Process Validation for Medical Device Manufacturers and Their Suppliers

2022 ◽  
pp. 441-462
Author(s):  
Vinny R. Sastri
Keyword(s):  
Medical Device ◽  
Process Validation ◽  
Medical Device Manufacturers

Lessons to be learnt from the PIP saga

2012 ◽  
Vol 94 (3) ◽  
pp. 82-83
Author(s):  
Norman Williams
Keyword(s):  
Medical Device ◽  
Professional Lives ◽  
Surgical Implants ◽  
Medical Device Manufacturers ◽  
Surgical Career

In the course of my surgical career I have witnessed many groundbreaking developments that have dramatically improved and saved patients' lives and been truly transformational. Such breakthroughs have invariably occurred from a combination of science, surgical ingenuity and skill underpinned by the enthusiasm and drive of a variety of surgical innovators and medical device manufacturers. We should all be proud of the progress that has been made and the lives that have been saved and improved. However, from time to time I have also witnessed scandals involving surgical implants that have marred the reputation of not only the manufacturers but also, on occasion, the surgeons involved. These scandals have a significant impact on the specialty and can often inhibit progress, cause suffering to patients and destroy professional lives.

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 Integrating a Usability Engineering Process into a Consisting Risk Management

2018 ◽  
Vol 4 (1) ◽  
pp. 645-647
Author(s):  
Michael Scholtes ◽  
Stephanie Buedenbender ◽  
Annemarie Behrend ◽  
Keywan Sohrabi ◽  
Volker Gross
Keyword(s):  
Risk Management ◽  
Medical Device ◽  
Engineering Process ◽  
Usability Engineering ◽  
User Interactions ◽  
Management Processes ◽  
Medical Device Manufacturers ◽  
Incident Reports ◽  
Development Step ◽  
Medical Device Regulation

AbstractThe complexity of medical devices and its user interactions increases. A growing number of incident reports are assumed to be associated primarily with user errors. This development is tackled through current modifications in standards, such as ISO 13485:2016 and legislations, such as the Medical Device Regulation. Both intensify the focus on use errors significantly. The aim of this paper was the development of a process orientated approach integrating usability engineering into a consisting risk management based on a classic V-model. An appropriate procedure was worked out. For each development step, risk and usability activities were cumulated. Thus, the present paper might help medical device manufacturers to reflect their risk management and usability management processes to find synergies. Prospectively, a step-by-step guide for the integration of risk management and usability engineering based on this approach should be developed.

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

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