Complexity stage model of the medical device development based on economic evaluation-MedDee

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F20%3A10411694" target="_blank" >RIV/00179906:_____/20:10411694 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/61989100:27240/20:10244959 RIV/62690094:18450/20:50016838

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=X~E__FO5oP" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=X~E__FO5oP</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3390/su12051755" target="_blank" >10.3390/su12051755</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Complexity stage model of the medical device development based on economic evaluation-MedDee

Popis výsledku v původním jazyce

The development of a new product is essential for the progress and success of any company. The medical device market is very specific, which is challenging. Therefore, this paper assesses an economic model for medical device evaluation using the economic, health, technology regulatory, and present market knowledge to enable the cost-time conception for any applicant. The purpose of this study is to propose a comprehensive stage model of the medical device development to subsequently describe the financial expenditure of the entire development process. The identification of critical steps was based on the literature review, and analysis, and a comparison of the available medical device development stages and directives. Furthermore, a preliminary assessment of the medical device development steps and procedures on the basis of the interviews was performed. Six interviews were conducted with an average duration of one hour, focusing on areas: relevance and level of detail of the medical device development stages, involvement of economic methods, and applicability of the proposed model. Subsequently, the improvement and modification of the medical device investment process, based on respondents&apos; responses, were conducted. The authors have proposed the complexity model MedDee-Medical Devices Development by Economic Evaluation. This model is comprised of six phases: initiation, concept, design, production, final verification, and market disposition in which the economic methods are incorporated.

Název v anglickém jazyce

Complexity stage model of the medical device development based on economic evaluation-MedDee

Popis výsledku anglicky

The development of a new product is essential for the progress and success of any company. The medical device market is very specific, which is challenging. Therefore, this paper assesses an economic model for medical device evaluation using the economic, health, technology regulatory, and present market knowledge to enable the cost-time conception for any applicant. The purpose of this study is to propose a comprehensive stage model of the medical device development to subsequently describe the financial expenditure of the entire development process. The identification of critical steps was based on the literature review, and analysis, and a comparison of the available medical device development stages and directives. Furthermore, a preliminary assessment of the medical device development steps and procedures on the basis of the interviews was performed. Six interviews were conducted with an average duration of one hour, focusing on areas: relevance and level of detail of the medical device development stages, involvement of economic methods, and applicability of the proposed model. Subsequently, the improvement and modification of the medical device investment process, based on respondents&apos; responses, were conducted. The authors have proposed the complexity model MedDee-Medical Devices Development by Economic Evaluation. This model is comprised of six phases: initiation, concept, design, production, final verification, and market disposition in which the economic methods are incorporated.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

50201 - Economic Theory

Projekt

<a href="/cs/project/GA17-03037S" target="_blank" >GA17-03037S: Hodnocení investic do vývoje zdravotních prostředků</a><br>

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2020

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Sustainability

ISSN

2071-1050

e-ISSN

—

Svazek periodika

12

Číslo periodika v rámci svazku

5

Stát vydavatele periodika

CH - Švýcarská konfederace

Počet stran výsledku

27

Strana od-do

1755

Kód UT WoS článku

000522470900056

EID výsledku v databázi Scopus

2-s2.0-85087517159