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In times of conflict you can take one of two positions. First the position is that of having your heels dug in and believing you are RIGHT. The second position is where you care enough to understand wh

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

at is motivating the other person’s behavior. My recommendation, as you might have guessed, is the second.

Just to make a point, I’d like you to think back to the last argument you had with your spous

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

Examples of combination products may in

e, parent, child, a friend or in a business situation. Do you see yourself in the argument? Now, I ask you which position did you take?“ The first,” you say? I thought so. If you had taken the position

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

of trying to understand the other’s position, there most likely would not have been an argument. We humans are not perfect. As such, we sometimes we fall into our stuff. At these times we are not the b

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

est people we could be. But, it is the person who recognizes that they are in their stuff and makes a new behavior decision that makes a good partner.

You might be thinking, “Thanks for the info, Ed,

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

Combination pro

but why do I have to always be the person who makes the change, the person who makes it works? Why can’t it be the other guy once in a while?” My answer to you is simply that you are the one who figure

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

it out first. Get out of your stuff and, as Nike says, JUST DO IT®.Listed below are some additional tactics to help you resolve conflict.

1. Evaluate your, and your partner’s, conflict management sty

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

les. Understanding each other is a great start.

2. Identify and plan strategies to deal with non-productive behaviors before they crop up.

3. Give positive feedback as often as possible so the relati

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

onship does not take on a negative tone through only fire fighting interactions.

4. Confront problem situations at once rather than waiting for the situation to escalate.

5, Invite comments from all

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

takeholders early in every project, especially your alliance partners.

6. Consider using humor and maybe even humility in certain situations.

7. Encourage dissent at a time and place that serves all

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

involved.

8. Review the value of the alliance relationship. Determine how much your circles of interest overlap. Ask if winning this battle will get you closer to an OSR, or further away from it.

9.

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

Following aspects would a

When you hear something you don’t like, repeat it back in an informational way. See if the message you received was the same as it was intended. Misunderstanding is the root of much conflict.

10. Know

dd to the challenges in developing combination products:

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

your buttons and don’t allow them to be pushed. You have control in this area.

11. Completely listen to what the other guy has to say before you open your mouth. Remember the adage, Listen twice befor

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

e speaking once. That’s why God gave you two ears and only one mouth.

12. Remember the principle of saving face. In some societies, it is a matter of life or death. Fortunately, or unfortunately, depe

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

nding on how you look at it, this is not usually the situation in North America.

13. Keep your ego in check. Be clear on the difference between high self-esteem and high ego. One serves and one does n

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. Need I say more?

14. Appoint a devil’s advocate and allow them to be involved in projects from the start, all the way through completion. Their job is to be a pain in the neck. It’s not that they a

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

Professional from academic institutions, pharmaceutical industries, health care indust

re just picking on a certain person or position. This keeps people from taking a dissenting opinion personally.

15. Keep the consequences of your decisions in mind.

16. Value the opinion of others. F

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

ocus on the clarity of the water, not the spring from which it flows.

I understand that building Outrageously Successful Relationships can be difficult at times. My best advise for you: Know the value

.

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

of your relationships. Know where you want the relationships to go and stay on course. Accept that quality Partnering just takes time and effort. Accept that there isn’t any magic--just dedicated imple

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

Companies that provide selfless information through particip

mentation.

To access helpful additional information from Ed Rigsbee at no charge, please visit www.rigsbee.com/downloadaccess.htm/

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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