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Product manufacture special technological equipment for the medical industry and its spare parts

For many industrial manufacturers, what was once a clear path to success is now fraught with uncertainty. Making equipment for a wide array of industrial activities — such as big construction projects, large industrial facilities, oil and gas fields, and refineries — has for years been difficult to navigate, but major companies often used their size to sidestep obstacles. The strength of having multiple product lines covering the full gamut of industrial operations frequently allowed industrial manufacturers to eke out profits from some segment of their customer base even as slowdowns imperiled other sectors. But juggling business in this way is no longer a viable strategy, particularly if a company relies on traditional machinery for its revenue streams, as many industrial manufacturers do.

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While many developing countries may not afford state-of-the-art medical equipment, they may take advantage of the significant price reduction and other benefits of remanufacturing to solve their perennial healthcare problems that are aggravated by the shortage of medical equipment. As a first step towards implementing medical equipment remanufacturing in developing countries, the regulatory perspectives which plays a crucial role in the industry should be understood.

However, since regulation of medical equipment is weak or inexistent in most developing countries, the regulatory perspectives with respect to remanufacturing or related activities in both the European Union EU and the United States of America US are first examined to determine their impacts.

Unfortunately, there appears to be a lack of precise definition of remanufacturing for medical devices. An unambiguous definition is necessary to promote effective research, improve understanding, ensure uniformity of standards, drive quacks out of the remanufacturing market and thus, enhance customer confidence in remanufactured products.

This paper proposes a definition for medical equipment remanufacture. The principal advantage of this definition is that it could be adopted in future research toward increasing access to functional medical equipment to developing countries through remanufacturing. It is difficult for many developing countries to access medical equipment necessary for healthcare. This impacts their capability to diagnose, prevent, monitor or treat diseases and injuries.

Consequently, developing countries are characterised by high mortality rates over conditions that could be treated or monitored successfully if the necessary resources and technologies such as were available. Apart from Ischaemic heart diseases, stroke, and lower respiratory diseases, other top causes of death in developing countries are now insignificant problems for developed countries.

Top causes of death in high low-income a and high income b countries in Many causes of death in low-income countries do not constitute a significant healthcare challenge to high-income countries. These conditions would be manageable if the right resources such as medical equipment are available. This inadequate access to medical equipment in developing countries has attracted global interest [ 2 , 3 ]. Consequently, many organisations in developed countries provide medical equipment as donations to them, to help alleviate the problem.

Some scholars suggest designing low-cost medical equipment for developing countries to increase affordability [ 6 , 7 ], while others question the appropriateness of low-cost medical devices in terms of reliability and effectiveness [ 8 ]; the reason being that what constitutes a reliable technology may require more research and development and hence, be more expensive products to deliver.

Investing in developing countries market may however, not be very appealing to many original equipment manufacturers OEMs who already have only nominal interest in the market; believing they can only make a minimal return on their investment from it [ 9 , 10 ]. Remanufacturing seems to be an attractive solution to this challenge since it is based on used equipment and components that would ordinarily be discarded.

Also, it can increase the service life of medical equipment, correspondingly extending the duration over which returns on investments can be achieved. In addition, implementing medical equipment remanufacturing in a developing country setting would provide employment, increase the knowledge of medical technology among the people and thus, provide a sustainable supply of skilled personnel for the healthcare industry. The three main players in the medical equipment lifecycle are the manufacturers, the regulators and the users [ 11 ].

Manufacturers usually aim to understand the health care needs of the users in order to design and develop medical equipment that would address them. Regulation is therefore a primary deciding factor in the medical equipment market that would potentially affect the implementation of medical equipment remanufacturing.

Since medical equipment regulation is weak or inexistent in many developing countries, this paper will instead, examine the perspectives of the US and EU regulations with respect to medical equipment remanufacturing or related practices in order to learn from them. Secondly, it would propose a working definition of medical equipment remanufacturing for the purpose of increasing access to quality medical equipment in developing and interested developed countries.

There are several ways to define a medical device. Each definition attempts to capture the roles of the numerous devices used in healthcare and so, appears lengthy. However, medical devices may be briefly defined as any apparatus, software, material, or other similar or related item intended to be used in diagnosing, preventing, monitoring, treating, or alleviating a disease [ 12 ].

Medical devices include about one million five hundred thousand different devices in over ten thousand generic groups available for healthcare worldwide; ranging from complex capital-intensive devices with significant financial value to common devices such as thermometers, software, and invitro reagents.

It is therefore a challenge to precisely capture all medical device types using one classification system. In practice, several classifications exist for medical devices. Typical classifications are based on the following considerations [ 12 ]:. In these countries, this classification is used to determine the market entrance requirement of a given medical device. SUDs refer to devices recommended to be used once on one patient; on a single procedure [ 13 ] while reusable devices can be reused on same or other patients after various levels of disinfection.

In practice, a reusable medical device may be capital or non-capital. Reusable capital medical devices usually have greater design maturity and are not implantable. However, only reusable capital medical devices also known as medical equipment [ 2 ] are included in the maintenance management programme of health care institutions.

Since medical equipment are a subset of medical devices, both terms will be used interchangeably in this paper. However, the more expensive devices or equipment will likely provide the necessary economic justification for remanufacture.

Medical equipment differ from products in other sectors because of their extreme safety requirements. For industrial or automotive equipment; degradation alone may only result in loss of quality until a critical component fails.

For these products, safety issues usually result when a combination of failures occur such as when a major component failure is accompanied by the failure of an alarm or warning system that sends the signal to the user. In contrast, degradation of medical equipment, as well as its failure, usually causes safety issues to the user or patient. Medical device directives and regulations in different countries are constituted to avoid such occurrences; ensuring that patients and healthcare institutions have access to quality medical equipment.

Thus, remanufacturers of medical equipment should also demonstrate that their products are safe and effective to comply with existing regulations. There is a paucity of information on medical equipment remanufacturing practice. Widera and Seliger [ 15 ] used business model canvass to address profitability issues associated with remanufacturing using an insulin pump manufacturer as a case study.

The authors demonstrated that product service systems could be used advantageously to increase the profitability of remanufacturing. A closed loop supply chain involving as case study, a medical equipment manufacturer who also engages in remanufacturing and supplies to a single retailer is considered in [ 16 ].

Deterministic relations for optimal product pricing and profit were derived for the manufacturer. The analysis assumes that the market demand is a linear function of the retail price which decreases with increases in price. Sloan [ 17 ] developed safety cost trade-offs to inform single-use medical device re-use using Markov decision process model. The model is primarily useful in resolving ethical, liability, environmental and cost issues associated with reusing single-use medical devices.

While these papers address medical equipment remanufacturing from various perspectives, none has reported the manner in which it is practised in the industry, especially from the perspective of fulfilling regulatory requirements which determine medical equipment market entry.

This paper therefore, intends to analyse the EU and US regulatory perspectives with respect to medical equipment remanufacturing or related practices and to propose a definition for remanufacturing which can help to achieve the goal of increasing access to functional medical equipment in developing countries.

This is particularly important as current approaches are unsustainable. Grey literature search was then performed to gather information on the regulation of activities relating to remanufacturing in both the US and EU. The positions of the two regulations regarding remanufacturing or related activities were analysed against the conventional definition of remanufacturing in [ 19 , 20 , 21 , 22 , 23 ].

This is because the OEM refurbishment practice was found to be similar in many aspects, to remanufacturing especially with respect to addressing medical equipment challenges facing developing countries.

The data highlight the similarity of the involved processes which follow popular recommendations of the EU Radiology and IT professionals with the conventional definition of remanufacturing. Based on the findings and the peculiarities of developing countries, a working definition of medical equipment remanufacturing is proposed which is believed to better position remanufacturing towards providing a sustainable solution to the shortage of medical equipment in developing countries.

The proposed definition was finally, improved upon and validated by experts selected from developing countries health care industry. The competent authority reports to the minister of health and ensures that the content of medical device directives are correctly integrated into the national law and properly applied to grant qualified medical devices access to the EU market [ 19 ].

