Main Subject - Business

Businesspeople are often in a difficult position when negotiating, enforcing policy, and making decisions t

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

hat impact relationships with customers, staff, vendors, and stakeholders. Many take the easy way out by p

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

Examples of combination products may in

ocrastinating or they do the comfortable thing by just allowing the issue to continue instead of doing the

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

right thing and deal with it.

Dealing with difficult issues by hoping they will go away might feel comfort

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

ble because human beings can fool themselves for a time and pretend those issues don’t exist. But by doing

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

Combination pro

the comfortable thing they open the door to long-term risk that is probably much worse and much less comfo

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

table than the current issue. Additionally, it really isn’t all that comfortable. There is a certain amou

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

nt of nagging memory of the issue that wakes you up in the middle of the night and calls attention to your

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

enial.

Doing the right thing, and dealing with difficult issues before they become huge takes on a certain

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

amount of personal risk – the risk of a confrontation. Often it takes personal courage to do the right th

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

ng. I’ve seen the word “courage” defined as: “Being brave enough to reach outside our existing paradigms,

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

Following aspects would a

thus overcoming our fears and providing new, bold lenses through which to see life.”

Putting on the bold l

dd to the challenges in developing combination products:

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

nses of courage allows the person doing the right thing to overcome the comfortable risk of self-deception

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

and face up to the responsibilities of the task at hand, overcoming the fears of confrontation, and becomin

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

empowered by knowing they are doing the right thing.

This, of course, opens up a conversation of defining

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

the “right thing” and that goes back to a business having, communicating, and living by its foundational e

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

Professional from academic institutions, pharmaceutical industries, health care indust

ements – the Mission Statement, Vision Statement, and Values Statement. If they are in place, relevant, an

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

d are adhered to, it’s easy to know what the “right thing” is in almost every circumstance. It becomes har

.

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

er to do the “comfortable thing,” hoping the issue goes away. It won’t go away! It will probably get much

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

Companies that provide selfless information through particip

worse over time. So do the right thing now and get over it! You will really be more comfortable that way

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.mainsubjects.org.ua/article/20812/mainsubjects-Are-You-Doing-the-Right-Thing-or-the-Comfortable-Thing.html">Are You Doing the Right Thing or the Comfortable Thing?</a>

BB link (for phorums):
[url=http://www.mainsubjects.org.ua/article/20812/mainsubjects-Are-You-Doing-the-Right-Thing-or-the-Comfortable-Thing.html]Are You Doing the Right Thing or the Comfortable Thing?[/url]

More and more people are turning to the intenet to find and/or offload specific items.

Back in the days when Super Bowls were numbered in single digits, and teams like the Packers and the Steelers reigned supreme, there was a legendary coach by the name of Vince Lombardi. He shared some interesting thoughts about the differences between winning and losing, and between winners and losers. Undoubtedly, you’ve come across his often derided line: “Winning isn’t everything—It’s the ONLY thing!” But that’s not my favorite Lombardi-ism. It’s: “Winning isn’t a sometime thing—It’s an ALL THE TIME THING!” Since when is occasionally doing a good or a great job an option?

When communication breaks down in your office or factory and workers lack motivation, what are the roots of the problem?

Tags

Links

Main Subject - Are You Doing the Right Thing or the Comfortable Thing?

Related Articles: