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"You must first plant the seeds in order to harvest the crop."
- Bryce's Law

The challenge facing systems development since the MIS movement of the 1960's has been to share and reuse information resources on an enterprise-wide basis. There are substantial benefits for doing so:

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

i>The elimination of redundant work effort in systems design and programming, thereby accelerating delivery.

Simplified maintenance and enhancements of systems by controlling the whereabouts of information resources and how they relate and affect other components.

Integration of systems and

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

Examples of combination products may in

oftware, thereby eliminating data redundancy and the production of inconsistent information.

Consider this, had companies been controlling information resources properly over the years, the crossover to Y2K would have been a nonevent. Instead, billions of dollars were spent in preparation for

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

the switch.

The concept of Information Resource Management (IRM) is actually quite simple: to inventory and control all of the resources needed to satisfy the information needs of an enterprise. This includes data components (data elements, records, files, data bases, etc.), system components (sys

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

ems, business processes, procedures, programs, etc.), and business components (functions, jobs, human and machine resources, skills, objectives, and projects).

To implement IRM, technology was introduced over the years, starting with the data dictionaries of the 1970's which evolved into more robust

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

Combination pro

products referred to as "Repositories" which included a manifest of all information resources and how they are interrelated. An IRM Repository, therefore, represents a centralized consolidation of the whereabouts of all corporate information resources, regardless of where used or how stored, includin

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

corporate records. For example, it is equally concerned with the information resources as maintained in manual files as it is with those as maintained by the computer. As such, an IRM Repository bridges manual processing to automated processing.

Basically, the concept of a Repository is to record

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

design decisions during a development project much like how an engineer records design decisions when defining the components of any product. In fact, the Repository concept is derived from "Bill of Materials Processing" (BOMP) which seeks to itemize and cross-reference parts to products, thereby pro

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

iding the means to share and reuse components. One important byproduct of both BOMP and the IRM Repository is that design documentation is always current and up-to-date; as design decisions and component relationships are updated, the documentation is automatically updated. Further, the design intel

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

ligence contained in the IRM Repository is so extensive and precise, it can be used to drive application development aids such as program generators, report writers, and other CASE related tools.

Although techniques such as IRM Repositories and BOMP are useful on a product-by-product basis (or system

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

by-system), the true benefits are derived when they are used on a corporate-wide scale, thereby promoting the true concept of sharing and reusing components. And herein lies the rub; whereas the technology is certainly available to implement this concept, the management needed to make it happen isn'

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

Following aspects would a

t. Despite the considerable benefits associated with Information Resource Management, it will never be realized in this day and age for three reasons:

IRM requires a global perspective of information resources. Unfortunately, corporate America is more conducive to the creation of fiefdoms

dd to the challenges in developing combination products:

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

and, as such, there is more of a spirit of competitiveness as opposed to cooperation in the workplace. It takes true visionaries to understand the benefits of IRM and true geniuses to make it happen.

IRM requires standardization and discipline. In order to implement a centralized facility to s

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

hare and reuse resources, agreement must be reached in terms of the standard components to be defined, their attributes, and how they relate to other components. This also requires standard processes (methodologies) for developing systems so they can be assembled in a consistent and predictable manne

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

. Regrettably, it is fallacious to believe there are any standards in the I.T. community and, as a result, most I.T. shops consist of mavericks with different interpretations of how to address systems development. Concepts such as standardization and discipline are steadfastly resisted. Bottom-lin

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

e: IRM implies a science with governing concepts and rules, not an undisciplined art form which is how most I.T. workers currently view it.

IRM requires long term thinking which is the exception as opposed to the rule in most companies. The true benefits of sharing and reusing resources will not

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

Professional from academic institutions, pharmaceutical industries, health care indust

be realized immediately. Instead, it is an investment in the future. Companies will benefit the moment they start to share and reuse information resources from one project to the next. But the real payoff is when the IRM Repository matures, and components are reused time and again.

The conc

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

ept of IRM reminds me of an incident years ago when there was a problem with famine in India. To help out, the United States sent seed grain to India for the local populace to plant and harvest. This was a viable long-term strategy to take. Unfortunately, when the sacks of seed were delivered to th

.

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

docks, the people opened them and ate the seed as opposed to planting it. This remedied their immediate hunger problem, but ruined their long term needs. You cannot harvest a crop if you do not sow the seeds. The same is true in IRM. To harvest the crop, we must first document our resources. Onl

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

Companies that provide selfless information through particip

y then can we realize the benefits of sharing and reusing them.

Even though IRM is a beautifully simple concept, its only weakness is the management needed to implement it. If you are considering the acquisition of an IRM Repository for your development efforts, consider your management skills first

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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