SlideShare a Scribd company logo

Reptes en la incorporació de nous biomaterials a dispositius mèdics / Neos Surgery, Montserrat Charles-Harris

Dra. Montserrat Charles-Harris, cap d’Operacions – Neos Surgery

1 of 20
Download to read offline
Reptes en la incorporació de nousReptes en la incorporació de nous 
biomaterials a dispositius mèdicsp
“Biomaterials: de la biònica cap a la 
ió i l t à i d ”regeneració i les teràpies avançades”
Montse Charles‐Harris
Neos Surgery S LNeos Surgery S.L.
“Biomaterials : de la biònica cap a la regeneració i les teràpies avançades”20 d’octubre 2010
Nuestra empresa
• Founded in Oct 2003: technological partners
• We design, produce and commercialise NEW SOLUTIONSWe design, produce and commercialise NEW SOLUTIONS
for Neurosurgery.
3
Surgeons / Medical Partners
Financial Partners
*Datos referentes a 2006
Strategy and Technology
Competition: Multinational companies with great comercial andp p g
financial power:
R ki C Nº E l b A l T *Ranking Company Nº Employees webpage Annual Turnover*
1 Johnson&Johnson 122.200 www.jnj.com 33.000 M$
3 Medtronic 37 000 www medtronic com 12 300 M$3 Medtronic 37.000 www.medtronic.com 12.300 M$
10 Stryker 18.800 www.stryker.com 5.405 M$
11 B Braun 30.000 www.bbraun.com 3.300 M$11 B.Braun 30.000 www.bbraun.com 3.300 M$
Our Strategy:gy
Reactivity
NEW l tiNEW solutions
Products : BHID
7
Products : Cranial LOOP
Challenges of working with New Biomaterials
1 Scale up and Industrialisation1. Scale-up and Industrialisation
2. Regulatory
3 Commercial /Marketing3. Commercial /Marketing
Scale-up: Industrialisation
1 Repeatable and Reproducible process1. Repeatable and Reproducible process
2. Regulatory strategy
3 Suppliers : technical capacity clean room facility + certification3. Suppliers : technical capacity, clean-room facility + certification
Regulatory
1 The MDD 93/42/EEC1. The MDD 93/42/EEC
2. ISO 10993 “Biological evaluation of medical devices”
•CytotoxicityCytotoxicity
•Sensitization
•Irritation/Intracutaneous
•Acute Systemic Toxicity•Acute Systemic Toxicity
•Subchronic Toxicity
•Genotoxicity
I l t ti•Implantation
•Chronic Toxicity
•Carcinogenicity
3. Customised devices
Commercial / Marketing
1 Convince clinicians1. Convince clinicians
1. Safety
2 Scientific studies2. Scientific studies
3. Clinical studies
2 C i h it l h i d t t2. Convince hospital purchasing departments
1. Price
2 St d h dli2. Storage and handling
3. Logistics
Examples
Company RESEARCHCompanyCompany
nº 1
RESEARCHCompany
nº 2
-Technical support for
processing
-Technical support for
processing
-Technical support for
processing ?processing
-ISO 10993
-Marketing
-€€€€!
processing
-ISO 10993
-Marketing
-€€€€!
processing ?
-ISO 10993
-Marketing
-€€€€ ?€€€€! €€€€! €€€€ ?
High riskLow risk
Discussion
1) I l d Bi t i l li i th R&D h i• 1) Include Biomaterial suppliers in the R&D chain
• → →Research Biomaterial
Company
Medical Device
CompanyCompany Company
Biomaterials Companies In Spain
• Biomaterials market dominated by major multinationals. Small companies tend to operate
in small, specialised niche markets
• Joint ventures and/or distributor agreements for small and medium-sized manufacturers
with major suppliers of orthopaedic productswith major suppliers of orthopaedic products
Biomaterials Companies In Europe
• Medical Implantable Materials Market US (forecast 2012)
• Metals : 273.8$ million
• Polymers : 50.9$ million
• Ceramics : 22.2 $ million
• Plastics in Medical Devices Market (2008)
Pl ti 449 8 € illi• Plastics: 449.8 €million
Discussion
• 2) Bridge the gap between Research and Medical Device2) Bridge the gap between Research and Medical Device
Companies
RESEARCH
-Technical support for
processing
ISO 10993
Medical Device
-ISO 10993
-Marketing
-Involvement in
Research projects
ISO 10993-ISO 10993
-Marketing
Discussion
• 2) Bridge the gap2) Bridge the gap
Permanent
implant MDTimplant MDT
Tissue/Bone Comments
Cytotoxicity x ISO direct contact 490€
Sensitization x Murine Local Lymph Node Assay 2490€y p y
Irritation/Intracutaneous x ISO intracutaneous test 760€
Acute Systemic Toxicity x 560€
Subchronic Toxicity x Intraperitoneal or intavenous
Genotoxicity
x
Ames test 2390€
Genotoxicity Ames test, Mouse Lymphoma Assay and Mouse micronucleus test 7260€
Implantation ISO implatation 90 days with hispatology 3600€
I l t ti ISO i l t ti 180 d ith hi t th l
x
Implantation ISO implantation 180 days with histopathology
Implantation ISO implantation 365 days with histopathology
Chronic Toxicity x > 400.000€*
Carcinogenicity x > 400 000€*Carcinogenicity x > 400.000€*
http://www.mdt-gmbh.com/
Conclusions
• Including “new” biomaterials in medical devices is challenging• Including new biomaterials in medical devices is challenging
• Often done by joint ventures, or in-house research
• Biomaterials suppliers must include:• Biomaterials suppliers must include:
• Technical support
R l t t• Regulatory support
• Despite commercial pressure, clinicians all agree on the
potential of regeneration and advanced therapies We mustpotential of regeneration and advanced therapies. We must
solve:
• Regulatory strategy for customised degradable materialsRegulatory strategy for customised, degradable materials
• Industrialisation
• Easy transfer from research to industry• Easy transfer from research to industry
“Biomaterials : de la biònica cap a la regeneració i les teràpies avançades”20 d’octubre 2010

