Suggest - Business

"I respect those who know their own wishes. The greatest part of all the mischief in the world arises from the fact that many do not sufficiently understand their own aims. The

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

y have undertaken to build a tower, and spend no more labor on the foundation than would be necessary to erect a hut." — Johann Wolfgang von Goethe

Over the years we've been i

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

Examples of combination products may in

volved in too many "vernacular engineering" debates as management teams argue about whether the statement they've been crafting is a vision, a mission, a statement of values an

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

d goals, or the like. Often these philosophical labeling debates are like trying to pick the flyspecks out of the pepper. Unless we're lexicographers and our company is in the

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

ictionary business, we shouldn't worry about the precise definition of vision, mission, values, or whatever we may be calling the words we're using to define who we are and whe

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

Combination pro

e we're trying to go.

What does matter is that our teams have discussed, debated, and decided on the answers to these three questions (in no particular order): Where are we go

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

ing (our vision or picture of our preferred future)? What do we believe in (our principles or values)? Why do we exist (our purpose or niche)? I call these the 3 Ps — picture o

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

preferred future, principles, and purpose. They are critically important questions. They are fundamental to leading others. This is the beginning point of effective leadership

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

These basic issues are the fabric with which we weave our Focus and Context (vision, values, and purpose). If we're attempting to change our team or organization culture, our

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

answers to these basic questions define the culture we're trying to create.

If we're going to further improve our leadership effectiveness, we need to have thought through and

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

answered these questions on our own. If you have a spouse or life partner, you need to work on these questions together.

Whatever we call our answers to these questions doesn'

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

Following aspects would a

matter. They can be termed vision, mission, values, strategic niche, aspirations, purpose, and so on. And how "snazzy", "different", or "original" our words are doesn't matter

dd to the challenges in developing combination products:

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

as much either. What does matter is: Can we give a unified answer to these questions? Is whatever we've developed clear and compelling? If we're a management team — and especi

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

lly a senior management team — does everyone on our team passionately own what we've developed? Do we give these critical leadership issues a sharp focus and meaningful context

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

for everyone? That can only be done through skilled, live communications and consistent management behavior.

There are no right answers to these questions. No consultant, expe

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

rt, or anyone else can answer them for us. There is no one way to answer them. Each of us has our own style and approach.

I was in speaking at a quality improvement conference

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

Professional from academic institutions, pharmaceutical industries, health care indust

a few years ago. Following my presentation, I had the pleasure of hearing Bill Pollard, chairman of the hugely successful ServiceMaster Company, speak about the management prin

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

iples and practices that took their organization to more than $3 billion in sales in a few decades. In his address he stressed the importance of clarifying and living the issue

.

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 that were introduced in this chapter. He introduced all this by relating a recent experience he had with calling a friend and getting this message on his voice mail: ". . . t

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

Companies that provide selfless information through particip

is is not an answering machine, it's a questioning machine. There are really only two questions in life: Who are you and what do you what? Please leave your answer at the tone.

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.suggest.org.ua/article/3858/suggest-Three-Core-Questions-That-Define-Organizational-Culture.html">Three Core Questions That Define Organizational Culture</a>

BB link (for phorums):
[url=http://www.suggest.org.ua/article/3858/suggest-Three-Core-Questions-That-Define-Organizational-Culture.html]Three Core Questions That Define Organizational Culture[/url]

Getting sales leads is vital to every business. Every business has to have customers; and prospective clients are what they identify as sales leads. Even the teenage girl who is eyeing some fashionable clothes in a magazine can be considered a sales lead...

When faced with the challenge of trying to find out information on companies, industries and sectors with no starting point (and often through stealth), there can be a tendency to believe that this 'new' knowledge does not come free. Yes, sometimes the answer is to buy a pre-written report, or pay to subscribe to certain data sources- however, these rarely give you the full picture. I find it satisfying to get this information free and often employ some of these methods, which unearth some gems that no report will give you.

For people running a technology based business, Mexico can offer a wonderful location to work from while providing the technology infrastructure to stay connected. This article discusses some of the things to think about when considering a move to Mexico.

Tags

Links

Suggest - Three Core Questions That Define Organizational Culture

Related Articles: