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

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

4. Surgeons / Medical Partners

5. Financial Partners

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

7. Products : BHID
7

8. Products : Cranial LOOP

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