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All in all, I'm pretty happy with how 2005 turned out. My business is taking off. I've built a solid foundation to support even more growth (which I forecast for 2006) and I

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

've even managed to take some time off.

I'd like other entrepreneurs and business owners to feel as good about their business as I do about mine, so I thought I'd take a mome

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

Examples of combination products may in

nt to share 5 things I attribute to my successful 2005.

1. Attended seminars. This one is HUGE. Nothing beats getting out of your office and away from your computer and act

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

ally meeting people face to face. I've come away from these events with clients, joint venture partners, and more. (And that doesn't even include the great information I abs

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

orbed and was able to put to use in both my business and my clients' businesses.) If you only put one of my 5 tips to use, this would be the one to do -- that's how valuable

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

Combination pro

I've discovered attending seminars to be.

2. Hired a coach. Again, this was another tough decision to make, but I'm really glad I did. It's difficult to see your business o

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

bjectively, so having a neutral observer on your team is extremely valuable. Coaches help you get out of your own way (and believe me, that's a biggie for us entrepreneurs.)

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

They can help you with both your inner game (your habits and mindset) and your outer game (your skills and business structure).

3. Started systemizing my business. Unless y

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

ou want to be chained to your business night and day, you have got to start systemizing your business. Yes, all businesses should have systems in place, even if you don't ha

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

e anyone else working for you and you primarily sell services. The best part is when you do have systems in place, your business suddenly starts running a lot more efficient

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

ly and effectively (and you can start sleeping better at night and relaxing on vacation).

4. Outsourced. For all you control freaks out there, this one is for you. If you don

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

Following aspects would a

't start hiring some help, I guarantee you'll never be able to grow your business because you'll be constantly doing tasks you have no business doing. Do yourself a favor

dd to the challenges in developing combination products:

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

nd get some help...NOW. I've just hired a project manager/director of client services, plus I have 2 backup writers and 2 virtual assistants. Building a team has been a big

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

stress reliever for me.

5. Focused on my inner game. Shifting my mindset away from "freelancer" to "business owner" was another big piece of the puzzle. As soon as I made tha

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

shift, all the other four techniques fell into place because it suddenly made them easier to do.

It's tough to change your inner game on your own -- hiring a coach is prob

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

ably the fastest way to do this. But there are some good resources out there if you want to begin dabbling in it first. Do a search and see what comes up, I started my journ

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

Professional from academic institutions, pharmaceutical industries, health care indust

y with free ezines and articles.

Creativity Exercise -- Make 2006 the best year ever

Go back and reread my list. Now get out a piece of paper and start brainstorming ways

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

you can integrate my tips into your business. Which one do you think will bring the quickest results? Which one will be more difficult for you to start doing? Which is the o

.

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 you SHOULD be doing?

Have fun with this exercise, really play around and see what comes up. Don't censor yourself, just write down the answers that bubble up even if it doe

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

Companies that provide selfless information through particip

sn't seem right. You might discover something important about yourself and your business that might be the key to launching you forward faster than you ever dreamed possible

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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