Recommended

Estrenos De Cine
Estrenos De CineEstrenos De Cine
Estrenos De Cineguest9af12e
 
Jose Vicente Ros / Recent advances in food innovation at the IIAD
Jose Vicente Ros / Recent advances in food innovation at the IIADJose Vicente Ros / Recent advances in food innovation at the IIAD
Jose Vicente Ros / Recent advances in food innovation at the IIADBiocat, BioRegion of Catalonia
 
My Biography
My BiographyMy Biography
My Biographymickstout
 
Data logging heart rate
Data logging  heart rateData logging  heart rate
Data logging heart rateMei Ping
 
Jean-Pierre Saintouil / The national SATT program in France
Jean-Pierre Saintouil / The national SATT program in FranceJean-Pierre Saintouil / The national SATT program in France
Jean-Pierre Saintouil / The national SATT program in FranceBiocat, BioRegion of Catalonia
 
Céline Thizon / BiotechDeva, a bioproduction partner to boost your R&D project
Céline Thizon / BiotechDeva, a bioproduction partner to boost your R&D projectCéline Thizon / BiotechDeva, a bioproduction partner to boost your R&D project
Céline Thizon / BiotechDeva, a bioproduction partner to boost your R&D projectBiocat, BioRegion of Catalonia
 
Bernard Dumas / Screening and identification of new natural compounds for pla...
Bernard Dumas / Screening and identification of new natural compounds for pla...Bernard Dumas / Screening and identification of new natural compounds for pla...
Bernard Dumas / Screening and identification of new natural compounds for pla...Biocat, BioRegion of Catalonia
 

More Related Content

Viewers also liked

Philippe Baralon / Workshop 2 Emergence Forum Barcelona
Philippe Baralon / Workshop 2 Emergence Forum BarcelonaPhilippe Baralon / Workshop 2 Emergence Forum Barcelona
Philippe Baralon / Workshop 2 Emergence Forum BarcelonaBiocat, BioRegion of Catalonia
 
Edu 5818 tugasan 1 instructional supervision
Edu 5818 tugasan 1 instructional supervisionEdu 5818 tugasan 1 instructional supervision
Edu 5818 tugasan 1 instructional supervisionIndra Maniam
 
Laura Coll / Preventing age-related disability: complex interventions and ICT
Laura Coll / Preventing age-related disability: complex interventions and ICTLaura Coll / Preventing age-related disability: complex interventions and ICT
Laura Coll / Preventing age-related disability: complex interventions and ICTBiocat, BioRegion of Catalonia
 
Tansforming healthcare condensed
Tansforming healthcare condensedTansforming healthcare condensed
Tansforming healthcare condensedNeeraj Mahajan
 
Hitting the target - how to tame chaos
Hitting the target - how to tame chaosHitting the target - how to tame chaos
Hitting the target - how to tame chaosDenis Petelin
 
SeshadriHRResume2
SeshadriHRResume2SeshadriHRResume2
SeshadriHRResume2Seshadri V
 
Marketing With Twitter
Marketing With TwitterMarketing With Twitter
Marketing With TwitterMichal Geva
 
Motivequest on Micro-marketing
Motivequest on Micro-marketingMotivequest on Micro-marketing
Motivequest on Micro-marketingMotiveQuest LLC
 
γλαστρεσ+ανακυκλωση
γλαστρεσ+ανακυκλωσηγλαστρεσ+ανακυκλωση
γλαστρεσ+ανακυκλωσηKaterina Mavrantonaki
 
Digital Health: “Healthcare Evolution: What is Different This Time”, VISHAL G...
Digital Health: “Healthcare Evolution: What is Different This Time”, VISHAL G...Digital Health: “Healthcare Evolution: What is Different This Time”, VISHAL G...
Digital Health: “Healthcare Evolution: What is Different This Time”, VISHAL G...Biocat, BioRegion of Catalonia
 
“Adding Value through Partnerships: the MedCity Experience”, SIMON HOWELL
“Adding Value through Partnerships: the MedCity Experience”, SIMON HOWELL“Adding Value through Partnerships: the MedCity Experience”, SIMON HOWELL
“Adding Value through Partnerships: the MedCity Experience”, SIMON HOWELLBiocat, BioRegion of Catalonia
 
2008estã¡..
2008estã¡..2008estã¡..
2008estã¡..AN7ONYO
 
Alfabet Des Corps
Alfabet Des CorpsAlfabet Des Corps
Alfabet Des CorpsAN7ONYO
 

Viewers also liked (20)

Philippe Baralon / Workshop 2 Emergence Forum Barcelona
Philippe Baralon / Workshop 2 Emergence Forum BarcelonaPhilippe Baralon / Workshop 2 Emergence Forum Barcelona
Philippe Baralon / Workshop 2 Emergence Forum Barcelona
 
Edu 5818 tugasan 1 instructional supervision
Edu 5818 tugasan 1 instructional supervisionEdu 5818 tugasan 1 instructional supervision
Edu 5818 tugasan 1 instructional supervision
 
Locating sources and search techniques
Locating sources and search techniquesLocating sources and search techniques
Locating sources and search techniques
 
Laura Coll / Preventing age-related disability: complex interventions and ICT
Laura Coll / Preventing age-related disability: complex interventions and ICTLaura Coll / Preventing age-related disability: complex interventions and ICT
Laura Coll / Preventing age-related disability: complex interventions and ICT
 
Tansforming healthcare condensed
Tansforming healthcare condensedTansforming healthcare condensed
Tansforming healthcare condensed
 
