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					\tt\ Table 1 Project index: select critical path projects from the Food and Drug
                              Administration (FDA)

     \txh\Center for Biologics Evaluation and Research
      15.   Advance the field of nanotechnology
      24.   Create new tools and methods to enable management of different types of data
     \txh\Center for Drug Evaluation and Research
      30.   Develop new tools to improve manufacturing quality
      37.   Advance personalized therapy using databases in different therapeutic areas
     \txh\Center for Devices and Radiological Health
      38.   Improve neurotoxicity testing to make clinical trials safer
      39.   Develop engineering and imaging design methods for medical device development
      43.   Develop standardized techniques for application of computational fluid dynamics in
            medical device development
      44.   Develop regulatory pathway for nanotechnology
      47.   Software for Bayesian-driven clinical trials
     \txh\National Center for Toxicological Research
      57.   Build infrastructure for electronic management of information on FDA-regulated
            products
      60.   Develop consensus on standards for using microarray data in personalized medicine
    \tfn\ Note: Numbers correspond with the projects listed in Ref 13
\tt\Table 2 Examples of materials and their applications

        \tch\Material                     Principal applications

        \txh\Metals and alloys

          316L stainless steel            Fracture fixation, stents, surgical instruments

          Commercially pure titanium      Bone and joint replacement, fracture fixation, dental

          Ti-Al-V, Ti-Al-Nb               implants, pacemaker encapsulation

          Ti-13Nb-13Zr, Ti-Mo-Zr-Fe

          Co-Cr-Mo, Cr-Ni-Cr-Mo           Bone and joint replacement, dental implants, dental

                                          restorations, heart valves

          Nitinol (Ni-Ti)                 Bone plates, stents, orthodontic wires

          Gold alloys                     Dental restorations

          Silver products                 Antibacterial agents

          Platinum and Pt-Ir              Electrodes

          Hg-Ag-Sn amalgam                Dental restorations

        \txh\Glasses and ceramics

          Alumina                         Joint replacement, dental implants

          Zirconia                        Joint replacement

          Calcium phosphates              Bone repair and augmentation, surface coatings on

                                          metals

          Bioactive glasses               Bone replacement

          Porcelain                       Dental restoration
    Carbons                              Heart valves, percutaneous devices, dental implants

 \txh\Polymers

    Polyethylene                         Joint replacement

    Polypropylene                        Sutures

    Polyethylene terephthalates          Sutures, vascular prostheses

    Polyamides                           Sutures

    Polytetrafluoroethylenes             Soft-tissue augmentation, vascular prostheses

    Polyesters                           Vascular prostheses, drug-delivery systems

    Polyurethanes                        Blood-contacting devices

    Polyvinyl chlorides                  Tubing

    Polymethyl methacrylate (PMMA)       Dental restorations, intraocular lenses, bone cements

    Silicones                            Soft-tissue replacement, ophthalmology

    Hydrogels                            Ophthalmology, drug-delivery systems

 \txh\Composites

    Bisphenol A-glycidyl quartz/silica   Dental restorations

    PMMA-glass fillers                   Dental restorations (dental cements)




\tfn\ Adapted from Ref 23
\tt\ Table 3 Examples of polymers used as biomaterials

        \tch\ Application            Polymer

        Knee, hip, shoulder joints   Ultrahigh-molecular-weight polyethylene

        Finger joints                Silicone

        Sutures                      Polylactic and polyglycolic acid

        Tracheal tubes               Silicone, acrylic, nylon

        Catheters                    Polyurethane, silicone rubber, Teflon (E.I. du Pont de

                                     Nemours and Company)

        Heart pacemaker              Acetal, polyethylene, polyurethane

        Blood vessels                Polyester, polytetrafluoroethylene, polyvinyl chloride

                                     (PVC)

        Contact lens                 Silicone acrylate (and hydrogels)

        Intraocular lens             Polymethyl methacrylate, silicone rubber, hydrogel

        Gastrointestinal segments    Nylon, PVC, silicones

        Facial prostheses            Polydimethyl, siloxane, polyurethane, PVC

        Bone cement                  Polymethyl methacrylate




      \tfn\ Source: Ref 45, 46
\tt\ Table 4 Context of sensor applications

        \tch\ Context                                         Application

        \txh\ External

          Noncontact                  No body fluids or drugs in contact with the sensor: syringe

                                      pumps, spirometers, ventilators

          Contact                     Body fluids come in contact with the sensor: dialysis,

                                      angioplasty, body cavity temperature and pressure

        \txh\ Implanted

          Temporary                   For duration of procedure or less than 30 days: catheter

                                      pressure sensors, intrauterine sensors, force-sensing, capsule

                                      endoscopy

          Permanent                   Implanted for more than 30 days: wireless aneurysm

                                      pressure sensors, bladder pressure sensors, tremor control

                                      electrodes, cochlear ear implants, implantable defibrillator,

                                      bone graft fusion
\tt\Table 5 Materials combinations in total hip replacement prosthesis

   \tch\Femoral component          Socket component                           Results

   Co-Cr-Mo                        Co-Cr-Mo             Early loosening rate and limited use; new

                                                        developments show lower wear rate

   Co-Cr-Mo                        UHMWPE               Widely employed; low wear

   Alumina/zirconia                UHMWPE               Very low wear; zirconia more impact resistant

   Alumina                         Alumina              Minimum wear rate (components matched)

   Ti-6Al-4V                       UHMWPE               Reports of high UHMWPE wear due to

                                                        breakdown of titanium surface

   Surface-coated Ti-6Al-4V        UHMWPE               Enhanced wear resistance to abrasion; only

                                                        thin layer achieved

\tfn\ Note: UHMWPE, ultrahigh-molecular-weight polyethylene. Source: Ref 45

				
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