continues to grow, since surgeons rely on it
during cancer surgery. Physicians need detailed images of breast lymph nodes, tissues,
and blood vessels in real-time to enable faster decisions and to ultimately reduce
procedure times.
Though there are many competing systems available in the market today, Frost & Sullivan
believes the NIRF LIGHTVISION system to be unrivaled, because it provides cutting-edge,
real-time contrast images of lymph vessels. It achieves this by administering the ICG dyethrough the lymph vessels and thereby exposing the corresponding tissue to excitation
light. With the NIRF LIGHTVISION system, surgeons gain a faster and deep visualization
to assist in determining the ablation range using three different images at once (i.e., ‘one’from the optical image, ‘two’ from the near-infrared fluorescence image, and ‘three’ acombined visible plus near-infrared fluorescence image). Furthermore, the NIRF
LIGHTVISION system is superior in terms of resolution to visualize the position of sentinel
lymph nodes for diagnosing the metastasis status of cancer cells. Another key advantage
with the NIRF LIGHTVISION system is that it enables image acquisition in a bright field ofview, without requiring the switching off of overhead lighting in the operating room.
Product Reliability and Quality
The NIRF LIGHTVISION system is currently approved for use in the APAC market. Upon
introduction in the Japanese market, the company has installed about 10 systems.
Currently, Shimadzu’s focus is on new geographical penetration in the Southeast Asian
countries.
With significant investment in R&D for diagnosis and treatment of breast cancer usingintraoperative fluorescence imaging, Shimadzu is quite confident in its ability to expand
globally to overtake its competitors in this space after regulatory clearance. The company© Frost & Sullivan 20183

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has a sterling reputation in optical imaging thanks to its superior fluoroscopic technology
and valuable product attributes. Frost & Sullivan firmly believes that Shimadzu is setting a
new industry benchmark in the near-infrared fluorescence imaging system space.
Product DesignShimadzu has clearly demonstrated its technological supremacy in redefining the healthcare
space in surgical oncology with its introduction of the NIRF LIGHTVISON system.
Below are the main NIRF LIGHTVISON system features that have greatly impressed Frost &Sullivan.
 A high definition image quality is emitted by the near-infrared fluorescent light from indocyanine
green. This light clearly differentiates lymph ducts and blood vessels as well as the placement andposition of surgical tools and tissues during surgery.
 User-friendly features are exhibited by the system’s operability in terms of hands-free imaging,camera movement up to 180 centimeters, and camera positioning depending on the anatomical
region of interest (breast, leg, and neck).
 NIRF LIGHTVISION is equipped with high-definition sensors that yield high-quality real-time images
on a single monitor for surgeons to gain deep visualization and definitive ablation range during
surgery.
 Additionally, features like automatic light exposure adjustment and automatic white balanceadjustment aid in better visual resolution and obtaining images up to a magnification of 10 times.

Product Positioning
Shimadzu’s remarkable performance in optical imaging is demonstrated by its highdefinition image quality. The three colors (white, green, and blue) improve visualization ofblood vessels and lymph ducts and provide clear differentiation from surrounding tissues.
This feature helps surgeons reference and confirm a large amount of information at aquick glance, thereby reducing the procedure time.
Shimadzu strives to enhance the quality and safety of care by improving surgicalworkflows and generating efficiencies in the operating room. Frost & Sullivan believes thatthe unique selling points of NIRF LIGHTVISION lie in its overall system design and intuitive
workflow coupled with it being a mobile surgical device system.
Brand Equity
Years of experience in optical control and biological tissue fluorescence imaging
technologies have led to the scintillating success of the NRIF LIGHTVISION system,aligning Shimadzu’s vision and transition towards transformational value-based
healthcare. Frost & Sullivan concludes that this vibrant breakthrough will increase the© Frost & Sullivan 2018

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overall brand presence of Shimadzu when compared to other competitors in the market.
With its new product launch, the company has achieved a comprehensive portfolio ofproducts required for medical imaging solutions focusing on enhanced automation,efficiency, image quality, and cutting-edge applications that enrich clinical value and build
solid partnerships with end users.

Conclusion
Frost & Sullivan’s independent analysis identifies Shimadzu as a trendsetter inintraoperative near-infrared fluorescence imaging systems, specifically because it brings
innovation in surgical treatment. Supported by the company’s stellar reputation in medical
imaging modalities, NIRF LIGHTVISION is expected to experience wide adoption as asurgical tool for breast cancer, while efforts are well underway for the technology to serve
other anatomical regions (e.g. Liver – to assess in identifying tumors in liver before
hepato-pancreato-biliary surgery, assessing vascular anastomosis during coronary artery
bypass surgery and identifying sentinel lymph nodes for melanoma) in the future.
Shimadzu is acting on its promise to significantly influence real-world healthcare
challenges with real-time medical imaging technologies that surgeons can rely on to locate
lymph nodes, lymphatic vessels, and tissues precisely. This system shortens surgicalprocedure time frames, leading Frost & Sullivan to conclude that Shimadzu is on the rightpath for continuing its market expansion.
For its strong overall performance, Shimadzu is recognized with the 2018 Frost & Sullivan
New Product Innovation Award in the Breast Cancer Fluorescence Surgical Imaging industry.

© Frost & Sullivan 2018

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Significance of New Product Innovation
Ultimately, growth in any organization depends upon continually introducing new products
to the market and successfully commercializing those products. For these dual goals tooccur, a company must be best-in-class in three key areas: understanding demand,nurturing the brand, and differentiating from the competition.

