A Platform and Multi-sided Market for Translational, Software-defined Medical Research in the Operation Room: OP 4.1 (Preprint)

2021 ◽  
Author(s):  
Magdalena Görtz ◽  
Michael Byczkowski ◽  
Mathias Rath ◽  
Viktoria Schütz ◽  
Philipp Reimold ◽  
...  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Heterogeneous Data ◽  
Healthcare Sector ◽  
Successful Development ◽  
Software Developers ◽  
Intelligent Support ◽  
Operation Room ◽  
Central Platform ◽  
Medical Device Manufacturers

BACKGROUND While digital and data-based technologies are widespread in various industries in the context of Industry 4.0, the use of smart, connected devices in healthcare is still in its beginnings. Innovative solutions for the medical environment suffer from difficult access to medical device data and high barriers for market entry due to proprietary systems. OBJECTIVE In the proof-of-concept project OP 4.1, we show the business viability of connecting and augmenting medical devices and data through software add-ons by giving companies a technical and commercial platform for the development, implementation, distribution, and billing of innovative software solutions. METHODS The creation of a central platform prototype requires the collaboration of several independent market contenders, amongst them medical users, software developers, medical device manufacturers, and platform providers. A dedicated consortium of clinical and scientific partners as well as industry partners was established. RESULTS We demonstrate the successful development of the prototype of a user-centric, open, and extensible platform for the intelligent support of processes starting with the operation room. By connecting heterogeneous data sources and medical devices from different manufacturers and making them accessible for software developers and medical users, the cloud-based platform OP 4.1 enables the augmentation of medical devices and procedures through software-based solutions. The platform also allows for the demand-oriented billing of applications and medical devices, thus permitting software-based solutions to fast-track their economic development and become commercially successful. CONCLUSIONS The technology and business platform OP 4.1 creates a multi-sided market for the successful development, implementation, distribution, and billing of new software solutions in the operation room and in the healthcare sector in general. Consequently, software-based medical innovation can be translated into clinical routine fast, efficiently, and cost-effectively, optimizing the treatment of patients through smartly assisted procedures.

Adopting Identification Standards in the Medical Device Supply Chain

2020 ◽  
Vol 13 (1) ◽  
pp. 1-14 ◽  
Author(s):  
Yousef Abdulsalam ◽  
Dari Alhuwail ◽  
Eugene S. Schneller
Keyword(s):  
Supply Chain ◽  
Medical Device ◽  
Medical Devices ◽  
Business Intelligence ◽  
Return On Investment ◽  
Survey Methods ◽  
Device Identification ◽  
Medical Device Manufacturers ◽  
High Level ◽  
The U.S

The U.S. Food and Drug Administration has recently mandated that medical device manufacturers adopt Unique Device Identification (UDI) standards on their medical devices. The benefits that UDI brings to hospitals and patients is relatively obvious, including inventory transparency, product safety, product equivalency, business intelligence. However, adoption by manufacturers, who face the mandate, has been slow in part because the benefit to them is not as readily perceived. This study focuses on the incentives, barriers, and benefits that medical device manufacturers perceive in UDI adoption. This study seeks to understand which adoption pressures are driving manufacturers to act, and attempts to gauge the benefits to manufacturers from UDI adoption. Through survey methods, the evidence suggests that medical device manufacturers implement UDI largely as a response to the coercive and normative pressures they face. There continues to be a high level of uncertainty regarding the return on investment for the medical device manufacturers, particularly from the late adopters.

scholarly journals New medical device regulations: the regulator’s view

2019 ◽  
Vol 4 (6) ◽  
pp. 351-356 ◽  
Author(s):  
Tom Melvin ◽  
Marina Torre
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Clinical Investigation ◽  
Pool Data ◽  
Critical Function ◽  
Core Dataset ◽  
Medical Device Manufacturers ◽  
In Vitro Diagnostic ◽  
And Performance

