Critical Factors and Economic Methods for Regulatory Impact Assessment in the Medical Device Industry

Abstract

Introduction The regulatory area is one that restricts human behaviour and opportunities, but it also allows the prevention of loss of property, health, or even life in various fields. Regulations provide the market with public confidence, which is extremely important in the field of innovative medical devices. The aim of this article is to analyse critical factors and economic methods for regulatory impact assessment in the medical device industry, to focus on the finances, processes, or innovation activity of organisations operating in the medical device sector. Methods The paper consists of a scoping review according to the PRISMA methodology of the available literature in Web of Science and Scopus database, whereby combing the keywords “regulation” AND “innovation” AND “medical device” AND “economic impact,” we obtained a set of 156 results in the form of English-written articles. The output was then limited to the period between 2011 and 2020. Finally, 23 papers were used based on the exclusion and inclusion criteria. Results The resulting challenges of the identified problems in particular are the amount of high-quality data available at an appropriate cost and the availability of a flexible notified body. There are also challenges specific to the situation, such as demands on the safety of medical devices for children. From a public expectations point of view, there is a continuing need to maintain the urgency of the balance between available innovation and safety. Discussion As for the methods of economic assessment in general, or methods for assessing the economic impact of regulations in particular, cost-effectiveness analysis is the most commonly used method for research and development, while internal rate of return is frequently used for the producers, and budget impact analysis is typically used for healthcare service providers. A non-financial indicator that is often discussed is the time demands associated with meeting compliance requirements. The time-to-market indicator is also often mentioned. Economic and financial topics are not discussed in depth, as the reviewed articles simply mention the generally high costs attendant on complying with regulations and obtaining certificates.

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“…Owing to the particularity of the medical industry and devices, governments around the world have clear classifications and strict specifications for the development and marketing of medical devices. Such regulations make the design, development, and market planning of this industry more challenging than those of general commodities [ 6 ]. One of the problems of medical device usage involves the medical device developer's failure to consider fully the application status of a product during the product design and development process, thereby resulting in equipment inapplicability.…”

“…Therefore, medical device developers need to be aware of the various aspects of the development process and focus on human factors and compliance with medical device marketing regulations to reduce postmarket risks. However, an important research gap exists regarding how to invest limited resources in product development and how to formulate development strategies to achieve optimal healthcare benefits based on product efficiency, medical regulations, and user needs [ 6 ].…”

The Impact of Industry 4.0 on the Medical Device Regulatory Product Life Cycle Compliance

“…Regulatory compliance is how manufacturers comply with the different regulatory requirements to ensure their products, processes, and services deliver a safe and effective product, meet customer requirements and expectations and meet the country-specific regulatory requirements [12]. Digital transformation through the use of digital technology builds regulatory intelligence and automation, ensuring data is collected, stored, and maintained globally; it will support complex regulatory strategies ensuring the most up-todate regulatory requirements are available and met, resulting in a faster turnaround time for activities such as registrations, enabling a more effective and efficient and compliant RA function that is aligned with the rest of the organisation [23].…”

“…The compliance requirement for organisations can be statutory, mandatory, or voluntary, depending on the industry and organisational function [1,12]. The effect of digitalisation on Medtech regulatory affairs and compliance to regulations while touched upon in Industry 4.0 literature as a benefit of digitalisation has not been studied.…”

Developing A Model on SME Innovation Strategies—Empirical Evidence and Confirmatory Analysis from Medical Device Industry in Germany

“…The regulation governs human behaviour and prevents property and health loss in various fields. Regulation is essential because it gives the market confidence in innovative medical devices (Maci, 2022).…”