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

Figures & data

Figure 1 PRISMA 2020 flow diagram of outputs obtained in step 2.

Notes: PRISMA figure adapted from Page MJ, McKenzie JE, Bossuyt PM et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. Creative Commons.²² *Results excluded following screening (reasons): 1) Focused on processes and their relation to regulation (influence of non-financial, non-medical variables). 2) Focused on regulation as such; methods for evaluating regulation are lacking. 3) Economic circumstances described only very superficially (eg financial data are missing); focused on the medical aspect. Necessary economic context in the form of costs, benefits, and financial impact as well as methods for an economic evaluation of the research problem are missing (missing numbers, data, methods). Regarding the work with articles classified as review, such articles were included, provided that the area of review concerned a medical problem, ie, the economic issue was not the primary topic but economic issues were desirably represented in the review.

Figure 2 Number of publications according to the filter from step 1 for the last 20 years.

Figure 3 Cluster analysis of keywords in step 1 (all, regulation, cost-effectiveness analysis, economy).

Table 1 Clusters of Keywords in WoS

Cluster 1 = healthcare (13 items)	Adult, breast cancer, cost-effectiveness analysis, delivery of healthcare, drug industry, Europe, European Union, healthcare access, healthcare delivery, healthcare policy, healthcare quality, health policy, reimbursement
Cluster 2 = safety (12 items)	Article, device safety, female, Food and Drug Administration, government regulation, healthcare cost, human, humans, patient safety, practice guideline, risk assessment, United States
Cluster 3 = medical device (7 items)	Biomedical equipment, economics, healthcare, medical devices, procedures, regulation, standards
Cluster 4 = public health (6 items)	Healthcare personnel, legal aspect, nonhuman, priority journal, public health, review

Note: See Cluster 1 – red, Cluster 2 – green, Cluster 3 – blue, and Cluster 4 – yellow colour in Figure 3.

