The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designers to apply these specialized techniques for greater innovation and time saving. The author discusses the historical background of various technologies, helping readers understand how and why certain devices were developed. This updated and expanded edition adds new information to help meet the challenges of the medical device industry, including strategic intellectual property management, operating room observation protocol, and the use of new technologies and new materials in device development. Theodore R.
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eHealth Spare Parts as a Service: Modular eHealth Solutions and Medical Device ReformVIDEO ON THE TOPIC: Design, Build, and Maintain Partner for Global Medical Device Companies
Although no safety and performance requirements apply yet to consumer eHealth, the medical apps are regulated. Their manufacturers must ensure the final apps are safe, while not being in control of the parts composing the apps. Generic components not meant for a specific medical device and their providers are not subject to safety and performance requirements. Market will likely push PaaS providers to offer mHealth manufacturers tools to ensure and control safety and performance when medical apps are concerned.
I foresee no such incentives for consumer mHealth. The sector of professional medical care, especially so in public healthcare, will too likely embrace eHealth to relief the tension between limited budgets and the rising costs of treatments; growing complexity and costs of care for an ageing population; and increasing expectations and demand for higher care quality. These generic elements can be used to build unique and different mHealth applications.
This article addresses two eHealth-related innovations: one technological the eHealth PaaS , and one regulatory. On a technological side, although mHealth applications and the applicable legal requirements have been a subject of academic analysis, 5 how these requirements apply to the eHealth PaaS and to modular approach to building eHealth applications has not been examined. The regulatory innovation this article considers is the eu reform of safety and performance regime for medical devices.
This article aims to fill in this gap and examines how compatible the adoption of eHealth PaaS as a toolkit for creating health apps is with the eu safety and performance requirements to health technology, both under the current and new regimes. The analysis unfolds as follows. Section 2 introduces eHealth PaaS and the remainder of this article covers the relevant law.
The legal analysis follows the taxonomy for descriptive research in law and technology. Following the logic of the taxonomy to move from identifying a broader area of law that is potentially relevant down to more specific analysis of how these norms will work in the context of the new technology, Section 3 starts with identifying broadly which legal regimes of safety and performance apply to eHealth and therefore may be of relevance to eHealth PaaS.
I review the general eu regime of product safety and a specific regime of safety and performance of medical devices. Section 5 briefly reflects on the challenges that the manufacturers of the mHealth apps may encounter when complying with their obligations to ensure that all the parts interacting within the app are compatible and safe and reliable as a whole when those parts are provided for and controlled, under some circumstances, by a third party.
The final caveat is that at the time of writing, the political agreement on the Medical Device Reform is still to be formally endorsed by the European institutions and go through language checks.
All references this text will make to the medical device reform will refer to the text of the political agreement reached in May as the latest publicly available full reform text, unless explicitly stated otherwise. Generally, eHealth PaaS offers advantages as any cloud computing solution does. Cloud computing refers to a body of web-based — as opposed to on-premises — services, such as providing storage and computing capacity.
Specifically, and regardless of the context of application, Platform as a Service provides its users with the capability. The consumer does not manage or control the underlying cloud infrastructure including network, servers, operating systems, or storage, but has control over the deployed applications and possibly configuration settings for the application-hosting environment.
PaaS can change how eHealth is built and operated. To illustrate, one of the goals of fi-star , a eu Seventh Framework project, 11 was to introduce PaaS to the health sector. The idea is that the fi-star eHealth PaaS operates as a toolbox for eHealth app developers.
These spare parts, or purpose-oriented components, are comparable to building blocks, each with a generic functionality of varying degrees of sophistication: connectivity, electronic health records support, or health questionnaires, 12 and potentially complex data analysis and decision support. For instance, fi - star tested a diabetes diary, a 2-D bar-coding solution for real-time reverse medicament supply chain, an app improving access to care for patients with mental health problems, and others.
As any cloud service, eHealth PaaS can be offered as a public, community, or private cloud, or a combination of the three: each layer of the cloud service — the hardware infrastructure and the platform itself — can be deployed in a different mode.
