Advice You - Business

Business is complex and that complexity demands big solutions. Yet, in many cases, in the quest to find a quick sol

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

ution, some management teams may use an elephant gun when a fly swatter would work even better.

Elephant guns range

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

Examples of combination products may in

from the big change management initiatives to the many training and development solutions to the quality programs su

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

ch as lean to six sigma. These guns shoot out round after round of new knowledge and skills all in the attempt to s

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

lve the current challenges. Yet, if the elephant guns were effective, then why are the same change challenges retur

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

Combination pro

ning? Why for example does it take up to 7 years to integrate a total quality management system? Could the aim have

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

missed the fly?

Flies are the attitudes and habits that swarm around the culture of every organization. They quick

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

swarm together to give the impression of a significant problem, but in a blink of an eye they can disappear. By th

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

time the elephant gun is loaded and fired, the fly is gone leaving three large holes.

Hole one is missi

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

ng the problem such as training and development or quality programs.

Hole two is the drain to the cash bo

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

Hole three creates another entry for more flies to enter the organization.

For years, comp

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

Following aspects would a

anies have focused their energies and resources on the knowledge and skills necessary for business success. Knowled

dd to the challenges in developing combination products:

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

e and skills are the big elephants and suggest the use of elephant guns through cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ocessspecialist.com/training-and-development.htm">training and development programs. However, the attitudes and

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

habits residing within each and every individual are the real leverage to business success or to business failure.

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

These small flies can bring down the very best companies. Common sense suggests that elephant guns are not effectiv

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

Professional from academic institutions, pharmaceutical industries, health care indust

in killing flies.

When the focus changes to the fly, then the tool to catch the fly also changes. By identifying t

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

he fly or flies, a more effective solution can be crafted to deal with the pending change issue. And in many instanc

.

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

s, this stops the constant drain to the cash box.

So if you are experiencing some negative change and begin to reac

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

Companies that provide selfless information through particip

h for that elephant gun, maybe you should separate the elephants from the flies and reach for the closet fly swatter

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 - Are Your Business Process Management Solutions Using an Elephant Gun to Kill a Fly?

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