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You’re an every man (or woman) you can handle it all because you have to, you call yourself a small business owner. Maybe your title is CEO, President, Founder, Executive Director, but no

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

matter what it is you want one simple truth, you want your company to be profitable. As we all know there are only twenty-four hours in the day. So unless you can rely on two hours a sleep

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

Examples of combination products may in

a night, you have a lot to do in a day. Every small business owner has to master the concept of time management.

First let’s throw out some myths about time management. First it is a nec

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

essary evil, structuring your life and planning out your activities aren’t sexy but they are necessary. Secondly, time management is not cramming all you can into a few hours and working y

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

ourself to the bone. As one man I know puts it all you’re left with are boney fingers. Thirdly and lastly time management is not a fad or a trend, it’s an established practice that can lea

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

Combination pro

d your company to profitability.

So why aren’t you as profitable as the next guy, you certainly work harder then he does, you sleep less and you do more. There in lies the problem, the co

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

mpetitor next door practices good time management. In this “do-it-yourself” world business owners lose sight of what their role is, and they begin wasting their time and energy working on

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

problems and projects that are beyond their role. Just because you wore many hats at the beginning of the company doesn’t mean you can’t retire them as time goes on. Here are a few tips to

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

getting time to work for you:

1.) Outsourcing is not a four-letter word. Hiring out projects, tasks, or entire processes are not the downfall of your company. If you take the time to fin

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

d a reputable company to oversee the task you won’t lose quality, or money because you’ll gain all that time and energy to put into what is necessary for you to succeed.

2.) Make prioriti

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

es: This is the key to time management. List out your daily tasks in order of priority. What should the criteria be for priority? What you excel in, what will help your company grow, what

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

Following aspects would a

is necessary for your business to continue, and what is most profitable for your company. Whatever doesn’t score why against these four areas needs to be either moved to the bottom of the

dd to the challenges in developing combination products:

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

list, or given to another to accomplish. This is where honesty comes in, and you have to step back and look at the macro of the company. Do I need to supervise the sales staff personally,

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

or should I be out networking with potential customers and clients?

3.) Know your strengths: You will spend more time focusing in on tasks outside of your strengths then those that come n

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

atural and easy to you. If you’re an owner or a top level executive remember your primary task is to be the visionary and leader of your company. You have hired employees for a reason, so

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

they could do what you had to do, so you could be freed up to make your company bigger and better in the end to pad your bottom line. Hiring people better at you in an area isn’t a sign of

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

Professional from academic institutions, pharmaceutical industries, health care indust

ineffective leadership; it’s the sign of wisdom.

4.) Downtime is good for you: Too easily we get caught up in the flow of doing business and forget about what’s making the business happe

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

n, ourselves. You need time to rejuvenate. Even if you think you can’t or it’s irresponsible take this into consideration. In farming a smart farmer knows that the ground needs to be fallo

.

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

w every so often. Does he lose out on revenues for that season, yes he does. What sets him apart though from how we think is his long-term vision. He knows it’s not a sprint it’s a maratho

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

Companies that provide selfless information through particip

n. You set a pace, you rest, meditate, go away for awhile. When you return your mind and body are refreshed, you come back with fresh and new ideas. Remember you have to be a priority too.

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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