ISSN:
1433-075X
Keywords:
Key words Porous-bioceramic
;
Hydroxyapatite
;
Bone repair innovation-steps
;
Time-involved
;
Replamine- form
;
Bone graft substitute
;
Coral
;
(Interpore International)
Source:
Springer Online Journal Archives 1860-2000
Topics:
Mechanical Engineering, Materials Science, Production Engineering, Mining and Metallurgy, Traffic Engineering, Precision Mechanics
Notes:
Abstract An innovative process for forming a wide variety of porous biomaterials was conceived of and developed over several years at a University and later by a company that licensed the early patents. The family of patents formed the basis for several promising innovative biomaterials devices. However, only one commercial product has been realized. That product is the very successfull coralline hydroxyapatite (HA) now widely used in orthopaedic surgery, oral and maxillofacial bone repair and plastic surgery. This paper challenges the equation of discovery with a genuine innovation which reaches the marketplace. The paper reviews several aspects of the innovation and development history with an emphasis on the challenges of bringing any new biomaterial through all the conceptual, developmental, business and regulatory hurdles. New class three medical devices require huge investments of time and money typically requiring a minimum of eight years and 15–20 million dollars per new device to take it from concept to an approved product. These hurdles are so high that most research innovations in biomaterials never get put into the developmental pipeline. This paper is presented from an anecdotal perspective of an innovator who has had a continuous research and development involvement in the technology but has no significant management involvement beyond the early startup activities. It differs from predecessors is that it deals not only with the initial step of discovery but in the very difficult steps that follow on the road to a real innovation. Several strategies that may help other R&D groups outside the biomedical industry shorten the development cycle and increase the probability that a given biomaterials innovation can be seen through to approved product are discussed. Guidelines are suggested for culling out ideas that are technically sound but that likely won’t lead to successful products.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1007/s100190050019
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