scholarly journals Regenerative Medicine: Analysis, Forecast and Regulatory Requirements

2020 ◽  
Vol 11 (03) ◽  
pp. 350-354
Author(s):  
M P. Venkatesh ◽  
A. Akil ◽  
V Balamuralidhara ◽  
T M Pramod Kumar
Keyword(s):  
Regenerative Medicine ◽  
Medical Device ◽  
Tissue Loss ◽  
Regulatory Requirements ◽  
Regenerative Medicines ◽  
Regenerate Tissue ◽  
Medicine Analysis ◽  
Best Fit ◽  
Guidance Development ◽  
Fda Regulations

Regenerative medicine is a new and expanding field in biomedical research. Organ and tissue loss through disease and injury, propel the development of a treatment that can regenerate tissue and help for less relaying in organ transplantation. Regenerative medicine has the potential to heal tissue and damaged organ. Currently, a patient suffering from diseased and injured organs can be treated with transplantation organs, but there is a shortage of donor organs. Dermatology is estimated to have a larger share in the market for regenerative medicine as skin being an organ with great cell replicate characteristics. US and Japan play a major role in the market for regenerative medicine. Food and drug administration (FDA) regulations for a medical device used in regenerative medicine are covered here to support risk-based, flexible regulatory methods to help and support the potential to bring novel treatment possibilities to market further. But due to incorrect FDA regulations, it stands as a barrier for the marketing regenerative medicines. Better and clear guidance development or a clear regulatory framework for both regenerative medicine and medical device can leads the product a best fit clinical development and product access in the market.

Regenerative medicine for end-stage fibrosis and tissue loss in the upper aerodigestive tract: a twenty-first century review

2021 ◽  
pp. 1-13
Author(s):  
F R Green ◽  
N M Shubber ◽  
F S Koumpa ◽  
N J I Hamilton
Keyword(s):  
Salivary Gland ◽  
Regenerative Medicine ◽  
Vocal Fold ◽  
Aerodigestive Tract ◽  
First Century ◽  
Tissue Loss ◽  
Cochrane Library ◽  
Upper Aerodigestive Tract ◽  
Twenty First Century ◽  
End Stage

Abstract Objective This review assesses regenerative medicine of the upper aerodigestive tract during the first two decades of the twenty-first century, focusing on end-stage fibrosis and tissue loss in the upper airways, salivary system, oropharynx and tongue. Method PubMed, Embase, Google Scholar, Cochrane Library, Medline and clinicaltrials.org were searched from 2000 to 2019. The keywords used were: bioengineering, regenerative medicine, tissue engineering, cell therapy, regenerative surgery, upper aerodigestive tract, pharynx, oropharynx, larynx, trachea, vocal cord, tongue and salivary glands. Original studies were subcategorised by anatomical region. Original human reports were further analysed. Articles on periodontology, ear, nose and maxillofacial disorders, and cancer immunotherapy were excluded. Results Of 716 relevant publications, 471 were original studies. There were 18 human studies included, within which 8 reported airway replacements, 5 concerned vocal fold regeneration and 3 concerned salivary gland regeneration. Techniques included cell transplantation, injection of biofactors, bioscaffolding and bioengineered laryngeal structures. Conclusion Moderate experimental success was identified in the restoration of upper airway, vocal fold and salivary gland function. This review suggests that a shift in regenerative medicine research focus is required toward pathology with a higher disease burden.

scholarly journals Regenerative medicine: the emergence of an industry

2010 ◽  
Vol 7 (suppl_6) ◽  
Author(s):  
Robert M. Nerem
Keyword(s):  
Tissue Engineering ◽  
Regenerative Medicine ◽  
Private Sector ◽  
Medical Device ◽  
Engineering Industry ◽  
Full Time ◽  
Business Units ◽  
The World ◽  
The Future ◽  
Pharmaceutical Industries

Over the last quarter of a century there has been an emergence of a tissue engineering industry, one that has now evolved into the broader area of regenerative medicine. There have been ‘ups and downs’ in this industry; however, it now appears to be on a track that may be described as ‘back to the future’. The latest data indicate that for 2007 the private sector activity in the world for this industry is approaching $2.5 billion, with 167 companies/business units and more than 6000 employee full time equivalents. Although small compared with the medical device and also the pharmaceutical industries, these numbers are not insignificant. Thus, there is the indication that this industry, and the related technology, may still achieve its potential and address the needs of millions of patients worldwide, in particular those with needs that currently are unmet.

