Advice You - Business

Most organisations have problems with their performance measurement systems. Some of the more common ones are discussed below.

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

Measures are Disconnected from Stakeholder Needs: Measures that organisations focus on sometimes have little b

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

Examples of combination products may in

aring on the needs of their important stakeholders - shareholders, customers and employees. As an example of such a disconnecti

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

n, consider the business school which measures itself by the accomplishments of its faculty, size of its facilities etc, rather

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

than the measure that should count, namely the post graduation success of its students. Or take the manufacturer of alcoholic be

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

Combination pro

erages that has measures of product quality based on esoteric factors that are not derived from consumer feedback.

Meas

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

res Do Not Support Major Business Goals: Sometimes measures are created without any associated goals or performance

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

standards. Such measures are just data collection exercises which have no contribution to the achievement of business objectives

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

as they are not actionable.

Measures Drive the Wrong Performance: In a surprisingly large number of instance

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

, measures and indicators selected by management not only to not support the goals of the organisation, but actually lead to per

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

ormance that opposes those goals.

For instance consider a situation in a production environment where product

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

Following aspects would a

s go through one machine (M1) before they are worked on by a second machine (M2). If the downstream machine has a lower capacity

dd to the challenges in developing combination products:

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

than the upstream machine, then using machine efficiencies to evaluate the operators will lead to a build up of work in process

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

nvetory in front of the downstream machine. Consider another instance where customer service personnel at a call centre are mea

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

sured on the number of customers they "process" per day and amount of time they spend on each call. The resulting effect will be

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

that customers are rushed off calls and issues are unresolved.

Contaminated Measures: Measures can be contami

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

Professional from academic institutions, pharmaceutical industries, health care indust

ated and lose validity for a number of reasons. Consider popular productivity measures like revenues per employee or something s

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

imilar. The problem with this measure is that the monetary values on which it is based can be contaminated by inflation. This it

.

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

can appear to improve for no other reason than that the purchasing power of the currency in question has declined.

Conc

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

Companies that provide selfless information through particip

usion To properly manage your business, your system of measures must be devoid of the common problems outlined above

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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