Main Subject - Business

Introduction

Most businesses have rules that define and implement policies, whether they relate to internal operations or to the products and services they offer to their customers. Often these rules define the strategy of

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

the business and determine its success or failure. Adjustments to the strategy typically mean changes to business rules. The problem is this—these days business rules are implemented in software, and everyone knows that soft

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

Examples of combination products may in

are changes don’t happen quickly. Business rules engines (BRE) expedite rapid changes in business rules within enterprise software.

The Business Rules Bottleneck

For years enterprise architecture has separated systems into

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

three tiers—a presentation tier, a flow control or application tier, and the data validation tier. Business logic is usually embedded across all three tiers. When policy makers decide to change direction, often database rou

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

ines must change, application server enterprise software may require adjustment, and user interface options will have to be altered. The entire IT infrastructure is affected. To bridge the gulf between IT and policy makers,

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

Combination pro

usiness analysts are often charged with creating detailed requirements and other documents which coders use to implement the business requirements in software. This translation of business logic into code creates a bottlenec

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

k for change and slows responsiveness to developing business needs and priorities.

The RBE Solution

The central principle of business rules management systems (BRMS) is to extract the embedded business logic from the multi

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

le tiers of enterprise applications and to centralize it into a set of rules that can be easily monitored, controlled, and altered by business analysts. Control of business rules and logic is thereby placed in the hands of t

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

he business professionals who know them. A business rules engine can be thought of as a fourth tier in enterprise applications, the tier that houses the rules of the business. Rules are written as declarative statements in p

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

ain English, typically as IF-THEN-ELSE statements. When integrated with the other tiers, the BRE works through the rules until all conditions are satisfied.

In the Financial Industry

BRMS has been most widely implemented i

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

the financial industry, which has seen an explosion of loan products, each governed by its own set of rules. Software applications typically check the applicant’s credit history, income and other factors bearing on credit,

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

Following aspects would a

as well as that of co-signers, and make recommendations for loan products and find the best price for the customer’s circumstances. This process is highly rule-intensive, but by using BRMS, business analysts are able to ente

dd to the challenges in developing combination products:

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

the rules that generate the code that approves loans. As a result, loan companies can create sophisticated and innovative products without incurring overwhelming IT investments. BRMS has not only reduced IT costs and redu

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

ced time to market for the industry, but importantly, it has reduced translation errors between the business experts and programming.

Other Industries

Other industries that rely heavily on rules-based systems are beginning

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

to catch on. Telecommunications companies are using BRMS to route messages, to schedule maintenance and to manage customer service. The health care industry is quickly adopting it for its heavily rules-laden processes, such

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

s claims processing and regulatory compliance. One health care insurer estimates that the number of rules in its systems has been growing and will continue to grow to tens of thousands of independent rules. A BRE is the only

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

Professional from academic institutions, pharmaceutical industries, health care indust

sensible way to get a handle on such overwhelming business logic. The right BRE will provide an environment in which these rules can be created, categorized, cross-referenced, searched, versioned, and approved.

Selecting t

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

e Right BRMS

There is a wide variety of BRMS products available now, from open source tools to full-blown enterprise offerings. Choosing the product that is right for your organization requires an examination of your organi

.

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

zation’s existing IT infrastructure, as well as the extensiveness of your organization’s rules base, the expectations for rules management, and the level of commitment by the business experts. Gartner estimates that IT can e

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

Companies that provide selfless information through particip

pect to reduce operating costs by 10% to 15% with a properly implemented BRMS. But the benefits of transparency in the organization’s business logic and the responsiveness of IT to changing business needs may be immeasurable

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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