Manufacturing Response Research Articles

JIT and supply chain disruptions following a major disaster: A case study from the auto industry

The just‐in‐time approach is widely regarded as an efficient and cost‐effective way to manage inventory. It may have quite the opposite effect, however, if there is an unforeseen disruption in the supply chain. A delay in one part of the supply chain can have a domino effect, affecting production and delivery commitments further down the chain, leading to significant losses for the companies involved. An analysis of a Malaysian manufacturer's response after an earthquake disrupted its supply chain shows other companies what they can do to minimize losses and curb the impact of both major and minor disruptions.

Ipilimumab for Previously Untreated Unresectable Malignant Melanoma: A Critique of the Evidence.

The National Institute for Health and Care Excellence (NICE) invited the manufacturer of ipilimumab (Bristol-Myers Squibb Pharmaceuticals Limited) to submit clinical and cost-effectiveness evidence for previously untreated advanced (unresectable or metastatic) melanoma as part of the Institute's Single Technology Appraisal process. The Centre for Reviews and Dissemination and Centre for Health Economics at the University of York were commissioned to act as the independent Evidence Review Group (ERG). This article presents a summary of the manufacturer's submission of ipilimumab, the ERG review and the resulting NICE guidance TA319, issued in July 2014. Ipilimumab at a recommended dose of 3 mg/kg monotherapy was previously granted marketing authorisation by the European Medicines Agency in adult patients who had received prior therapy and was recommended by NICE in guidance TA268. In October 2013, the EMA approved the extension of this indication to previously untreated advanced melanoma patients. NICE decisions are bound by the marketing authorisation; therefore, the decision problem faced by the NICE Appraisal Committee was whether ipilimumab at a recommended dose of 3 mg/kg monotherapy was effective and cost effective compared with first-line standard of care involving dacarbazine (DTIC) and vemurafenib (for BRAF V600 mutation-positive patients). The CA184-024 trial was the primary source of clinical evidence for ipilimumab. However, this was based on a dose of 10 mg/kg with concomitant DTIC. The results over a 5-year period indicated that ipilimumab 10 mg/kg plus DTIC demonstrated a significant increase in median overall survival (OS) of 2.1 months compared with DTIC plus placebo (11.2 vs. 9.1 months). The BRIM-3 trial, which was an open-label randomised controlled trial (RCT) in BRAF V600 mutation-positive patients, was the primary source of evidence for an indirect comparison with vemurafenib. The results showed that vemurafenib increased median OS by 3.6 months compared with DTIC (13.2 vs. 9.6 months). The economic evaluation compared the costs and outcomes of ipilimumab by assuming that the 3 mg/kg dosing regimen was clinically equivalent in efficacy to an ipilimumab 10 mg/kg dosing regimen plus DTIC and by using a treatment sequencing approach that incorporated second-line active therapy and third-line best supportive care (BSC). In the first appraisal meeting, the committee recommended ipilimumab only in the context of research as part of a clinical study. This was primarily based on the lack of robust evidence to support the assumption of clinical equivalence between dosages and the absence of evidence available to inform the sequential use of treatments. Following the consultation, the manufacturer submitted additional analyses and evidence to support the cost effectiveness of ipilimumab at first line. The manufacturer's response was based on concerns relating to uncertainty surrounding the relative efficacy of ipilimumab 3 mg/kg monotherapy compared with DTIC and vemurafenib, comparability of the patient populations at first and second line, and the effects of concomitant DTIC. These additional analyses indicated that the incremental cost-effectiveness ratio (ICER) was £ 47,900 per quality-adjusted life-year (QALY) gained for ipilimumab compared with DTIC and £ 28,600 per QALY gained for ipilimumab compared with vemurafenib. Following consideration of the additional evidence and the responses from a large number of consultees and commentators, the committee recommended ipilimumab as an option for adults with previously untreated advanced melanoma.

Editorial Comment: Manufacturer's Response to Thermal Burn Associated with Intraoperative Convective Forced-Air Warming Blanket (Bair Paws™ Flex Gown System).

Editorial Comment: Manufacturer's Response to Thermal Burn Associated with Intraoperative Convective Forced-Air Warming Blanket (Bair Paws™ Flex Gown System).

