The Development and Commercialization of Medical Technologies

2021 ◽  
Author(s):  
Anthony A Bertrand ◽  
Michael R DeLong ◽  
Akash Chandawarkar ◽  
Chandler Robinson
Keyword(s):  
Medical Device ◽  
Medical Technology ◽  
Unmet Needs ◽  
Medical Community ◽  
Delivery Of Care ◽  
Medical Technologies ◽  
Drug Test ◽  
Level Of Understanding ◽  
And Training

Abstract It is not uncommon for physicians to think of ways to improve the delivery of care, which may take the form of a new medical device, drug, test, or service. In recent years, structured approaches to the identification of unmet needs and the development of solutions have been introduced to the medical community. Yet, due to gaps in exposure and training, there remains an opportunity to improve the level of understanding within the medical community regarding how to develop an innovation, once conceived, to the point of commercialization. The purpose of this article, therefore, is to provide an overview of some of the relevant considerations and requirements when bringing an idea for a new medical technology to market.

An Assessment of the Potential for Reducing Future Combat Deaths Through Medical Technologies and Training

2001 ◽  
Author(s):  
Christopher G. Blood ◽  
◽  
Julia Fridman ◽  
G. Jay Walker ◽  
Juan Carlos Puyana ◽  
...  
Keyword(s):  
Medical Technologies ◽  
And Training

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

scholarly journals EVALUASI PROGRAM PEMBERDAYAAN PEREMPUAN MELALUI PELATIHAN MENJAHIT DI SANGGAR KEGIATAN BELAJAR (SKB) UJUNG PANDANG

GANEC SWARA ◽  
2021 ◽  
Vol 15 (1) ◽  
pp. 935
Author(s):  
NINI PRATIWI ◽  
ILHAM SUPIANA
Keyword(s):  
Research Result ◽  
Evaluation Research ◽  
Training Material ◽  
Level Of Satisfaction ◽  
Level Model ◽  
Level Of Understanding ◽  
Evaluation Of Learning ◽  
Research Type ◽  
And Training ◽  
Reaction Level

      This study was aimed to describe evaluation results of: (1) participants’ level of satisfaction, (2) participants’ level of understanding of the material, (3) participants’ post-training level of implementation, (4) improved success of participants due to the training.      The research type was evaluation research using Kirkpatrick’s Four Level model, which consisted of: Reaction, learning, behavioral, and result levels. The research samples were 20 former training participants. Data was collected by questionnaire, observation, and unstructured interview. Quantitative data was processed with the help of SPSS 21.0 for Windows. Validity of instrument at reaction, learning, behavioral, and result levels used Corrected Item-Total Correlation. Reliability calculation used Alpha formula.      The research result showed that: 1) evaluation of reaction level: the satisfaction to sewing making training in terms of material, tutor, facility, and training method by PAP and PAP was “satisfying” 2) evaluation of learning level: understanding of material of the participants of making training sewing in terms of understanding of training material by PAP and PAN was “Mastering” 3) evaluation of behavioral level: participants’ implementation after training sewing of making in terms of post-training behavioral aspect by PAP and PAN was “implementing” 4) evaluation of result level: improved resulting competence due to training sewing of making by PAP and PAN was “poorly improved”.

scholarly journals PEMAHAMAN APARATUR PEMERINTAH TERHADAP PENERAPAN AKUNTANSI KEUANGAN DEMI TERCIPTANYA GOOD GOVERNANCE

2017 ◽  
Vol 5 (1) ◽  
Author(s):  
Herlin ◽  
Yanto Effendi
Keyword(s):  
Human Resources ◽  
Good Governance ◽  
Educational Background ◽  
Financial Accounting ◽  
Reliability Test ◽  
Alpha Coefficient ◽  
Government Officials ◽  
R Value ◽  
Level Of Understanding ◽  
And Training

Herlin dan Yanto Effendi: The purpose of this study to determine the understanding of government apparatus in the area of financial accounting application in order to realize good governance. Government Personnel Rejang Lebong still has a bit of an apparatus / HR background in accounting, from 25 respondents, only 9 respondents (36%) accounting background and the rest comes from other disciplines.The results showed that the correlation obtained the r value of 0, 203 a positive correlation between the variables x and y variables where the value of r lies in the interval 0 <r <1, and has a level of low relation because r value lies in the interval coefficient of 0, 20 -, 399. Reliability test alpha value of 0.60 is said to be reliable so that the new variable of educational background alpha coefficient of 0.6123, the education and training of alpha coefficient of 0.622 and Awareness Regional Financial Accounting alpha coefficient of 0.710. T-count value <the t-table, t-count equal to 3,699 while the t-table at significant level of 0.05% t-table of 4,946, this means that the level of understanding of government officials in Rejang Lebong specifically the application of financial accounting still weak or low , so they need to increase human resources through education, training, and understanding of financial accounting has become a standard government.Key words: Good Governance.

