Medical Device Development - BOI · Medical Devices © NSTDA 2017 Medical Device Development Driving Innovation from Research to Industry KRISKRAI SITTHISERIPRATIP, D.Eng

Medical Devices© NSTDA 2017www.nstda.or.th

Medical Device DevelopmentDriving Innovation from Research to Industry

KRISKRAI SITTHISERIPRATIP, D.EngPrincipal Researcher

National Metal and Materials Technology Center


Overview

Driving Innovation from Research to Industry

CBCT Scanning Technology

3D Printing Technology


Clinical3D

PrinterCAD

DesignMedical Imaging

Customized Implant Design and Manufacturing


Clinical3D Printer

CAD Design

Medical Imaging



3D Printing MEDICAL APPLICATIONS

Neuro (50%)

CranioMaxillofacial (30%)

Orthopaedic (15%)

Dentistry (4%)

Vascular (1%)


Pre-operative Planning

Surgical Simulation

Medical Training

Medical Models


CUSTOMIZED IMPLANT

Perfect Restoration

Pre-fabricated Implant

Reduce Operative Time

Reduce Risks

Surgical Aid/Devices

Linking from Planning to Surgery

Improve precision and accuracy


4 8 610

2233

5659

115

165

143

186

209

174

144

136

165

206

32

0

50

100

150

200

250

Number of Patients

1999 2000 2002 2004 2006 2008 2010 2012 2014 2016 2017 (14 Feb)

Clinical Experiences > 1,800 Cases (100 Hospitals)


Clinical3D

PrinterCAD




3D Printing Technologies (R&D)

Selective Laser Lithography (SLL)

Selective Laser Melting (SLM)

Selective Laser Ceramics

Lithography (SLCL)

The samples

SLL Machine SLCL Machine

HA part

SLM Machine

CoCr part


3D Printing Technologies (R&D)

Digital Light Processing (DLP)

Multi-Extrusion Printer

3D Bioprinter

Scaffold after sintering at 1,300 °C

DLP Machine

Multi-Extrusion Printer

The samples

3D Bioprinter

cellular patterns


Clinical3D

PrinterCAD




DentiiScan (เดนตีสแกน)Dental Cone Beam CT

Prof.Dr.Pairash Thajchayapong, Program DirectorDr.Kriskrai Sitthiseripratip, Head of Hardware Team

Dr.Saowapak Thongvigitmanee, Head of Software Team


: Thai Dental CBCT Scanner Research & Development

• Hardware Development (DentiiSCAN)

• Software Development (DentiiVIEW,

DentiiPLAN)

Clinical Trials under National EC Approval(10/2011-06/2012) > 500 cases

• Faculty of Dentistry, Chiang Mai University:

Installed 06/2011

• SDC (Suthasinee Dental Clinic):

Installed 07/2011

Compliance Testing

• Radiation Safety Passed (Inspected by

Department of Medical Science, MOPH)

• Electronic Safety Passed IEC 60601-1

(Inspected by PTEC, MOST)

Production Facility

• NECTEC Pilot Plant: TÜV SÜD ISO 13485

(Issued since: April 2015)

Installed in 3 Hospitals/ Dental Clinics (>4,000 Cases)

• Faculty of Dentistry, Chiang Mai University

(Since 2011)

• SDC (Suthasinee Dental Clinic: Since

2011)

• Thammasat University Hospital

(Since 2013)

Installing 6 Hospitals

Supported by TCELS 4 M/C

• Chiang Rai

• Phrae

• Sakon Nakhon

• Surat Thani

Supported by NRCT (วช) 2 M/C

• Institute of Dentistry

• Lerdsin

Licensing : Under Negotiation


Ref. SDC Dental Center

Application: Dental Implant Planning


MobiiScan (โมบีสแกน)Mobile CBCT

Research & Development

• Hardware Development (MobiiSCAN)

• Software Development (MobiiVIEW)

Clinical Trials

• Faculty of Dentistry, Chiang Mai University

• Faculty of Medicine, Chulalongkorn University

• Faculty of Medicine, Prince of Songkha

University

Compliance Testing

• Radiation Safety Passed (Inspected by

Department of Medical Science, MOPH)

• Electronic Safety Passed IEC 60601-1

(Inspected by PTEC, MOST)

Production Facility

• NECTEC Pilot Plant: TÜV SÜD ISO 13485

(Audited)

http://www.google.co.th/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&docid=TkOLUHwVw7J7tM&tbnid=s2VVtJqgPZtA6M:&ved=0CAUQjRw&url=http://www.royalthaident.org/dentist/&ei=v63gU_WQG5aJuATMxoGwDQ&bvm=bv.72197243,d.c2E&psig=AFQjCNH4qOfH7KTpR6gWRT9OyYAZ3tBpyg&ust=1407319841835122


Valley of DeathScientific Discovery

Round B

IPO

Medical Devices

Technology Demonstration

Industry

Valley1

Valley2

Valley3

Valley4

ClinicalTrials Multi

Centers

Pre-Commercial

Lab Model

Research Grant

Prototype

ManufacturingMarket Testing

Business ModelMarket

Assessment Create Management

Team

First Sales

Seed

Round A

Discovery Development Commercialization

Investors

R&D

Translational Research

Po

ten

tial

Ris

kLo

wH

igh

Compliance Testing

Standard


Total System for Medical Devices Development

Compliance

Testing

Clinical

Trials

Idea

Evaluation

Working

Group

Performance

& Reliability

Test

R&DProcess

Inspection

Prototype

Manufac

turing

Regulator IndustryClinical

Services

NHSO/SSO/CGD

Bureau of the Budget

Funding Agency

KOL Surgeon

R&D Institute/ University

Regulator

Industry

Committee

PTEC

TISTR

สถาบนัไฟฟ้า

สถาบนัเหล็ก

University Labs

Testing Agency

University Hospitals

Public Hospitals

Clinical Trials Center

Thai FDA

TISI (สมอ)

Regulator

Surgeons

(Neuro/Plastic

Ortho/Dental/Surgery/…)

Hospitals

(University/ Public/Private)

Clinical

NSTDA (NECTEC/MTEC/

BIOTEC/NANO)

Universities

TCELS

R&D

BOI

MOI (DIP/BSID)

FTI (MEDIC)

INNOTHAI

Thai Med

Industry


Pilot Collaborative Project: Thai-Japanese Total Knee Arthroplasty

“Cooperative Research and Development Projecton Knee Joint Prostheses and Three-dimensional Surgery Support System”

Title

Collaborative Project: –

Japanese

Co-Design Artificial Joint

Thai

Manufacturing - Thailand

Thai Market

Japanese Market

AEC Market

Supported by NEDO


Total Solutions for Medical Device Development

Public Procurementof Innovation Product

10-30%

Committee

Global Player

Global Private Sector


Dental Clinic

Digital Image

Design Center

Fabrication

Patients

Digital Disruption : Digital Dentistry

McKinsey


Thank You

KRISKRAI SITTHISERIPRATIP, D.Eng

Principal Researcher

Email: [email protected], [email protected]

Line id: kriskrai

National Metal and Materials Technology Center (MTEC)

National Science and Technology Development Agency (NSTDA)

Medical Device Development - BOI · Medical Devices © NSTDA 2017 Medical Device Development Driving Innovation from Research to Industry KRISKRAI SITTHISERIPRATIP, D.Eng

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