Table 2 Step 2 – Medical Device, Regulation, and Innovation – Economic Context

Author(s)	Paper Category*	Article Context	Economic Evaluation Method Mentioned or Used	Economic Variable Considered	Citations (Scopus)**
Laslett et al^Citation74	II	The authors discuss direct and indirect medical costs of cardiovascular disease and potential costs of disease prevention.	The authors work indirectly with cost-minimisation and cost-effectiveness analyses.	Indirect medical costs	412
Dunn et al^Citation75	II	The article is dedicated to wearables and their potential role in reducing medical costs.	The authors work indirectly with cost-minimisation and cost-effectiveness analyses.	Costs	71
Becker et al^Citation76	II	The article deals with genetic testing and common disorders from a healthcare perspective. New possibilities for genetic testing confront healthcare workers with the question of whom to test and which test to use.	The authors work with traditional assessment methods: cost-benefit, cost-minimisation, cost-effectiveness, and cost-utility. (Note: The incorrect use of these terms in other medical studies is pointed out.)	Direct and indirect costs	61
Herder^Citation77	III	The article is focused on orphan diseases. A new approach to rare, orphan diseases is needed.	The authors use cost-effectiveness analysis; from the manufacturer point of view, internal rate of return (IRR) is considered.	Costs of clinical trials subsidised through tax credits	21
Pirnay et al^Citation78	II	The rationale and elaboration process of the recent EU HCT/P regulatory framework (EUCTDs and ATMP Regulation) are analysed.	Cost-effectiveness analysis is mentioned as a tool for evaluation when comparing two similar treatments.	Compliance costs (which are also reflected in the product price) as a consequence of regulation	20
Gelijns et al^Citation28	III	The article assesses left ventricular assist devices for destination therapy. The authors point out that the results of the Cost-effectiveness analysis in the pivotal trial may differ significantly from later results.	Cost-effectiveness analysis is used. (The cost-effectiveness ratio of left ventricular assist devices for destination therapy, for example, decreased within a relatively short time from around $600,000 to around $100,000 per life year saved based on results from a pivotal trial.)	Costs	15
Hull & Pasquale^Citation79	III	The article emphasises the issue of wellness as a potential prevention of diseases.	Wellness is considered to help bring a positive return on investment (ROI) for both employers and employees. Numerous studies undermine ROI to be positive in relation to healthcare costs.	Costs	14
Hall et al^Citation80	II	The study makes a case for diagnostic tests of acute kidney injury: test-directed care is compared with standard care.	The authors use cost-effectiveness analysis. (The study finds that the incremental cost-effectiveness ratios ranged from £11,476 to £19,324 per quality-adjusted life-year, with a probability of cost-effectiveness between 48% and 54%.)	Costs	9
Kazzazi et al^Citation81	I	The study deals with BREXIT and scenarios of possible development of the pharmaceutical industry regulation in relation to the EU.	Rather than applying an elaborate method of assessing economic impacts, the paper lists a number of possible losses for the pharmaceutical industry according to selected scenarios.	Costs, administrative costs, and custom taxes	9
Chan et al^Citation82	II	This diabetes study works extensively with healthcare costs as well as societal costs associated with the disease.	The authors apply cost-effectiveness analysis. (With the expiry of patents, costs of widely used therapies decrease, and thus cost-effectiveness increases.)	Costs (direct, indirect, out-of-pocket) and spending per capita	7
Vallespin et al^Citation34	II	The study argues that a lack of clear rules or guidelines for mHealth regulation produces uncertainty in the industry and decreases confidence of healthcare professionals.	Cost-effectiveness analysis is mentioned as an evaluation tool that can be adopted for mHealth.	Costs (savings)	7
Blüher et al^Citation31	I	The study provides an overview of the health-economic aspect in current European HTA guidelines concerning medical devices and identifies issues raised and potential improvements proposed in recent literature.	The authors consider cost-effectiveness analysis, cost-utility analysis, cost-benefit, cost-minimisation, budget-impact analysis, and discounting.	Costs (direct, indirect, societal), discount rate, and price (dynamic pricing)	6
Markiewicz et al^Citation30	III	The study explores whether and how Dutch manufacturers perform an early assessment of medical devices through semi-structured interviews with key informants from medical device companies.	The authors provide a financial analysis; considering, from the company perspective, price determination, net present value (NPV), and return on investment (ROI), and from the buyer perspective, budget impact analysis and ROI.	Costs, price, and societal value	4
Plun-Favreau et al^Citation27	II	The article considers the perspectives of different stakeholders on the provision of a research-enabled, patient-focused molecular diagnostics platform that supports optimal patient care.	The authors consider cost-effectiveness analysis and costs-saving.	Spending, costs, and savings	3
Heidt et al^Citation26	II	The article summarises current research describing the use of point-of-care diagnostics in resource-limited settings and potential bottlenecks along the value chain that prevent their widespread application.	The authors consider cost-effectiveness analysis.	Costs and price	2
Dabbous et al^Citation83	I	The study describes the current landscape of managed entry agreements in Europe and analyses the main obstacles they face in implementation, providing a policy perspective.	The authors consider cost-effectiveness. (Currently, novel, costly technologies with high uncertainties about their real-life value to patients typically fail the traditional effectiveness and cost-effectiveness assessments.)	Costs (cost-containment, caps) and pricing	2
Singh et al^Citation35	I	The study examines aspects of governmental influence on innovation by analysing the impact of the Obamacare excise tax on the medical device industry.	The authors conduct a quantitative analysis. (The relationship between product counts and revenues and excise duty in relation to innovation activity are considered.)	Excise tax and revenues	2
Gruska et al^Citation24	III	The article aims to provoke a critical discussion of the digital change in cardiology and to make recommendations for the implementation of those telemedical processes that have been shown to exert positive effects on a wide variety of medical and economic parameters.	The authors consider cost-effectiveness, cost-benefit ratio, and costs reduction. (The total costs for patient care were reduced by 10–55% with remote monitoring.)	Costs	1
Wright et al^Citation25	II	The study illustrates the importance and quantifies the impact of varying marginal costs and benefits on the value of implementation for a case study in precision medicine.	The authors consider a decision analytic model based on cost-effectiveness analysis.	Marginal costs and benefits	1
Orubu et al^Citation84	I	The article describes key barriers to quality medicines and presents five selected approaches leveraging the scale-up of universal Health Coverage (UHC) for medicine quality assurance.	The authors consider cost-effectiveness. (Detection of falsified products was found to be cost-effective for any of the six selected portable or field-use technologies with unit purchase costs of $3–1400.)	Costs (cost-saving)
Miesler et al^Citation29	III	The study focuses on the concept of frugal innovation in general and specifically in the field of diagnostics (point-of-care tests).	The authors consider cost-effectiveness, cost-performance ratio, value-based reimbursement, and qualified estimate.	Costs and price	1
Scanell & Cormican^Citation32	III	The paper investigates the impact of the medical device regulatory framework on the academic spinoff formation process.	NA	Costs (considered as being the greatest barrier to spinoff formation)	0
Bollka^Citation36	I	The article attempts to shed light on the medical device excise tax by examining its history, its technicalities, and the political arguments on both sides in depth.	NA	Costs, employment, R&D spending, excise tax, and tax shift	0

Notes: *Classification in the sense of Guerra-Bretaña & Flórez-Rendón,²³ ie Category I (legal and ethical aspects, international harmonisation), Category II (HTA), and Category III (innovation process analysis, including financing, patenting, and clinical evaluation). **As of 2021-03-31. Bold text highlights the methods and economic variables used in the given literary sources.

Figure 4 Basic economic variables and frequently used methods of economic impact assessment – key stakeholders.

Figure 5 Critical moments and processes.

PRISMA. PRISMA flow diagram; 2021. Available from: http://prisma-statement.org/prismastatement/flowdiagram.aspx. Accessed January 6, 2022.

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