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It goes by many names -- conflict prevention, conflict resolution, conflict management, the names go on. These terms were all created to combat a simila

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

r problem. For the most part, people who deal with these issues all agree with the same principle:

Conflict resolution at an early stage is less costly

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

Examples of combination products may in

and more manageable than trying to deal with its repercussions later.

First, let’s discuss the types of conflicts we have observed in our years of expe

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

ience working with organizations.

We have observed 3 major types of workplace conflict:

Task Conflict
Task conflict arises among me

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

mbers of work teams and specifically affects the goals and tasks they are striving to achieve. Differences in vision, intentions and quality expectation

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

Combination pro

often lead to task conflict. Employee relationships may initially appear to survive task conflict but an important project may not. It is essential to

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

hannel task conflict so that these differences become collaborative and improve the way the team thinks about accomplishing current and future tasks.

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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

b>Process Conflict
This form of conflict centers around the steps or methods used by a team to reach a goal. One person might like to plan 100

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

teps ahead while another might like to dive in head first. These differences in process can lead to communication breakdown and ultimately conflict. But

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

like task conflict, process conflict can be useful, if managed correctly. Healthy differences in process often will lead to an IMPROVED way of achievin

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

goals.

Relationship Conflict
Often misunderstood, relationship conflict undermines and tears at the fabric of a team’s ability to achieve

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

Following aspects would a

goals effectively, efficiently and profitably. Relationship conflict penetrates all aspects of an organization. When people in a workplace fail to commu

dd to the challenges in developing combination products:

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

icate effectively, entire work teams or even an entire organization will suffer. This type of conflict will quickly consume all the attention and energy

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

of an organization, leaving little time to accomplish profitable tasks.

What can you do to bring conflict to a reasonable resolution? And how can it be

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

beneficial to everyone involved? The goal is to increase the benefits achieved from encouraging task and process conflict while at the same time reduci

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

g, managing and understanding the negative effects of relationship conflict.

The benefits of effective conflict resolution are great:

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

Professional from academic institutions, pharmaceutical industries, health care indust

Improve organizational decision making

Inspire employees to articulate and clarify their ideas and positions

Stimulate innovation, c

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

reativity and forward thinking

Improve individual and group performance

If no resolution is sought for conflict the affects ar

.

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

often devastating:

Job stress and burnout rises which typically increases absenteeism and turnover
Distrust and suspicion deve

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

Companies that provide selfless information through particip

ops often creating an “us versus them” culture

Job satisfaction and performance falters

Employee loyalty and commitment declines

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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