E-Folder - Business

In business, as in life, adversity is a recurrent and inescapable event. The clich?:

“Into every life a little rain must fall”

is true no matter one’s education or level of success

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

. The key difference between the businesses that close never to reopen again and those that thrive through their adversity is resilience.

Everyone knows that there is nothing more d

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

Examples of combination products may in

angerous than a wounded animal. An injured animal seeks to protect itself by striking out against all who approach. However dogs are unique in that they will invariably find one per

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

son with whom to bond. This difference is inexplicable, but predictable. They may not even choose their owner or master. Nonetheless wounded dogs will drag themselves to the feet o

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

f their chosen protector, nuzzling and begging for help. These wounded dogs know that they are no longer capable of caring for themselves and that one more adversity befalls them and

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

Combination pro

they will die.

Businesses become wounded dogs when they fail to ensure that an adversity does not evolve into a disaster. In two decades of disaster field work and consulting to com

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

panies large and small I have seen and helped more than my share of wounded dogs. In all cases it did not matter whether the adversity came from outside the company such as a hurrica

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

ne, earthquake or terrorist attack or if the adversity came from within; poor product design, marketing mishaps, financial missteps, or employee sabotage. The result is always the sa

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

me. Some critical business pathway collapses resulting in a business disaster.

Observers both inside and outside the wounded business say that the disaster was “inevitable.” In the

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

disaster field office, we know that no disaster is “inevitable.” Disaster is a simple equation no more different than profit and loss.

Disaster = Needs > Resources.

The most basic

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

analogy is the financial disaster of “want” exceeding “wallet,” but this same equation holds true in all other critical areas of business. Conversely, resilience, the ability to cope

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

Following aspects would a

with adversity and stave off disaster, is also represented by the simple equation:

Resilience = Resources > Needs.

Again the analogy is the financial resilience of “wallet” exceedin

dd to the challenges in developing combination products:

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

g “wants.”

Now if this were the end of the story, one short speech, one short consultation, one small article in the Wall Street Journal and I could end all business disasters. The

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

trick here is being able to identify what resources to have in abundance since nobody can have resources for all contingencies. Resource identification is based not on determining ev

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

ery possible adversity that can face a business. This is an incalculably high number and bounded only by the imagination not only of those that run the business but all of those who

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

ay wish it ill.

Rather, resource determination is based on an evaluation of the processes and pathways unique to each business. It requires the identification of “choke points,” tho

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

Professional from academic institutions, pharmaceutical industries, health care indust

se critical pathways that, if narrowed or destroyed, will choke off the life of the business. It is these critical steps for which resources are amassed. The goal is to ensure that n

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

o choke point becomes so narrow as to strangle the life of the business. This ensures resilience.

Some have adapted well through the application of the lessons I learned in the disa

.

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

ster field office. Others have failed to learn these lessons resulting in business disaster. In a few cases, the businesses stumbled upon their resilience. In others they were guide

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

Companies that provide selfless information through particip

d to it. But in all cases it was the identification of choke points and the allocation of resources that ensured that a business remained in business and did not become a wounded dog

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.e-folder.org.ua/article/44536/e-folder-Dont-Let-Your-Business-Become-a-Wounded-Dog.html">Don't Let Your Business Become a Wounded Dog</a>

BB link (for phorums):
[url=http://www.e-folder.org.ua/article/44536/e-folder-Dont-Let-Your-Business-Become-a-Wounded-Dog.html]Don't Let Your Business Become a Wounded Dog[/url]

Business Owners tend to identify themselves with their business. They show pride in the name, the function and the growth of their business. After all, it's their 'baby.' Here's what you need to know about Privacy, Protection and Capital Expansion.

Marketing outsourcing is a growing trend in most companies. Companies spend a major part of their funds on promotion and research. Some experts feel that outsourcing marketing to other companies can damage the marketing projects of the business.

Setting a business for the first time can be very confusing. If you prefer to keep it simple, read this article.

Tags

Links

E-Folder - Don't Let Your Business Become a Wounded Dog

Related Articles: