To manage medical devices, medical institutions classify them into high-risk, mid-risk, and low-risk devices. In particular, life support systems, such as respirators, anesthetic equipment, cardiopulmonary bypass machines, and surgical equipment, are directly related to the patient’s life and are thus classified as high-risk medical equipment. In the case of these high-risk medical devices, voluntary management by medical institutions is implemented, so even if the same product is used, the use period is different for each medical institution, and the risk to patients increases due to device aging. Meanwhile, the use of artificial intelligence (AI) medical devices is expanding to provide personalized medical care and realize precision in medicine. An AI medical device, which is a software-based medical device, is considered high-risk because the operation of the software can be directly impact the patient, and every part of the product life cycle requires management to ensure performance and safety.
- Once healthcare companies make adequate publicity via advertising, press releases, or social media, they can go ahead with the pricing strategy.
- Check with your local GE HealthCare representative for availability in your country.
- Kuehne+Nagel covers the highly sensitive and sophisticated logistics that are required for the product’s clinical phase through its subsidiary QuickSTAT, a company with over 40 years of experience managing clinical trial and commercial logistics for drugs and medical devices in more than 150 countries.
- In the maturity phase, the sales volume peaks, and the majority of the customers who are willing to purchase the product have already done so.
Today forward-thinking product teams focus on delivering a Minimum Lovable Product (MLP) — the minimum required for customers to love (not just tolerate) a product. The development stage encompasses everything from early-stage ideation and research to planning and the actual building of a product. Typically company leadership sets the strategic direction, including a theory of how a new offering will create value — the vision for the product.
To manage this, each country has regulatory agencies to manage medical devices in accordance with established laws and regulations (6, 7). Our study is the first one to report statistical differences in the number of shortages of products of different age. According to this study, products aged 15–19, 20–24, 25–29, and 50–54 were most likely to face a shortage. Strikingly, products aged 15–19, 20–24, and 25–29 in short supply mainly belong to the reimbursable medicines group, while products aged 50–54 in short supply include both reimbursable and non-reimbursable products. It seems that in the reimbursable medicines group, shortages peak after the exclusive selling rights and possible additional protection have expired. Typically, this happens approximately 15–20 years after the initial patent was granted (Garattini et al., 2022).
Product lifecycle management: optimizing medical imaging with scalability
Accordingly, in this study, a case analysis and an on-the-spot survey were conducted targeting 10 major domestic and foreign medical institutions to confirm the specific medical device replacing the evaluation criteria. As a result of the analysis, there were fewer than 10 evaluation items, and the evaluation items for medical device replacement and the mark-distribution table for each item are shown in Table 3. On the other hand, examining the empirical life cycle calculation method, the Canadian Association of Medical Radiation Technologists (CAMRT) has published the life cycle guidelines for medical imaging devices to help determine when to upgrade or replace existing medical devices (18). In South Korea, the public procurement service (PPS) has determined basic matters regarding the acquisition, storage, usage, and disposal of national goods. For the efficiency of goods management, the life cycle — an economical usage period — is set, determined by the priority for goods having a large amount of stock and high activity frequency. The life cycle of similar products can be applied to goods without one; in the case of medical devices, the life cycle must be determined for only some of the devices.
The life cycle of medical devices — the period during which the medical device can be used while maintaining the state of the technical inspection certificate — refers to the life expectancy of the device that can be used for being used for treatment and inspection. The lifespan of a medical device is determined by various factors, in which representative factors include function, reliability, availability, and maintainability. The life cycle of a medical device is the usage limit that may meet the target values of these factors and guarantees safety. If the usage period is specified in the device specifications of the manufacturer, the usage limit will follow the standards (13). This is the first stage of the product life cycle across all industries including healthcare. In this stage, companies try to build awareness of their products or services in the market.
In addition to knowledge about the preference study, interviewees from all stakeholder groups also referred to patients’ educational level and knowledge about the MPLC and about the medical product. To increase patient understanding, some patients advocated for the inclusion of an educational component in PP studies. Interviewees from all stakeholder groups were concerned about the complexity of questions in PP studies. Some regulators and academics underlined how a lack of understanding among participants decreases the reliability of the preference study results and advocated for more research verifying whether patients actually understood the questions. Growth in remote patient monitoring, wearables and point-of-need (not just point-of-care) devices has significantly influenced design options and requirements for new medical devices. These markets are being driven by the desire for more functionality with increased portability and mobility.
