Co-development Of Products Research Articles

Integrated Model for Co-Development of Products and Production Systems - A Systems Theory Approach

The seamless co-development of products and production systems is still an unresolved challenge. Undoubtedly, progress has been made through the proposal and application of new methodologies in the collective of concurrent engineering. Still, there is a gap between modeling approaches in product development and in production system design. This gap is an obstacle, especially if many interdependencies exist among the constituents of products and production systems. This article aims at closing this gap by modeling these constituents in an integrated model. This model represents the product and the production plant as co-equal systems with subsystems, interactions, and behavior. It allows modeling every subsystem in all its lifecycle phases together with the rationale behind its design. A class model is refined for purpose of laying a structured basis for modeling that can be implemented in computer-based support. A real-life example from the automotive industry illustrates the application of an integrated model and highlights its benefits for co-development.

Assessment Methodology for Performing Regulatory Due Diligence Based on a Quantitative Approach

Regulatory due diligence is an essential part of every assessment when it comes to mergers, transfer of regulatory licenses, co-development of products or other business activities in the pharmaceutical sector. So far, there is no uniform standard for a quality assessment of registration dossiers. The usual approach is based on a written description of the deficiencies found with eventual recommendations for corrective measures. We propose a newly developed assessment system, applied mainly to generic type of dossiers based on semi-quantitative criteria with weight factors and scores. The reasons for development of this system root in the regulatory harmonization process in Sopharma during the accession of Bulgaria to the European Union (EU). The important advantages provided by our system can also be found in the measurement of efforts put in the dossier upgrade, for example comparing the initial and final scores. The analysis of the score could provide a reliable reference point for the real value of a registration file, as well as its potential for improvement.

Co-evolution hypotheses and model for manufacturing planning

It is desirable to prolong manufacturing systems life and use them for many product generations. The matched evolution course of co-evolving biological species demonstrates their symbiotic interdependency. Analogously, this hypothesis forms the foundation of a new co-evolution model in manufacturing between products design and manufacturing capabilities which is mathematically formulated and interpreted using parsimony analysis of cladograms. The model is validated using case studies involving assembly of automotive engine accessories. The new co-evolution model supports a more efficient co-development of products and manufacturing capabilities, links their past generations to the present and identifies their promising future evolution directions.

A decision methodology for customising software products

Improving the product development processes is critical in the competitive business environment, where customers are the main focus. Codevelopment of products have been gaining importance. The objective of this paper to understand and characterise potential users of a software product through a collaborative process. During this product conceptualisation stage, the customer ideas are captured through a survey questionnaire. A new theory of Technologies, Attributes, Consequences, Values, Attitude and Satisfaction (TACVAS) is generated though Technology Adoption Model (TAM), Theory of Reasoned Action (TRA), Theory of Planned Behaviour (TPB) and Means–end Chain models.

Letter from the Executive Director.

Personalized MedicineVol. 6, No. 1 News & ViewsFree AccessLetter from the Executive DirectorEdward AbrahamsEdward AbrahamsPersonalized Medicine Coalition, 1225 New York Avenue, NW, Suite 400, Washington, DC 20005 USA. Search for more papers by this authorEmail the corresponding author at eabrahams@personalizedmedicinecoalition.orgPublished Online:23 Dec 2008https://doi.org/10.2217/17410541.6.1.11AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit The election of Barack Obama as President of the USA presents an unprecedented, perhaps not-to-be-repeated opportunity to advance the agenda for personalized medicine, change the way medicine is practiced and improve healthcare.President-elect Obama wrote the first bill in Congress that identified the promise of personalized medicine. Among other things, his bill created incentives to encourage the co-development of diagnostic and therapeutic products, called for funding to train a new workforce in genetics and genomics, established a biobanking database and authorized an interagency workgroup to coordinate the government’s policies so that they promote the new paradigm.As president, his horizon is much broader, but his interest in personalized medicine is likely to increase. He faces the central conundrum of healthcare: extend coverage to the 15% of the American public who do not have health insurance, spur the future research and development upon which patients depend and, at the same time, cut systemic, exploding costs that reduce productivity in the economy.Unless President-elect Obama can simultaneously achieve these three competing goals, his healthcare plan is likely to face serious opposition. Americans, historically a “people of plenty”, as the sociologist David Potter wrote 50 years ago, are nearly certain to reject any plan to which the label ‘rationing’ can be applied. Indeed, a plan that does not promise improved overall quality of care, offer an expectation that new discoveries will lead to better medicine tomorrow and lower systemic costs is unlikely to garner sufficient public support to be enacted.The only way to square the circle of increasing the quality and supply of healthcare while simultaneously cutting costs is to deploy new technologies and new approaches that introduce efficiencies in the system, while also emphasizing prevention, which will keep people healthier and also reduce the costs of chronic care. This is why during the recent presidential campaign, building on Health and Human Services Secretary Michael Leavitt’s generally unfunded initiative, President-elect Obama (and presidential candidate Senator John McCain) supported investing in health information technologies. Since the election, President-elect Obama has floated the idea of including US$10 billion in a stimulus package for health information technologies that could help build an infrastructure for more rational decision-making in medicine.One reason I believe that President-elect Obama did not focus on personalized medicine during the campaign, with the exception of a reference to it in his “plan to combat cancer”, was because the relatively new concept requires a review of complex biomedical issues that do not lend themselves to the exigencies of modern politics. In addition, although the Personalized Medicine Coalition estimates that there are almost 40 personalized medicine products on the market today, we have not yet reached a tipping point when physicians, payers, and particularly patients demand a diagnostic test before therapy is prescribed.This is why the Personalized Medicine Coalition contends that our proposed agenda of increasing investment in translational research, creating a friendlier regulatory environment that facilitates the co-development of diagnostic and therapeutic products, and putting in place a reimbursement system that supports personalized medicine products is all the more compelling.We know, moreover, that without more examples of widely used drug–diagnostic products, risk-adverse skeptics will not support reconstructing health systems around the world along these lines. We therefore also propose that clinical trails designed to determine if personalized approaches to care can produce both better patient outcomes and reduced costs be conducted sooner rather later.In brief, the principles of personalized medicine, including getting the treatment right the first time and preventing illness when possible, are the only way Obama’s health plan can achieve everything the American public wants.Edward Abrahams, Executive Director,Personalized Medicine CoalitionFiguresReferencesRelatedDetails Vol. 6, No. 1 Follow us on social media for the latest updates Metrics History Published online 23 December 2008 Published in print January 2009 Information© Future Medicine LtdPDF download