Social Articles - Computers and Technology

This research arises out of projects to create systems to facilitate management of design and cost related knowledge within aerospace organisations, with the aim of using this knowledge to reduce the costs of designing and manufacturing products. The research is to id

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

entify ways that problems arising from the model development process can be addressed, by a new way of providing for the creation of software. With experience from projects, which have used a combination of proprietary software solutions and bespoke software, it is po

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

sible to identify the approach of User Driven Programming (UDP) as an effective software development technique. This research unites approaches of object orientation, the semantic web, relational databases, and model driven and event driven programming, (Frankel et al

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

, 2004) explain the opportunities for and importance of this kind of research. The approach encourages much greater user involvement in software development. The advantages of increasing user involvement in software development are explained by (Olsson, 2004). The int

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ntion of this research is to allow users to create the whole model/program they develop without typing code.

For this research summary the terms user, and domain expert are used interchangeably. The user is a domain expert who wants a problem represented and modelled

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

using software. The domain is engineering but this research could be applied to other domains. The users/domain experts may well be computer literate and able to model certain problems using a software tool such as a spreadsheet. For reasons that will be explained lat

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

er, this is only sufficient for simpler problems. The reasons that spreadsheets should not be used to represent complex models are connected with difficulties in maintaining, extending, and reusing spreadsheet models. So to be able to model a complex problem, the user

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

/domain experts currently must specify their requirements to other software experts, who may or may not have domain knowledge themselves. It is difficult to find and afford to employ those who have sufficient expertise in both the software and the domain. Someone with

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ut the domain knowledge may not understand the requirements. Putting the right team together is a difficult balancing act, and project teams will not be able to model a problem such as a new design unless all team members can access relevant software, to understand th

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

problem to be modelled and solved (Rodgers et al, 2001).

Software development is time consuming and error prone because of the need to learn computer languages. If people could instruct a computer without this requirement they could concentrate all their effort on t

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

e problem to be solved. This would mean they could customise software to model problems before and while they are trying to solve them instead of having to request the IT software provider to add features, at great cost in terms of time, money, and added complexity of

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

software. I call this personal programming alternative User Driven Programming (UDP) within this research, and for the examples demonstrated the term User Driven Modelling (UDM) is used to explain the application of User Driven Programming to model development. This

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

esearch aims to create software that enables people to program using visual metaphors. Users enter information in a diagram, which for these examples is tree based. Tree based visualisation is often a good way of representing information structures and/or program code

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

structures. Sometimes other types of network based visualisations are used, and I also examine converting these visualisations into other diagrammatic forms, including CAD style representations, and charts. The software developed as part of this research translates th

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

s human readable representation into computer languages. The tree also shows the flow of information.

This technique is a kind of End User Programming, research in this area is undertaken by the (End Users Shaping Effective Software (EUSES), 2006) research collaborat

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

on mainly in the USA, and (Network of Excellence on End User Development in Europe (EUD.Net), 2006), and by the (Institute for End User Computing, IEUC). Fabio Patern? has investigated this subject as part of the End User Development in Europe network (Patern?, 2005).

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

References

Frankel, D., Hayes, P., Kendall, E., McGuinness, D., 2004. The Model Driven Semantic Web. 1st International Workshop on the Model-Driven Semantic Web (MDSW2004) Enabling Knowledge Representation and MDA® Technologies to Work Together.

Olsson, E.,

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

2004. What active users and designers contribute in the design process. Interacting with Computers 16, pp 377-401.

Rodgers, P. A., Caldwell, N. H., M., Clarkson, P.J., Huxor, A. P, 2001. The management of concept design knowledge in modern product development organiz

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

tions. International Journal of Computer Integrated Manufacturing, 14(1), pp 108-115.

End Users Shaping Effective Software (EUSES), 2006. Welcome to EUSES [online]. Available from: http://eusesconsortium.org/.

Network of Excellence on End User Development in Europe

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

EUD.Net), 2006. Network of Excellence on End User Development [online]. Available from: http://giove.cnuce.cnr.it/eud-net.htm.

Institute for End User Computing (IEUC), 2006. Institute for End User Computing Inc. [online]. Available from: http://www.ieuc.org/home.html

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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