2016 North American Colonoscope New Product Innovation Award

2016

BEST PRACTICES RESEARCH

Contents Background and Company Performance ........................................................................ 3 Industry Challenges .............................................................................................. 3 New Product Attributes and Customer Impact of invendo medical GmbH ..................... 3 Conclusion........................................................................................................... 6 Significance of New Product Innovation ......................................................................... 7 Understanding New Product Innovation ......................................................................... 7 Key Benchmarking Criteria .................................................................................... 8 The Intersection between 360-Degree Research and Best Practices Awards ....................... 8 Research Methodology .......................................................................................... 8 About Frost & Sullivan ................................................................................................ 9

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Background and Company Performance Industry Challenges According to the American Cancer Society, excluding skin cancers, colorectal cancer is the third most common diagnosed cancer in the United States (US) and will lead to an estimated 49,190 deaths in 20161. As with all cancers, early detection is a large factor in boosting survival rates. Physicians conduct a colonoscopy to examine the inside of the rectum and colon for polyps, or small growths that could become cancerous over time. A colonoscope is a thin, flexible tube with a video camera on the end used by physicians during a colonoscopy. The colonoscope pumps small amounts of air to keep the colon open and clear, allowing physicians to take pictures as the colonoscope is eased inside the patient and throughout the colon. Colonoscopes also have a retrieval feature, enabling providers to remove polyps for biopsy during the procedure. Physicians generally recommend that patients get a colonoscopy every ten years unless the patient is at a heightened risk of colorectal cancer. Traditional colonoscopes are reusable, causing the Centers for Disease Control (CDC) to release extensive and complex guidelines for the proper sterilization and disinfection of scopes. While these guidelines are comprised of five primary segments—clean, disinfect, rinse, dry, and store—due to the complex and flexible nature of the scopes, there are over a hundred manual steps that staff must conduct on each scope to ensure that they are properly sterilized and disinfected. Despite these comprehensive standards, audits have shown that they do not completely eliminate bacteria on the scope, due either to personnel not following guidelines or instrument complexity.2 The CDC estimates that at least 1 in 276,000 gastrointestinal procedures place a patient at risk of attracting an endoscopyassociated infection3. Even when staff correctly follows thorough sterilization procedures, there is still a chance of residual bacteria remaining, as scope designs have small cavities and intricate, retractable pieces. A variety of hospital-acquired infections (HAI) have been attributed to scopes and improper sterilization procedures, heightening demand for a solution to overcome the challenges of scope sterilization.

New Product Attributes and Customer Impact of invendo medical GmbH Based in Garden City, New York, US and Kissing, Germany, invendo medical GmbH (invendo) designed the first and only single-use colonoscope to eliminate infections acquired from inefficient scope sterilization. The company’s advanced invendoscopy E200 system utilizes robotic technology and has a single-use, sterile colonoscope providing physicians with a simple-to-use system that improve procedure safety and efficiency. The system has 1

http://www.cancer.org/healthy/findcancerearly/examandtestdescriptions/faq-colonoscopy-and-sigmoidoscopy http://www.cdc.gov/hicpac/disinfection_sterilization/3_0disinfectequipment.html 3 Rutala WA, Weber DJ, and the Healthcare Control Practices Advisory Committee (HICPAC). CDC. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf 2

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three primary components: the invendoscope SC200, the invendo ScopeController, and the invendo SPU E200, the software and control center. invendoscope SC200 The advanced invendoscope SC200 is a single-use, sterile colonoscope that eliminates the risk of cross-contamination between uses. The scope has a 170-centimeter tube length and provides standard functions—i.e., suction, flushing, rinsing, and insufflation—allowing physicians to insert, guide, and use the advanced scope as they would traditional systems. The invendoscope SC200 has three white-light LEDs and has an advanced CMOS imaging chip for image capture to ensure physicians can clearly examine pathways. Additionally, it allows for 180-degree bending with a tighter than industry standard radius (35 millimeters compared to the traditional 52 millimeters) providing physicians with greater flexibility to examine behind folds in more spatially confined areas of the colon. The invendoscope SC200 is also delivered with pre-attached sterile and single-use water supply and waste tubes, ensuring the hygienic safety of the procedure. Finally, the system’s sterile packaging attaches to an IV pole, ensuring an easy and aseptic two-stage unpacking process. invendo ScopeController Traditional colonoscopes have a mechanical design in which cables run through the scope tubing and are controlled by wheel interfaces on the controller unit. Physicians must turn wheels to move the camera on the scopes tip. The advanced invendoscope SC200 relies on robotic technology, giving physicians a more enhanced scope interface via a joystick-like control plate. Additionally, the instrument can detach from the controller, making it ergonomically easier for physicians to use the controller and feed the scope simultaneously. It is also reusable and easily cleaned. invendo medical plans on making controllers of different sizes and suited to both right and left-handed physicians, enhancing its ease of use. invendo SPU E200 The invendo SPU E200 activates the supplies and controls of the procedure, and has a touch screen interface for easy data entry, set-up, and switching between functions. The system controls the internal fluidic system that runs the deflecting and LED cooling functions as well as the external fluidic system that enables the rinsing and suction functions. The portable system also has containers to collect waste products vacuumed out during the procedure. The system’s touchscreen provides a variety of interfaces, including: 

Vacuum



CO2



Image capture or recording



Medical grade monitoring

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Ensuring a Completed Screening Procedure: The Diagnostic Mode

Physicians traditionally rotate the scope camera tip in a slow spiral motion when removing the scope providing them with a 140-degree view of the colon pathway as a redundant procedure

to

ensure

clinical

efficacy.