Hitting the target - how to tame chaos
Hitting the target - how to tame chaosHitting the target - how to tame chaos
Hitting the target - how to tame chaos
 
Biocat Report 2009 (English)
Biocat Report 2009 (English)Biocat Report 2009 (English)
Biocat Report 2009 (English)
 
People
PeoplePeople
People
 
E.Art.Com
E.Art.ComE.Art.Com
E.Art.Com
 
wonderfull World
wonderfull Worldwonderfull World
wonderfull World
 
Animals
AnimalsAnimals
Animals
 
SeshadriHRResume2
SeshadriHRResume2SeshadriHRResume2
SeshadriHRResume2
 
Marketing With Twitter
Marketing With TwitterMarketing With Twitter
Marketing With Twitter
 
Journey neeraj
Journey neerajJourney neeraj
Journey neeraj
 
Motivequest on Micro-marketing
Motivequest on Micro-marketingMotivequest on Micro-marketing
Motivequest on Micro-marketing
 
γλαστρεσ+ανακυκλωση
γλαστρεσ+ανακυκλωσηγλαστρεσ+ανακυκλωση
γλαστρεσ+ανακυκλωση
 
Digital Health: “Healthcare Evolution: What is Different This Time”, VISHAL G...
Digital Health: “Healthcare Evolution: What is Different This Time”, VISHAL G...Digital Health: “Healthcare Evolution: What is Different This Time”, VISHAL G...
Digital Health: “Healthcare Evolution: What is Different This Time”, VISHAL G...
 
“Adding Value through Partnerships: the MedCity Experience”, SIMON HOWELL
“Adding Value through Partnerships: the MedCity Experience”, SIMON HOWELL“Adding Value through Partnerships: the MedCity Experience”, SIMON HOWELL
“Adding Value through Partnerships: the MedCity Experience”, SIMON HOWELL
 
2008estã¡..
2008estã¡..2008estã¡..
2008estã¡..
 
Alfabet Des Corps
Alfabet Des CorpsAlfabet Des Corps
Alfabet Des Corps
 

Similar to Reptes en la incorporació de nous biomaterials a dispositius mèdics / Neos Surgery, Montserrat Charles-Harris

Microneedles for drug delivery patent landscape 2020 flyer
Microneedles for drug delivery patent landscape 2020 flyerMicroneedles for drug delivery patent landscape 2020 flyer
Microneedles for drug delivery patent landscape 2020 flyerKnowmade
 
Pharma Integrates 2013 Keynote Speaker Trevor M Jones CBE
Pharma Integrates 2013 Keynote Speaker Trevor M Jones CBEPharma Integrates 2013 Keynote Speaker Trevor M Jones CBE
Pharma Integrates 2013 Keynote Speaker Trevor M Jones CBEChristopher Watt
 
SW Biotechnology pack
SW Biotechnology packSW Biotechnology pack
SW Biotechnology packRichard Male
 
171123 presentation ram siddappa hcm medical (smb meeting)
171123 presentation ram siddappa hcm medical (smb meeting)171123 presentation ram siddappa hcm medical (smb meeting)
171123 presentation ram siddappa hcm medical (smb meeting)SMBBV
 
10 step marketing plan (oxivir)
10 step marketing plan (oxivir)10 step marketing plan (oxivir)
10 step marketing plan (oxivir)restyrmines
 
The East Of England The Future Of Medical Technologies
The East Of England The Future Of Medical TechnologiesThe East Of England The Future Of Medical Technologies
The East Of England The Future Of Medical TechnologiesEast of England International
 
Ldb 145 geni mutanti_2014-11-07 franchini - marketing e trasferimento tecnolo...
Ldb 145 geni mutanti_2014-11-07 franchini - marketing e trasferimento tecnolo...Ldb 145 geni mutanti_2014-11-07 franchini - marketing e trasferimento tecnolo...
Ldb 145 geni mutanti_2014-11-07 franchini - marketing e trasferimento tecnolo...laboratoridalbasso
 
Newseletter Smartnano 7 - Nanoparticles
Newseletter Smartnano 7 - NanoparticlesNewseletter Smartnano 7 - Nanoparticles
Newseletter Smartnano 7 - NanoparticlesSMARTNANO Project
 
Littmann stethescope all models,littmann stethoscope buy online delhi/india
Littmann stethescope all models,littmann stethoscope buy online delhi/indiaLittmann stethescope all models,littmann stethoscope buy online delhi/india
Littmann stethescope all models,littmann stethoscope buy online delhi/indiaSurgicals Shoppeseo
 
Stratified Medicine - Setting the Scene
Stratified Medicine - Setting the SceneStratified Medicine - Setting the Scene
Stratified Medicine - Setting the SceneSpace IDEAS Hub
 
Crb Bio Ii Summary Nov2010 Eng
Crb Bio Ii Summary Nov2010 EngCrb Bio Ii Summary Nov2010 Eng
Crb Bio Ii Summary Nov2010 Engasantos100
 
Quintain Consulting Presentation
Quintain Consulting PresentationQuintain Consulting Presentation
Quintain Consulting Presentationjeanettepritchard
 
NanoTextile_EnglishOnePager 3
NanoTextile_EnglishOnePager 3NanoTextile_EnglishOnePager 3
NanoTextile_EnglishOnePager 3Shay Hershcovich
 
NanoTextile_EnglishOnePager 3
NanoTextile_EnglishOnePager 3NanoTextile_EnglishOnePager 3
NanoTextile_EnglishOnePager 3Shuki Hershcovich
 
Prize_Winner_Profiles
Prize_Winner_ProfilesPrize_Winner_Profiles
Prize_Winner_ProfilesMarie Mainil
 
