Strategies for Derisking Translational Processes for Biomedical Technologies.

Inefficient translational processes for technology-oriented biomedical research have led to some prominent and frequent failures in the development of many leading drug candidates, several designated investigational drugs, and some medical devices, as well as documented patient harm and postmarket product withdrawals. Derisking this process, particularly in the early stages, should increase translational efficiency and streamline resource utilization, especially in an academic setting. In this opinion article, we identify a 12-step guideline for reducing risks typically associated with translating medical technologies as they move toward prototypes, preclinical proof of concept, and possible clinical testing.

Changing the mindset in life sciences toward translation: a consensus.

Participants at the recent Translate! 2014 meeting in Berlin, Germany, reached a consensus on the rate-limiting factor for advancing translational medicine.

Demineralized bone matrix in bone repair: history and use.

Demineralized bone matrix (DBM) is an osteoconductive and osteoinductive commercial biomaterial and approved medical device used in bone defects with a long track record of clinical use in diverse forms. True to its name and as an acid-extracted organic matrix from human bone sources, DBM retains much of the proteinaceous components native to bone, with small amounts of calcium-based solids, inorganic phosphates and some trace cell debris. Many of DBM's proteinaceous components (e.

Biodegradable sleeves for metal implants to prevent implant-associated infection: an experimental in vivo study in sheep.

Objective: To evaluate biocompatibility of biodegradable sleeves containing antimicrobial agents, designed for local drug delivery to prevent implant-related infection.

Study Design: Synthetic polyester sleeves (a copolymer of glycolide, caprolactone, trimethylene carbonate, lactide) were cast as thin films. The antimicrobial agents incorporated in the sleeves included gentamicin sulfate, triclosan, or a combination of these drugs.

Fiber-reinforced calcium phosphate cement formulations for cranioplasty applications: a 52-week duration preclinical rabbit calvaria study.

The in vivo tissue response to a newly developed fiber-reinforced calcium phosphate cement (CPC) formulation was assessed using a well-established rabbit calvarial defect model. Bilateral subcritical sized (8-mm diameter) defects were surgically created in the parietal bones of each rabbit (a total of 48 rabbits), and randomized to be filled with either the new fiber-reinforced formulation, a conventional CPC (positive control), or left unfilled (negative control). The implant sites were subsequently retrieved after 12, 24, and 52 weeks postsurgery.