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Today’s IT executives want the best software available. With business process management that means finding solutions that provide key benefits. In addition to facilitating system integration, these solutions must minimize costs, protect software investments, and increase corporate flexibility—

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

all while generating a quick return on investment (ROI).

Previously, IT executives had an option. They could either create their own processing solutions or buy them as packaged applications. Both approaches were costly. These solutions also had a major downside. Once encoded, they were diffic

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

Examples of combination products may in

ult to change. This encoding prevented businesses from quickly meeting its customers’ needs. More importantly, it hindered adaptability to a dynamic increasingly demanding marketplace.

Combining BPM and Web services changes that. This union provides businesses with a powerful set of benefits.

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

t increases efficiency and flexibility, reduces costs, and protects software investments by integrating and recombining with a company’s existing systems. In addition, the union provides real-time visibility into processing systems as well as a way to monitor and evaluate key performance indica

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

tors— the prerequisites needed to implement a continuous improvement program.

A Tactical Implementation of SOA

The foundation for BPM and Web services is a service-oriented architecture (SOA). Web services is a tactical implementation of SOA, which bridges the gap between businesses and IT th

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

Combination pro

ough a set of business-aligned services using a unique set of design principles, patterns, and techniques.

SOA involves the dynamic discovery, organization, and description of services, which enables companies to select, bind, and invoke a service over the Internet. SOA differs from service-ba

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

sed architectures, like RosettaNet or OBI (Open Buying on the Internet), which focus on formats and protocols. A service-based architecture is part of an SOA.

Key SOA Components

The major components of an SOA are a service directory, a service provider, and a service requestor. The service di

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

ectory contains information about all the available services. A service provider publishes a service by adding the appropriate entries to the directory, which a service requestor uses to find the appropriate service.

When a service requestor finds a match, it binds to the provider using inform

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

ation maintained by the directory. The binding information contains the protocol specifications that requestors must use as well as the structure of the request messages and the resulting responses. The two companies then form a “business partnership.”

When the service requestor no longer need

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

the provider’s services, it dissolves the partnership. It then forms new requirements and puts them into a query called a locator, which is run against the service directory. The locator returns a list of possible providers, from which the service requestor chooses a new business partner, and

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

the whole process starts again.

When the business partners bind, they create a “virtual” application. The partners temporarily combine their services to meet an immediate need and capture a business process. Once captured, the business process is automated using workflow management technology.

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

Following aspects would a

The applications are then integrated and work is routed to the appropriate departments.

Considerations in Deploying an SOA

Businesses who want to deploy an SOA face three considerations. First, current object-oriented analysis and design (OOAD) methods don’t address the primary elements of a

dd to the challenges in developing combination products:

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

SOA: services, flows, and components for realizing services. Companies must develop or acquire the techniques and processes required to identity, specify, and realize the individual services. The also need the enterprise-wide components to ensure the quality of services.

Second, a shift in co

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

rporate mindset must occur. Companies must shift their thinking from strictly a production-oriented goal to the key SOA objective: enhanced customer service. Whether its Web services or another implementation, SOA is designed to provide customers with services that meet their unique requirement

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

. That’s a major leap for some companies but making the transition is a must obtain SOA’s benefits.

Third, applications created for one business or product line can now be used in a supply chain and be exposed to business partners who might compose, combine, and include them into new applicati

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

ons, creating what some analysts are calling the service ecosystem or a service value-net. Executive must accept this possibility.

Companies need to address these considerations before deploying an SOA. Unless they do, they won’t reap the benefits of an SOA. Nor will they have the adaptability

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

Professional from academic institutions, pharmaceutical industries, health care indust

need to compete successfully in the days ahead.

The Role of BPM Technology

BPM technology provides the tools and infrastructure to define, simulate, and analyze this business process model. It does so in such a way that the process is manageable from a business perspective using business solu

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

tion management tools. A dashboard, for example, provides information about execution status and progress in various levels of detail.

Business analysts then compare readouts to key performance indicators to evaluate the processes performance. If a process is not meeting its objectives, execut

.

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

ves change the process. It’s here where methodologies, like Six Sigma, are implemented as part of a continuous improvement program. The goal, of course, is to provide customers with the highest quality services.

Conclusion

Combining BPM technology and Web services represents more than just an

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

Companies that provide selfless information through particip

advanced approach to automating business processes. It takes it to a whole new level. With support from SOA, the combination provides benefits cost-conscious enterprises want from their IT solutions—increased flexibility, ease of integration, protection of existing investments, and a quick ROI

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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