The following is a view of Chul-Hi Park Ph.D., founder of Endoscape Surgical (see below 5. for the CV) on how the

current surgical stapling market would evolve and transform with restoration of scientific discipline in the

developments (reinvention) of surgical stapling products and a guideline for collaboration with a goal of reshaping

and revitalizing the surgical stapling market as expeditiously as possible.





1. STRATIFICATION OF SURGICAL STAPLING PRODUCT MARKET



Generation 1: the currently marketed, legacy surgical stapling products


Generation 2: the reinvented surgical stapling products including adjunct specialty products supporting the expanded

parameterization and novel surgical staplers based on the new stapling methods/technologies






2. BASIS OF GENERATIONAL EVOLUTION OF SURGICAL STAPLING PRODUCT



2.1. Scientific Foundation Broadened


- The Gen. 1 surgical stapling product, not including those with steps or bumps

on the staple cartridge deck and offset leg staples, were based on a scientific foundation, albeit rudimentary.


- The scientific foundation and associated parameterization of the Gen. 2 surgical stapling product are broadened in

multiple steps with progressively increasing complexities to enable analysis of appropriate scientific rigor required to

properly understand the surgeon user experiences with the products in clinical setting and to analyze and identify the

root causes of adverse events reported to the FDA.



2.2. Informed Clinical Decision Making Enabled



Newly available to the surgeon users are:


- A new set of adjunct analytical instruments designed to enable quantification of selected new parameters associated

with the broadened scientific foundation of the Gen. 2 surgical stapling product.


- A new set of adjunct analytical instruments designed to enable in-situ inspection and evaluation of performance of

surgical stapling products



2.3. Regulatory Clearance Framework Redefined



The key elements for the 510(k) framework would be in tune with the well established scientific research methodology

and updated to accommodate the broadened scientific foundation of the Gen. 2 surgical stapling products.






3. COMPETITIVE BARRIERS FOR THE GEN. 2 SURGICAL STAPLING PRODUCT



3.1. The trade secret - The broadened scientific foundation of the Gen. 2 with distance to the nearest competitor of

5~10 calendar years PROVIDED that the academic, scientific research on the art of surgical stapling as well as critical

analysis of the real world, surgeon user experiences and reported adverse events are diligently and continually

performed by scientist(s) highly trained (15~20 years) in the basic science research closely alongside the technological

development projects for surgical stapling products which, in turn, must be carried out solidly guided by the

knowledges and findings resulting from the academic and real world scientific research.



3.2. The intellectual property - 40~50 patented and patentable intellectual properties (not counting off-springs) with

distance to the nearest competitor of the duration of patent rights in addition to the time required for the academic

and real world scientific research to reach a certain degree of maturity



3.3. The redefined regulatory framework






4. COLLABORATION PROPOSED (GUIDELINE)



4.1. Aim - Establish dominance in the surgical stapling market by offering both high (the Gen. 2) and low (the Gen. 1

with no steps, bumps or offset legs) end products in all geographies



4.2. Model 1 - Joint effort



- Endoscape Surgical: Product development and regulatory clearance



- Prospective Partner:


-- Manufacturing and marketing/sales, No need to build up an in-house competency in basic science research on the

surgical stapling


-- Upfront payment commensurate with market share goal and/or other financial metric pertinent to market

performance of the reinvented surgical stapling products, and and product loyalty



4.3. Model 2 - Buyout and reinvention assistance



- Endoscape Surgical:


-- All intellectual properties (current and future patent, patentable and trade secret with specific and exclusive

relevance to the surgical stapling) developed over ~10 years to address most of the entrenched adverse events

associated with clinical use of surgical stapling reported to the FDA including such intractable and persistent

complications as the staple line leakage at the gastrointestinal junction following the gastrectomy, prolonged air leak

following the lung resection, and bleeding and leakage following the colon resection that have historically been left

unaddressed by the surgical stapling industry.


-- Assistance in reinvention of the partner's surgical stapling product portfolio including 5~10 years worth of

scientific knowledge base essential for reinvention of surgical stapling



- Prospective Partner:


-- An in-house competency in basic science research on the surgical stapling (or a joint or independent research

program in an academic institution sponsored by the partner) would be needed for effective collaboration. It is

essential that the development of scientific foundations and associated parametric models involving interdependency

among key parameters for and subsequent development of such sophisticated and complex clinical technologies,

products as well as methods of their applications, as the surgical stapling be solidly grounded on and supported by

organized laboratory science carried out by dedicated scientists and support staffs, similarly to development of a

cancer drug. Again, as in drug development/discovery or development of any other technology products of high degree

of complexity that directly derives from a discipline of the basic sciences, the scientists, comprehensively and deeply

versed in the art of surgical stapling, but NOT the front end or product design engineers should be the ones tasked

with hatching ideas for, i.e., brainstorming and conceptualizing, creation of a new product or modification of an

existing product for improvement based on and/or supported by the result(s) and/or findings (knowledge acquired in

the course) of the scientific research on surgical stapling. It is desired that a highly experienced surgical stapling

scientist be given a role of a principal architect, if not a sole leadership responsibility, for reinvention of the surgical

stapling product portfolio in entirety to ensure consistency and coherence in the engineering development, regulatory

compliance, clinical engagement, marketing/sales, and post-market intelligence and follow-up*,**.


