Main Subject - Business

Overwhelm, distractions and the inability to say NO keep many people from achieving their potential. Too many opportunities paralyzes your ability to make the right decisions; Email prevents focus.

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

Guilt and 'shoulds' keep us busy with activities that fill our days, but do not get us closer to success!

We are not machines, so these things will happen. The key is to prioritize what you will

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

Examples of combination products may in

allow to use your time. What is most important to you?

We read stories in Oprah's magazine and see on TV all these women who start multi-million dollar businesses while raising their 4 kids and 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.

ir sister's 3 kids and all while volunteering at the school. Don't be fooled! You do not have the same life nor the same opportunities.

Here is what we don't see - her mom helps take care of the k

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

ids and cooks and cleans, her husband fronted the money, she didn't get more than 3 hours of sleep a night for 6 years, or her kids are completely out of control. Her priorities are not the same as

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

Combination pro

ours and mine. Avoid comparing yourself to others - it is a dangerous trap, and you never know all the facts!

What are your priorities?

For me, raising my two girls as a single/only parent to be r

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

esponsible, caring, contributing adults is my top priority. A distant second, is growing my business to a place where I work less and make more, and have lots of money for my retirement. Without ra

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

ising my kids the way I want, it wouldn't matter how much money I had, I would be miserable. Besides, they will grow up and I will have a shift in my priorities then.

Setting your priorities is a v

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

ery personal process. The big things are fairly easy; it's the every day stuff that becomes challenging. For example, I see many people who get asked to volunteer and say yes again and again, even

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

though they know it delays the achievement of their goals. The little voice in their heads says, "Don't do it this time!", but they find themselves saying yes.

One of the hidden reasons behind this

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

sometimes is that she wants to have a good excuse for not achieving her goals. "I've been so busy at the school/the networking group/the chamber of commerce, that I just couldn't build my business t

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

Following aspects would a

he way I wanted!"

Setting priorities is the first step. Put them on paper, then flesh out an action plan to accomplish your goals. For example, if it is your goal to exceed $50,000 in revenues thi

dd to the challenges in developing combination products:

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

s year, you will need to detail how you plan to do this, and get to work. The money will not fall in your lap, and you're not getting any younger! Once you have put your plan on paper, put it where

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

you can see it and review it regularly.

When a new opportunity presents itself (that will absorb your time), delay your decision for an hour or a day - whatever time you have. Really think strateg

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

ically - will this get me closer to my success as I have defined it? What will the benefit be and what will it cost in time and money if I say yes?

If you aren't making money right now, that needs

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

o be your priority over long-term gains. You do need to keep longer term goals in mind, but don't find yourself spending all your resources on future gains - future gains won't pay the electric bill

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

Professional from academic institutions, pharmaceutical industries, health care indust

! Analyze opportunities as they present themselves:

1. How will this benefit me and my family in the short term?

2. Long term?

3. What will this cost me in the short and long terms?

4. What is t

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

hat little voice in my head telling me?

Sometimes, you have to do the 'right thing'. If you are in debt and not taking care of yourself and your family properly, buck up and get a job. Pay off the

.

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

debt and save your money so you can try starting your business later without being desperate.

Trust your inner wisdom, but at the same time, ask your 'trusted advisors'. Keep in mind that some of

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

Companies that provide selfless information through particip

your advisors have their own agendas, and have a vested interest in the result.

Bottom Line: Having specific, written priorities keeps you focused on your plan, and helps you say NO when you need to

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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