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During my 25 years as an advertising consultant, I had many husband and wife business teams as clients. In my mind, it was the good, the bad, and the ugly. I wasn’t necessarily referring to their physic

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

al attributes. But it usually did not lead to a positive outcome. Not that all of these type of partnerships are doomed, but the majority were less than successful. The reasons are varied and easy to en

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

Examples of combination products may in

merate here:

You have a vested interest in the spouse, first, before work.
It’s hard to separate business and leisure.
How can you tell your spouse they made a bad b

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

siness decision?

If you have an argument at work, do you bring it home?

You have no chance to escape talking about the job or company.

Even if you say it’s work-rela

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

ted, it’s always personal.

If you divorce, how do you divide the company?

Can you fire your spouse if they are bad for business?

What if one ends up doing all the wor

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

Combination pro

Your personal issues, like adultery, carry over into the business.

Who will make most of the big decisions and why?

Who gets paid the most and why?

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

w, in a good relationship, both people should share all the burdens and rewards. They need not bring work home, but that’s somewhat impossible. If the two of you are the top executives, then discussing

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

the company at home will be a common occurrence. Even going out to a restaurant may eventually lead the dinner conversation back to work-related discussions. How do I know so much? My wife is the CEO of

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

our family business. I am the lowly Marketing Director, albeit, by choice I might add.

We formed the business a few years ago when I retired from my previous job. She then retired the following year an

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

we began designing a website to provide health information. She had been an RN and I was an advertising consultant. We had been married just a year when all this happened, although we had both already

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

aised our separate families. So children was not an issue. But I was a bit apprehensive about a home-based business where we would be living and breathing this new venture together, without a break from

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

Following aspects would a

one another.

It had been my prior experience with other business couples that gave me that negative implication. I had seen the bitter feuds and arguments that resulted from power struggles and bicker

dd to the challenges in developing combination products:

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

ng, common in marriages. But this was over advertising, budgets, and the future of a business. It often reached a whole new level of ugliness. Most of the time, the husband was the president and the wif

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

the VP or accountant. But the lines blurred when money was the topic and the wife would take charge of the finances, as if I were stealing from their retirement fund. It’s very awkward standing there

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

while a couple fight in a personal manner. It’s more like witnessing a social war than a company dispute. The words turn to an attack on character and qualifications rather than business savvy. They mig

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

t even bring up non-business issues that I prefer not to know. But that’s what couples do, when their emotions take over.

That’s also the main difference between a couple running a business and regular

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

Professional from academic institutions, pharmaceutical industries, health care indust

corporate partnerships. The co-owners will be adversarial but objective. The couples are too close and pick on the weaknesses they already know how to exploit. So, do I regret being married to my busine

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

ss partner? No, I am luck because we rarely fight and seem to agree on most things. But I feel we are the exception and therefore I do have a word of warning. If you already have a so-so marital relatio

.

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

ship, don’t expect running a business together to make it any better. If anything, the additional strain and stress will push it to the limit. Try to separate the two when back at home. Talk as little a

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

Companies that provide selfless information through particip

possible about the company when on vacation or just relaxing. The business will still be there with all it’s troubles and benefits alike. And perhaps you’ll still have a chance to be successful at both

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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