Advice You - Business

If you can’t measure it, you can’t manage it. Companies may be able to survive for a while if mana

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

gers aren’t using data to make decisions, but they will eventually see their demise; likely sooner

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

Examples of combination products may in

than later. Those companies to benchmark off are the ones who are not only surviving, but thriving

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

! Pick your favorite phrase: TQM, Process Management, Quality Circles, Improvement Teams, Standard

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

and Measurement departments or any other title you prefer. The function is the same. Look at base

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

Combination pro

line data – percentages, dollars, hours, quantities – and continuously monitor the performance.

T

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

ere should not be any task that a supervisor or staff members perform that cannot be measured. If

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

you can’t measure it, you can’t manage it. Take a fast food restaurant for example. There are a pl

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

thora of areas that can be measured such as days without an accident, customer wait time in line,

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

length of time burgers are in the warmer, amount of money off in the drawers, customer complaints,

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

etc. Graph it out and keep a spread sheet of your figures. Clearly you’re looking for improvement.

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

Following aspects would a

If there was a decline, brainstorm, find the root cause and then fix the problem.

The process is

dd to the challenges in developing combination products:

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

the same no matter what industry you’re managing. Whether you manufacture widgets, if you are the

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

CEO of an internet marketing firm or if you sell cookies, take a look at all the steps involved in

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

day to day operations. Assign values to the process. Set goals. Review the results on a daily, wee

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

kly or monthly basis. Remember, if you can’t measure it, you can’t mange it. Charts and graphs are

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

Professional from academic institutions, pharmaceutical industries, health care indust

an excellent tool to visually remind you of where you have been and where you plan to go.

In the

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

midst of measuring your subordinates’ performance, don’t neglect to measure and manage your own op

.

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

rations. Don’t think for a minute that your boss isn’t looking at your performance. And if you’re

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

Companies that provide selfless information through particip

the top dog, you had better be managing yourself well, or you will never succeed at managing other

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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Advice You - Measure It First, Then You Can Manage It

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