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The year was 1939 when Ray Bolger first appeared as the Scarecrow in the Wizard of Oz singing these words:

"And my head I'd be scratchin' While my thoughts were busy hatchin' If I onl

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

y had a brain."

Then Dorothy responded with her helpful reply,

"With the thoughts you’d be thinkin’ You could be another Lincoln If you only had a brain."

The travelers down

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

Examples of combination products may in

the Yellow Brick Road needed everyone on the team to use the best of their talents for the adventure the Tin Man's heart, the Cowardly Lion's nerve, Dorothy's spunk, and yes, the Scarecrow

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

's brain so the whole team could unravel the riddles.

Modern business is like Oz. Too many Scarecrows in your company deny what they already have going for them: the capacity to think bey

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

nd boundaries and the inclination to think through any challenge. In other words, they've been unable to engage their best thinking on behalf of the company. But, business requires the gre

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

Combination pro

atest effort of all employees. Together their talents can be combined and leveraged to better accomplish your strategic goals.

In interviews over the last 5 years, we've asked more than 3,

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

500 employees from several dozen major companies if they faced a problem they could not solve or a question on the job everyday that they could not answer. 100% have responded, Yes. When gi

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

en a real-world problem solving challenge; however, only 4% could accurately identify the goal.

Overall, these are bright people. And we've discovered, almost without exception, that they

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

're victims of the Scarecrow Syndrome: when people deny their own abilities to think beyond their limitations, and so fail to use everything within their power to consciously pursue the goa

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

ls of the organization.

Just-In-Time-Learning

If corporate history shows us anything, it suggests that some of the best people to develop and implement the ideas your company depen

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

s on are already on your payroll. They're creative and competent. They are energized but not engaged.

Your company was built on great ideas. You need employees who implement those ideas an

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

Following aspects would a

d continually generate new ones to propel you ahead of the competition. These employees want to take responsibility for their part in your company's future. But you'll never know how valua

dd to the challenges in developing combination products:

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

ble they can be until you adopt a two-point plan to help them beat the Scarecrow Syndrome.

FIRST - Engage their minds. To do that, you must accomplish three things:

Teach

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

them to think beyond their limitations and to think through their roles in your companys success,

Equip them with the specific skills needed to close the Strategy-to-Performance Gap

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

nd reach company goals in the workplace, and

Connect them to the business and show them why and how they are vitally important in achieving your company's goals.

SECOND - Igni

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

te their learning engines. Give employees the ability to:

Learn and uncover new issues,
Unlearn past teachings in an effort to discover new approaches, and
Relearn

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

Professional from academic institutions, pharmaceutical industries, health care indust

so that they can transfer learning to different situations.

Today's organizations need just-in-time learning. When employees learn that they need to consciously work towards the orga

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

izational goals to fill problematic gaps at work, and that their daily actions must align with business strategy, a company's capability increases by an average of 75%.

Have you unleashed

.

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

the creativity and competence in your own staff to help you outperform the competition?

Until you have created this continuous learning loop, your staff is like the Scarecrow, wandering ar

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

Companies that provide selfless information through particip

ound in The Land of Oz chasing after fairy godmothers and wizards that don't truly exists.

Song lyrics from: (E.Y. Harburg and Harold Arlen, “If I Only Had a Brain,” The Wizard of Oz, 1939

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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