Improving the odds that patients and caregivers will use inhalers correctly: a manufacturer's response

Improving the odds that patients and caregivers will use inhalers correctly: a manufacturer's response

The effects of imbalanced competition on demonstration strategies

This paper analyzes the effect of competition on product demonstration decisions. Pre-purchase product demonstration enables marketers to differentiate products that are ex-post differentiated but are judged according to perceived fit, rather than actual fit, due to pre-purchase consumer uncertainty. Imbalanced competition accompanied by fit uncertainty motivates the follower to offer demonstrations to avoid a price war. This paper explores the conditions that lead the leader to retaliate. In addition to effects on quantity, competition may increase the quality of demonstrations offered by the leader. We analyze a business case, showing that competition may increase the demonstration intensity and that the leading manufacturer's response to changes in competition is stronger than the responses of the followers. Our research has the potential to aid managers in formulating demonstration strategies and in responding to competitors' demonstration efforts.

Adverse Events with Medical Devices in Anesthesia and Intensive Care Unit Patients Recorded in the French Safety Database in 2005–2006

French regulations require that adverse events involving medical devices be reported to the national healthcare safety agency. The authors evaluated reports made in 2005-2006 for patients in anesthesiology and critical care. For each type of device, the authors recorded the severity and cause of the event and the manufacturer's response where relevant. The authors compared the results with those obtained previously from the reports (n = 1,004) sent in 1998 to the same database. The authors identified 4,188 events, of which 91% were minor, 7% severe, and 2% fatal. The cause was available for 1,935 events (46%). Faulty manufacturing was the main cause of minor events. Inappropriate use was the cause in a significantly larger proportion of severe events than minor events (P < 0.001) and was usually considered preventable via improved knowledge or device verification before use. Compared to with that in 1998, the annual number of reported events doubled and the rate of severe events decreased slightly (12-10%, P = 0.03). The rate of events related to manufacturing problems remained stable (59-60%, P = nonsignificant), and the rate of events caused by human errors was 32-42% (P = 0.01). There were no changes in the mortality rate (2% in both studies). The number of adverse events related to medical devices indicates a need for greater attention to these complex pieces of equipment that can suffer from faulty design and manufacturing and from inappropriate use. Improvements in clinician knowledge of medical devices, and to a lesser extent improvement in manufacturing practices, should improve safety.

The manufacturer's response to stock-outs in a single manufacturer-retailer channel

Product unavailability is a common problem in supply chains with stochastic end-consumer demand and the impact of stock-outs extends beyond the short term to also affect long-term profits. Furthermore, the long-term stock-out effect for the manufacturer is not necessarily the same as the long-term stock-out effect for the retailer owing to brand substitution by the retailer in the event of a stock-out. In this paper, we incorporate the long-term stock-out effects on the manufacturer's profit in a single manufacturer-retailer distribution channel. We study the merits of the manufacturer's response to these effects via an incentives campaign targeting the consumers who experience stock-outs. Our findings show that the manufacturer reduces the wholesale price and the retailer responds by stocking a larger quantity, resulting in fewer stock-outs in the channel. Our model can serve as a building block to study the long-term stock-out effects in more complex supply chain structures.

Manufacturer's Response to PediapredTM Labelling

Manufacturer's Response to PediapredTM Labelling

Greater switchboard safety — the manufacturer's response

Safety is now becoming a key issue for manufacturers. This article looks at the many factors to be taken into account in the safety of distribution switchgear

Modeling Induction Motors for System Studies

Deriving induction motor equivalent circuit parameters from manufacturer's response curves is a difficult and time consuming task. Parameters for locked rotor and running conditions are supplied with the curves, but neither accurately describes motor response between these conditions. This paper presents a convenient way to derive a set of parameters suitable for the entire operating range and, therefore, suitable for use in induction motor-starting studies. An accurate model is essential to predict available starting torques.

Pharmaceutical Manufacturer's Responses to Drug Information Inquiries

Pharmaceutical Manufacturer's Responses to Drug Information Inquiries

Manufacturer's Response to Consumer Complaints on Guaranteed Products

Journal of Consumer AffairsVolume 10, Issue 1 p. 86-90 Manufacturer's Response to Consumer Complaints on Guaranteed Products Milla D. Boschung, Milla D. Boschung Alabama Farm Bureau Federation Montgomery, AlabamaSearch for more papers by this author Milla D. Boschung, Milla D. Boschung Alabama Farm Bureau Federation Montgomery, AlabamaSearch for more papers by this author First published: Summer 1976 https://doi.org/10.1111/j.1745-6606.1976.tb00574.xCitations: 5 This paper is drawn from an M.S. Degree thesis written by Milla Dailey Boschung while a student at the University of Alabama and supervised by Helen Goetz. AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Citing Literature Volume10, Issue1Summer 1976Pages 86-90 RelatedInformation