Reptes en la incorporació de nousReptes en la incorporació de nous 
biomaterials a dispositius mèdicsp
“Biomaterials: de 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 desig...
Surgeons / Medical Partners
Financial Partners
*Datos referentes a 2006
Strategy and Technology
Competition: Multinational companies with great comercial andp p g
financ...
Products : BHID
7
Products : Cranial LOOP
Challenges of working with New Biomaterials
1 Scale up and Industrialisation1. Scale-up and Industrialisation
2. Regulator...
Scale-up: Industrialisation
1 Repeatable and Reproducible process1. Repeatable and Reproducible process
2. Regulatory stra...
Regulatory
1 The MDD 93/42/EEC1. The MDD 93/42/EEC
2. ISO 10993 “Biological evaluation of medical devices”
•CytotoxicityCy...
Commercial / Marketing
1 Convince clinicians1. Convince clinicians
1. Safety
2 Scientific studies2. Scientific studies
3. ...
Examples
Company RESEARCHCompanyCompany
nº 1
RESEARCHCompany
nº 2
-Technical support for
processing
-Technical support for...
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
...
Biomaterials Companies In Spain
• Biomaterials market dominated by major multinationals. Small companies tend to operate
i...
Biomaterials Companies In Europe
• Medical Implantable Materials Market US (forecast 2012)
• Metals : 273.8$ million
• Pol...
Discussion
• 2) Bridge the gap between Research and Medical Device2) Bridge the gap between Research and Medical Device
Co...
Discussion
• 2) Bridge the gap2) Bridge the gap
Permanent
implant MDTimplant MDT
Tissue/Bone Comments
Cytotoxicity x ISO d...
Conclusions
• Including “new” biomaterials in medical devices is challenging• Including new biomaterials in medical device...
“Biomaterials : de la biònica cap a la regeneració i les teràpies avançades”20 d’octubre 2010
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Reptes en la incorporació de nous biomaterials a dispositius mèdics / Neos Surgery, Montserrat Charles-Harris

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

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

  1. 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. 2. “Biomaterials : de la biònica cap a la regeneració i les teràpies avançades”20 d’octubre 2010
  3. 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. 4. Surgeons / Medical Partners
  5. 5. Financial Partners
  6. 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. 7. Products : BHID 7
  8. 8. Products : Cranial LOOP
  9. 9. Challenges of working with New Biomaterials 1 Scale up and Industrialisation1. Scale-up and Industrialisation 2. Regulatory 3 Commercial /Marketing3. Commercial /Marketing
  10. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 20. “Biomaterials : de la biònica cap a la regeneració i les teràpies avançades”20 d’octubre 2010

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