Advice You - Business

Is the pressure of being in business getting to you? Do you feel like you have the weight of the world on your shoulders? Do you lie awake nights with a thousand points of worry flashing through your poor, tired brain? Welcom

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

e, my friend, to the wonderful world of entrepreneurship. Come on now, you really didn’t think it was going to be that easy, did you?

Forget all those reasons you’ve heard as to why businesses fail. It’s the pressure of entre

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

Examples of combination products may in

preneurship that sends many folks running back to the supposed security of a real job. I’ve seen perfectly good businesses flushed down the tubes simply because the owner couldn’t handle the day-to-day pressure of keeping the d

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

oors open.

So I ask you again: is the pressure of being in business getting to you? Is worrying about your business taking up so much of your time that there’s no time left to actually work on the business? If so, take a dee

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

breath and count to ten because there is hope. Here’s how I went from being a chronic worrier to someone who doesn’t sweat the small stuff. And that’s what most topics of worry are: small stuff.

The first step is to make a l

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

Combination pro

ist of everything that’s worrying you. We’re discussing business here but if you’re worrying about personal things write those down, too. Do you have an employee who is giving you trouble? Are you afraid you can’t meet payrol

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

l next month? Are you worried about losing a big customer or not winning a big contract? Is your spouse unhappy with the number of hours you’re away from home? Write it all down.

Now divide what you’ve identified as worry to

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

pics into three categories: Past Worries (things you’re worrying about that have already happened), Present Worries (things that are happening now), and Future Worries (things that may happen in the future).

Now put a big fat X

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

through all of the Past Worries and Future Worries you’ve listed. Forget the past. There’s nothing you can do about it now. Worrying about things that happened in the past is like a bald man pining over lost hair. If you owe

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

someone an apology, apologize. If you owe someone a debt, make arrangements to pay it. If someone did you wrong either forgive or forget them. The past is history. Forget about it and move on.

The same is true for Future Wor

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

ries. Why worry about something that hasn’t even happened yet or may never happen, at all? If there’s something looming on the horizon that is a valid point of worry you should have a plan to deal with it when it comes, not su

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

Following aspects would a

ffer in anticipation. Worrying about tomorrow today will drive you nuts. Forget the past and prepare for the future, but don’t waste time worrying about them.

Next divide the Present Worries into two subcategories: things you

dd to the challenges in developing combination products:

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

can do something about and things you can’t do anything about. Now put another big fat X through those things that you can’t do anything about. Worrying about things you can’t control is wasted worrying. You’re worried that a

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

proposal you submitted won’t get accepted. You’re worried that a vendor might go out of business. You’re worried that a giant meteor is going to strike earth and that your building will be dead center in the strike zone.

You

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

can’t do anything about these things except prepare to handle them if they do occur. In business you have enough legitimate things to worry about. Stop driving yourself crazy worrying about things you can’t control.

So now yo

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

u have your list of present worry points that are within your control. Now prioritize them from most urgent to simply bothersome and create a plan to deal with each point. That’s right, instead of worrying about these things t

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

Professional from academic institutions, pharmaceutical industries, health care indust

ke a proactive stance and create a plan to do something about them. Face the monster head on. You’ll be surprised how much better you’ll sleep at night.

If you’re afraid you can’t meet payroll next month start looking for sol

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

utions today. Can you get a line of credit to see you through the lean times? Can you get extended terms with vendors that will free up cash? Can you find an investor who will put in the money and let you pay him back over tim

.

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

e? Every problem has a solution. It may not be the solution you desire, but it will be a resolution that takes one thing off your plate.

Work through each point of worry until you have a plan to deal with each one. Then start

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

Companies that provide selfless information through particip

dealing with them. And if you can’t do anything about an item mark it out as something you can’t control. This exercise will take some effort and discipline on your part, but trust me; you’ll immediately start sleeping better

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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