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I never imagined suboptimal healthcare collaboration would happen to me. Twenty-four hours before a g

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

roup presentation, we were arguing over the format of our presentation rather than putting the final t

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

Examples of combination products may in

ouches on it. We had spent so much time gathering data that we never talked about our expectations fo

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

r how we would work together.

In medicine, good judgment comes from bad experiences. From then on, I

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

resolved to discuss process issues up front and teach healthcare colleagues to do the same. We use ch

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

Combination pro

ecklists all the time when doing procedures. Why not use them at the start of meetings or other group

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

projects?

Here is the checklist I use with healthcare professionals at the start of meetings and tas

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

k forces. I find it a helpful starting point for discussion about necessary issues, such as expectati

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

ns for tactful discussions and maintaining confidentiality of proprietary data:

As team members, we r

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

esolve to:

· Show up on time for meetings and notify leader in advance when unable to be present

· A

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

ctively listen and participate

· Openly exchange ideas and viewpoints

· Build on one another’s ideas

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

Following aspects would a

· Refrain from personal criticism

· Remain focused on the tasks for which we are responsible

· Mon

dd to the challenges in developing combination products:

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

tor our progress at regular intervals

· Share responsibility for deadlines and ownership of results

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

· Develop win-win solutions

· Respect members’ confidentiality

Checklist reprinted with permission f

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

rom “Surgeon frustration: Contemporary problems, practical solutions.” Contemporary Surgery. 2003;59(

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

2):76-85, Dowden Health Media.

About the author

Dr. Kenneth H. Cohn is a practicing surgeon/MBA and

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

Professional from academic institutions, pharmaceutical industries, health care indust

he author of Better Communication for Better Care and Collaborate for Success!: Breakthrough Strategie

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

s for Engaging Physicians, Nurses, and Hospital Executives. His website, .

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

//www.healthcarecollaboration.com">www.healthcarecollaboration.com contains a wealth of informativ

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

Companies that provide selfless information through particip

e resources on improving physician-hospital relations and collaboration among healthcare professionals

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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