Capsule Endoscopy Patent Landscape Flyer 2014
Capsule Endoscopy Patent Landscape Flyer 2014Capsule Endoscopy Patent Landscape Flyer 2014
Capsule Endoscopy Patent Landscape Flyer 2014Knowmade
 
Sinoscopy ENT Catalogue
Sinoscopy ENT CatalogueSinoscopy ENT Catalogue
Sinoscopy ENT CatalogueNikhilesh Shah
 

Similar to Reptes en la incorporació de nous biomaterials a dispositius mèdics / Neos Surgery, Montserrat Charles-Harris (20)

Microneedles for drug delivery patent landscape 2020 flyer
Microneedles for drug delivery patent landscape 2020 flyerMicroneedles for drug delivery patent landscape 2020 flyer
Microneedles for drug delivery patent landscape 2020 flyer
 
Pharma Integrates 2013 Keynote Speaker Trevor M Jones CBE
Pharma Integrates 2013 Keynote Speaker Trevor M Jones CBEPharma Integrates 2013 Keynote Speaker Trevor M Jones CBE
Pharma Integrates 2013 Keynote Speaker Trevor M Jones CBE
 
OneStart 2013 Finalists (Europe)
OneStart 2013 Finalists (Europe)OneStart 2013 Finalists (Europe)
OneStart 2013 Finalists (Europe)
 
SW Biotechnology pack
SW Biotechnology packSW Biotechnology pack
SW Biotechnology pack
 
171123 presentation ram siddappa hcm medical (smb meeting)
171123 presentation ram siddappa hcm medical (smb meeting)171123 presentation ram siddappa hcm medical (smb meeting)
171123 presentation ram siddappa hcm medical (smb meeting)
 
10 step marketing plan (oxivir)
10 step marketing plan (oxivir)10 step marketing plan (oxivir)
10 step marketing plan (oxivir)
 
The East Of England The Future Of Medical Technologies
The East Of England The Future Of Medical TechnologiesThe East Of England The Future Of Medical Technologies
The East Of England The Future Of Medical Technologies
 
Ldb 145 geni mutanti_2014-11-07 franchini - marketing e trasferimento tecnolo...
Ldb 145 geni mutanti_2014-11-07 franchini - marketing e trasferimento tecnolo...Ldb 145 geni mutanti_2014-11-07 franchini - marketing e trasferimento tecnolo...
Ldb 145 geni mutanti_2014-11-07 franchini - marketing e trasferimento tecnolo...
 
Newseletter Smartnano 7 - Nanoparticles
Newseletter Smartnano 7 - NanoparticlesNewseletter Smartnano 7 - Nanoparticles
Newseletter Smartnano 7 - Nanoparticles
 
Littmann stethescope all models,littmann stethoscope buy online delhi/india
Littmann stethescope all models,littmann stethoscope buy online delhi/indiaLittmann stethescope all models,littmann stethoscope buy online delhi/india
Littmann stethescope all models,littmann stethoscope buy online delhi/india
 
Stratified Medicine - Setting the Scene
Stratified Medicine - Setting the SceneStratified Medicine - Setting the Scene
Stratified Medicine - Setting the Scene
 
Nano4Health
Nano4HealthNano4Health
Nano4Health
 
Arthroscopy Catalogue
Arthroscopy CatalogueArthroscopy Catalogue
Arthroscopy Catalogue
 
Crb Bio Ii Summary Nov2010 Eng
Crb Bio Ii Summary Nov2010 EngCrb Bio Ii Summary Nov2010 Eng
Crb Bio Ii Summary Nov2010 Eng
 
Quintain Consulting Presentation
Quintain Consulting PresentationQuintain Consulting Presentation
Quintain Consulting Presentation
 
NanoTextile_EnglishOnePager 3
NanoTextile_EnglishOnePager 3NanoTextile_EnglishOnePager 3
NanoTextile_EnglishOnePager 3
 
NanoTextile_EnglishOnePager 3
NanoTextile_EnglishOnePager 3NanoTextile_EnglishOnePager 3
NanoTextile_EnglishOnePager 3
 
Prize_Winner_Profiles
Prize_Winner_ProfilesPrize_Winner_Profiles
Prize_Winner_Profiles
 
Capsule Endoscopy Patent Landscape Flyer 2014
Capsule Endoscopy Patent Landscape Flyer 2014Capsule Endoscopy Patent Landscape Flyer 2014
Capsule Endoscopy Patent Landscape Flyer 2014
 
Sinoscopy ENT Catalogue
Sinoscopy ENT CatalogueSinoscopy ENT Catalogue
Sinoscopy ENT Catalogue
 

More from Biocat, BioRegion of Catalonia

Innovation, Entrepreneurship & Network Thinking: A Growth Model for the Catal...
Innovation, Entrepreneurship & Network Thinking: A Growth Model for the Catal...Innovation, Entrepreneurship & Network Thinking: A Growth Model for the Catal...
Innovation, Entrepreneurship & Network Thinking: A Growth Model for the Catal...Biocat, BioRegion of Catalonia
 
Public session: Lessons learned from successful medtech entrepreneurs - CRAAS...
Public session: Lessons learned from successful medtech entrepreneurs - CRAAS...Public session: Lessons learned from successful medtech entrepreneurs - CRAAS...
Public session: Lessons learned from successful medtech entrepreneurs - CRAAS...Biocat, BioRegion of Catalonia
 
Toby Reid, Managing Director – BioCity Group: “How entrepreneurs can accelera...
Toby Reid, Managing Director – BioCity Group: “How entrepreneurs can accelera...Toby Reid, Managing Director – BioCity Group: “How entrepreneurs can accelera...
Toby Reid, Managing Director – BioCity Group: “How entrepreneurs can accelera...Biocat, BioRegion of Catalonia
 