Advances in medical device technology have been dramatic in recent years resulting in both an increased number of medical devices and an increase in the invasiveness and critical function which devices perform. Two new regulations entered into force in Europe in May 2017, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR). These regulations will replace the current directives over the coming years. These regulations, for the first time introduce requirements relating to registries. Medical device manufacturers are required to have systematic methods for examining their devices once available on the market, by systematically gathering, recording and analysing data on safety and performance. Registries can assist public health protection in very practical ways, for example, to help urgently identify patients or devices. Registries can also be powerful tools for collecting and appraising real-world clinical evidence concerning medical devices. Clinical investigations are limited in terms of the sample size and the duration of follow-up which can reasonably be expected. Registries may also be the only available tool to examine rare adverse effects, sub-populations or for time durations which it is not possible or feasible to study in a clinical investigation. By ensuring that a core dataset is collected which can be compared to other registries or trial data, it is possible to pool data to better examine outcomes. There are a range of excellent initiatives which have aimed at ensuring the appropriate regulatory application of registry data. Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180061

Software-as-a-Medical Device: demystifying Connected Health regulations

2016 ◽  
Vol 18 (2) ◽  
pp. 186-215 ◽  
Author(s):  
Noel Carroll ◽  
Ita Richardson
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Healthcare Service ◽  
Healthcare Sector ◽  
Future Research ◽  
Extensive Literature ◽  
Comprehensive Overview ◽  
Content Type ◽  
Connected Health ◽  
The Impact

Purpose Connected Health is an emerging and rapidly developing field never before witnessed across the healthcare sector. It has the potential to transform healthcare service systems by increasing its safety, quality and overall efficiency. However, as healthcare technologies or medical devices continuously rely more on software development, one of the core challenges is examining how Connected Health is regulated – often impacting Connected Health innovation. The purpose of this paper is to present an understanding of how Connected Health is regulated. Many of these regulatory developments fall under “medical devices”, giving rise to Software-as-a-Medical Device (SaaMD). Design/methodology/approach Through an extensive literature review, this paper demystifies Connected Health regulation. It presents the outcome of expert discussions which explore the key regulatory developments in the context of Connected Health to provide a practical guide to understanding how regulation can potentially shape healthcare innovation. Findings Several key issues are identified, and the authors present a comprehensive overview of regulatory developments relating to Connected Health with a view to support the continued growth of IT-enabled healthcare service models. The authors also identify the key challenges in Connected Health and identify areas for future research. Originality/value A key outcome of this research is a clearer understanding of the opportunities and challenges that regulation and standards present to Connected Health. Furthermore, this research is of critical importance in a first attempt towards recognising the impact of regulation and standards compliance in Connected Health.

scholarly journals Biocompatibility of Medical Devices - A Review

2021 ◽  
Vol 10 (36) ◽  
pp. 3152-3158
Author(s):  
Ramya Shree Gangadhar ◽  
Balamuralidhara V ◽  
Rajeshwari S.R.
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Human Body ◽  
The Body ◽  
Biological Responses ◽  
Medical Device Manufacturers ◽  
Biocompatibility Testing ◽  
Biological Environment ◽  
Key Words Biocompatibility

BACKGROUND Biomaterial is defined as "any substance or combination of medicine, artificial or natural origin, which can be used at any time, in whole or part by a system that controls, adds to, or restores any tissue, organ or function". ISO 10993-1: 2018 standard defines bio compliance law as "the ability of a medical device or tool to perform a selected program with the acceptable response of experts". Incompatible factors cause chemical reactions in patients, with little or no side effects. The body can respond in a sort of way after the installation of medical devices, so testing and improvement is important here. Therefore, testing and improvement in this field are important. Biocompatibility is required for any significant use of components or materials in medical devices. Inconsistent factors create negative biological responses in patients, which may have serious consequences. Biomaterials are substances utilized in medical devices, especially in applications where the device is touched, temporarily embedded, or permanently implanted within the body. Because of the significant impact of biocompatibility, many countries have imposed regulations on medical device manufacturers to meet biocompatibility specifications. Here is a brief explanation about the biocompatibility and incompatibility parameters of medical devices with a human body and its need for biocompatibility of medical devices with the human body. Medical devices have improved doctors' ability to diagnose and treat disease, which has led to significant improvements in health and quality of life. Thus, medical devices are prone to various incompatibility issues and procedures that affect the biological environment must be followed. KEY WORDS Biocompatibility, Material Interactions, Sterilization, Medical devices, Biocompatibility Testing, Incompatibility Factors.

