Given the importance of the medical device manufacturing industry in the medical industry and the effects of poor-quality control in the same, it is not surprising that it is one of the most heavily regulated industry. However, despite the implementation of strict regulations, FDA alone receives thousands of reports every year regarding deaths, malfunctions and serious injuries related to medical devices, and in the last 10 years, quality issues related to medical devices have resulted in deaths of more than 83,000 patients. The importance of quality control in the MedTech industry is also evident from the fact that disturbances or defects in the function of medical devices can expose patients to severe risks. This paper examines the quality management system of the medical device industry in order to identify common gaps in already established quality management system of the medical devices industry. It will help to answer why the medical devices fail although having a quality department in almost all major manufacturing companies. The findings of the research suggest that a controlled and structured way of designing, distributing and producing such a device is necessary to ensure the devices are free from unacceptable risk for environment, property or the person.
The common trends in the industry suggest that better quality control measure should be implemented in place to facilitate suitability of such devices, as device users and device use environments are changing. The findings of the literature review further suggest that in terms medical errors related to device design/technical design, ergonomics, manufacture, device failure, system failure, IT medical device, and accessory and consumable. Moreover, in order to mitigate the likelihood and impact of several management standards enforced on medical device manufacturing industry, some of the most common standards include ISO 9001, ISO 13485, ISO 14001, OHASA 18001.ISO 45001, and ISO 27001. Based on the review of common errors and the prevalent quality standards, one can infer that the problem is not necessarily in the quality standards but its compliance.
Manufacturers are not able to effectively adhere to the mentioned quality standards which are the major cause behind the resulting errors and malfunctions. Common problems in the medical device, quality standard guidelines and published literature include CAPA procedures, complaint handling, nonconforming product, purchasing controls, process validation, quality audit, device history records and design validation. On the basis of the identified errors and mistakes, the paper proposes the use of automated quality management, and quality 4.0 approaches to improve quality standards in the said industry. In addition to this, the paper also mentions some recommendations for mitigating risk associated with manufacturing medical devices. Therefore, the paper identifies the common problems in the quality management aspect of the medical devices manufacturing industry and proposes recommendations to improve the same. However, one of the aspects of the medical device quality control, which was not elaborated in this paper is of software used in such devices, even though they are also responsible for serious malfunctions and errors.
Problem Statement & Justification.
Changing landscape of medical devices.
Medical device quality standards.
OHASA 18001/ISO 45001.
Common mistakes in compliance with quality standards.
Device history records.
Automated quality management
It is difficult to imagine what human life would be like without the medical industry. The medical industry and its various stakeholders are responsible for transforming the lives of many patients and have tremendous influence over the standard of living. But at the same time, it is also important to note that the capability of healthcare professionals would be quite restricted in respect of treating individuals without the use of such devices. The influence of medical devices over the performance of medical professional and the lives of patients is one of the main reasons why it is also one of the highly regulated industries (Doan & Grewal, 2018). The industry is subjected to stringent laws and regulations to make sure that devices introduced in the market are safe to use. One of the best ways to guarantee this safety is through quality control (Abuhav, 2018).
According to a study conducted by Teixeira (2019), in medical device industry, the direct cost of quality in the is approximately 6.7 to 9.3 per cent of the total sales of the industry, which equals to around $25 billion to $35 billion annually. One-third of this cost is the direct cost of ensuring good quality while the rest of the cost results from the direct cost of poor quality. The significance of quality control in the MedTech industry is also evident from the fact that disturbances or defects in the function of medical devices can expose patients to severe risks. This is especially true in case of devices which handover pharmaceutical or energy to patients such as devices supporting vital functions, infusion pumps etc. Nonetheless, safety standards should be high for all medical devices to make such devices reliable and safe.
Moreover, deviations from the claims and expectations can be a danger to patients in respect to their pain, suffering, dissatisfaction and discomfort. A controlled and structured way of designing, distributing and producing such a device is necessary to ensure the devices are free from unacceptable risk for environment, property or the person. Therefore, to avoid risking the patient's health and accidents, several different regulations and standard are imposed on the medical devices industry. For instance, Europe’s regulations are issued in the Medical Device Directive, while US Food and Drug Administration (FDA) has implemented the Quality System Regulation (QSR) to certify the safety and performance of medical devices. The underlying aim of these regulations is to ensure a high degree of protection for human safety and health. The regulation primarily exists to enable the patients’ access to effective and safe medical devices and to restrict the use of devices that have limited clinical use or are unsafe.