scholarly journals Improving patient self-care using diabetes technologies

2019 ◽  
Vol 10 ◽  
pp. 204201881882421 ◽  
Author(s):  
Valeria Alcántara-Aragón
Keyword(s):  
Cost Effectiveness ◽  
Unmet Needs ◽  
Diabetes Management ◽  
Glycated Hemoglobin ◽  
Diabetes Education ◽  
Self Care ◽  
Use Of Technology ◽  
Diabetes Technology ◽  
Improve Patient ◽  
And Training

Diabetes technologies are an unstoppable phenomenon. They offer opportunities to improve patient self-care through empowerment. However, they can be a challenge for both patients and clinicians. Thus, the use of technology may empower or burden. To understand and benefit from the use of diabetes technologies, one must understand the currently unmet needs in diabetes management. These unmet needs call for perspectives beyond glycated hemoglobin and an evaluation of technology solutions. Optimal use of these technologies is necessary to obtain benefits and achieve cost-effectiveness; this process depends on diabetes education and training. This review evaluates clinician and patient perspectives regarding diabetes technologies, followed by an evaluation of technology solutions. Diabetes technology solutions are evaluated according to available results about their effectiveness and their potential to empower people living with diabetes.

Assessment of Clinical Technologies

1988 ◽  
Vol 4 (3) ◽  
pp. 435-445 ◽  
Author(s):  
Bryan Jennett
Keyword(s):  
Economic Impact ◽  
Medical Technology ◽  
Hospital Environment ◽  
Patient Relationship ◽  
Doctor Patient Relationship ◽  
Profound Impact ◽  
Inappropriate Use ◽  
Medical Technologies ◽  
Ongoing Assessment

AbstractThe author contends that the diffusion and use of modern medical technologies has had a profound impact on the hospital environment, the doctor-patient relationship, and the humanity of the patient. On these grounds the author argues for a rigorous, comprehensive, and ongoing assessment of diagnostic and therapeutic technologies. He stresses the importance of developing standards by which to judge the human and economic impact of particular technologies. These studies would decrease the inappropriate use of medical technology and would provide guidelines to improve current use.

Disaster response and people experiencing homelessness: Addressing challenges of a population with limited resources

2015 ◽  
Vol 13 (3) ◽  
pp. 195 ◽  
Author(s):  
Bryan Wexler, MD, MPH ◽  
Mary-Elise Smith, MD, MA
Keyword(s):  
United States ◽  
Best Practices ◽  
Disaster Response ◽  
Planning Process ◽  
The United States ◽  
Limited Resources ◽  
Delivery Of Care ◽  
Psychiatric Conditions ◽  
Communication Methods ◽  
And Training

In this article the authors provide an overview of some issues that inhibit disaster planning and response for people experiencing homelessness and discuss the planning process conducted for this population in Worcester, MA. People experiencing homelessness face numerous challenges in preparing for disasters both natural and human caused. Similarly, providers attempting to aid these individuals must recognize and overcome various factors that hamper efforts to provide assistance. People experiencing homelessness lack the general resources many in the United States take for granted, including food, shelter, communication methods, and transportation. The population also has an increased prevalence of medical and psychiatric conditions. These factors amplify the typical difficulties in preparedness, communication, sheltering, and training for disasters. With these principles in mind, the authors reviewed the literature for best practices, identified potential stakeholders, and developed an annex to help address organization and delivery of care to those experiencing homelessness during a disaster.

scholarly journals Review of the role of NICE in promoting the adoption of innovative cardiac technologies

Heart ◽  
2018 ◽  
Vol 104 (22) ◽  
pp. 1817-1822 ◽  
Author(s):  
Peter H Groves ◽  
Chris Pomfrett ◽  
Mirella Marlow
Keyword(s):  
Medical Devices ◽  
Medical Technology ◽  
Professional Community ◽  
Evidence Based ◽  
Medical Technologies ◽  
Professional Societies ◽  
Diagnostic Technologies ◽  
Improve Health

The National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP) promotes the adoption of innovative diagnostic and therapeutic technologies into National Health Service (NHS) clinical practice through the publication of guidance and briefing documents. Since the inception of the programme in 2009, there have been 7 medical technologiesguidance, 3 diagnostics guidance and 23 medtechinnovation briefing documents published that are relevant to the heart and circulation. Medical technologies guidance is published by NICE for selected single technologies if they offer plausible additional benefits to patients and the healthcare system. Diagnostic guidance is published for diagnostic technologies if they have the potential to improve health outcomes, but if their introduction may be associated with an increase in overall cost to the NHS. Medtechinnovation briefings provide evidence-based advice to those considering the implementation of new medical devices or diagnostic technologies. This review provides reference to all of the guidance and briefing medical technology documents that NICE has published that are relevant to the heart and circulation and reflect on their diverse recommendations. The interaction of MTEP with other NICE programmes is integral to its effectiveness and the means by which consistency is ensured across the different NICE programmes is described. The importance of the input of clinical experts from the cardiovascular professional community and the engagement by NICE with cardiovascular professional societies is highlighted as being fundamental to ensuring the quality of guidance outputs as well as to promoting their implementation and adoption.

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