These characteristics are decisive in the analysis of compatibility of eHealth PaaS with the legal landscape of safety and performance of health technology. The subsequent sections address key legal challenges that could form obstacles for adoption of the eHealth PaaS from a legal compliance point of view. These effects can also be non-existent or negative in case of a technology malfunction.
Yet, the applicability of any safety and performance regime to mHealth is still a grey area, ridden with legal uncertainty. The legal status of mHealth apps as a product or a medical device is currently uncertain. Consequently, whether or not any safety and performance regime applies and, if yes, which one, is uncertain as well.
The safety and performance of a large body of health apps appears unregulated, i. These concepts define the material scope of the Directives and are fundamental for establishing which set of the requirements is applicable.
Yet, both concepts present difficulties in the context of mHealth. The apps that do not fall under this definition, often wellbeing and lifestyle apps, are not medical devices and hence, not subject to mdd.
Yet, there are no binding eu rules concerning the delimitation between lifestyle and wellbeing apps not subject to mdd and apps that are medical devices subject to mdd. Bellow follows a short overview of the criteria decisive for the status of a medical device, according to the Guidelines. The software, to be considered as a medical device, needs to be stand-alone, i. Otherwise, it is considered part of that medical device and is subject to the respective safety and performance requirements.
The Commission completes its Guidelines with examples of apps that are likely to be medical devices. The Guidelines also contain examples of software functionalities that do not lead to qualification as a medical device according to meddev. Namely, there are cases where two solutions performing a comparable function e. BioSemi vof and Others. While the definition of a medical device explicitly includes software, the software is not mentioned in the definition of a product in Article 2 a gpsd.
However, at present, the relevance of gpsd for mHealth apps remains unclear. Hence, no legal requirements will be considered in relation to the gpsd.
To conclude, there are two types of mHealth apps: mHealth apps specifically intended by a manufacturer for a medical purpose and subject to the mdd safety and performance regime; and mHealth apps that are not intended for a medical purpose, and hence not subject to any safety and performance regime. This gap in regulation does not necessarily present a problem in the context of professional medical care, since the established practice of the medical institutions corrects possible abuses and only devices with certification under the mdd are used.
However, this is not the abuse alone that presents a problem. These apps often are meant to produce real health effects, and may also create real health risks. Yet, they are not unequivocally subject to the general product or any other safety regulations. The uncertain legal status of mHealth solutions and resulting gap in safety regulations have been acknowledged in the Reform efforts.
The definition of a medical device under the mdr remains without significant changes. According to Article 2 1 1 mdr ,. As it is the case under mdd , the definition has two key components: 1 the objective list of medical purposes that the device should serve, and 2 a subjective intent of the manufacturer. As for the objective criterion of the medical purposes, these are as generally formulated as under the mdd , which may call for guidelines similar to the current meddev.
It is generally up to the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation Recital 8 mdr. However, the Commission is empowered, on request of the Member States or independently, and after consulting an expert authority — the Medical Device Coordination Group mdcg , to determine whether a specific product or a group of products falls under a definition of a medical device Article 3 mdr.
The improvement compared to the current regime is that such Commission guidelines will be binding and will reduce the uncertainty in applying the definition. The second key element defining a medical device remains to be a subjective intent of the manufacturer.
Consequently, the future mdr regime may suffer from the same vulnerability as the current mdd , i. This change, even if slightly, opens up a possibility to argue that a device is subject to the mdr even though the documentation states otherwise, if the device is marketed, including oral statements, to medical professionals as intended for a medical purpose.
At the same time, while solving one problem it could have created another, namely, a slippery slope towards including not only lifestyle and wellbeing apps, but also generic software into the material scope of the mdr. The latter are not considered medical devices, and as such are not to be subjected to the same safety and performance regime as the medical devices are. Examples of Annex xv devices are contact lenses or other articles intended to be introduced into or onto the eye, some equipment used in cosmetic procedures such as equipment for liposuction, lipolysis or lipoplasty, and intense pulsed light equipment, etc.
