Digg It - Business

A series of articles exploring the seven critical areas that can indicate a partnership is in trouble.

Conflict Becoming the N

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

orm – Part 1

Dr. Dean Ornish, noted cardiologist, says the greatest cause of disease is the stress that comes from conflict. C

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

Examples of combination products may in

onflict is bad for your health, your personal life and definitely bad for your business.

When disagreements have reached the s

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

age of conflict, emotions have overcome the issue. At this point no one is thinking clearly or speaking truthfully about the or

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

iginal problem. It becomes all about winning. How useful is that?

You can win the battle and lose a whole lot more. Conflict b

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

Combination pro

comes a nail in the coffin of your marriage, or in your business partnership. Though you may win in court, you often lose in li

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

fe. This is a major component of the scenario that accounts for the high rate of divorce in marriage and even higher rate of di

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

solution of business partnerships.

Even if conflict doesn't reach this dramatic result, living with conflict is an unhappy, un

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

healthy situation. Not only does it cause you misery, but it is contagious. Employees, clients and family members feel the tens

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

on. They may be taking sides even without realizing the unspoken details of the issue. You and your partner avoid meeting, may

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

deteriorate into a yelling match when you do meet, or live in silence avoiding addressing other important issues as well. This

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

Following aspects would a

is not the scenario that inspires you to get out of bed in the morning.

The best solution is prevention. Resolve things at the

dd to the challenges in developing combination products:

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

disagreement level before they become conflicts. If the two of you can't get to resolution where you both feel like winners, ca

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

ll in a coach. Actually, my clients find that a monthly meeting is a great preventative and also teaches them the tools needed

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

o handle most situations on their own.

Now is the time to remember that there were good reasons you chose your partner. If you

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

were honest and sincere in your initial evaluation and desire to succeed, it's helpful to keep that in mind and if things have

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

Professional from academic institutions, pharmaceutical industries, health care indust

gotten out of hand, hire an outside expert who can help you get back to that place of harmony and mutual respect.

The first st

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

ep in resolving conflict is to agree to do so and to agree on the ultimate goal which is greater than each of you as individual

.

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

. When you are seriously committed to the same outcome things can usually work out. When you've reached this point, a third par

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

Companies that provide selfless information through particip

ty, non-biased expert listener and coach is not just desirable, but essential to direct the discussion and keep emotions at bay

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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