As

traditional

methods

dictate,

mechanical

colonoscopes require physicians to circulate the camera with the wheel controls manually. Physicians do not conduct these redundant procedures at consistent speeds or views leading to an inefficient overall process. As a result of this inefficiency, some physicians do not circulate the tip to save time. invendo medical created its diagnostic mode which automates the tip circulation during removal, ensuring the entire colon pathway receives a double check. Additionally, the tight bending of the tip radius provides physicians with a greater than 140-degree view, further expanding surgical site visual-coverage. High Value and Increased Patient Safety and Satisfaction The invendoscopy E200 system’s cost approximately $35,000 for the hand-held controller and the core unit. The company expects that the sterile, single-use scopes will cost $200 to $300. But as the demand for scopes rises and production scales up, the company is projecting replacement scopes will eventually cost below $200 each. The economic solution provides end users with a greater overall investment as hospitals no longer waste time and money on complex cleaning and disinfection procedures that run the risk of patients getting infections from cross-contamination, and therefore, removing the risk of additional costs of infection treatment. Additionally, patients have a growing awareness of possible inefficient scope reprocessing processes; the invendoscopy E200 system enhances hospitals’ patientcentric focuses. invendo medical’s Commitment to Customer Satisfaction As the invendoscopy E200 system’s use is similar to traditional, reusable scopes, physicians can easily utilize the system without requiring extensive training. invendo medical travels onsite to provide training to physicians that consists of a short introduction of the system’s capabilities and short, hands-on training allowing physicians to get comfortable with the controller; the overall training takes less than a day. invendo medical is conducting a soft, 6 to 12-month launch of the invendoscopy E200 system, allowing the company’s direct sales and support staff to observe initial cases and gather feedback. Additionally, the soft launch will enable the company to increase manufacturing capabilities, ensuring that it can meet the demand upon launching the invendoscopy E200 system fully into the US market. After the soft launch, invendo medical will determine whether it will leverage only a direct sales force or work with a distributor partner to provide service and support for its products. In addition to gathering feedback of its invendoscopy E200 system and ensuring a strategic market expansion, invendo medical is continuing innovation of its invendoscopy E200 system. The company is planning on replacing the standard-resolution CMOS imaging chip on the invendoscope with a high-definition CMOS camera to provide physicians with higher resolution

images.

Moreover,

invendo

medical

is

investigating

its

technological

advancements and single-use sterile scope design use in other gastrointestinal scopes; the © Frost & Sullivan 2016

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company plans to release a full line of sterile, single-use scopes as it continues to grow. invendo medical’s Focus on Expanding Awareness invendo medical understands that basically all of its potential customers are utilizing traditional, reusable colonoscopes. As a result, the company’s priority is to educate physicians regarding the advanced invendoscopy E200 system value offering in relevant trade shows and events. While invendo medical targets physicians to gain key contacts within the industry, many times physicians are unaware of details of the cleaning and disinfection processes, as they receive the scope after reprocessing. As a result, the company is also focusing education materials that emphasize infection-control to staff members and nursing practitioners, as these members focus primarily on proper reprocessing techniques. Finally, the company is focusing on educating potential patients of the increased safety of the invendoscopy E200 system, to help patients ask questions about their health procedures or travel to centers using the system to ensure their safety. In addition to expanding market awareness, invendo medical is conducting strategic analysis of the market to determine if a direct sales force or a distribution partner would enable most efficient market expansion while still offering advanced levels of support to providers. The company is also pursuing CE mark approval and hopes to continue expanding the invendoscopy E200 system into global markets.

Conclusion Due to the complex design of the flexible endoscope, various professional societies like AAMI, AORN, SGNA and the Centers for Disease Control created extensive reprocessing guidelines to eliminate cross-contamination between endoscopic procedures. Despite these comprehensive regulations, inefficient endoscope reprocessing leads to at least 1 in 276,000 gastrointestinal procedures placing patients at risk of getting an endoscopyassociated infection. invendo medical GmbH developed the first and only single-use, sterilized colonoscope, the invendoscope SC200, to eliminate possible cross-contamination between procedures. Frost & Sullivan’s independent analysis clearly shows that its advanced design uses robotic-assisted endoscopy technology to provide physicians with heightened control, streamlining the colonoscopy procedure and increasing patient safety and comfort. invendo medical is continuing its innovation and plans to release a full line of single-use gastrointestinal solutions, eliminating infections due to improper or inefficient reprocessing procedures. For its advanced innovation increasing patient safety, invendo medical GmbH earns Frost & Sullivan’s 2016 North America New Product Innovation Award in the colonoscope market.

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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 to occur, 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 translating ideas 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 Criterion 2: Reliability Criterion 3: Quality Criterion 4: Positioning Criterion 5: Design 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

analytical

360-DEGREE RESEARCH: SEEING ORDER IN THE CHAOS

rigor of our research process. It offers a 360-degree-view of industry challenges, trends, and issues by integrating all 7 of Frost & Sullivan's research methodologies. Too

often,

growth

companies

decisions

understanding

of

make

based

on

their

important a

narrow

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 analyses. The integration of these research disciplines into the 360-degree research methodology platform

provides

for

an

benchmarking

evaluation industry

players and for identifying those performing at best-in-class levels.

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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 disciplin ed research and best practice models to drive the generation, evaluation and implementation of powerful growth strategies. Frost & Sullivan leverages over 50 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from 40 offices on six continents. To join our Growth Partnership, please visit http://www.frost.com.

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