This document discusses the challenges of incorporating new biomaterials into medical devices. It notes that including new biomaterials often requires joint ventures or in-house research given regulatory and industrialization hurdles. Specifically, biomaterials suppliers must provide technical and regulatory support to bridge the gap between research and medical device companies. While there is commercial pressure, clinicians agree on the potential of regenerative therapies. Key challenges include developing regulatory strategies for customized degradable materials, industrializing production processes, and facilitating the transfer of technologies from research to industry.

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