From an Idea to a Product –

a Long Way, an Unpaved Road

Hezi Himelfarb, CEO, IceCure Medical Ltd.

MIT Enterprise Forum of Israel

January 19, 2011

Agenda

• What is “Medical Device” (Israeli MOH)

• Are medical devices unique?

• (Why) How do we start

• Categorization of medical devices

• Product Development Process (“PDP”)• Product Development Process (“PDP”)

• Differences between medical devices and

other products

• Marketing and sales of medical device

• Summary

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מהו אביזר רפואי

– ) Medical devices - ר "אמ(אביזר מכשיר רפואי

, מוצר ביולוגי או טכולוגי, חומר כימי, אביזר, מכשיר

או הנדרש לצורך פעולתו , רפואי בטיפול המשמש

של מכשיר או אביזר המשמש לטיפול ושאינו מיועד של מכשיר או אביזר המשמש לטיפול ושאינו מיועד

.בעיקרו לפעול על גוף האדם כאמצעי תרופתי

מעקב, מדידה, גילוי, לזיהוי): ה.ח(גם

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IceCure Medical

Providing a minimally invasive, office-based,

Cryoablation treatment in the area of women's health

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O.R Minimally-invasive treatment

(out of O.R)

What is Cryoablation?

� Use of extreme cold to ablate tissue effectively

� Accurately ablates tumor zone

� Performed with Ultrasound guidance

� Minimally invasive

� Office procedure

Minimally Invasive

� Office procedure

� 5-15 minutes

� No scars or breast deformity

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Ablation

zone

Ice ball

Ice ball on Ultrasound

IceSense™ 3

Disposable

probe

Handle enables

Full control by

One operator

Insulated

Dewar

Console

Control

Unit

Insulated

conduits (flexible hose)

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Innovative Platform for Cryoablation Treatment

Freezing

area

Are Medical Devices Unique?

• Different:

– Requirements: (pre) clinical, regulatory, quality

– New material (example - Nitinol)

– Same material - different use

(example – Sirolimus /rapamycin, Taxol/Paclitaxel)(example – Sirolimus /rapamycin, Taxol/Paclitaxel)

– Beta site

• Similar

– Life cycle dilemma (example: pacemaker)

– IP

– Classification

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Why (How) Do We Start?

� Improve treatment, QOL, save costs

� Examples

� Is it really a need?

� A problem seeking a solution or vice-versa

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� A problem seeking a solution or vice-versa

� The clinician role

� The engineer role

Categorization of Medical Devices (1)

� “Pure” mechanical (e.g. stents)

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Categorization of Medical Devices (2)

� “Pure” electronics (e.g. ultrasound)

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Categorization of Medical Devices (3)

� Electro-mechanical (e.g. surgical robot)

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Categorization of Medical Devices (4)

� Combination of drug-device (e.g. insulin pump)

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Categorization of Medical Devices (5)

� Other methods:

� Active / non-active

� Diagnostic-monitoring / therapeutic

� Permanent / temporary (implants)

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Product Development Process (PDP)

� Definitions: bench, in-vitro, in-vivo

� Pre-clinical: ex-vivo, in-vivo (animal testing – animal model)

� Clinical study: feasibility, pilot, pivotal, registry, randomized,

orphaned indication

� Regulatory approval in different geographies (CE, 510K, PMA)

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� Regulatory approval in different geographies (CE, 510K, PMA)

� Quality system requirements

� Traceability

� Product qualification

� Process validation

� Sterilization (EtO, Gamma, E-beam)

Differences Between Medical Devices

and Other Products

Non-Medical Hi-Tech Products

Medical Devices

Prototypes can be tested in real environment

Prototypes can be tested in bench and animals

Safety requirements are straightforward

Safety requirements are “complex” (guidelines, follow-up, statistics)

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statistics) Before commercialization: Beta sites

Before commercialization: bench, animals, qualification & validations, FIM, pilot, pivotal, statistics

Customers pay if product fits the needs and provides realistic ROI

Reimbursement

Warranty (maintenance) Liability

Marketing and Sales of A Medical Device

� Importance of "marketing-in" (all the time)

� Is my product ready for sale?

� Reimbursement (reduced)

� Sales force

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� Sales force

� Direct

� Distributers

� Mixed

� New?

Summary� Medical Device Environment is Very Dynamic…

� Regulatory:

� European MDD becomes harder…

� FDA is unpredictable…

� The market is changing…

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� The market is changing…

� Intellectual property: the world becomes crowded

� Patentability Vs. infringement

� Invalidity of patents

� A long way, unpaved road