Advice You - Business

For many mid-career professionals, a Second (or third or fourth) Career turns out to be a business. If your industry disappears, you’re leaving a high

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

-profile job, or you’ve risen through the ranks, self-employment can be your most realistic option.

While you’re working for an organization, it’s nev

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

Examples of combination products may in

er too early to start asking, "What will I if my job goes away – or I decide to run away from my career?" Once you begin moving in this direction – ev

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

n in a small way – you’ll most likely develop momentum and become really creative.

But – what can you do? That’s the Number 1 Challenge, my clients sa

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.

1. Find a need. As you move through your day, listen for comments like, "I wish I had…." Or, "I wish I could find…"

Many business writers believe

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

Combination pro

your first step should be finding a need -- not listing your own skills. Often you recognize your own needs first. Many businesses have begun when so

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

meone said, "I wish I could find someone to…" And a service was created soon afterward.

2. Look for opportunities when a marketplace changes.

In Si

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

ver City, New Mexico, where I live now, some old-timers can’t bring themselves to pay three dollars for coffee "with stuff in it." Ten years ago, they

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

tell me, they washed their own dogs and mowed their own lawns. Today, people from New York, California and Chicago want double-shot lattes, dog groome

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

s and lawn care services – and they expect to pay.

Nationally, career marketplace has changed, as displaced executives recognize that career change sk

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

ills differ from career growth skills. I find senior managers increasingly seek career consulting – and they’re very direct about what they want.

And

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

Following aspects would a

some companies have moved their creative work in-house, adding jobs for writers and designers. But others have cut back on permanent staff and now us

dd to the challenges in developing combination products:

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

more freelancers.

3. Focus on delivery and demand.

When clients consider starting a business – even going into freelancing – they begin with, "Where

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

do I get startup capital?" and "What kind of licenses and insurance will I need?" These questions are critical – but the answers will be straightforwa

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

d.

Your real challenge is to identify a market that will pay for what you have to offer. Once you’ve identified the market, you have to decide how you

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

’ll build relationships and deliver services. You may have a brilliant idea that uses your unique skills – but nobody wants to pay.

Or you may find a

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

Professional from academic institutions, pharmaceutical industries, health care indust

reative way to deliver a mundane service. In his latest book, Blink, Malcolm Gladwell describes an accountant who found financial success selling donut

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

s to offices, collecting money through an honor system.

Bottom Line: When considering a new business venture, your first question should be, "Is there

.

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

a market – that is, a large number of people who are able and willing to buy? Do they need something that is not yet available?"

Once you get excited

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

Companies that provide selfless information through particip

about reaching a market, the insurance, taxes and licensing chores begin to seem manageable – even effortless. You’ll find ways to make it all happen

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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A corporations or an LLC can choose to be treated as an S corporation for Federal tax purposes. Electing to be treated as an S corporation allows income to flow through the corporation without being taxed until it is claimed as income by the shareholders. If you are considering whether to elect to be treated as an S corporation, there are certain IRS limitations that you should discuss with your accountant.

Seven common cover letter writing mistakes to avoid when you submit your resume. These all too common yet easily avoidable blunders can sink your chances of landing an interview, even before your resume is ever looked at. Here's what not to do.

Everyone is today concerned about globalization. Love it or hate it, globalization is here to stay! Even political parties that are left behind are willy, nilly forced to admit that it is a phenomenon that is well and truly out of the bottle !

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