Regulation of Medical Devices and their Clinical Trials Studies in the USA: An Update

2020 ◽  
Vol 13 (2) ◽  
pp. 94-109
Author(s):  
Manita ◽  
Aakash Deep ◽  
Vikram ◽  
A.C. Rana ◽  
Monu Yadav ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Device ◽  
Medical Devices ◽  
Clinical Studies ◽  
Healthcare Sector ◽  
Regulatory Body ◽  
Class Iii ◽  
General Control ◽  
Dental Floss ◽  
The Usa

Background: Need for Medical devices is very important in the healthcare sector and related processes for global regulation. Medical devices are the apparatus or instruments which are specifically used for diagnostics and therapeutic applications. In the USA, a regulatory body known as FDA (Food and Drug Administration) has its unit called CDRH which looks the manufacture, packaging and use of medical devices in the USA. Objective: In USA, Medical devices are classified into 3 classes: class I which look for the medical devices used for the general control as dental floss and bandages, etc., class II which regulate the medical devices used for the general control as well as special control as powered wheelchairs and pregnancy kits. Class III medical devices look the general control. PMA (Premarket Approval) and Premarket Notification application has been filed to FDA for seeking the market authorization of medical devices. We perform clinical trials for medical device which are quite different from the clinical trials performed for drug analysis. These trials are performed on various age groups such as on paediatrics, adult and old age group commonly called phase 1,2,3,4. Regulatory approval of high-risk medical device is based on clinical studies submitted with pre-market approval. The main objective of this article is to make the researcher aware of the regulation and clinical trials of medical devices in the USA. Conclusion: Every medical device should comply with FDA, QMS and QSR for marketing in the USA. The present article has focused on the regulation of medical devices, clinical trial phases and clinical studies on medical devices.

scholarly journals Using the monocyte activation test as a stand-alone release test for medical devices

ALTEX ◽  
2021 ◽  
pp. 151-156
Author(s):  
Jeffrey Brown
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Safety Assessment ◽  
National Institutes Of Health ◽  
Monocyte Activation ◽  
Device Development ◽  
Medical Device Manufacturers ◽  
Regulatory Evaluation ◽  
Limulus Amebocyte Lysate Test ◽  
The U.S

Monocyte activation tests (MAT) are widely available but rarely used in place of animal-based pyrogen tests for safety assessment of medical devices. To address this issue, the National Toxicology Program Interagency Center for the Eval­uation of Alternative Toxicological Methods and the PETA International Science Consortium Ltd. convened a workshop at the National Institutes of Health on September 18-19, 2018. Participants included representatives from MAT testing laboratories, medical device manufacturers, the U.S. Food and Drug Administration’s Center for Devices and Radio­logic Health (CDRH), the U.S. Pharmacopeia, the International Organization for Standardization, and experts in the development of MAT protocols. Discussions covered industry experiences with the MAT, remaining challenges, and how CDRH’s Medical Device Development Tools (MDDT) Program, which qualifies tools for use in evaluating medical devices to streamline device development and regulatory evaluation, could be a pathway to qualify the use of MAT in place of the rabbit pyrogen test and the limulus amebocyte lysate test for medical device testing. Workshop outcomes and fol­low-up activities are discussed.

scholarly journals Do Regulatory Changes Seriously Affect the Medical Devices Industry? Evidence From the Czech Republic

2021 ◽  
Vol 9 ◽  
Author(s):  
Petra Maresova ◽  
Lukas Rezny ◽  
Lukas Peter ◽  
Ladislav Hajek ◽  
Frank Lefley
Keyword(s):  
Czech Republic ◽  
Medical Device ◽  
Medical Devices ◽  
Single Case ◽  
Healthcare Providers ◽  
Regulatory Regime ◽  
Product Recalls ◽  
The Czech Republic ◽  
Emergency Situations ◽  
Medical Device Manufacturers