Medical Device Safety is the Foundation for Total Product Life Cycle
Emergency equipment, including automated external defibrillators (AEDs), must be inspected at least once a month in accordance with the Emergency Medical Service Act. Medical devices are used to provide safer and more accurate diagnoses and treatments for patients; however, such a gap in legal regulations can lead to performance deterioration https://1investing.in/ of medical devices, causing an increased risk to patients (10). Medical devices are used to diagnose or treat patients, and they have direct or indirect effects on human life and health. For this reason, safety is paramount during their use, and it is necessary to prevent downtime and maintenance costs due to unexpected shutdowns.
Moreover, performing the planned replacement of medical devices will reduce the risk to patients due to the deterioration of devices and have a positive impact on the management performance of medical institutions by estimating the annual budget for purchasing. Interviewees from all stakeholder groups except patients, caregivers, and patient organization representatives questioned the feasibility and lack of a clear strategy for including PP in current development, marketing authorization, and reimbursement decisions. Several HTA/payers, industry representatives, and academics questioned how PP should be weighted in decisions.
Webinars Related to Pharmaceutical Product Lifecycle Management
Unfortunately, the data did not include information on the reimbursement status of each individual product; instead, it only included information on whether at least one product in the class was reimbursable. In addition, the information on reimbursement status and the first marketing authorization dates was searched product life cycle in healthcare in February 2022, which means there might have been some changes in comparison to 2017–2019. Nonetheless, we believe that possible changes have been minor and would not have significantly affected the results. It is also noteworthy that the data of this study reflects the situation prior to the COVID-19 pandemic.
7The interview guide included fixed questions, obligatory to address in the interview, and questions to be asked if interviewees were familiar with preference methods and studies. Per question, additional questions could be asked for further explanation, for confirmation or for more in-depth answers from interviewees. 6RJ, EvO, CW, and KSB are PhD researchers with backgrounds in biomedical sciences (RJ, EvO), global health (CW), and public health (KSB).
A national health program for the United States. A physicians’ proposal.
Product teams that enjoy lasting success focus on continual improvement — looking for ways to cut costs, attract new users, reduce churn, and grow existing accounts. Establishing your product’s place and demonstrating why it is the best solution becomes vitally important. Users are becoming familiar with your offering — folks are actively using and purchasing it.
A final limitation relates to terminology; after interviewees’ personal definitions of PP were elicited, a definition of PP was provided at the beginning of the interview. Nevertheless, interviewees might have referred to their own pre-existing definitions during the interview. Healthcare started as a service provided for a fee by individual practitioners known for quality by word of mouth advertising. It has grown predominantly in relation to the growth of third party payers with quality still being recognized to a large extent by word of mouth.
In the introduction stage, the costs are high, but in the growth stage, the rates decrease drastically. As manufacturers increase production to meet the demands of consumers, the costs are reduced. Market promotion is at its highest and companies invest in capital to promote a product or service. This is best represented in Apple’s famous launches which showcase new features of their new products. Once healthcare companies make adequate publicity via advertising, press releases, or social media, they can go ahead with the pricing strategy.
At the government level, it is necessary to exercise authority over regulations by establishing management standards through the reorganization of legislation and systems related to medical device replacement. However, the application of the same policy level to all medical devices is realistically limited; therefore, it is necessary to take a step-by-step approach through the appropriate classification system. Furthermore, medical institutions must establish and operate standards for the life cycle considering the characteristics of medical devices through expert organizations.
In the case of the life cycle calculation by the empirical methods presented in this study, there is a limit within which deviations may occur, according to the characteristics of each medical institution, on-site conditions, etc. Therefore, it is necessary to simultaneously utilize both engineering and empirical methods to calculate life cycles. To achieve this, it is necessary to accumulate a database with careful history management so that the history of medical devices may not be missing. In future research, it will be possible to derive replacement decision factors for all medical devices and calculate the appropriate life cycle of medical devices by applying engineering and empirical methods together. Nevertheless, in this study, we calculated the proper life cycle of high-risk medical devices as the priority management target; based on this, the annual plan for medical devices seems to be enabled.