When properly employed such regulations and standards ensure the safety of workers, patients and the broader community. Still, despite the implementation of strict regulations, FDA alone receives thousands of reports every year regarding deaths, malfunctions and serious injuries related to medical devices, and in the last 10 years, quality issues related to medical devices have resulted in deaths of more than 83,000 patients (Bayon, Boher, Eglin, Procter, Richards, Weber & Zeugolis, 2016). Between 2018 and 2019, the recalls of medical devices jumped 71% to 595.98 million forms 409.5 million between 2016 and 2017. This threat is further exacerbated by the fact that the life-threatening class 1 recalls increased 9,811% between 2017 and 2018. FDA categorizes devices according to the risk they pose to patients and class 1 devices have a "reasonable chance" of death or severe health problems. Considering this increasing rate of product recalls and the importance of maintaining high-quality standards in the medical devices industry, this paper examines the quality management system of the medical device industry.
The drive behind this research can be summarized by the fact that in 2019 more medical devices were recalled than there were in each of the last four years. Moreover, Fearis & Petrie (2017) found that over the last decade, malfunctions in medical devices have led to more than 1.7 million injuries and around 83,000 deaths. Authors also found that FDA not only puts patients lives at risk by pushing devices via a shortened consent procedure but also replies slowly to force companies to correct errors in life-threatening products. Faulty devices are seldomly pulled from the market even when significant problems arise. Authorities like the FDA acknowledge the limitations and mistakes in their data, but rejects any suggestion of failed oversight.
Errors related to medical devices can be due to inappropriate practices and in part due to manufacturer related errors. It is commonly agreed upon that errors in medical devices are caused by a amalgamation of causes, and most of the investigations into medical error fail to report or conduct an in-depth analysis of the error. More often than not, the blame is pointed at the user of the devices which masks the reasons behind the error (Gupta, 2016). However, as Burns, Johnson & Honeyman (2016) reported, there is often a link between what is traditionally referred to as the user error and poor design of such medical devices. Also, regardless of the cause, a variety of problems can result from errors related to medical devices.
For instance, between June 1985 and Jan 1987, in North America, 6 incidents of massive radiation overdoses happened because of an electron accelerator which resulted in several deaths. Further inquiries exposed that the treatment errors were triggered by insufficient design quality assurance practices, serious device design flaws, insufficient error reporting procedures and unrealistic risk assessment. Furthermore, in 2002, more than 8,683,000 syringes were recalled in the USA as it was difficult to remove bubbles in the product. In another case, a hip and knee implant manufacturing company had to pay approximately $1 billion to settle lawsuits against its defective products (Wan & Quan, 2019).
Similar cases are more prevalent than one might imagine, in 2001, an investigation of inhalers used by elderly patients in the UK found that more than 65 per cent of patients could not use the inhalers 24 hours after being trained to operate the same (Lonnbratt & Sundgren, 2019). Such examples illustrate that a lack of proper quality control in manufacturing medical devices can expose patients, practitioners, device manufacturers and caregivers to a host of problems. Also, even though the situation is rapidly changing, with increasing appreciation of the scale of problems in medical devices quality assurance, there is still a paucity of research in this area. As Klein (2016) pointed out, health care is more than a decade behind other high-risk industries in terms of giving consideration to confirming basic safety.
The Guardian reported that between 2015 and 2018, regulators received 62,000 reports of an adverse incident in the UK alone, and around 1000 of such cases led to patient's death (The Guardian, 2018). Calling for drastic changes, the Royal College of Surgeons president Prof Derek Alderson stated that in contrast with drugs, numerous surgical innovations are introduced in the market without centrally held evidence or clinical trial data which presents a risk to public confidence and patient safety (Umachandran et al., 2019). In light of the above-mentioned facts, the research is undertaken to ascertain the common and basic reasons behind the same.