Presentation Moebio & d·HEALTH Barcelona & CRAASH 2018
Presentation Moebio & d·HEALTH Barcelona & CRAASH 2018Presentation Moebio & d·HEALTH Barcelona & CRAASH 2018
Presentation Moebio & d·HEALTH Barcelona & CRAASH 2018Biocat, BioRegion of Catalonia
 
"Breaking up pharma´s value chain - what can we expect", MICHAEL MÜLLER
"Breaking up pharma´s value chain - what can we expect", MICHAEL MÜLLER"Breaking up pharma´s value chain - what can we expect", MICHAEL MÜLLER
"Breaking up pharma´s value chain - what can we expect", MICHAEL MÜLLERBiocat, BioRegion of Catalonia
 
“Does Catalonia need a Chief Scientist?”, MEHRDAD HARIRI
“Does Catalonia need a Chief Scientist?”, MEHRDAD HARIRI“Does Catalonia need a Chief Scientist?”, MEHRDAD HARIRI
“Does Catalonia need a Chief Scientist?”, MEHRDAD HARIRIBiocat, BioRegion of Catalonia
 
"Successful model of public and private collaboration: MaRS", ZAYNA KHAYAT
"Successful model of public and private collaboration: MaRS", ZAYNA KHAYAT"Successful model of public and private collaboration: MaRS", ZAYNA KHAYAT
"Successful model of public and private collaboration: MaRS", ZAYNA KHAYATBiocat, BioRegion of Catalonia
 
"A new role for government in accelerating life science innovation: The Massa...
"A new role for government in accelerating life science innovation: The Massa..."A new role for government in accelerating life science innovation: The Massa...
"A new role for government in accelerating life science innovation: The Massa...Biocat, BioRegion of Catalonia
 

More from Biocat, BioRegion of Catalonia (20)

Informe de la BiRegió de Catalunya 2020
Informe de la BiRegió de Catalunya 2020Informe de la BiRegió de Catalunya 2020
Informe de la BiRegió de Catalunya 2020
 
Catalonia BioRegion report 2020
Catalonia BioRegion report 2020Catalonia BioRegion report 2020
Catalonia BioRegion report 2020
 
Biocat presentation
Biocat presentationBiocat presentation
Biocat presentation
 
2019 BioRegion of Catalonia Presentation
2019 BioRegion of Catalonia Presentation2019 BioRegion of Catalonia Presentation
2019 BioRegion of Catalonia Presentation
 
Design Health Barcelona Presentation 2019
Design Health Barcelona Presentation 2019Design Health Barcelona Presentation 2019
Design Health Barcelona Presentation 2019
 
Biocat Report 2017 Presentation
Biocat Report 2017 PresentationBiocat Report 2017 Presentation
Biocat Report 2017 Presentation
 
Innovation, Entrepreneurship & Network Thinking: A Growth Model for the Catal...
Innovation, Entrepreneurship & Network Thinking: A Growth Model for the Catal...Innovation, Entrepreneurship & Network Thinking: A Growth Model for the Catal...
Innovation, Entrepreneurship & Network Thinking: A Growth Model for the Catal...
 
Public session: Lessons learned from successful medtech entrepreneurs - CRAAS...
Public session: Lessons learned from successful medtech entrepreneurs - CRAAS...Public session: Lessons learned from successful medtech entrepreneurs - CRAAS...
Public session: Lessons learned from successful medtech entrepreneurs - CRAAS...
 
EIT Health Presentation | CRAASH Barcelona
EIT Health Presentation | CRAASH BarcelonaEIT Health Presentation | CRAASH Barcelona
EIT Health Presentation | CRAASH Barcelona
 
CIMIT (Boston) Presentation | CRAASH Barcelona
CIMIT (Boston) Presentation | CRAASH BarcelonaCIMIT (Boston) Presentation | CRAASH Barcelona
CIMIT (Boston) Presentation | CRAASH Barcelona
 
CRAASH Barcelona Presentation
CRAASH Barcelona PresentationCRAASH Barcelona Presentation
CRAASH Barcelona Presentation
 
Toby Reid, Managing Director – BioCity Group: “How entrepreneurs can accelera...
Toby Reid, Managing Director – BioCity Group: “How entrepreneurs can accelera...Toby Reid, Managing Director – BioCity Group: “How entrepreneurs can accelera...
Toby Reid, Managing Director – BioCity Group: “How entrepreneurs can accelera...
 
Presentation Moebio & d·HEALTH Barcelona & CRAASH 2018
Presentation Moebio & d·HEALTH Barcelona & CRAASH 2018Presentation Moebio & d·HEALTH Barcelona & CRAASH 2018
Presentation Moebio & d·HEALTH Barcelona & CRAASH 2018
 
Presentation Moebio 2018
Presentation Moebio 2018Presentation Moebio 2018
Presentation Moebio 2018
 
"Breaking up pharma´s value chain - what can we expect", MICHAEL MÜLLER
"Breaking up pharma´s value chain - what can we expect", MICHAEL MÜLLER"Breaking up pharma´s value chain - what can we expect", MICHAEL MÜLLER
"Breaking up pharma´s value chain - what can we expect", MICHAEL MÜLLER
 
“Does Catalonia need a Chief Scientist?”, MEHRDAD HARIRI
“Does Catalonia need a Chief Scientist?”, MEHRDAD HARIRI“Does Catalonia need a Chief Scientist?”, MEHRDAD HARIRI
“Does Catalonia need a Chief Scientist?”, MEHRDAD HARIRI
 
"Successful model of public and private collaboration: MaRS", ZAYNA KHAYAT
"Successful model of public and private collaboration: MaRS", ZAYNA KHAYAT"Successful model of public and private collaboration: MaRS", ZAYNA KHAYAT
"Successful model of public and private collaboration: MaRS", ZAYNA KHAYAT
 
"A new role for government in accelerating life science innovation: The Massa...
"A new role for government in accelerating life science innovation: The Massa..."A new role for government in accelerating life science innovation: The Massa...
"A new role for government in accelerating life science innovation: The Massa...
 
