From in vivo to in vitro: The medical device testing paradigm shift

Myers, Dayna Kerecman; Goldberg, Alan M.; Poth, Albrecht; Wolf, Michael; Carraway, Joseph W.; McKim, James M.; Coleman, Kelly P.; Hutchinson, Richard W.; Brown, Ronald P.; Krug, Harald F.; Hartung, Thomas

doi:10.14573/altex.1608081

Cited by 44 publications

(49 citation statements)

References 66 publications

(80 reference statements)

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“…Currently, in the EU there are in vitro validated tests to replace animal testing for irritation and skin sensitization [ 111 , 112 ]. In vitro skin irritation tests are validated on 3D reconstructed epidermis such as EpiDerm™, SkinEthic™, Episkin™ and LabCyte EPI-MODEL24 SIT [ 113 , 114 , 115 , 116 , 117 ].…”

Section: Preclinical Evaluation Of Medical Devicesmentioning

confidence: 99%

Nanotechnology-Based Medical Devices for the Treatment of Chronic Skin Lesions: From Research to the Clinic

et al. 2020

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Chronic wounds, such as pressure ulcers, diabetic ulcers, venous ulcers and arterial insufficiency ulcers, are lesions that fail to proceed through the normal healing process within a period of 12 weeks. The treatment of skin chronic wounds still represents a great challenge. Wound medical devices (MDs) range from conventional and advanced dressings, up to skin grafts, but none of these are generally recognized as a gold standard. Based on recent developments, this paper reviews nanotechnology-based medical devices intended as skin substitutes. In particular, nanofibrous scaffolds are promising platforms for wound healing, especially due to their similarity to the extracellular matrix (ECM) and their capability to promote cell adhesion and proliferation, and to restore skin integrity, when grafted into the wound site. Nanotechnology-based scaffolds are emphasized here. The discussion will be focused on the definition of critical quality attributes (chemical and physical characterization, stability, particle size, surface properties, release of nanoparticles from MDs, sterility and apyrogenicity), the preclinical evaluation (biocompatibility testing, alternative in vitro tests for irritation and sensitization, wound healing test and animal wound models), the clinical evaluation and the CE (European Conformity) marking of nanotechnology-based MDs.

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Section: Preclinical Evaluation Of Medical Devicesmentioning

confidence: 99%

Nanotechnology-Based Medical Devices for the Treatment of Chronic Skin Lesions: From Research to the Clinic

et al. 2020

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“…Manufacturers may end up delaying their regulatory submission while they repeat testing on the individual device components. If disinfection or sterilization is required in the final finished form of the device, then it is important that all biocompatibility studies use test samples that have already been disinfected or sterilized under identical methods that will be used in the finished product [189].…”

Section: Testing Materials Versus a Composite Of The Finished Devicementioning

confidence: 99%

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

Reifschneider

2018

Preprint

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The U.S. Food and Drug Administration ("FDA") regulates all medical devices in the United States. As part of its regulatory duties, the FDA provides guidance documents on various regulatory topics as mandated by the U.S. code of federal regulations. Since 2015, the FDA has begun to issue many substantial revisions to their guidance documents that directly affects the regulatory framework on biocompatibility, reprocessing, and sterilization.These regulatory issues are of paramount importance for many companies because of the potential high costs involved in changing their internal design, controls, manufacturing, and quality systems. This master’s thesis examines the various changes made by the FDA in recent years on the inter-related topics of biocompatibility, reprocessing, and sterilization. Some of the major changes by the FDA involve an increase in the importance of chemical characterization, a reduction in the use of animal testing, a requirement for an independent validation of the user instructions for reusable devices, and increased usability testing.The principal reasons for these major policy changes by the FDA are shown to be the major device scandals that recently involved duodenoscopes, metal-on-metal hip implants, and vaginal surgical mesh implants. Along with several other regulatory failures that made national news headlines in the United States, the FDA began to revise several of their previous medical device guidances. The information from this master’s thesis can be used by medical device developers and manufacturers, especially when they are located outside of the United States and lack sufficient regulatory affairs resources to provide independent advice and recommendations on these important FDA changes. A thorough analysis is made of the new FDA guidances to clarify several potentially difficult questions for medical device manufacturers, specifically the following: (1) "Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", (2) "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", and (3) "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". This master’s thesis is intended to provide not only an overview of the current FDA requirements, but to function as a guide for both researchers and engineers to improve their medical device design and development process.

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“…Therefore, since in vivo models exhibit inherent complexity and low controllability, using in vitro reduced neuronal systems to model precise and reproducible neuronal network lesions and test neuroprosthetic devices for their treatment may be advantageous. This approach is also justified by a growing recognition that in vitro testing of both research and medical devices can be more effective in terms of cost, time consumption, and ethical issues and much more reliable than in vivo testing (Myers et al, 2017).…”

Section: Introductionmentioning

confidence: 99%

A Neuromorphic Prosthesis to Restore Communication in Neuronal Networks

et al. 2019

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Summary Recent advances in bioelectronics and neural engineering allowed the development of brain machine interfaces and neuroprostheses, capable of facilitating or recovering functionality in people with neurological disability. To realize energy-efficient and real-time capable devices, neuromorphic computing systems are envisaged as the core of next-generation systems for brain repair. We demonstrate here a real-time hardware neuromorphic prosthesis to restore bidirectional interactions between two neuronal populations, even when one is damaged or missing. We used in vitro modular cell cultures to mimic the mutual interaction between neuronal assemblies and created a focal lesion to functionally disconnect the two populations. Then, we employed our neuromorphic prosthesis for bidirectional bridging to artificially reconnect two disconnected neuronal modules and for hybrid bidirectional bridging to replace the activity of one module with a real-time hardware neuromorphic Spiking Neural Network. Our neuroprosthetic system opens avenues for the exploitation of neuromorphic-based devices in bioelectrical therapeutics for health care.

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From in vivo to in vitro: The medical device testing paradigm shift

Cited by 44 publications

References 66 publications

Nanotechnology-Based Medical Devices for the Treatment of Chronic Skin Lesions: From Research to the Clinic

Nanotechnology-Based Medical Devices for the Treatment of Chronic Skin Lesions: From Research to the Clinic

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

A Neuromorphic Prosthesis to Restore Communication in Neuronal Networks

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