Main Subject - Business

Imagine you are a commercial airline pilot responsible for the safe delivery of a plane full of passengers to their scheduled destination.

The

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

successful outcome of your flight depends on precise completion of a series of proven, sequential processes. What happens when a sequence is

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

Examples of combination products may in

iolated? What if you changed the process and retracted the landing gear while the plane was still on the ground? You would need a very good r

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

ason to jeopardize the outcome of the flight while dropping a $45 million aircraft and 200 paying passengers onto the pavement. Why do I offer

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

this seemly silly example? It's because I routinely see businesses shortcut or abandon their critical processes in similar fashion. And then

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

Combination pro

hey wonder: What happened?

For your preflight checklist for any major achievement, there are eight criterion for effective goal setting. They

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

re organized below with the SMART WAY acronym:

Specific

Measurable

Attainable

R<

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

/strong>ealisticly High

Target Date

Written

Aligned

Yours

Similar to p

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

eparing for airliner take-off, shortcutting any single element of the goal setting process will also jeopardize your outcome. An often overloo

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

ed element is "Attainable. Have you ever worked in an organization where the goals were viewed as unattainable? What happened to your commitm

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

nt? What was the level of frustration? What happened to achievement? Yet how often do we see unrealistic goals handed down from above withou

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

Following aspects would a

t concern for buy-in?

So, how should we apply what we know about process and attainability to improve execution?

* Effective goal setting fo

dd to the challenges in developing combination products:

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

your critical initiatives should be treated as a process. That is, a sequence of steps or events that produce a desired outcome. Ignoring an

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

of the eight elements above will compromise your likelihood for achievement.

* To support the critical element of attainability, consider th

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

e words of Henry Ford: "Whether you believe you can do a thing or not, you are right."

As a leader, ask yourself: How strong are your people's

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

beliefs in your desired outcomes? Who is responsible for instilling those beliefs? Neglecting to assure goal attainability can have the same

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

Professional from academic institutions, pharmaceutical industries, health care indust

rounding effect as retracting your landing gear prior to take-off.

When achievement wanes from lack of commitment, we can loose faith in the p

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

rocess and possibly dismiss goal setting as an unrealistic practice. We then throw the baby out with the bath water. How often do we then star

.

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

some new initiative without understanding what went wrong with the old one?

Attainability is just one of eight critical elements for your pre

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

Companies that provide selfless information through particip

flight checklist for achievement. What short-cuts might you be taking any with the other seven criteria? How are your outcomes being affected

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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