So far Annex xv does not include software or specifically mHealth apps. However, the Commission may add other groups of products, such as wellbeing and lifestyle apps, to the list by way of delegated legislation Article 1 1 c mdr when such apps appear similar to medical devices in terms of functioning and risks. A risk profile of a lifestyle app is likely to be deemed similar to medical devices when that app produced real health effects and hence creates real health risks in case it does not or mal-functions.
It is possible that the similarity to medical devices in functioning refers to the situations where a device is not intended by a manufacturer as a medical device e.
This is another element pointing towards objectivisation of the mdr compared to the mdd that can bridge the gap in safety and performance regulation of the mHealth lifestyle and wellbeing apps with real health effects. Since the regime of medical devices currently, under the mdd and in future under the mdr is the only safety and performance regime that clearly applies to some categories of health-related software, and more specifically mHealth apps, further analysis will focus on this regime.
Namely, the idea of eHealth PaaS is an expression of the modular approach to building apps out of spare parts provided and controlled by third parties. While these generic spare parts may be vital for the safety and performance of a medical app, safety and performance requirements both under the mdd and mdr are unlikely to apply to them, or bind the eHealth PaaS provider with any obligations.
However, this scenario is less representative of the innovative idea of a PaaS as a tool-box of spare parts for new devices. Second, more consistent with the idea of an eHealth toolbox, eHealth PaaS may provide software that is not self-sufficient as a medical device with its own function, but serves as one of the building blocks for new eHealth devices.
This scenario will be the focus of further analysis. Currently, only medical devices and their accessories are subject to the mdd. This section will show that the eHealth PaaS components, when the eHealth PaaS operates as a toolbox, providing pre-made generic spare parts for future mHealth apps, cannot be considered a medical device, and can be considered an accessory only under very limited circumstances. At the same time, other components may not have own medical function e.
A clear example of this is a data analytics component that is generic but, once built into a medical app, obtains a medical use. When included in a newly built app, the proper functioning of the data analytics component will be critical for the safety and performance of the entire app. Currently, the existing requirements refer to the end product e. This definition requires that there is an intent of the manufacturer of the accessory in question to design it for a specific medical device.
It is certainly possible that components specifically designed for a particular eHealth device are made available and powered via a PaaS. However, this form of delivery of eHealth PaaS components defeats the very purpose of the eHealth PaaS — to produce and make available a set of components with generic, i. Such PaaS components will most likely not be accessories to medical devices, or under very limited circumstances. This is important since the entire mdd regime is effectuated by the obligations that the Directive imposes on the manufacturers.
A statutory obligation to ensure that the device is safe and performs as intended, backed up by a possibility of sanctions, lies with the manufacturer alone.
Device manufacturer under the mdd is not necessarily the one who actually makes the device e. The decisive criterion is the name under which the device is placed on the European market. Any third parties involved in the device production, e. Any responsibility for safety and performance of a device on their part will be derived from their contractual relationship with the manufacturer. Given that the components are not self-sufficient medical devices, and accessories only in limited circumstances, the burden of ensuring safety and performance of the medical apps built with these components and legal compliance is for the manufacturers of such medical apps alone.
As Section 5 will show, ensuring safety and performance of the medical apps in this multi-actor and multi-component context may prove challenging. The Reform does not change the approach of the regulator to grant the status of a medical device to the final product only, and not to the pre-made generic components, or to grant the status of an accessory when software is intended for a specific medical device.
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MRI Service Strategies Part 2
We set up the MSF Access Campaign in to push for access to, and the development of, life-saving and life-prolonging medicines, diagnostic tests and vaccines for people in our programmes and beyond. Read stories from our staff as they carry out their work around the world. Hear directly from the inspirational people we help as they talk about their experiences dealing with often neglected, life-threatening diseases. They participate in internal training sessions and assessment missions in the field. Based in Brussels, MSF Analysis intends to stimulate reflection and debate on humanitarian topics organised around the themes of migration, refugees, aid access, health policy and the environment in which aid operates.
