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You likely invest in corporations. As an investor, you try to identify precisely how you are to gain a return on your investment and have some idea of what that return should be.

Do you realize that the corporations that you invest in have no wa

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

y to do the same when they use the money you have invested. Corporations do not have a fundamentally strong means to plan and manage the return on their investments, from initiation through to measuring the return. So corporations rarely really i

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

Examples of combination products may in

vest, they either spend or speculate.

Many corporations approach investor funds as money to spend rather than considering use of the funds as an obligation to gain a return on the funds used. The money simply disappears into normal operations.

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

ven when corporations attempt to invest in capital development and growth, they face difficulties because they are not structured to plan and manage investments. They cannot identify the precise points that benefits are produced to build up the i

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

dividual benefits that justify the investment. And if they cannot plan these benefits, they certainly cannot manage benefits through to the return.

Corporations estimate the return for core business investments like a new production line. But th

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

Combination pro

y rarely have a precise idea of the return from investments, particularly for investments in business change. The objective of business change investments is performance improvement or solution implementation. Investments meeting these objectives

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

are investments in costs, but provide no benefit per se.

Most investment projects itemize the cost of the investment, but do not correspondingly itemize the benefits or return on the investments. Return on investment is a estimate of how much c

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

rtain entities like sales or revenues will improve. The estimate is often camouflaged as a sophisticated cost-benefit or internal rate of return analysis.

Rather than estimating how an investment will increase sales and revenues, the corporation

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

must itemize and manage the individual benefits of each improvement to justify investment and follow through to see that the actual individual benefits add up to increased sales and revenues.

Those of you familiar with conventional development

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

ethods will wonder how to do this. Conventional development methods follow such steps as identify the problem, design the solution, plan the cost of the solution, acquire or develop the solution, test the solution, train users on the solution, im

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

lement the solution, and operate the solution. All of these steps are on the cost side of the investment. There are no steps on the benefit side.

This problem has existed, since the beginning of business. 20th century corporations are structured

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

Following aspects would a

to incur and manage tangible costs, but they are not structured to manage unknown costs and to create and manage the value required to provide benefits and the return on investments. Corporations do not manage the utilization of each item of cap

dd to the challenges in developing combination products:

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

tal in operations, so they have no professional capabilities to manage the development of capital.

Since corporations find investments so hard to manage, many do not develop the internal capability to manage investments. They bring in consultant

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

to manage the investment for them. The consultants face the same problem. Their methods do not plan or manage the benefits or return on investments.

Corporations and consultants will never be able to manage investments with conventional develop

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

ent methods that develop and manage contrived entities like processes, systems, and activities, rather than business reality.

Result-performance Management (R-pM) organizes, manages, and develops the business through the only two entities that d

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

rectly portray business reality; results produced and performance solutions utilized.

R-pM provides a way for the enterprise to develop results in addition to performance. The value and benefit of investment come from result development; the cos

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

Professional from academic institutions, pharmaceutical industries, health care indust

ts come from performance development. The corporation must use R-pM to take three fundamental steps to be able to manage investments properly:

Structure corporation results to plan and manage value, including the value-added by investments

Stru

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

ture capital as performance solutions to be professionally managed in development and operations.

Develop a professional investment management capability to plan and manage development over time.

Value can be planned and managed only through re

.

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

ults. So, only when the corporation has structured its results properly, has structured its capital, and has the professional capability to manage change over time, will the corporation be able to plan and manage the benefits of investment and me

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

Companies that provide selfless information through particip

sure of the precise return on investment.

It is only when a corporation is structured through R-pM that we as investors can be confident that the corporation will plan and manage the utilization of our investment for a planned and managed return

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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