HEALTH & BIO TEAM DATING
HEALTH & BIO TEAM DATINGHEALTH & BIO TEAM DATING
HEALTH & BIO TEAM DATING
 
The BioRegion of Catalonia at BIO 2015
The BioRegion of Catalonia at BIO 2015The BioRegion of Catalonia at BIO 2015
The BioRegion of Catalonia at BIO 2015
 

Recently uploaded

Fetal and Neonatal Physiology - Dr Faiza.pdf
Fetal and Neonatal Physiology - Dr Faiza.pdfFetal and Neonatal Physiology - Dr Faiza.pdf
Fetal and Neonatal Physiology - Dr Faiza.pdfMedicoseAcademics
 
EUTHANASIA: WORLD AND INDIAN PERSPECTIVEpptx
EUTHANASIA: WORLD AND INDIAN PERSPECTIVEpptxEUTHANASIA: WORLD AND INDIAN PERSPECTIVEpptx
EUTHANASIA: WORLD AND INDIAN PERSPECTIVEpptxDr. Sumit KUMAR
 
MICTURITION AND DEFECATION REFLEXES.pptx
MICTURITION AND DEFECATION REFLEXES.pptxMICTURITION AND DEFECATION REFLEXES.pptx
MICTURITION AND DEFECATION REFLEXES.pptxDr. Aniket Shilwant
 
Physiology of Growth hormone and applied aspects 4.pptx
Physiology of Growth hormone and applied aspects 4.pptxPhysiology of Growth hormone and applied aspects 4.pptx
Physiology of Growth hormone and applied aspects 4.pptxSai Sailesh Kumar Goothy
 
Yantropakaranani 2: Heating Devices used in Ayurveda
Yantropakaranani 2: Heating Devices used in AyurvedaYantropakaranani 2: Heating Devices used in Ayurveda
Yantropakaranani 2: Heating Devices used in AyurvedaAparnaNandakumar12
 
U_4.Medicinal Chemistry 3rd .B pharm 6th sem AKTU.Mansoor Ansari .pdf
U_4.Medicinal Chemistry 3rd .B pharm 6th sem AKTU.Mansoor Ansari .pdfU_4.Medicinal Chemistry 3rd .B pharm 6th sem AKTU.Mansoor Ansari .pdf
U_4.Medicinal Chemistry 3rd .B pharm 6th sem AKTU.Mansoor Ansari .pdfMansoor (Ansari Group of Institution)
 
Antisense oligonucleotides ppt.ppt ISF COLLEGE OF PARMACY
Antisense oligonucleotides ppt.ppt ISF COLLEGE OF PARMACYAntisense oligonucleotides ppt.ppt ISF COLLEGE OF PARMACY
Antisense oligonucleotides ppt.ppt ISF COLLEGE OF PARMACYISF COLLEGE OF PHARMACY
 
How AI will transform Pediatric Practice - Feb 2024
How AI will transform Pediatric Practice - Feb 2024How AI will transform Pediatric Practice - Feb 2024
How AI will transform Pediatric Practice - Feb 2024Gaurav Gupta
 
Gallstones (Cholelithiasis) Lifestyle, Risk factors, preventions.pdf
Gallstones (Cholelithiasis) Lifestyle, Risk factors, preventions.pdfGallstones (Cholelithiasis) Lifestyle, Risk factors, preventions.pdf
Gallstones (Cholelithiasis) Lifestyle, Risk factors, preventions.pdfSudeb Ganguly
 
Cell :Structure & Functions for Medical and Health allied Students
Cell :Structure & Functions for Medical and Health allied StudentsCell :Structure & Functions for Medical and Health allied Students
Cell :Structure & Functions for Medical and Health allied StudentsRajendra Dev Bhatt
 
Introduction to anatomy and physioligy.pptx
Introduction to anatomy and physioligy.pptxIntroduction to anatomy and physioligy.pptx
Introduction to anatomy and physioligy.pptxMarbahunJalaKharbhih
 
Guía síndrome coronario agudo.pdf Guía síndrome coronario agudo.pdf
Guía síndrome coronario agudo.pdf Guía síndrome coronario agudo.pdfGuía síndrome coronario agudo.pdf Guía síndrome coronario agudo.pdf
Guía síndrome coronario agudo.pdf Guía síndrome coronario agudo.pdfJuniorAlexanderCasti
 
Materials for Spectacle Lenses​ UG STUDENTS.pptx
Materials for Spectacle Lenses​ UG STUDENTS.pptxMaterials for Spectacle Lenses​ UG STUDENTS.pptx
Materials for Spectacle Lenses​ UG STUDENTS.pptxKAUSAR NAHID
 
Nanotechnology and it's application for various uses
Nanotechnology  and it's application for various usesNanotechnology  and it's application for various uses
Nanotechnology and it's application for various usesaksilentkiller51
 
Dasha vidha Pareeksha.pptx Dr Akshay Shetty
Dasha vidha Pareeksha.pptx Dr Akshay ShettyDasha vidha Pareeksha.pptx Dr Akshay Shetty
Dasha vidha Pareeksha.pptx Dr Akshay ShettyAkshay Shetty
 
Hydrocele and tumors of testis Introduction.pptx
Hydrocele and tumors of testis Introduction.pptxHydrocele and tumors of testis Introduction.pptx
Hydrocele and tumors of testis Introduction.pptxSizan Thapa
 
Disruption at the Neuromuscular Junction: Relevance of Autoantibodies to Ther...
Disruption at the Neuromuscular Junction: Relevance of Autoantibodies to Ther...Disruption at the Neuromuscular Junction: Relevance of Autoantibodies to Ther...
Disruption at the Neuromuscular Junction: Relevance of Autoantibodies to Ther...PeerVoice
 
Physiology of Pituitary gland and its hormones -3.pptx
Physiology of Pituitary gland and its hormones -3.pptxPhysiology of Pituitary gland and its hormones -3.pptx
Physiology of Pituitary gland and its hormones -3.pptxSai Sailesh Kumar Goothy
 

Recently uploaded (20)

Fetal and Neonatal Physiology - Dr Faiza.pdf
Fetal and Neonatal Physiology - Dr Faiza.pdfFetal and Neonatal Physiology - Dr Faiza.pdf
Fetal and Neonatal Physiology - Dr Faiza.pdf
 
EUTHANASIA: WORLD AND INDIAN PERSPECTIVEpptx
EUTHANASIA: WORLD AND INDIAN PERSPECTIVEpptxEUTHANASIA: WORLD AND INDIAN PERSPECTIVEpptx
EUTHANASIA: WORLD AND INDIAN PERSPECTIVEpptx
 
MICTURITION AND DEFECATION REFLEXES.pptx
MICTURITION AND DEFECATION REFLEXES.pptxMICTURITION AND DEFECATION REFLEXES.pptx
MICTURITION AND DEFECATION REFLEXES.pptx
 
Physiology of Growth hormone and applied aspects 4.pptx
Physiology of Growth hormone and applied aspects 4.pptxPhysiology of Growth hormone and applied aspects 4.pptx
Physiology of Growth hormone and applied aspects 4.pptx
 
Yantropakaranani 2: Heating Devices used in Ayurveda
Yantropakaranani 2: Heating Devices used in AyurvedaYantropakaranani 2: Heating Devices used in Ayurveda
Yantropakaranani 2: Heating Devices used in Ayurveda
 
U_4.Medicinal Chemistry 3rd .B pharm 6th sem AKTU.Mansoor Ansari .pdf
U_4.Medicinal Chemistry 3rd .B pharm 6th sem AKTU.Mansoor Ansari .pdfU_4.Medicinal Chemistry 3rd .B pharm 6th sem AKTU.Mansoor Ansari .pdf
U_4.Medicinal Chemistry 3rd .B pharm 6th sem AKTU.Mansoor Ansari .pdf
 
Antisense oligonucleotides ppt.ppt ISF COLLEGE OF PARMACY
Antisense oligonucleotides ppt.ppt ISF COLLEGE OF PARMACYAntisense oligonucleotides ppt.ppt ISF COLLEGE OF PARMACY
Antisense oligonucleotides ppt.ppt ISF COLLEGE OF PARMACY
 
How AI will transform Pediatric Practice - Feb 2024
How AI will transform Pediatric Practice - Feb 2024How AI will transform Pediatric Practice - Feb 2024
How AI will transform Pediatric Practice - Feb 2024
 
Gallstones (Cholelithiasis) Lifestyle, Risk factors, preventions.pdf
Gallstones (Cholelithiasis) Lifestyle, Risk factors, preventions.pdfGallstones (Cholelithiasis) Lifestyle, Risk factors, preventions.pdf
Gallstones (Cholelithiasis) Lifestyle, Risk factors, preventions.pdf
 
Cell :Structure & Functions for Medical and Health allied Students
Cell :Structure & Functions for Medical and Health allied StudentsCell :Structure & Functions for Medical and Health allied Students
Cell :Structure & Functions for Medical and Health allied Students
 
eye disorders .pptx
eye disorders .pptxeye disorders .pptx
eye disorders .pptx
 
Introduction to anatomy and physioligy.pptx
Introduction to anatomy and physioligy.pptxIntroduction to anatomy and physioligy.pptx
Introduction to anatomy and physioligy.pptx
 
Guía síndrome coronario agudo.pdf Guía síndrome coronario agudo.pdf
Guía síndrome coronario agudo.pdf Guía síndrome coronario agudo.pdfGuía síndrome coronario agudo.pdf Guía síndrome coronario agudo.pdf
Guía síndrome coronario agudo.pdf Guía síndrome coronario agudo.pdf
 
Materials for Spectacle Lenses​ UG STUDENTS.pptx
Materials for Spectacle Lenses​ UG STUDENTS.pptxMaterials for Spectacle Lenses​ UG STUDENTS.pptx
Materials for Spectacle Lenses​ UG STUDENTS.pptx
 
Nanotechnology and it's application for various uses
Nanotechnology  and it's application for various usesNanotechnology  and it's application for various uses
Nanotechnology and it's application for various uses
 
Dasha vidha Pareeksha.pptx Dr Akshay Shetty
Dasha vidha Pareeksha.pptx Dr Akshay ShettyDasha vidha Pareeksha.pptx Dr Akshay Shetty
Dasha vidha Pareeksha.pptx Dr Akshay Shetty
 
A Comprehensive Fatty Liver Program .pptx
A Comprehensive Fatty Liver Program .pptxA Comprehensive Fatty Liver Program .pptx
A Comprehensive Fatty Liver Program .pptx
 
Hydrocele and tumors of testis Introduction.pptx
Hydrocele and tumors of testis Introduction.pptxHydrocele and tumors of testis Introduction.pptx
Hydrocele and tumors of testis Introduction.pptx
 
Disruption at the Neuromuscular Junction: Relevance of Autoantibodies to Ther...
Disruption at the Neuromuscular Junction: Relevance of Autoantibodies to Ther...Disruption at the Neuromuscular Junction: Relevance of Autoantibodies to Ther...
Disruption at the Neuromuscular Junction: Relevance of Autoantibodies to Ther...
 