Much of the laboratory and medical equipment in resource-poor settings is out-of-service. The most commonly cited reasons are 1 a lack of spare parts and 2 a lack of highly trained technicians. However, there is little data to support these hypotheses, or to generate evidence-based solutions to the problem. We studied 2, equipment-repair requests of which 2, were out-of-service medical equipment from 60 resource-poor hospitals located in 11 nations in Africa, Europe, Asia, and Central America.SEE VIDEO BY TOPIC: John Rogers and the Future of Medical Devices
Much of the laboratory and medical equipment in resource-poor settings is out-of-service. The most commonly cited reasons are 1 a lack of spare parts and 2 a lack of highly trained technicians. However, there is little data to support these hypotheses, or to generate evidence-based solutions to the problem. We studied 2, equipment-repair requests of which 2, were out-of-service medical equipment from 60 resource-poor hospitals located in 11 nations in Africa, Europe, Asia, and Central America. Each piece of equipment was analyzed by an engineer or an engineering student and a repair was attempted using only locally available materials. Of those pieces repaired, 1, were sufficiently documented to determine what knowledge was required to place the equipment back into service. We conclude that a great majority of laboratory and medical equipment can be put back into service without importing spare parts and using only basic knowledge. The lack of working equipment has a devastating effect on healthcare in resource-poor settings. Certainly one of the most common causes for a piece of medical equipment being out-of-service is the lack of consumables [ 2 ], including reagent packs, electrodes, and other single use devices.
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Field Ready has worked in Nepal with Trishuli District Hospital to fix and maintain vital medical equipment using 3D printed parts. The hospital was badly affected by the earthquake, and with many of its buildings destroyed, it has been running services from tents. Harsh conditions and lack of technical staff mean that medical equipment often breaks down. There are particular challenges around mending damaged equipment; much of the equipment is donated by aid agencies and imported from overseas, so when a component breaks, it is exceptionally difficult to locate or economically obtain a spare part. Field Ready visited the hospital with a set of Vernier calipers and a 3D printer to see how we could help — here are some of our top items:. Dental Chair. Frustratingly, the dental chair provided to the hospital, after its original was destroyed, never worked. The mechanism was so damaged, a direct replacement part could not be fitted, so Field Ready designed a custom part to enable the chair to be lowered. IEC Connector.
Maintenance of specialized equipment in resource-poor environments adds a heavy burden to already stretched health systems. WHO emphasized that equipment maintenance should be an integral part of a complete medical equipment donation. Lack of funding to support recurrent costs, such as salaries for biomedical technicians or training on the use and maintenance of the donated equipment, led to a situation where life-saving medical donations were not utilized to the maximum extent, if not completely wasted. First, the project launched a 5-month-long, first-of-its-kind inventory assessment of the USAID-funded laboratory and medical equipment in sites in all 10 administrative departments of the country. The assessment concluded that 75 percent of all equipment was functional, 17 percent was due for repair, 4 percent was not installed, and 4 percent was due for disposal.
Cannibalization of machine parts, in maintenance of mechanical or electronic systems with interchangeable parts , refers to the practice of removing parts or subsystems necessary for repair from another similar device, rather than from inventory , usually when resources become limited. The source system is usually crippled as a result, if only temporarily, in order to allow the recipient device to function properly again. Cannibalization is usually due to unavailability of spare parts , due to an emergency, long resupply times, physical distance, or insufficient planning or budget. Cannibalization can also be due to surplus inventory. At the end of World War II a large quantity of high quality, but unusable war surplus equipment such as radar devices made a ready source of parts to build radio equipment. Sometimes, removing parts from old equipment is the only way to obtain spare parts, either because they are no longer made, are obsolete, or can only be manufactured in large quantities.
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Although no safety and performance requirements apply yet to consumer eHealth, the medical apps are regulated. Their manufacturers must ensure the final apps are safe, while not being in control of the parts composing the apps. Generic components not meant for a specific medical device and their providers are not subject to safety and performance requirements.
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Кое-где Реку пересекали узкие мосты, и она текла по Парку, описывая геометрически правильное замкнутое кольцо, время от времени прерываемое плесами. То обстоятельство, что эта Река с довольно быстрым течением могла впадать в себя самое после каких-то шести миль, никогда не поражало Олвина как нечто необычное.