Main Subject - Business

A frustrated business owner was grousing over lunch because a long time vendor he has depended on

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

for a commodity service has recently had some quality issues.

“Look, he said, “I live a complex l

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

Examples of combination products may in

fe. My business is complex, my personal life is complex, I often feel pulled in many directions a

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

t once. All I ask of my long-term vendors is that they give me good service, fair pricing, and no

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

mistakes. That way I don’t have to spend the time and energy to replace them and I can work on ot

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

Combination pro

her, more important things.”

“Recently, one of my vendors, who has preformed the same function ev

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

ry two weeks without fail for twenty-six years, has not shown up on the normal day and has caused

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

me wasted extra effort and frustration. The first time it happened we called to alert them and t

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

ey took care of it. The same thing happened the next two scheduled appointments though the last t

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

ime we had to call them three times before they showed up and the person I talked to told me in a

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

ored, matter-of-fact-voice, she is forwarding my complaint to her supervisor and, ‘I can’t do anyt

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

Following aspects would a

ing more than that.’ I guess they don’t care whether I buy from them or not and I’m sure there ar

dd to the challenges in developing combination products:

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

e other companies that will give me what I need without the problems we are experiencing.”

This s

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

d scenario is played out every day to companies in all industries, but it truly doesn’t have to ha

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

ppen. While errors occur in all businesses, there should be a process in place to resolve them, m

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

nitor them, institute changes in service delivery, and make amends to the customer. What kind of

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

Professional from academic institutions, pharmaceutical industries, health care indust

“red flag” should be on the note the telephone person left for the supervisor? What action should

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

the supervisor take whenever a “red-flag” is received? What further action should be taken to sav

.

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

e the customer? Those are the questions that could save a twenty-six year relationship and questi

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

Companies that provide selfless information through particip

ns every business should ask whenever they recognize they are delivering less than optimum quality

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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