Useful Advices - Business

As a business owner and coach, I come across the issue of building integrity and reputation on a daily basis. It is something I feel strongly about, as who can build a business without integrity and a good reputation. As business o

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

wners, we know that if we want repeat business and referrals (both of which are the foundation of growing our business) then we need to include integrity and reputation in everything we do. Now, this may sound like common sense, but

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

Examples of combination products may in

sometimes business owners forget these 2 important key concepts and make a mistake. That one mistake, let’s call it a step forward, can take their business back 20 steps. From time to time, it may take them so far back that they wo

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

’t be able to recover and their business will fold. So how can we, as business owners ensure that we are continually moving forward in building our integrity and reputation in a positive light? Actually, if we remember a few simple

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

“rules,” then we can continue to build and grow.

Rule 1- Always be timely.

I know, this sounds like common sense, but how many times have you been told something, and it has not been carried through. For example, you ordered a bi

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

Combination pro

thday present and it was promised you would receive it in 2 days (1 day before the birthday), and then not received it for 4 days. Now you don’t have the gift to give because someone was not timely. This is a simple example but I a

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

s a business owner live by this rule. In fact, if I tell someone I will have their project to them by a certain time, I shoot for 24 hours before. Why do I do this? What happens if I plan to send it to them when it is due, but oop

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

, my hard drive crashes? They don’t get the project on time-even though it was finished in advance, and it puts them behind. This does not help my integrity or reputation, and it will probably affect if the client will do business

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

ith me again, or not.

Now, all of us understand that acts of God can interfere with our work or we can make a mistake (after all, we are all human). It’s bound to happen sometime. So what do we do?

Rule 2- Always be honest.

This

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

is a hard rule to live by, because sometimes you are so ashamed of your mistake, you don’t want to admit your foolishness. Let me share a horrifying mistake I made that could have destroyed my business. I was creating an e-book for

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

a client. I found beautiful pictures which I designed the cover with and added throughout the book. I sent the book to her and she was delighted. The day before she was to send it to her webmaster to get it added to her site, I ha

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

Following aspects would a

ppened to realize that the pictures were not royalty free, which means we did not have permission to use them. I could have pretended I didn’t know and let the book go on the market and hoped that no one said anything about the pict

dd to the challenges in developing combination products:

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

res and my client didn’t get in trouble. I didn’t do this. I embarrassingly relayed my mistake to my client as soon as I discovered it (who is by the way, still my client). Because I was honest, she was understanding. Now, do you

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

think I charged her to fix this mistake? See the next rule.

Rule 3- Always fix your mistakes immediately.

Do you charge for your mistakes to be fixed? Absolutely not! It is not your client/customers fault that there was a mistak

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

! How did I fix my big mistake? I went and bought royalty free pictures (with my money). I then redid the whole book (on my own time). I stayed up late that night and got the book fixed and ready to go. My client did not have to

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

pay out a dime for my mistake. I took full blame and then went the extra step to fix the mistake. This client has been with me for a year now, and continues to refer me to everyone she comes across. We have a wonderful relationshi

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

Professional from academic institutions, pharmaceutical industries, health care indust

p, that could have been ruined had I not followed Rule #2 and #3.

Now these are just 3 rules to help you along the way in your business. There are many more things we must do to build our integrity and reputation, but if you follow

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

these 3 rules, you will not take those 20 steps backwards, but go 20 steps forward.

If you would like to see the book I did for my client, Kimberly Chastain, you may visit her at www.kimberlychastain.com and check out her newest boo

.

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

“Help, My Preteen/Teenager is Driving Me Nuts!” If you have preteens/teenagers or children who will eventually hit these stages, this is a fabulous book!

In the meantime, take the extra steps to grow your business by being an hone

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

Companies that provide selfless information through particip

t, timely, and committed business owner!

© 2005 JERPAT

You have permission to reprint this article electronically or in print, as long as the text and byline remain unedited. A courtesy copy of your publication would be appreciated

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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