This research on the failure scenarios will help to identify the gaps in the already established quality management system of the medical devices industry. It will help to answer why the medical devices fail although having a quality department in almost all major manufacturing companies. In addition to this, although many medical errors cannot be evaded, such as side effects related with medical treatment, each of the investigation into case mentioned above stated that more than half of the negative events could have been prevented with proper quality control. Therefore, in general, not only does the medical devices industry has a high occurrence of error, but there is also significant possible to recover the current situation. By facilitating the recognition and identification of common causes of errors in the advance of medical devices and the quality management system of the same, this research will not only improve the understanding related to current practices but will also provide practical insight into improving the current situation.
Medical devices are omnipresent in treatment and diagnosis of medical circumstances in hospitals, GP's surgery, at home and are the tools for the trade of medical professionals. Such devices range from asthmatic inhalers to tongue depressors, from complex MRI scanners to safety-critical pacemakers. All over the world, more than 14,000 firms are producing more than 100,000 different brands of medical devices in more than 1600 categories. Designing such devices is critical and complex which makes them prone to errors. Even if medical devices operate reliable and correctly, they still contribute towards increasing numbers of medical errors by operating in a counter-intuitive manner. The common trends in the industry suggest that better quality control measure should be implemented in place to facilitate suitability of such devices, as device users and device use environments are changing (Klein, 2016).
Currently, devices are increasingly being used for home-use and community care, rather than being limited to specialised healthcare settings like hospitals. This is not only resulting in new environmental challenges, but such devices are also being managed by unskilled and untrained users whose illness further deteriorates their ability to effectively operate such devices. The global shortage of medical professionals and the increasing need to perform complex interventions is also putting extra pressure on healthcare professionals to rapidly perform interventions (Vlckova & Thakur-Weigold, 2019). As a result, the risk related to errors is also increasing which further emphasizes the need for the implementation of effective quality control measures from the manufacture's end.
Another change in the current landscape of the medical devices industry is related to the devices itself. Along with vicissitudes in the environment, individuals working in medical institutions are tackling the need to function devices that are becoming more and more complex. This further increases the challengers to efficient and safe operation. Individual users and the overall society, in general, are becoming less and less tolerant towards inefficient and poorly designed devices. Furthermore, medical devices are also becoming more safety-critical in medical treatments, as much of the effort in terms of monitoring, treatment, and diagnosis is increasingly being transferred from medical professionals to devices. In addition to these factors, the mounting issues of product liability are placing larger stress on medical device constructors to design better quality devices (Wan & Quan, 2019).
Regardless of such variations, and the palpable need to manufacture better quality devices that are fit for market use, the nature and scale of issues which arise from ineffective devices have largely been neglected by preceding literature. Thus, while an increasing number of papers examine medical faults in general. This paper concentrates on errors related to medical devices. In order to do so, one of the very first steps would be to categorise types of mistakes connected to medical devices and to examine their prevalence, causes and effects.
Medical errors can also be regarded as adverse events or adverse incidents which occur during or as a result of medical treatment. Such errors are usually a result where an improper act is performed or corrective action is not undertaken. There are an enormous variety of medical errors such as drug mix-ups, opposing drug reactions, incorrect dosages and misdiagnoses, and the severity of their outcome can range form no direct harm to severe injuries or even death. Under medical errors, there is a distinct category of errors related to medical devices and these errors can on part arise due to device manufacturer or due to inappropriate usage. Manufacturer related errors can be caused by devise design errors or manufacturing errors which are not identifying during quality checks (Sim, 2020). Emergency Care Research Institute (ECRI), a non-profit, independent organization which conducts independent evaluations of medical devices classifies medical device incidents as follows:
Support system failures
Sabotage or tampering
Failure to read the label
Inappropriate relation on automatic features
Incorrect control settings
Abuse of device
Failure to conduct peruse inspections
Incorrect clinical use
Failure to train or/and credential
Lack of competent accident investigation
Poor purchase evaluation
Error in hospital policy
Failure or lack of peruse and incoming
Use of inappropriate devices
Invalid device foundation
Failure of accessory
Random component failure
Environmental (humidity, temperature)
Power supply (with piped medical gas)
Radiofrequency or electromagnetic
Vacuum supplies and medical gas
Table 1: ECRI classification of medical device incidents (Maldonado Vargas, 2018)
Academic literature further mentions the subcomponents of each of the aforementioned categories related to device incidents. However, since this research is mainly concerned with the errors related to manufacture and design, here, the paper only mentions the main components of device failures related to the same and neglects the other categories even though they also exert significant influence on medical errors. The expanded version of the table investigates the causes of incidents involving medical devices is mentioned below.
