Advice You - Business

Yesterday, FORTUNE interviewed retired GE CEO Jack Welch, whose management principl

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

es have been coming under attack, recently.

Defending every one with simplicity an

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

Examples of combination products may in

logic, Welch went on to say that the idea of rank ordering your employees as to th

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

ir relative effectiveness is still a good practice, and it isn’t in any way, “cruel

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

” as its detractors contend.

“It's all about fielding the best team,” Welch said.

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

Combination pro

It's been portrayed as a cruel system. It isn't. The cruel system is the one that d

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

esn't tell anybody where they stand.”

Consider that last line, which to some might

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

be a throwaway, but it’s critical.

“The cruel system is the one that doesn’t tell

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

nybody where they stand.”

A salesperson identifies a prospect, gets in touch, visi

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

s, and is asked to submit a proposal.

He follows up not once but several times, an

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

yet his calls are dodged and his emails are unanswered. That’s CRUEL, but it’s no

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

Following aspects would a

an isolated incident.

Closer to that which Welch is speaking of, countless people

dd to the challenges in developing combination products:

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

in our economy receive no viable feedback on their performances. They haven’t a clu

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

as to whether the jobs they’re doing are unacceptable, acceptable, good, or superi

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

r.

They could be reengineered, downsized, tossed out the door tomorrow, or have 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

ir job outsourced to another part of the world for all they know.

That’s CRUEL.

I

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

Professional from academic institutions, pharmaceutical industries, health care indust

ve seen this in customer service and technical support departments that not only ha

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

e failed to adopt objective criteria for monitoring, measuring, and managing the wo

.

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

k but that actively resist telling people where they stand.

This is not only bad m

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

Companies that provide selfless information through particip

nagement; it’s cowardice, and it impeaches the integrity of the entire organization

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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