Digg It - Business

You may recall the scene in the film, “The Lion King,” in which Simba, having been banished from his murdered father’s kingdom, is floundering in the forest looking for sympat

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

hy from anyone who would listen to his sad tale of self-pity. He comes to a stream and, as he gazes into the waters, the form of his father appears and says: “Simba, you hav

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

Examples of combination products may in

forgotten who you are -- you are more than what you have become.”

We all are more than what we have become.

There are several reasons why this is so. One of the reasons ha

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

to do with our work environments. In college, I had a job in a pizza restaurant. One of my tasks was to keep the stainless steel oven doors clean. My manager showed me how

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

he wanted me to do it. After a while I realized I could improve on the process and did so with the results he said he wanted – clean and no streaks. One day, he saw me doing

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

Combination pro

it my way and marched up to me and said: “What do you think you’re doing? I showed you how I wanted it done!” Thinking he would listen to reason I said, “I thought . . .” a

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

d he cut me off right there and shouted, “I’m not paying you to think, I’m paying you to do what I tell you to do!” Our work environments often do not require us to think in

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

rder to perform our responsibilities; in fact, they often require us NOT to think in order to do our job.

Prolonged exposure to this kind of work environment results in a psy

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

hological situation that can be illustrated by imagining an iceberg, only the tip of which is visible. What lies below is immense in comparison. The top of the iceberg I cal

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

the “operational consciousness,” which comprises the actions most of us take on a daily basis in our jobs, at home and in our communities. We’re seldom called upon to go any

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

deeper than our operational consciousness. We’ve grown accustom to thinking that what’s in the tiny top of the iceberg is all there is to us and, that once we’ve performed to

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

Following aspects would a

the best of our perceived ability, we can’t do any better. “I did my best” is often used as an excuse for not doing any better. Occasionally, however, we are challenged to g

dd to the challenges in developing combination products:

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

deeper into ourselves, beneath our “operational consciousness” into what I call the “deep down;” once there, we find ourselves performing better than what we previously thoug

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

t our best was. We can challenge ourselves to do better than our best by simply spending time in silence and solitude thinking into our “deep down,” communing with what we of

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

en ignore and forget: our memories, our hopes, our dreams. The power of any organization lies not in its balance sheet assets that can be assigned a monetary value but in th

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

“off balance sheet” intangible assets: the untapped depth of its employees.

A well-known definition of “synergy” is “the whole is greater than the sum of the parts;” and th

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

Professional from academic institutions, pharmaceutical industries, health care indust

s definition is often illustrated by the equation, “1 + 1 = 3.” Synergy, from this understanding, can only happen as an outcome of the interaction between two or more people.

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

This is true, but not the whole truth about synergy. I’ve found that there’s tremendous power in what I call, “the synergy of the solitary soul.”

When an organization forma

.

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

izes a process that encourages and enables every employee to spend time thinking into their deep down, the synergy of multiple solitary souls that emerges will result in quick

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

Companies that provide selfless information through particip

r and more creative solutions to problems, better decisions, more complete, accurate and timely information and a much more lively, livable, enjoyable and productive workplace

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.diggit.org.ua/article/23374/diggit-Making-Your-Work-Environment-Work-Well-Tap-Into-the-Synergy-of-the-Solitary-Soul.html">Making Your Work Environment Work Well: Tap Into the Synergy of the Solitary Soul</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/23374/diggit-Making-Your-Work-Environment-Work-Well-Tap-Into-the-Synergy-of-the-Solitary-Soul.html]Making Your Work Environment Work Well: Tap Into the Synergy of the Solitary Soul[/url]

I often recommend that my clients consider offering free consultations. They provide a great opportunity to get a “foot in the door” while, at the same time, allowing a relationship (i.e., rapport and trust) to begin to form. To the extent you decide to offer free consultations, I recommend the following guidelines:

Sooner or later, you're going to disappoint a customer. How you handle that crisis, will determine whether you lose a patron or gain a devoted supporter. If you can make a customer feel special after you've disappointed them, you’ve taken a negative situation and transformed it into a positive. Here's how:

6 ways Customers look at Six Sigma: The foundation of Six Sigma is customer satisfaction and cost reduction by using various metrics and statistical tools. This is a customer-focused approach equipped with strategies and discipline at all levels of administration, planning and production. Six Sigma is aimed at achieving only 3.4 defects per million opportunities...

Tags

Links

Digg It - Making Your Work Environment Work Well: Tap Into the Synergy of the Solitary Soul

Related Articles: