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Business owners have four options to resolve disputes with partners, vendors or customers. Each option is based on different assumptions, and entails a d

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

ifferent cost. Therefore, it pays to understand them better.

Option #1 – Direct negotiation

Direct negotiation is certainly the cheapest - but not nece

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

Examples of combination products may in

sarily the easiest – way to resolve a conflict. A good place to start, is to get clear about what one wants, why, and how much one cares for the future r

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

elationship with the other person. The next step, is finding out how the situation looks from the other person’s perspective. This task requires effectiv

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

questioning, listening, and observing. The final negotiation step, is crafting an agreement that both parties believe to be better than all other altern

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

Combination pro

tives.

To negotiate successfully one needs some planning, communication and negotiation skills. Without them, it is easy to end up with no deal, or a ba

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

d deal, or even a personal war.

Option #2 - Mediation

The goal of mediation is not to find who is right or wrong, but how the problem at hand can best

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

e resolved. Mediation is a process in which parties who disagree meet with a neutral third-party, who facilitates their negotiations. The mediator doesn'

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

have any decision-making authority. The parties decide how to resolve their problem, in a way that is mutually acceptable.

Since mediation is confident

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

ial, mediation discussions and materials are not admissible in court. In a sense, when people mediate they have everything to gain and nothing to lose. I

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

they are able to reach a mutually acceptable agreement with the mediator’s assistance, that’s great. Otherwise, they can still use the remaining two opt

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

Following aspects would a

ons. And in that case, whatever they have said or heard, offered or counter-offered during mediation, doesn’t matter.

Option #3 – Arbitration

The busin

dd to the challenges in developing combination products:

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

ess dispute is submitted to a neutral arbitrator, who examines the evidence, listens to the parties and renders a binding decision. The conflicting parti

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

s must accept the arbitrator’s decision, no matter whether they like it or not. Arbitration is past-oriented, and requires a certain amount of fact-find

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

ng. Therefore, generally it takes more time (and money) than mediation, but less than litigation.

Option #4 – Litigation

The fourth option is to let th

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

e judge decide which party is right or wrong, based on the facts and the law. In actuality, though, the vast majority of civil cases never get that far (

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

Professional from academic institutions, pharmaceutical industries, health care indust

ome statistics say up to 90%). They settle out of court. A few days – or even hours – before the trial, the two conflicting parties, assisted by their re

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

pective attorneys, prefer to negotiate their own agreement, rather than running the risk of losing in court.

For business owners – as well as for anyone

.

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

else - litigation has two major drawbacks. First, it inevitably has a detrimental effect on the future relationship between the parties. Second, it can

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

Companies that provide selfless information through particip

e quite expensive in terms of time, money and stress. Nonetheless, when a business dispute cannot be resolved any other way, litigation is a valid option

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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The advisor is productive in a variety of ways. In this example the role of the consultant resembles a lot like that of a

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