In the EU, the Directives require manufacturers to declare the conformity of their class I devices. For other classes of medical devices, a designated independent body or notified body in the state assesses the conformity of the products before placing them on the market.

Similarly, while general and special controls apply to class II and class III medical devices in the US, only the general controls apply to class I devices. The entity that performs full refurbishment according to the directive has the same obligations as a manufacturer in the appropriate EU device directives.

Such operators are therefore required to satisfy the same conditions expected of manufacturers such as quality systems management and declare the conformity of their products with appropriate directives by applying for and affixing a CE marking on them.

It is essential to remark that fully refurbished medical equipment is based on used equipment which is adequately restored and then placed on the market for sale, hire or use by a different user. As shown, the first stage is apparently the same as remanufacturing as long as replacement parts are identical to the replaced parts such that the intended use of the resultant product is sustained.

The first stage is apparently the same as remanufacturing as long as replacement parts are identical to the replaced parts such that the intended use of the resultant product is sustained. Although relatively less strict, this definition attempts to accommodate all the end-of-life processes in the medical device sector such as reprocessing of single use and multiple use devices.

PMA, on the other hand, is the most stringent approval route required by the FDA for devices that do not have an existing equivalent or predicate in the US market [ 26 ]. Currently, FDA does not have any regulations exist operators in this category.

According to Parkinson and Thompson [ 28 ], reprocessing includes both refurbishment and remanufacturing. Anyone that reprocesses a device or remanufactures it would therefore, accept the full legal responsibility of a manufacturer. The MHRA distinguishes SUD remanufacture from reprocessing and released guidelines for potential remanufacturers which explicitly regards them as manufacturers. The guideline also requires them to operate in closed loop supply arrangement with partnering healthcare institutions.

According to the MHRA, the operators are to both demonstrate that their products are fit for the EU market just like manufacturers of new medical equipment and accept to be liable in case of any adverse incidents arising from using their finished products [ 29 ]. Sterilisation is the highest level of disinfection which aims at killing all the microorganisms present in a component using physical, chemical or physiochemical means.

It is distinct from cleaning and usually introduces several quality and safety issues as the number of reprocessing cycle increases. For instance, Tessarolo [ 30 ] found that the physicochemical Nano-scale etching of electrophysiology catheter shaft sterilised with hydrogen peroxide gas plasma increased with the number of reprocessing cycles. Similarly, Lee [ 31 ] noted that deep cracks and deposit of contaminants begin to occur if an endoscope is reprocessed up to five times. Thus, reprocessing of medical devices can cause loss of colour, material degradation such as cracking and chemical change while residual sterilising agent may cause toxic effects if they make contact with patients [ 32 ].

Despite these observations, the reprocessing of SUDs appears to be gaining greater support both in the developed and developing countries. However, in developed countries, only expensive SUDs are reprocessed while developing countries reprocess even inexpensive SUDs to save cost [ 33 , 34 ]. Economic reasons as some single-use devices are costly and several may be used in a single procedure. For instance, an ultrasound catheter costs up to US dollar [ 35 ].

The belief that some devices are just labelled as SUDs by manufacturers who would profit if hospitals replace rather than reuse them [ 3 , 19 ]. To reduce environmental pollution and cost of safe disposal of medical wastes [ 35 , 36 ].

OEMs however, simply label their devices SUD because they do not wish to carry out studies to show that the devices can be reused. Moreover, OEMs of some reusable products often relabel the products SUD without changing the design significantly [ 13 ]. FDA finds no reasonable evidence that reprocessing and reuse of single-use devices result in increased risk of cross-infection [ 36 , 37 ].

To correctly apply remanufacturing, it would be necessary to determine what constitutes remanufacturing in relation to SUDs and whether existing practice within the reprocessing industry can be regarded as remanufacturing or amended to comply with remanufacturing requirements. One way of achieving this may be to make the guidelines process-dependent while specifying necessary quality system requirements. More than the developed world, SUD reprocessing and remanufacturing of medical devices would be more beneficial to developing countries given their poor socioeconomic reality and technological advancement.

However, many developing countries do not yet have sufficient regulatory framework in place, to monitor both SUD reprocessing and remanufacture to ensure that resultant products would be safe and effective [ 13 , 33 ]. As full refurbishment is said to alter the intended use of the medical device, the fully refurbished device is regarded a newly manufactured from regulatory perspective and therefore, subject to the appropriate device directives.

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Medical device

Heavy machinery, especially Mining, Industrial or Farming Equipment, requires constant maintenance to keep it in good working order. Conversely, poorly maintained large machinery equipment runs inefficiently. Breakdowns are costly and safety is also an important consideration. Many types of large machinery have multiple operators. One of the ongoing inspections on any checklist should be overseeing the correct operation of the equipment.

Article: Medical Device Support.

Medical applications for 3D printing are expanding rapidly and are expected to revolutionize health care. Three-dimensional 3D printing is a manufacturing method in which objects are made by fusing or depositing materials—such as plastic, metal, ceramics, powders, liquids, or even living cells—in layers to produce a 3D object. There are about two dozen 3D printing processes, which use varying printer technologies, speeds, and resolutions, and hundreds of materials. A 3D printer uses instructions in a digital file to create a physical object. Radiographic images can be converted to 3D print files to create complex, customized anatomical and medical structures. Companies that use 3D printing for commercial medical applications have also emerged. Since , two open-source 3D printers have become available to the public, Fab Home www.

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The product brand Ampack has been part of Bosch since October Ampack is specialized in developing and manufacturing machines with high hygienic requirements for filling and packaging of sensitive liquid and viscous products into pre-made cups and bottles.

Find out how companies have been able to achieve significant business advantages by using EOS solutions. Please note: We also provide selected Case Studies in French. Time-critical development and production of a cable routing mount for a camera in the vertical stabilizer of the A using additive manufacturing. Reduction to a single component and manufacturing on an EOS M minimizes production time to 19 hours. Substitute a conventional primary flight control hydraulic component with an additively manufactured part — fulfilling all certification requirements for flight. Manufacturing of a lightweight 3D printed component with fewer parts and an efficient process chain. Production of a component using additive manufacturing, which, by virtue of to its complex structures, fulfills all requirements of weight and stability. Additive manufacture of extremely robust and at the same time thin probes featuring a long service life and precise measurements. Use of DMLS to allow the use of different materials, optimised design and more energy efficient processes under consideration of a holistic analysis that included sourcing of raw material. Optimised use of the existing EOS machines for the construction of safe and cost-effective series components. The EOSINT M makes it possible to build more complex drilling equipment, that even withstands in the harsh environment of oil and gas wells.

by exponentially growing technologies (e.g. intelligent robots, autonomous drones, of innovation for the Swiss manufacturing industry and its competitiveness. Resources and products are networked, and materials and parts can be deliver spare parts, at any time of day or night and in any terrain and weather, are  Missing: medical ‎| Must include: medical.

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Device manufacturers speed repairs and reduce costs by working with a single source for a full gamut of machine repairs. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media. Login Join. Subscribe Free Magazine eNewsletter. From engineering to fabrication, finishing, and assembly, medical device manufacturing incorporates a range of advanced mechanical, hydraulic, and electronic technologies into its processes. With many enterprises utilizing digital design and prototyping systems, automated fabrication, CNC finishing, and multi-axis, laser-based quality assurance systems, the demands for effective and timely repair or replacement of equipment are often critical. Given the vast array of parts involved, the seemingly straightforward task of maintaining equipment often presents a logistical nightmare that involves farming out components to a variety of specialty repair shops with variable capabilities, quality, pricing, and turnaround time.

One-Stop Repair for Medical Device Manufacturing Equipment

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A medical device is any device intended to be used for medical purposes. Thus what differentiates a medical device from an everyday device is its intended use. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life.

While many developing countries may not afford state-of-the-art medical equipment, they may take advantage of the significant price reduction and other benefits of remanufacturing to solve their perennial healthcare problems that are aggravated by the shortage of medical equipment. As a first step towards implementing medical equipment remanufacturing in developing countries, the regulatory perspectives which plays a crucial role in the industry should be understood.

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