Incorrect – faulty
Human factors design
Lack of clarity
Instructions for use
Component failure (electrical, subassembly, mechanical)
Wear and tear
Communication failure between devices
Incompatibility between devices
Data protection compromised
Accessory and consumable
Table 2: Causes for medical device incidents related to device manufacturing and design
The findings of the literature review further suggest that in terms medical errors related to device design/technical design, one of key cause is too mains input socket being fixed to the circuit board by solder connections and manufacturers cutting pins short. This is a design failure as mains input socket are only held in place by solder connections due to manufacturers cutting pins short to prevent pins to case contact which tends to reduce solder connection surface area. This usually does not harm patients but can result in a burning smell from home use ventilation to assist medical devices (McMohan, Williams, Samtani, Patton & Chen, 2017). Devasena, Jagadeesan Alamelu, Amudha & Motha (2018) in their research found another major cause for errors in medical devices which is of over infusion by a syringe pump. Authors found that because of improper setting up/peruse checks and inadequate storage, device failure occurs. This leads to over infusion, and authors mentioned that even though the infusion rate was set at 10mL/hr, the pump was infusion at a rate of 15mL/hr. In addition to this, a damaged syringe size detector in pumps often detect 50mL syringe as a 30mL one and cause a high flow rate.
Also, with pumps piled into a box, inadequate storage can contribute to physical damage to devices which corrodes the size detector and leads to further damage. Another device error is of loose connections and failure of setting up device assembly connections securely. Rao-Nicholson, Kahn & Akhtar (2019) reported that close examination exposed an insecure assembly amid pacemaker and pacemaker cable which is a form of device-technical error and is also influenced by improper peruse checks. Authors also mentioned device errors related to ergonomics. According to the authors, there is also a problem of mistaken diagnosis and identity due to medical devices. This happens due to a lack of clear print controls which contribute to wrong ECG printing, what happens is that instead of printing ECG of the current patient, the device prints out the ECG from the previous patients. Westgard & Westgard (2016) also conducted research on errors related to medical devices and suggested that due to the lack of ergonomically sound design, patients have died from an air embolism. Air embolism refers to the blockage of blood supply due to air bubbles in the heart or blood vessel.
Authors reported that in order to prepare for intravenous infusion, with luer-lok connector, a cannula was inserted into the vein of the patient, but was not yet connected to the infusion pump. Blood pressure was monitored. Hose linking limb cuff to monitor also had a luer-lok connector, and when the hose was disconnected for a bathroom visit, on return, instead of being connected to blood pressure monitor, it was connected to the intravenous cannula. As a result, at the next blood pressure monitor, air got pumped into the vein of the patient instead of a blood pressure cuff. This is again an example of poorly designed medical devices with similar connectors being used on the intravenous cannula and cuffs. In addition to this, another issue related to device ergonomics which lead to medical issues is the proximity of pump controls.
Faris & Shuren (2017) claimed that neonate receiving medication from several different syringe pumps and due to proximity of controls sometimes nurses can press wrong buttons which can lead to severe damage or even death. Authors reported a case in which one of the neonates at the hospital was under supervisions and was getting medicine from syringe pumps. One of the pumps was set to deliver diamorphine at 0.1mL/hr, but it was not started yet. Later on, the pump alarmed "please attend-to-me", and since the nurse was not ready to start the infusion, she stretched to press the silence alarm button and was relieved by alarm getting silenced. However, when the nurse commenced the infusion and pressed start, the neonate suffered massively over infusion at a rate of 10.1mL/hr. What happened was that while stretching to silence the alarm, instead of pressing the "alarm silence" control, the nurse accidentally pressed the "10mL/hr-increment", as both controls were located closely with each other (Chen, 2019).