Background: Within the EU, some of the challenges and perceived risks now facing medical device (MD) developers result from changes in the regulatory framework, emphasizing safety. Therefore, medical technology companies must adopt stricter quality assurance measures so that individual devices can be speedily tracked and retrieved in emergency situations.Objectives: We highlight the challenges and risks faced by the European medical devices industry, particularly those faced by SMEs in the Czech Republic. We address two important research questions: Q1. Do advantages from increased regulation outweigh the additional expenses? Q2. As many MD developers are SMEs, will the new regulatory regime result in some of those companies going out of business and therefore impede future innovation?Methods: The paper focuses on a single case study, with the situation and outcomes discussed in the context of the financial results of a further 50 medical device manufacturers marketing in the Czech Republic.Results: Our findings suggest that the new legislation will result in improved safety, facilitate product recalls, but the cost and administrative burden may be high. The evidence also indicates that some SMEs may be forced to diversify to “non-medical” products, with the inevitable loss of innovative MDs being made available to patients and healthcare providers.

Assessing Detergent Residuals for Reusable Device Cleaning Validations

2021 ◽  
Vol 55 (4) ◽  
pp. 165-170
Author(s):  
Terra A. Kremer ◽  
Daniel Olsen ◽  
Chad Summers ◽  
Alpa Patel ◽  
Julie Hoover ◽  
...  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Safety Data ◽  
Healthcare Personnel ◽  
Sufficient Detail ◽  
Device Processing ◽  
Medical Device Manufacturers ◽  
Instructions For Use ◽  
As Toxicity ◽  
Dilution Curves

Abstract Cleaning chemistries are detergent-based formulations that are used during the processing of reusable medical devices. Manufacturers are responsible for demonstrating the safety of cleaning formulations when they are used during a device processing cycle, including the risk of device-associated cytotoxicity over the concentration ranges for recommended use and rinsing during cleaning. However, no regulation currently exists requiring manufacturers to demonstrate such safety. Although manufacturers' safety data sheets (SDSs) provide information on the safe use of chemicals for users, this information may not provide sufficient detail to determine the risks of residual chemicals on device surfaces. SDSs are not required to contain a comprehensive list of chemicals used, only those of risk to the user. They should be supplemented with information on the correct concentrations that should be used for cleaning, as well as instructions on the rinsing required to reduce the levels of chemicals to safe (nontoxic) levels prior to further processing. Supporting data, such as toxicity profiles or cytotoxicity data that support the instructions for use, would provide medical device manufacturers and healthcare personnel with the necessary information to make informed decisions about selection and correct use of detergents. In the current work, cytotoxicity profiles for eight commonly used cleaning formulations available internationally were studied. Although all of these products are indicated for use in the cleaning of reusable medical devices, results vary across the serial dilution curves and are not consistent among detergent types. The information presented here can be leveraged by both medical device manufacturers and processing department personnel to properly assess residual detergent risks during processing. This work also serves as a call to cleaning formulation manufacturers to provide this information for all chemistries.

Quality Assurance in Medical Devices

2021 ◽  
pp. 302-314
Author(s):  
Juliana Shaibun
Keyword(s):  
Quality Assurance ◽  
Medical Device ◽  
Medical Devices ◽  
High Performance ◽  
Quality Management System ◽  
Business Environment ◽  
Future Research ◽  
Medical Device Manufacturers ◽  
Device Manufacturer ◽  
Assurance Process

Quality management system (QMS) is acknowledged as the primary method for any manufacturer, especially medical device manufacturers, in order to sustain the product quality in the competitive advantage in business environment. QMS is an essential requirement for regulatory control in high risk medical devices. Globally, the number of medical device manufacturers certified by ISO 13485 is escalating. Ownership of this certification symbolizes the medical device manufacturer acquired high performance in their QMS. This bibliometric provides a brief review of the quality assurance and how safety plays an important role in medical devices. Bibliometric analysis guided user to summarize the essential part of quality assurance process in medical device. The insights presented in this research assist in building a firm theoretical base and direction for future research.

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