Advice You - Business

Last time I was hiking in Montana's Glacier National Park, I stopped to view through binoculars, a mountain goat trekking atop a rock cliff. M

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 husband, viewing the switch-back trail we'd just climbed, happened to see a grizzly bear cross behind a group of hikers a hundred yards belo

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

Examples of combination products may in

us. With my narrowed focus, I never saw the bear. Our different views yielded different impressions.

It's like that at work, too. We survey

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

our landscape using departmental binoculars, seeing through lenses of a work group, a site, a division, a subsidiary, or a corporation. We m

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

y see the goat and miss the bear, or vice versa. We make decisions, offer solutions, create ideas and do our work based on an understanding of

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

Combination pro

what we've gleaned from a partial view.

So if you're in software development or human resources, customer service or accounting, sales or cr

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

ative services, manufacturing or marketing, legal or public relations, or any number of departments, professions, industries or businesses, yo

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

u'll tend to see your work-world from that role perspective, making interpretations accordingly.

But if you want to be winning at working, yo

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

need to get beyond a narrow orientation. Doing that requires a different mind-set. One that understands that actions taken by one individual

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

or department impact other individuals or departments; actions taken in one business or industry impact other businesses or industries; and ac

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

ions taken in one country, impact other countries.

Changing your view has nothing to do with larger numbers of people or the size of a depart

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

Following aspects would a

ment or business enterprise. It has nothing to do with where you are in the hierarchy either. People with myopic self-interests can be found a

dd to the challenges in developing combination products:

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

every level of an organization. It's not the position that helps us see differently, it's the "eyes" we develop.

Let's say, you implement a

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

simple change, going from paper to electronic invoices. That decision impacts the printer of the paper invoices, the shipper of the forms, the

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

IT department needed to build new systems, suppliers who must adapt to your way of doing business, employees who must be trained on the electr

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

onic system and ... you get the point. Knowing the impact doesn't mean you won't make the change. But it produces better decision making, enha

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

Professional from academic institutions, pharmaceutical industries, health care indust

ced communications and more positive results.

People who are winning at working think beyond their narrow roles, stepping back to gain a larg

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

er perspective. Mao Tse-tung puts it this way, "We think too small. Like the frog at the bottom of the well. He thinks the sky is only as big

.

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 the top of the well. If he surfaced, he would have an entirely different view."

If you want to be winning at working, you need to surface f

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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Quick and cheap isn't good enough anymore. The entire global market seems to have developed mature and sophisticated tastes, almost overnight. Learn how to take advantage of this trend, before you get hung on a clearance rack.

The importance of immediate, massive, daily action has been written about many times already but it is so important that it is worth writing about again and again. The examples in this article come from the world of business but they could apply to any other walk of life as well.

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