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I worked as a Yellow Page consultant for nearly 25 years, and before that ran an advertising agency. Over those three decades, I met with many husband and wife teams. The small business was, and still is, the backbone of the directory b

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

usiness. I got to observe the good, the bad, and the ugly. Being in a relationship, whether as a marriage or a business, a partnership can bring out the best and the worst in people. I don’t think that a business arrangement can save or

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

Examples of combination products may in

improve a bad marriage. But it can certainly put a strain on one.

During my tenure, most of the time the man was the boss. The wife was the accountant, junior partner, advisor, or vice-president. But, although I met with the husband,

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

the wife always seemed to have the last word. He would begin to make an advertising decision and then she would overrule it. This wasn’t always the case, but it turned out that way more often than not. I witnessed physical fights, intim

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

dation, name-calling, verbal or mental abuse, power plays, and general discontent. I frequently got the front row seat to a “brawl in the hall” or the “doom in the room” and therefore it wasn’t pretty.

That’s not to say that all couple

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

Combination pro

s fought. Some were relatively compatible and still used subtle ways to get their points across. I noticed that the older ones tended to battle less. Perhaps it was because they knew each other longer and better. But even with them, th

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

ere was still this struggle to maintain control. I watched several divorces born from this atmosphere of conflict and progress toward an inevitable outcome. Later, they would split up and divide the business. One gentleman kept his shar

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

and had to offer his wife a massive buyout. Another situation had the man leaving with all the firm’s accounts, letting his wife keep just the business name. Another split the business and each had to cope with half the accounts and ha

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

lf the bills. Each got a new business name as they dissolved the original company.

I used to advise my accounts that partnerships were destined to fail, whether they were husband and wife or friend and associate. My belief was based on

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

observations and some personal experience. I saw businesses where one partner did well more than half the work, yet equally divided the profits. I rarely saw a partnership where each owner did their fair share. There was almost inevita

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

ly hard feelings because of this inequality of labor. Someone began to complain about the other shirking responsibility, coming in late, not following up at all, or placing personal commitments ahead of the business. In a marriage, it’s

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

Following aspects would a

much tougher to cope with.

The husband or wife has to go home with that person. So, if they criticize their work habits on the job, that negative action follows them back into their house, and eventually, into the bedroom. So you can

dd to the challenges in developing combination products:

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

imagine the fireworks there. It’s a tricky balancing act. Who is the head person in the business and who follows orders? Who has the final say and who has the right to question the verdicts that will guide the company? When do you reali

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

ze that it’s not working out and which one will decide that it’s for the best interest of the firm for one to step down? It’s rather like the results of a divorce . Instead of children and property to split, there are assets, perhaps st

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

cks, inventory, and the corporation itself at risk. Who gains and who loses?

So, am I saying that a husband and wife team can’t run a business? Well, I have some qualifications to make such a judgment. My wife and I run a web-site busi

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

ness and have for over two years. She is the founder and CEO and I man the marketing director. She has the final say unless she is wrong. How do I know when she is wrong? Well, she hasn’t made a bad decision yet so she is never wrong an

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

Professional from academic institutions, pharmaceutical industries, health care indust

d I am smart enough to know that. She and I would never do anything to jeopardize the business. She created the original business plan we follow and I use my marketing background to design the web pages, implement the media, and do onli

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

e promotions. Because the site provides health information and she is an RN with a Masters degree, she has the expertise in that field. I recognize her strong points and she does mine. We try not to argue, but rather, we discuss and yes

.

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

, there is a difference. We must agree on every aspect and that’s not always easy, but it is necessary. We realize that our business has the potential to be very profitable and have had the patience to take our time to do things right.

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

Companies that provide selfless information through particip

We’ve already made many mistakes, but we’re learning. So, if you have a business partner that’s also your spouse, then take a tip from me. Love your business, but love each other first. That’s the real bottom line for both relationships

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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