Download - Hezi Himelfarb - From an Idea to a Product
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
Page 2
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
Page 3
IceCure Medical
Providing a minimally invasive, office-based,
Cryoablation treatment in the area of women's health
Page 4
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
Page 5
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)
Page 6
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
Confidential Page 7
Why (How) Do We Start?
� Improve treatment, QOL, save costs
� Examples
� Is it really a need?
� A problem seeking a solution or vice-versa
Page 8
� A problem seeking a solution or vice-versa
� The clinician role
� The engineer role
Categorization of Medical Devices (1)
� “Pure” mechanical (e.g. stents)
Page 9
Categorization of Medical Devices (2)
� “Pure” electronics (e.g. ultrasound)
Page 10
Categorization of Medical Devices (3)
� Electro-mechanical (e.g. surgical robot)
Page 11
Categorization of Medical Devices (4)
� Combination of drug-device (e.g. insulin pump)
Page 12
Categorization of Medical Devices (5)
� Other methods:
� Active / non-active
� Diagnostic-monitoring / therapeutic
� Permanent / temporary (implants)
Page 13
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)
Page 14
� 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)
Confidential Page 15
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
Page 16
� 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…
Page 17
� The market is changing…
� Intellectual property: the world becomes crowded
� Patentability Vs. infringement
� Invalidity of patents
� A long way, unpaved road