-- Upfront payment commensurate with market share goal and/or other financial metric pertinent to market

performance of the reinvented surgical stapling products, and contingency payment tied to the market share

expansion into the current competitor's territory



4.4. An exemplary demonstration project 1 - A hand held stapling system of 12 mm profile diameter


- A laparoscopic linear cutter & a Tissue Probe device (an Overload Indicator type) for measuring a static mechanical

property of tissue in situ jointly optimized with the formed height of staple in the staple (cartridge) type offering


-- A legacy (currently marketed) hand-held stapling system is reinvented to address more "visible" ones among

the adverse events reported to the FDA including instrument overload (resulting in breakage and/or deformation),

over- and under-compression of tissue (resulting in tissue injury and/or bleeding) in such a way that does not

necessitate substantial broadening of the historically validated scientific foundation of the legacy stapling system



- Staple (cartridge) type offering with the formed height of staples optimized jointly with the Tissue Probe


-- Blue and gold in conventional staple cartridge


-- Green and black in specialty staple cartridge (flat deck) for accommodating the large open staple height


-- Open staple height selected to provide a consistent shape and dimension to the legs of closed staple regardless of

staple cartridge type



- Staple cartridge type selection (organ specific) criteria based on the static mechanical property of tissue measured

in situ



- Applicability range of staple type (corresponding to the tissue thickness range of the legacy staple type) specified in

a mechanical quantity corresponding to the mechanical property inherent to the tissue but not in the physical

dimension of tissue compressed to 8 g/mm2 which has little relevance to the performance of staple line



- Redefined 510(k) Framework


-- Clear presentation of the academic and real world scientific foundation, including development of foundational

and subject device specific model(s) and associated parameterization with model validation tests, where needed, upon

which the subject stapling system is developed, i.e., conceived, designed and tested


-- Validation and verification tests and risk analysis based on the scientific foundation


-- Design and analysis of performance tests based on the scientific foundation



4.5. An exemplary demonstration project 2 - A robotic assisted stapling system of 12 mm profile diameter


- A robotic assisted stapling instrument & a hand-held Tissue Probe device (an Overload Indicator type) for measuring

a static mechanical property of tissue in situ optimized for use with the staple cartridge offering of the robotic

assisted stapling system


-- A robotic assisted stapling instrument of a leading manufacturer of robotic assisted surgery system is reinvented to

address more "visible" ones among the adverse events reported to the FDA including instrument overload (resulting in

breakage and/or deformation), over- and under-compression of tissue (resulting in tissue injury and/or bleeding) in

such a way that does not necessitate substantial broadening of the historically validated scientific foundation of the

legacy stapling system



- Staple (cartridge) type offering: blue, green and black in conventional staple cartridge (flat deck)



- Staple cartridge type selection (organ specific) criteria based on the static mechanical property of tissue measured

in situ



- Applicability range of staple type (corresponding to the tissue thickness range of the legacy staple type) specified in

a mechanical quantity corresponding to the mechanical property inherent to the tissue but not in the physical

dimension of tissue compressed to 8 g/mm2 which has little relevance to the performance of staple line



- Redefined 510(k) Framework


-- Clear presentation of the academic and real world scientific foundation, including development of foundational

and subject device specific model(s) and associated parameterization with model validation tests, where needed, upon

which the subject stapling system is developed, i.e., conceived, designed and tested


-- Validation and verification tests and risk analysis based on the scientific foundation


-- Design and analysis of performance tests based on the scientific foundation






5. CURRICULUM VITAE



Chul-Hi Park Ph.D., Seoul, Korea


2014-present Founder, Endoscape Surgical, Seoul, Korea for modernization of surgical stapling

2006-2014 Founder, Endoscape Inc. (defunct), Sunnyvale, CA, USA for modernization of screening colonoscopy

1994-2006 Assistant, Associate Professor, Department of Physics, Soongsil University, Seoul, Korea

1990-1994 Research Associate, Fermi National Accelerator Laboratory, Batavia, IL, USA

1984-1990 Ph.D., High Energy Physics, University of Maryland, College Park, MD, USA

1982-1984 M.S., Medical Physics, University of Alberta, Edmonton, Alberta, Canada

1978-1982 B.S., Physics, Sogang University, Seoul, Korea






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