In order to mitigate the likelihood and impact of several management standards enforced on the medical device manufacturing industry, some of the most common standards are mentioned below.
This is the universal standard intended for quality management and is not specific for any industry. It can be successfully implemented by any organization to improve its quality control process. In terms of medical device manufacturers, ISO 9001 helps the organization to make wide-ranging changes in the quality process to improve accountability and to simplify regulatory compliance (Fonseca & Domingues, 2017).
This quality standard is specially designed and aimed at medical device manufacturers and it enlarges on the established standards of ISO 9001. The aim of this standard is to harmonise regulatory requirements and to help with overall traceability, risk management, process validation, and quality control. Compliance with ISO 13485, helps organizations to streamline their process and run in a more well-organized and risk-averse manner (Abuhav, 2018).
To run a leaner business, sustainability is another major concern of manufacturers. ISO 14001 standards facilitate the same and help manufacturers to conserve energy, cut down waste and to decrease their general carbon footprint while working with worldwide supply chains (Kuhre, 2018). The latest version of ISO 14001, i.e. ISO 9001:2015 is based on Annex SL structure and is comparatively straightforward to implement
OHASA 18001/ISO 45001
Medical device and pharmaceutical manufacturing often present certain occupational threats, especially while working with more advanced technology. OHSAS 18001/ISO 45001 mentions the health and safety requirements for the medical device industry to decrease risk and to enhance responsibility while improving the strategic position of the organization at the same time (Yaqoob, Abbas & Atiquzzaman, 2019). This is used to reduce issues related to liability and accidents on an ongoing basis.
With medical devices becoming more and more sophisticated, one of the concerns which are becoming more and more pertinent for quality control is of cybersecurity. The increasing market of smartphone-based health monitoring apps along with connected devices in the operating theatre and diagnostic room require proactive information security standards (Hsu, Wang & Lu, 2016). In addition to these variables, the risk of a data breach makes ISO 27001 a critical standard for the industry. The said standard assesses and manages cybersecurity risks within the organization (Sagay & Jahankhani, 2020).
Based on the review of common errors and the prevalent quality standards, one can infer that the problem is not necessarily in the quality standards but its compliance. Manufacturers are not able to effectively adhere to the mentioned quality standards which are the major cause behind the resulting errors and malfunctions. Although, one can also state the this illustrates an inherent problem in the enforced quality standards, here the paper mentions the common mistakes in terms of compliance with quality standards to examine why medical devices fail despite the stringent quality standards in the industry. Common problems in the medical device, quality standard guidelines and published literature are used to infer the below-mentioned gaps.
Corrective and preventive action (CAPA) procedures are one of the leading causes for which manufacturing companies receive observation and warning letters from compliance authorities like FDA. This is a risk-based process and requires a lot of oversight because there are seven subparts of requirements which should be included in the CAPA procedure which makes it trickier to comply with as compared to other requirements (Choi, Lee & Bae, 2019). Some of the common areas in which manufacturers fall short in terms of compliance with CAPA procedures include a lack of proper document control, not adhering to SOPs established for CAPAs, poor root cause determination and overuse of underuse of CAPAs (Westgard & Westgard, 2016).
Complaint handling is another area of focus when it comes to poor quality system management in the manufacturing company. Every manufacturer is supposed to maintain complaint files and should maintain and establish procedures for reviewing, evaluating and receiving complaints by the formally designated body (Stein, 2017). There have countless documentaries, websites and advocacy groups to highlight the unsuitable handling of complaints against medical devices which suggests that manufacturers are not being proactive to manage any issues related to their product's performance (Kozak, Ruzicky, Stefanovic & Schindler, 2018).
Another major issue with quality control in medical device manufacturing is the control of nonconforming products (Reedy, 2019). According to the enforced quality standards, every manufacturer should maintain and establish procedures to control devices that are not according to specified requirements. Such a procedure is supposed to address the documentation, segregation, identification, disposition and evaluation of the non-conforming product. Furthermore, every medical device has to be accompanied by a device master record (DMR), which defines the specifications, manufacturing instructions, dimensions and materials of the manufactured devices (Manz, 2018). In case the device fails to meet the specifications, it should be captured as a nonconformance. Manufacturing companies fail to implement document control sooner in the development process which limits their ability to establish good document control habits which feed into your later work (Kim, Ko & Han, 2018).
