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How many minutes are in a year? My niece, Sarah, and her third grade classmates sang a song from the Broadway show, “Rent.” The song breaks down how many minutes are in a year and asks us how ma

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

ny ways we count a year. It’s catchy. I’ve been humming the song all day, but I don’t remember how many minutes it turned out to be.

Measuring is important. Figuring out what to measure is even

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

Examples of combination products may in

more important. I just finished speaking about precise communication. I can’t imagine a more precise way to communicate than through exact quantities. How many times must something happen to kn

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

ow that it is successful? How much money must you earn to cover the cost of an endeavor? How much time is needed to determine when something is working or not working?

There is no key to answer

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

ing those questions. Your comfort level will determine how much of a risk you want to take. It will also determine when you do your measurements. I developed a terrible habit a few years ago. I

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

Combination pro

learned to do all of my banking and trading on the internet and I became obsessed with the movement of money. I put a lot of energy into trying to do the right things but all it did was cause an

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

xiety. Some information is not meant for daily consumption.

Working with government agencies taught me to plan ahead for measurements. Daily feedback was fed into monthly reports which were the

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

n compiled into annual reports. Summaries were distributed and a major piece of the full story of our efforts was available for all to see. It wasn’t the whole story, but numbers can tell you a

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

lot.

After an organization has finished their mission statement, the next question is “How will you know when you have achieved your goals?” I always suggest having some quantity in mind. How m

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

any calls did you answer? How many people did you serve? How much money did you make? The biggest mistake that an organization can make is having ideals with no ideas.

Statements like “We want

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

to help educate our community” and “We want to help single mothers” are common. How will you help? What services will you offer? How often? To how many? Effectively serving people means that you

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

Following aspects would a

have to be realistic about your capacity to serve. No one has unlimited physical resources, in fact, one of the best ways to measure your capacity is to look at your resources. Personally, I ne

dd to the challenges in developing combination products:

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

ver count anything that I don’t have yet. You can always add things and expand, but its very difficult to recover when you have exhausted all of your resources.

The biggest complaint that I hea

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

r from churches that are growing is that the employees and volunteers are overworked. The church’s effort grew faster than expected or involved many tasks that no one anticipated. In my work wit

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

h those churches, I find that the big picture of “helping humanity” blinds the decision makers to nurturing talent and reserving energy.

Beginning with the end in mind is crucial, no one should

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

lose sight of the goals. Bringing someone like me in to break down tasks and insert evaluation tools is also important, but its not nearly as exciting. Yes, I can be a buzz killer, but someone

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

Professional from academic institutions, pharmaceutical industries, health care indust

has to keep in mind that you are in it for the long haul. Doing everything right now will not work when you don’t have everybody and everything you need.

Organizations need guidance to grow in

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

a positive direction. We have all seen the rapid decline of very good ideas. There are ways to determine if you are on the right track before your growth is out of control. How you measure this

.

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

year will be different than how you measure next year. New people and new resources will likely send you in directions that you cant even imagine right now. Patience and even a tiny commitment t

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

Companies that provide selfless information through particip

o precision can make a world of difference from the beginning.

I pulled out my calculator – 525, 600 minutes. That’s how many minutes are in a year. Now I know that I am humming the right tune.

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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Establishing Basic Needs At Work / Work Environment Factors / Salary and Benefits - These include basic income, fringe benefits, bonuses...

Not likely to happen unless business, non-profit and association managers like you do something positive about those important external audiences of yours that most affect your operation.

When you're setting goals for your small business ideas, you really create your future in advance. You write down your goals,and mentally prepare yourself to do what ever it takes to realize them.

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