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Medicine shortages: Product life cycle phases and characteristics of medicines in short supply A register study PMC

Nonetheless, interviewees’ opinions were most likely influenced by their familiarity regarding the topic. For example, the stakeholder groups least familiar with PP studies may also be the individuals least positive about using PP study results in decisions. Second, interviewees were recruited upon suggestion by PREFER members and by interviewed persons. This might have resulted in a biased sample because these persons may be more positive about PP. The opinions presented in this paper should therefore not be interpreted as representative of a larger population than the interviewed sample; there may very well be persons within each stakeholder group with views other than those presented in the paper. Both on the HTA/reimbursement and marketing authorization level, some interviewees argued that using PP could improve the quality of decision making by increasing certainty for decision makers when they need to evaluate uncertain clinical evidence.

  1. Furthermore, medical institutions must establish and operate standards for the life cycle considering the characteristics of medical devices through expert organizations.
  2. 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.
  3. More than half (55%) of Jabil survey participants affirm being concerned or challenged with regulatory processes, certifications and approvals.

As per a 2019 report by Gartner, 45 percent of product launches are delayed by at least one month. There are mainly three ways in which a product can be innovated and these are creating new products, improving the existing ones, and adding new features. Here, the mobile manufacturers start with the highest price, and with time eventually, the price of the latest mobile version drops as new ones are released.

Close to half of digital health solutions providers, 43%, are seriously considering their options to use the data they collect through devices to create additional revenue streams. These devices also check a significant number of boxes on the value-based care wish list. Demand for medical care increased and Blue Cross-Blue Shield, a health insurance company was formed.18 From 1940 through the 1960’s there was a dramatic increase in the number of commercial health insurance companies and the people who had health insurance. Medicare and Medicaid were programs initiated in 1966 and have grown dramatically.19Examined this way, the real “growth” in the industry of medicine was the growth of the health insurance industry and its financing of the medical and pharmaceutical industries. Interviewees from all stakeholder groups, particularly regulators, underlined that the value of PP in decision making depends on factors such as the type of medical product and disease area (Fig. 1). Furthermore, some academics and regulators stated that PP studies only need to be conducted when they are relevant for decision making.

Definition of Patient Preferences (PP) and Awareness

In particular, in an environment where life cycle management is not conducted to replace medical devices, there is a limit to replacing medical devices using objective evaluation methods (28). In this study, we intended to derive the life cycle of high-risk medical devices through empirical methods, based on the life cycles of the Korea PPS and the AHA, and on the mean period used for the replaced devices of the Samsung Medical Center. Thus, the proper life cycle of high-risk medical devices related to life support was calculated as 13 years for anesthesia machines, 14 years for defibrillators, 16 years for heart-lung machines, and 13 years for ventilators. Therefore, management must be performed on the devices, as risk occurs in the medical device itself, as well as through the carelessness of users. As performance degradations or quality abnormalities, caused by insufficient management of medical devices, may induce direct harm to patients, it seems that the replacement at the right time through life cycle management will be able to prevent harm. In particular, because medical devices, such as life-support machines, belong to the high-risk medical devices and thus are included in the priority management target, the life cycle management of these devices must be performed first.

Concerns and Needs Regarding the Use of PP in Decision Making

Specifically, the life cycle of medical devices is divided into physical, commonplace, and economic life. Physical life refers to the state in which the malfunction of the device exceeds the tolerance limit due to the high frequency of failures caused by wear, corrosion, damage, etc. Commonplace life refers to the state in which it is advantageous to replace the device with a new one because the function has deteriorated due to technological advancement; there is a tendency for rapid technological advancement to shorten equipment lifespan.

The Product Life Cycle

There is a growing need to improve the understanding of the determinants of medicine shortages and to find novel strategies to combat the issue of shortages. The causes of medicine shortages often remain unclear, partly due to the complexity of the issue and the plurality of the causes (Shukar et al., 2021). Earlier research has recognized supply and demand issues and regulatory issues as major determinants of shortages (Dill and Ahn 2014; Alsheikh et al., 2016; Fox and Tyler 2017; Heiskanen et al., 2017; Phuong et al., 2019; Shukar et al., 2021). A retrospective cohort study has reported the lowest priced medicines being at a substantially elevated risk of shortage (Dave et al., 2018).

The concept of product life cycle helps inform business decision-making, from pricing and promotion to expansion or cost-cutting. Companies with highly talented designers and supply chain teams can deliver heroic workarounds to keep a dated product in the hands of customers, but when a competitor comes along with a new product with fewer supply chain headwinds, they’ll get off the blocks much more efficiently. Building a framework for anticipating future standards likely ensures you will prevail. Competitiveness in this context means placing risk and change management front and center, proactively developing the entire product lifecycle strategy so that it’s both proactive and predictive and conceived with full awareness of macro trends. Products are not static entities frozen in time; they respond organically to market changes and must be adaptive to intelligence garnered from supply chain management.

In part, mature products may be more exposed to shortages because the market does not reward manufacturers for investing in quality and back-up systems when it comes to mature products (U.S. Food and Drug Administration 2019). Minimizing investments might eventually lead to quality issues that potentially cause shortages. Previous findings by the United States Food and Drug Administration (FDA) define mature products as those with the median time of 35 years since first approval (U.S. Food and Drug Administration 2019).

RD is a senior director of benefit-risk and epidemiology at Janssen Research & Development. All authors contributed to the protocol design of this study and/or the acquisition of the data. RJ and SR performed the analysis and wrote the initial draft and IH and JV were involved in the further refinement of the main text and figures. In addition, the results of deriving the top 10 factors by assigning weights according to the frequency of evaluation items are shown (Table 4). The most important items were age (15.87%), followed by maintenance cost (11.11%), partial discontinuation (11.11%), failure rate (9.52%), high physical risk (6.35%), model discontinuation (4.76%), BMET evaluation (4.76%), equipment risk (4.76%), accident history (3.17%), and device obsolescence (3.17%). On the basis of the life cycle concept of health technologies (see Figure ​Figure1),1), this article will go through some of these initiatives and define the role that Health Technology Assessment could play in each step.

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. 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. These stakeholder groups but also particularly regulators underlined that PP should be considered together with other evidence.

From these suggestions, 22 persons met the inclusion criteria and were invited to participate via e-mail. Twelve persons (55%) accepted; the others did not answer, did not consider themselves knowledgeable enough, or did not have time. Recruitment was slowest in Romania and Italy and product life cycle in healthcare in the HTA and regulatory stakeholder group.5 No relationship between interviewers and interviewees was established prior to invitation. Today, medicine shortages pose an increasing challenge to patient care worldwide (U.S. Food and Drug Administration 2019; Shukar et al., 2021).

During the three years research period, a total of 3,526 medicine shortages were reported and the duration of the shortage was 83 days. To avoid such conditions, deeply understanding the product life cycle in healthcare is essential. During its rollout throughout 2021 and beyond, the center is focused on advancing digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables, and technologies used to study medical products. The center is also engaging with internal and external partners to create best practices for creating digital health devices and reimagining digital health oversight and regulatory processes.

Companies may need to spend less on prototyping due to a clearer structure of planning and innovating. If the company feels confident in its product and feels there is a market for the product, the product goes to the production stage. This stage involves the manufacture of the product including sourcing raw materials, assembling components, and testing the final product. At this point, the company should have a fully-fleshed out product and should not be continually tweaking the design.