Understanding New Product Innovation
Innovation is about finding a productive outlet for creativity—for consistently translatingideas into high-quality products that have a profound impact on the customer.

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Key Benchmarking Criteria
For the New Product Innovation Award, Frost & Sullivan analysts independently evaluated
two key factors—New Product Attributes and Customer Impact—according to the criteria
identified below.

New Product Attributes
Criterion 1: Match to Needs
Requirement: Customer needs directly influence and inspire the product’s design andpositioning.
Criterion 2: Reliability
Requirement: The product consistently meets or exceeds customer expectations forconsistent performance during its entire life cycle.
Criterion 3: Quality
Requirement: Product offers best-in-class quality, with a full complement of features andfunctionalities.
Criterion 4: Positioning
Requirement: The product serves a unique, unmet need that competitors cannot easily
replicate.
Criterion 5: Design
Requirement: The product features an innovative design, enhancing both visual appeal
and ease of use.

Customer Impact
Criterion 1: Price/Performance Value
Requirement: Products or services offer the best value for the price, compared to similarofferings in the market.
Criterion 2: Customer Purchase Experience
Requirement: Customers feel they are buying the most optimal solution that addresses
both their unique needs and their unique constraints.
Criterion 3: Customer Ownership Experience
Requirement: Customers are proud to own the company’s product or service and have apositive experience throughout the life of the product or service.
Criterion 4: Customer Service Experience
Requirement: Customer service is accessible, fast, stress-free, and of high quality.
Criterion 5: Brand Equity
Requirement: Customers have a positive view of the brand and exhibit high brand loyalty.

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BEST PRACTICES RESEARCHBest Practices Recognition: 10 Steps to Researching,Identifying, and Recognizing Best Practices
Frost & Sullivan analysts follow a 10-step process to evaluate Award candidates andassess their fit with select best practice criteria. The reputation and integrity of theAwards are based on close adherence to this process.
STEPOBJECTIVE

1Monitor,target, andscreen

Identify Award recipient
candidates from around theglobe

 Conduct in-depth industry
research Identify emerging sectors
 Scan multiple geographies

Pipeline of candidates who
potentially meet all bestpractice criteria

2

Perform
360-degree
research

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 of all
candidates’ performance
relative to one another

3Invitethought
leadership in
best
practices

Perform in-depth
examination of all candidates

 Confirm best-practice criteria
 Examine eligibility of all
candidates
 Identify any information gaps

Detailed profiles of allranked candidates

4Initiateresearch
director
review

Conduct an unbiased
evaluation of all candidate
profiles Brainstorm ranking options
 Invite multiple perspectives
on candidates’ performance Update candidate profiles

Final prioritization of alleligible candidates andcompanion best-practice
positioning paper

Assemble
panel ofPresent findings to an expert
panel of industry thought
leaders

 Share findings Strengthen cases forcandidate eligibility
 Prioritize candidates

Refined list of prioritizedAward candidates

Build consensus on Award
candidates’ eligibility

 Hold global team meeting toreview all candidates
 Pressure-test fit with criteria
 Confirm inclusion of alleligible candidates

Final list of eligible Award
candidates, representing
success stories worldwide

Develop official Award
consideration materials Perform final performancebenchmarking activities
 Write nominations
 Perform quality review

High-quality, accurate, andcreative presentation of
nominees’ successes

Finalize the selection of thebest-practice Award recipient Review analysis with panel Build consensus
 Select recipient

Decision on which company
performs best against all
best-practice criteria

Inform Award recipient ofAward recognition

 Present Award to the CEO
 Inspire the organization forcontinued success Celebrate the recipient’s
performance

Announcement of Awardand plan for how recipient
can use the Award toenhance the brandUpon licensing, company isable to share Award news
with stakeholders andcustomers

 Coordinate media outreach Design a marketing plan Assess Award’s role in future
strategic planning

Widespread awareness ofrecipient’s Award statusamong investors, media
personnel, and employees

5 industry
experts

6

Conduct
globalindustry
review7

Perform
quality check8

Reconnectwith panel ofindustry
experts

9

Communicate
recognitionTake

10 strategic
action© Frost & Sullivan 2018

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The Intersection between 360-Degree Research and BestPractices Awards
Research Methodology
Frost & Sullivan’s 360-degree research
360-DEGREE RESEARCH: SEEING ORDER IN
methodology represents the analytical
THE CHAOS
rigor of our research process. It offers a360-degree-view of industry challenges,
trends, and issues by integrating all 7 of
Frost & Sullivan's research methodologies.
Too often companies make important
growth decisions based on a narrow
understandingof
theirenvironment,
leading to errors of both omission andcommission. Successful growth strategies
are founded on a thorough understandingof market, technical, economic, financial,customer, best practices, and demographicanalyses. The integration of these researchdisciplines into the 360-degree researchmethodology
providesanevaluation
platformforbenchmarking
industry
participants and for identifying those performing at best-in-class levels.

About Frost & Sullivan
Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth
and achieve best-in-class positions in growth, innovation and leadership. The company's
Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined
research and best practice models to drive the generation, evaluation, and implementationof powerful growth strategies. Frost & Sullivan leverages more than 50 years ofexperience in partnering with Global 1000 companies, emerging businesses, and theinvestment community from 45 offices on six continents. To join our Growth Partnership,
please visit http://www.frost.com.

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