Useful Articles - Business

I once had a boss who informed me there was no such thing as company politics. At the time, I decided that depended on whether

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

you were the person wielding power or influenced by it. In my career experience, I’d categorize self-serving antics, sabotagi

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

Examples of combination products may in

g behaviors, information hoarding and artful manipulation under the heading of company politics. I’d throw in veiled threats,

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

perpetuated mistruths, finger-pointing and coercion. There’s a long list of behaviors I’ve personally experienced or witnessed

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

in the workplace under the politics label. And I’m sure you can add your own.

These negative work cultures are fraught with f

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

Combination pro

ar. Fear you’ll step on a career grenade, lose your job, be labeled a trouble-maker or relegated to the non-promotable categor

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

y. Fear you’ll say the wrong thing, fall into project quicksand, find no support or be kept out of the loop. These soul-deplet

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

ng cultures trample self-esteem, negate initiative, encourage survival behavior and diminish motivation.

But in twenty years

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

n management I’ve learned something else about company politics. It doesn’t have to be a blood-sport. The politics label can b

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

e assigned to assisting other departments, supporting company initiatives, cooperating with those in charge, sharing informati

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

n, and helping others achieve results. You see, strategic alignments, interdepartmental collaboration and volunteering for add

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

Following aspects would a

tional work assignments are politics, too.

Politics can be served with a negative or a positive impact. Samuel B. Bacharach,

dd to the challenges in developing combination products:

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

a Cornell University professor, puts it this way in Get Them on Your Side: “Politics is simply the way we influence others to

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

chieve our goals. As long as those goals are positive, and not achieved at the expense of others, the politics of getting them

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

accomplished is neither manipulative nor negative. Dictators may be political, but saints might be, too.”

It’s the intention

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

behind an action that determines whether politics creates fear or builds relationships. What’s the motive? If politics is a di

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

Professional from academic institutions, pharmaceutical industries, health care indust

ty word where you work, undermining results and reducing staff engagement, consider your contribution to that culture.

You se

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

, we have a choice how we use our power and influence. And don’t be na?ve to think you don’t have both. We all have power and

.

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

influence over people in our lives: staff, coworkers, family, bosses, children. We can serve our brand of politics from well-i

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

Companies that provide selfless information through particip

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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As management members and business owners we detest dealing with unions in our businesses. Unfortunately, the government has allowed people to collectively bargain for compensation & wages, benefits and terms of employment. This leaves many companies at a loss for an effective labor relations strategy.

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