Generally speaking, purchasing is a broad category and is also an area ripe for mistakes. MedTech manufacturers should establish procedures to make sure that all received and purchased services and products are according to predetermined requirements. Supplier management is also an area in this category which can use enhancement in due diligence form manufacturers, as it is normal for manufacturers to purchase or even outsource the complete manufacturing process form third party suppliers (Abuhav, 2018). Such third-party resources can be valuable resources; however, it is important for manufacturers to take ownership of the activities of the third party. Manufacturers fail to establish a proper criterion for qualifying those suppliers which result in poor quality products (Ogrodnik, 2019).
This includes any process within the manufacturing company, from hardware manufacturing to software installation. As a good practice, the manufacturing process should be validated according to approved procedures to facilitate a high degree of assurance. The underlying idea is to have replicable processes that can support the same expected quality every time (Lee, 2018). This common quality control problem in medical device manufacturing organizations limits their ability to ensure the production of quality product on a consistent basis.
Sousa-Mendes, Gomes-Salgado & Moro-Ferrari (2016) mentioned another issue in MedTech quality control is a lack of effective quality audits. According to the authors, manufacturers in the MedTech industry should have proper quality audits to assure the quality of the products is adhering to the established system requirements in order to determine the effectiveness of the established system. Audits present a medium to organizations for assessing their policies, procedures and resources, which supports continuous improvement within the organization. Regardless of this fact, many companies simply go through the motion and treat such audits as checkbox activities, they do not get value from them (Figueroa Pabon, 2019).
Device history records
Moreover, device manufactures also fail to keep an easily accessible and up to date for all versions of devices in the device master record (DMR). It is important for effective quality control to maintain device history and maintain procedures to make sure that history records show that devices are manufactures according to the DMR (Jin, Menechika, Sano, Kajihara, Kaneko & Guo, 2016).
Design validation is another main challenge that manufacturers deal with is the proper documentation of their design validation activities. Here, validation refers to the evidence of the product meets the needs of the end consumer (Hake, Rehse & Fettke, 2019). Simply put, this means showing the proper objective evidence as proof that the manufacturer has designed the right device. In addition to this, design validation also includes having suitable risk management controls in place, which is another area where MedTech manufacturers need improvement (Chiarini, 2017).
Considering the aforementioned key issues associated with quality control in the MedTech manufacturing industry and the severe implications of such issues. This paper presents the following measures to be incorporated in the quality assurance process to support the delivery of high quality and less error-prone products.
Maldonado Santiago (2018) reported that medical device manufacturers have been able to decrease the time it takes to register products with the FDA by 92% and saving around $71,000 per year. Such manufacturers have been able to do so by replacing their manual audit system with an automated one. Authors reported that scheduling and planning audits in a paper-based system are difficult and time-consuming which further complicates the process. The importance of this recommendation is also emphasized by the fact that with the launch of FDA's Medical Device Single Audit Program (MDSAP), organizations are supposed to conduct 100 to 200 internal audits every year (Bayrak & Copur, 2017). More importantly, the automated system supports specific critical needs of the manufacturing process. Furthermore, automation is just one aspect of such a system which can help to optimize quality management. Another aspect of automated quality management is its ability to utilize real-time monitoring and analytics and applying it for overall efficient equipment practices.
Real-time monitoring in medical device manufacturing can feed a series of analytics which can help to show ongoing quality and compliance levels on a dashboard. This enables quality control team to immediately see what is happening, recognize issues, use resources effectively to mitigate the impact of the problem or to correct it before it forces a shutdown. Such data streams can also be designed for triggering alerts in case potential issues arise so that manufacturers can resolve them in a timely fashion (McMohan, Williams, Samtani, Patton & Chen, 2017).
Moreover, automated quality management also maximizes the ability to make informed decisions. In addition to ensuring better quality management, senior executives can also use real-time monitoring data for more informed decision making. Manufacturing execution software (MES) can be used to capture metrics and key performance indicators (KPIs) and can be aggregated using analytics and business intelligence (Teixeira, 2019). The resulting insight can be further used to support better quality management within the organization and for a better strategic view of the development process.
Another key advantage of the automated quality management system, over a traditional one, is its ability to support close collaboration. When product engineers, production management and senior management uses the same base of analytics and BI, manufacturing intelligence becomes a core part of organizational operations (Bayon, Boher, Eglin, Procter, Richards, Weber & Zeugolis, 2016). This facilitates better collaboration and stabilizes product quality to maximize customer satisfaction while decreasing manufacturing cost.
Quality 4.0 refers to the new digital transformation which is using, analytics, scalability, data, connectivity and collaboration to drive and inform quality management. This can be referred to as a more advanced version of quality automation which connects the devices, data and people and introduces transformative capabilities in material science, connectivity and analytics (Sim, 2020).
Its has wide-ranging implications in MedTech quality management. For instance, to improve the introduction of products to the market, medical device manufacturers nowadays rely on supply chains and distributed teams, including design partners, contract manufacturers and tiered component suppliers (Vlckova & Thakur-Weigold, 2019). Manufacturers who have embraced the cloud-based systems and new technology understand the unique benefits in terms of device manufacturers product capabilities, regulatory compliance objectives, and product requirements (Abuhav, 2018).
Using product-centric and connected quality management system (QMS), can also help improve integration by giving organizational teams a more unified system to address audits, identify issues and to resolve issues in a timely fashion. This helps to make sure that all of the mechanical, software and electrical components are contained within a single system. Such a strong foundation enables manufacturers to gain a competitive advantage by having better quality process insights and intelligence-driven product (Oppenheimer, 2016). As a result, manufacturers become better at cross-functional visibility and data-driven decisions with engineering, supply chains, quality and operations teams.
In addition to the aforementioned approach towards better quality management in the medical device manufacturing industry, literature also mentions some recommendations for mitigating regulatory risk associated with manufacturing medical devices. Some of the theses common strategies are as follows:
In addition to the above-mentioned recommendations, medical device manufacturers can also leverage a strong audit program to determine areas of concern based on regulatory activity and trends. However, while doing so, manufacturers must ensure that the key areas of focus are production and process controls, clinical, records and packaging (Oppenheimer, 2016). Implementing metrics and addressing issues in these key areas is vital to reduce the overall risk of delivering a poor-quality product in the market. It is also recommended that a balanced approach should be undertaken by manufacturers which includes monitoring and training of manual activities such as approval, review and data entry of production records (Teixeira, 2019).
In conclusion, it is evident that despite the fact that the medical device manufacturing industry has to adhere to stringent compliance regulations and the effect of poor-quality products, quality control in the industry needs improvement. A controlled and structured way of designing, distributing and producing such a device is necessary to ensure the devices are free from unacceptable risk for environment, property or the person. The common trends in the industry suggest that better quality control measure should be implemented in place to facilitate suitability of such devices, as device users and device use environments are changing. The findings of the literature review further suggest that in terms medical errors related to device design/technical design, ergonomics, manufacture, device failure, system failure, IT medical device, and accessory and consumable. Moreover, in order to mitigate the likelihood and impact of several management standards enforced on medical device manufacturing industry, some of the most common standards include ISO 9001, ISO 13485, ISO 14001, OHASA 18001.ISO 45001, and ISO 27001.
Based on the review of common errors and the prevalent quality standards, one can infer that the problem is not necessarily in the quality standards but its compliance. Manufacturers are not able to effectively adhere to the mentioned quality standards which are the major cause behind the resulting errors and malfunctions. Common problems in the medical device, quality standard guidelines and published literature include CAPA procedures, complaint handling, nonconforming product, purchasing controls, process validation, quality audit, device history records and design validation. On the basis of the identified errors and mistakes, the paper proposes the use of automated quality management, and quality 4.0 approaches to improve quality standards in the said industry. In addition to this, the paper also mentions some recommendations for mitigating risk associated with manufacturing medical devices. Therefore, the paper identifies the common problems in the quality management aspect of the medical devices manufacturing industry and proposes recommendations to improve the same. However, one of the aspects of the medical device quality control, which was not elaborated in this paper is of software used in such devices, even though they are also responsible for serious malfunctions and errors.
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