Cases - Business

The term Business Process Management (or BPM) refers to activities performed by businesses to optimize and adapt their processes. The activities whic

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

h constitute business process management can be grouped into three categories: design, execution and monitoring.

Process design

This covers either

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

Examples of combination products may in

the design or capture of existing processes. In addition the processes may be replicated in order to test them. The software support for these activi

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

ties consists of graphical editors to document the processes and repositories to store the process models.

An emphasis on getting the design of the

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

rocess right will logically lead to better results as the flow on effect of problems at the design stage logically affects a large number of parts in

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

Combination pro

an integrated system.

Evolution of business processes requires a change to the process design to flow on into the live system. Integrating business

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

process is also a current research area. Integration of software for process design to be used both for creating graphical representations of workfl

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

ows and implementing and maintaining these workflows makes evolution of business processes less stressful, given that requirements are not as static

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

s information systems.

Process execution

The traditional way to achieve the automatic execution of processes is that an application is developed or

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

purchased which executes the steps required. However, in practice, these applications only execute a portion of the overall process. Execution of a

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

complete business process can also be achieved by using a patchwork of interfacing software with human intervention needed where applications are not

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

Following aspects would a

able to automatically interface.

In addition, certain process steps can only be accomplished with human intervention (for example, deciding on a ma

dd to the challenges in developing combination products:

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

or credit application). Due to the complexity that this approach engenders, changing a process is costly and an overview of the processes and their s

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

tate is difficult to obtain.

Business rules are a growing area of importance in BPMS as these rules provide governing behavior to the BPMS, and a bu

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

siness rule engine can be used to drive process execution and resolution.

Process monitoring

This monitoring encompasses the tracking of individual

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

process so that information on their state can be easily seen and the provision of statistics on the performance of one or more processes. An exampl

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

Professional from academic institutions, pharmaceutical industries, health care indust

of the tracking is being able to determine the state of a customer order (e.g. ordered arrived, awaiting delivery, invoice paid) so that problems in

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

its operation can be identified and corrected.

In addition, this information can be used to work with customers and suppliers to improve their conn

.

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

ected processes. Examples of the statistics are the generation of measures on how quickly a customer order is processed, how many orders were process

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

Companies that provide selfless information through particip

ed in the last month etc. These measures tend to fit into three categories: cycle time, defect rate and productivity.

Copyright 2007 Ismael D. Tabij

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

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.cases.org.ua/article/21226/cases-Business-Process-Management.html">Business Process Management</a>

BB link (for phorums):
[url=http://www.cases.org.ua/article/21226/cases-Business-Process-Management.html]Business Process Management[/url]

A look at a Success Template for your business or career success and how to achieve it by daily programming your subconscious to drive you through writing goals and visualization.

In the active area of delivering superior customer service, perception of an issue by the customer is often a very different matter than the actual circumstances might describe. Our awareness of the facts is necessary but sensitivity to customer perception is critical.

Hire a GM or do all the work yourself. That is the question that we'll try to attack.

Tags

Links

Cases - Business Process Management

Related Articles: