Abstract
This paper considers the critical role that academics can have in the development of clinical innovations and especially how their impact can be optimized. The focus should be on establishing the safety and efficacy of new approaches while also incorporating human factors and human use considerations into the inventions. It is very advantageous to work in concert with the end-users (operators and clinicians) to help ensure that the innovation will be useful and feasible to be incorporated into actual clinical practice as intended. This strategy enables developments to tackle real clinical needs by providing novel strategies to improve patient care while using solutions that fit into clinical practice and that are welcomed by patients and clinical staff. These principles are illustrated by a case study of the development of clinical in vivo EPR oximetry.
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Notes
- 1.
Note: all volunteers are under IRB approved protocols.
References
Fargen KM, Frei D, Fiorella D et al (2013) The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation? J Neurointerv Surg 5:269–275
Dimasi JA, Grabowski GH, Hansen RW (2016) Innovation in the pharmaceutical industry: new estimates of R&D costs. J Health Econ 47:20–33
Van Norman GA (2016a) Drugs, devices and the FDA, part 1 an overview of approval processes for drugs. Am Coll Cardiol Basic Trans Sci 1(3):170–179
Van Norman GA (2016b) Part 2: FDA approval of medical devices. Am Coll Cardiol Basic Trans Sci 1:277–287
Citron P (2012) Ethics considerations for medical device R&D. Prog Cardiovas Dis 55:307–315. https://doi.org/10.1016/j.pcad
Sung NS, Crowley WF Jr, Genel M et al (2003) Central challenges facing the national clinical research enterprise. JAMA 289(10):1278–1287
Westfall JM, Mold J, Fagnan L (2007) Practice-based research—“Blue Highways” on the NIH roadmap. JAMA 297(4):403–406
US Food and Drug Administration (2016) Applying human factors and usability engineering to medical devices. Guidance for industry and Food and Drug Administration staff. Last accessed 1 Oct 2017. http://1.usa.gov/1WLMzPO; 81 Fed. Reg. 5762 (Feb. 3, 2016) https://www.gpo.gov/fdsys/pkg/FR-2016-02-03/pdf/2016-01887.pdf
Grunkemeier GL, Jin R, Wang L et al (2013) Chapter III.2.9: clinical trials for medical devices. In: Ratner BD, Hoffman AS, Schoen FJ, Lemons JE (eds) Biomaterials science: an introduction to materials in medicine, 3rd edn. Elsevier, Boston, pp 1443–1358. https://doi.org/10.1016/B978-0-08-087780-8.00137-6
Hirata H, Walczak T, Swartz HM (2000) Electronically tunable surface-coil-type resonator for L-band EPR spectroscopy. J Magn Reson 142(1):159–167
Schreiber W, Petryakov S, Kmiec MM et al (2016) Flexible, wireless, inductively coupled surface coil resonator for EPR tooth dosimetry. Radiat Prot Dosim 172(1–3):87–95. https://doi.org/10.1093/rpd/ncw153
Flood AB, Williams BB, Schreiber W et al (2016) Advances in in vivo EPR tooth biodosimetry: meeting the targets for initial triage following a large-scale radiation event. Radiat Prot Dosim 172(1–3):72–80. https://doi.org/10.1093/rpd/ncw165
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Flood, A.B., Wood, V.A., Schreiber, W., Williams, B.B., Gallez, B., Swartz, H.M. (2018). Guidance to Transfer ‘Bench-Ready’ Medical Technology into Usual Clinical Practice: Case Study – Sensors and Spectrometer Used in EPR Oximetry. In: Thews, O., LaManna, J., Harrison, D. (eds) Oxygen Transport to Tissue XL. Advances in Experimental Medicine and Biology, vol 1072. Springer, Cham. https://doi.org/10.1007/978-3-319-91287-5_37
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