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Managers have for many years been evaluated against standards of personal traits and work characteristic. T

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

ypical trait-rating evaluation systems may list ten to fifteen personal characteristics, such as ability to

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

Examples of combination products may in

get along with people, leadership, analytical competence and initiative. The list may also include such wor

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

-related characteristics as job knowledge; ability to follow through on assignments, production or cost res

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

lts; or success in seeing that plans are carried out.

Managers resist doing this type of evaluation or ten

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

Combination pro

to go through the paperwork without knowing exactly how to rate. Even in firms that have made earnest atte

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

pts to “sell” such programs, to indoctrinate managers, and to train them in the meaning of traits so that t

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

ey can improve their appraisal ability, few managers can or will evaluate properly.

One practical problem

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

f the trait approach to appraisal is that trait evaluation cannot be objective. Serious and far-minded mana

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

ers do not wish to utilize their obviously subjective judgment on a matter as important as performance. To

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

omplicate matters, employees receiving a rating lower than what they feel is justified almost invariably fe

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

Following aspects would a

el that they have been dealt with unfairly.

One widely used approach to managerial appraisal is the system

dd to the challenges in developing combination products:

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

of evaluating managerial performance against the setting and accomplishing of verifiable objectives. Once a

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

program of managing by verifiable objectives is operating, appraisal is a fairly easy step. Supervisors det

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

rmine how well managers set objectives and how well they have performed against them. In cases where apprai

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

al by results has failed or been disillusioning, the principal reason is that managing by objectives was se

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

Professional from academic institutions, pharmaceutical industries, health care indust

n only as an appraisal technique. The system is not likely to work if used only for this purpose. Managemen

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

by objectives must be a way of managing, a way of planning as well as the key to organizing, staffing, lea

.

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

ing and controlling. When this is the case, appraisal boils down to whether or not managers have establishe

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

Companies that provide selfless information through particip

adequate but reasonably attainable objectives and how they have performed against them in a certain period

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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