The Impact of Regulatory Compliance on Agile Software Processes with a Focus on the FDA Guidelines for Medical Device Software

2011 ◽  
Vol 2 (2) ◽  
pp. 67-81 ◽  
Author(s):  
Hossein Mehrfard ◽  
Abdelwahab Hamou-Lhadj
Keyword(s):  
Medical Device ◽  
Software Process ◽  
Regulatory Compliance ◽  
Extreme Programming ◽  
Organizational Processes ◽  
Medical Device Software ◽  
Development Processes ◽  
Agile Software ◽  
The Impact ◽  
Fda Regulations

The difficulty of complying with different regulations has become more evident as a large number of regulated businesses are mandated to follow an ever-increasing set of regulations. These regulations often drive significant changes in the way organizations operate to deliver value to their customers. This paper focuses on the impact of the Food and Drug Administration (FDA) regulations on agile software development processes, which in many ways can be considered as just another type of organizational processes. Particular focus is placed on the ability for Extreme Programming (XP) to support FDA requirements. Findings show that XP fails to meet many of the FDA guidelines for medical device software, which increases the risks of non-compliance for organizations that have adopted XP as their main software process. The results of this study can lead the work towards designing an extension to XP for FDA regulations.

Cultural Barriers to the Transition from Product to Product Service in the Medical Device Industry

2014 ◽  
Vol 5 (2) ◽  
pp. 36-50 ◽  
Author(s):  
Linda Ryan ◽  
David Tormey ◽  
Perry Share
Keyword(s):  
Medical Device ◽  
Value Chain ◽  
Service Provision ◽  
Cultural Barriers ◽  
Manufacturing Companies ◽  
Regulatory Requirements ◽  
Product Service ◽  
High Level ◽  
Product Service Systems ◽  
Service Transition

Manufacturing companies are increasingly moving up the value chain by expanding their value offering to include service components, namely Product Service Systems (PSS). Due to the fundamental differences between the provision of products and services, many struggle to effectively integrate the two into a single cohesive offering. This is particularly true of companies operating in the medical device field as, due to the high level of regulatory requirements and controls, implementation of the ‘soft' components of service provision is difficult. The aim of the research is to facilitate companies to move up the value chain from product to product-service provision. Once identified, barriers can then be directly addressed and overcome, thereby allowing the development of a cohesive PSS offering. This will be achieved by identifying existing cultural barriers in relation to the application of PSS strategy within a product-orientated business. This information can be used to facilitate the application of PSS models with produc-orientated companies. This paper details qualitative research, undertaken with eight product-orientated medical device companies and two service practitioners, which establishes, details and analyses the primary cultural barriers in relation to product to product-service transition. These cultural barriers are further extrapolated through a supporting literature research.

One health in regenerative medicine: report on the second Havemeyer symposium on regenerative medicine in horses

2020 ◽  
Vol 15 (6) ◽  
pp. 1775-1787
Author(s):  
Lisa Ann Fortier ◽  
Laurie Ruth Goodrich ◽  
Iris Ribitsch ◽  
Lauren Virginia Schnabel ◽  
David Owen Shepard ◽  
...  
Keyword(s):  
Stem Cells ◽  
Bone Marrow ◽  
Regenerative Medicine ◽  
Platelet Rich Plasma ◽  
Stromal Vascular Fraction ◽  
Human Patient ◽  
Tenogenic Differentiation ◽  
Autologous Conditioned Serum ◽  
Regenerative Medicines ◽  
Regenerative Therapies

Regenerative medicine is commonly used in human and equine athletes. Potential therapies include culture expanded stem cells, stromal vascular fraction of adipose tissue, platelet-rich plasma, bone marrow concentrate, or autologous conditioned serum. The purpose of this manuscript is to disseminate findings from a workshop on the development of translational regenerative medicine in the equine field. Five themes emerged: stem cell characterization and tenogenic differentiation; interactions between mesenchymal stem cells, other cells and the environment; scaffolds and cell packaging; blood- and bone marrow-based regenerative medicines; clinical use of regenerative therapies. Evidence gained through the use of regenerative medicine applications in the horse should continue to translate to the human patient, bringing novel regenerative therapies to both humans and horses.

scholarly journals 3D Bioprinting Regulations: a UK/EU Perspective

2017 ◽  
Vol 8 (2) ◽  
pp. 441-447 ◽  
Author(s):  
Phoebe LI ◽  
Alex FAULKNER
Keyword(s):  
Tissue Engineering ◽  
Regenerative Medicine ◽  
Medical Device ◽  
3D Bioprinting ◽  
Medicinal Products ◽  
Legal Regime ◽  
Advanced Therapy ◽  
Regulatory Instruments ◽  
The Eu ◽  
Medical Device Regulation

AbstractThis report introduces the challenges 3D bioprinting poses to the existing legal regime across bioethics, safety, regenerative medicine, and tissue engineering. We briefly review the 3D bioprinting technology and look into the relevant regulatory instruments for the pre-printing, printing, and post-printing stages. Special attention is paid to the applications of the EU Advanced Therapy Medicinal Products Regulation and the new Medical Device Regulation.

A Review of Design for X Methods for Medical Devices: The Introduction of a Design for FDA Approach

2011 ◽  
Author(s):  
Lourdes A. Medina ◽  
Richard A. Wysk ◽  
Gu¨l E. Okudan Kremer
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Development Process ◽  
Regulatory Compliance ◽  
Design For Manufacturing ◽  
Design For X ◽  
Device Development ◽  
Unites States ◽  
Fda Regulations

This paper focuses on the importance of the regulations, in particular the Food and Drug Administration (FDA), in the development of medical devices. The FDA regulates medical devices to assure that these products are safe and effective before their release into the Unites States market. We introduce the concept of Design for FDA (DfFDA) and describe DfFDA guidelines for medical device development. While many researchers describe the regulations in the form of reviews and models, the literature to date has not reported a DfFDA method. Here, DfFDA is proposed as a method to be used in parallel with other DfX methods when applicable. The DfX methods identified include: Design for Validation (DfV), Design for Reliability (DfR), Design for Quality (DfQ), Design for Manufacturing (DfM), Design for Assembly (DfA) and Design for Usability (DfU). This paper also reviews the literature addressing the FDA regulations and DfX methods, and an overview of the FDA regulations is presented. DfFDA is developed to increase awareness about regulatory compliance and promote designers to consider the regulations throughout the development process of medical devices.

scholarly journals Facility Registration and Initial Regulatory Compliance Activities for Acidified Food and Low-Acid Canned Food Processors in Florida

EDIS ◽  
2019 ◽  
Vol 2019 (2) ◽  
pp. 3
Author(s):  
Matthew Krug ◽  
Soohyoun Ahn
Keyword(s):  
Regulatory Compliance ◽  
Human Nutrition ◽  
Food Science ◽  
Regulatory Requirements ◽  
Canned Food ◽  
Wide Range ◽  
Canned Foods ◽  
Business Regulations ◽  
Acidified Foods ◽  
Fda Regulations

Food businesses are subject to a wide range of regulatory requirements. Food entrepreneurs who want to produce and sell acidified foods or low-acid canned foods must abide by specific FDA regulations. This new 3-page document intends to clarify the initial steps food entrepreneurs must implement to comply with these regulations. This factsheet is one in a Food Entrepreneurship in Florida series, which assists beginning and established food entrepreneurs by providing them information on topics highly relevant to starting and running a food business: regulations, safety, labeling, processing, and marketing. Written by Matthew Krug and Soohyoun Ahn, and published by the UF/IFAS Food Science and Human Nutrition Department, February 2019.  http://edis.ifas.ufl.edu/fs318

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