Physiology of Pituitary gland and its hormones -3.pptx
Physiology of Pituitary gland and its hormones -3.pptxPhysiology of Pituitary gland and its hormones -3.pptx
Physiology of Pituitary gland and its hormones -3.pptx
 

Reptes en la incorporació de nous biomaterials a dispositius mèdics / Neos Surgery, Montserrat Charles-Harris

  • 1. Reptes en la incorporació de nousReptes en la incorporació de nous  biomaterials a dispositius mèdicsp “Biomaterials: de la biònica cap a la  ió i l t à i d ”regeneració i les teràpies avançades” Montse Charles‐Harris Neos Surgery S LNeos Surgery S.L.
  • 2. “Biomaterials : de la biònica cap a la regeneració i les teràpies avançades”20 d’octubre 2010
  • 3. Nuestra empresa • Founded in Oct 2003: technological partners • We design, produce and commercialise NEW SOLUTIONSWe design, produce and commercialise NEW SOLUTIONS for Neurosurgery. 3
  • 6. *Datos referentes a 2006 Strategy and Technology Competition: Multinational companies with great comercial andp p g financial power: R ki C Nº E l b A l T *Ranking Company Nº Employees webpage Annual Turnover* 1 Johnson&Johnson 122.200 www.jnj.com 33.000 M$ 3 Medtronic 37 000 www medtronic com 12 300 M$3 Medtronic 37.000 www.medtronic.com 12.300 M$ 10 Stryker 18.800 www.stryker.com 5.405 M$ 11 B Braun 30.000 www.bbraun.com 3.300 M$11 B.Braun 30.000 www.bbraun.com 3.300 M$ Our Strategy:gy Reactivity NEW l tiNEW solutions
  • 9. Challenges of working with New Biomaterials 1 Scale up and Industrialisation1. Scale-up and Industrialisation 2. Regulatory 3 Commercial /Marketing3. Commercial /Marketing
  • 10. Scale-up: Industrialisation 1 Repeatable and Reproducible process1. Repeatable and Reproducible process 2. Regulatory strategy 3 Suppliers : technical capacity clean room facility + certification3. Suppliers : technical capacity, clean-room facility + certification
  • 11. Regulatory 1 The MDD 93/42/EEC1. The MDD 93/42/EEC 2. ISO 10993 “Biological evaluation of medical devices” •CytotoxicityCytotoxicity •Sensitization •Irritation/Intracutaneous •Acute Systemic Toxicity•Acute Systemic Toxicity •Subchronic Toxicity •Genotoxicity I l t ti•Implantation •Chronic Toxicity •Carcinogenicity 3. Customised devices
  • 12. Commercial / Marketing 1 Convince clinicians1. Convince clinicians 1. Safety 2 Scientific studies2. Scientific studies 3. Clinical studies 2 C i h it l h i d t t2. Convince hospital purchasing departments 1. Price 2 St d h dli2. Storage and handling 3. Logistics
  • 13. Examples Company RESEARCHCompanyCompany nº 1 RESEARCHCompany nº 2 -Technical support for processing -Technical support for processing -Technical support for processing ?processing -ISO 10993 -Marketing -€€€€! processing -ISO 10993 -Marketing -€€€€! processing ? -ISO 10993 -Marketing -€€€€ ?€€€€! €€€€! €€€€ ? High riskLow risk
  • 14. Discussion 1) I l d Bi t i l li i th R&D h i• 1) Include Biomaterial suppliers in the R&D chain • → →Research Biomaterial Company Medical Device CompanyCompany Company
  • 15. Biomaterials Companies In Spain • Biomaterials market dominated by major multinationals. Small companies tend to operate in small, specialised niche markets • Joint ventures and/or distributor agreements for small and medium-sized manufacturers with major suppliers of orthopaedic productswith major suppliers of orthopaedic products
  • 16. Biomaterials Companies In Europe • Medical Implantable Materials Market US (forecast 2012) • Metals : 273.8$ million • Polymers : 50.9$ million • Ceramics : 22.2 $ million • Plastics in Medical Devices Market (2008) Pl ti 449 8 € illi• Plastics: 449.8 €million
  • 17. Discussion • 2) Bridge the gap between Research and Medical Device2) Bridge the gap between Research and Medical Device Companies RESEARCH -Technical support for processing ISO 10993 Medical Device -ISO 10993 -Marketing -Involvement in Research projects ISO 10993-ISO 10993 -Marketing
  • 18. Discussion • 2) Bridge the gap2) Bridge the gap Permanent implant MDTimplant MDT Tissue/Bone Comments Cytotoxicity x ISO direct contact 490€ Sensitization x Murine Local Lymph Node Assay 2490€y p y Irritation/Intracutaneous x ISO intracutaneous test 760€ Acute Systemic Toxicity x 560€ Subchronic Toxicity x Intraperitoneal or intavenous Genotoxicity x Ames test 2390€ Genotoxicity Ames test, Mouse Lymphoma Assay and Mouse micronucleus test 7260€ Implantation ISO implatation 90 days with hispatology 3600€ I l t ti ISO i l t ti 180 d ith hi t th l x Implantation ISO implantation 180 days with histopathology Implantation ISO implantation 365 days with histopathology Chronic Toxicity x > 400.000€* Carcinogenicity x > 400 000€*Carcinogenicity x > 400.000€* http://www.mdt-gmbh.com/
  • 19. Conclusions • Including “new” biomaterials in medical devices is challenging• Including new biomaterials in medical devices is challenging • Often done by joint ventures, or in-house research • Biomaterials suppliers must include:• Biomaterials suppliers must include: • Technical support R l t t• Regulatory support • Despite commercial pressure, clinicians all agree on the potential of regeneration and advanced therapies We mustpotential of regeneration and advanced therapies. We must solve: • Regulatory strategy for customised degradable materialsRegulatory strategy for customised, degradable materials • Industrialisation • Easy transfer from research to industry• Easy transfer from research to industry
  • 20. “Biomaterials : de la biònica cap a la regeneració i les teràpies avançades”20 d’octubre 2010