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When I was a little girl my father would ask me what I thought to be very strange mind bending questions. Once asked, they would send me off on a never ending search for answers. One o

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

f his favorites that always stuck with me was…

"If a camel is carrying a bag of feathers and he's carrying as many feathers as he can, can the camel carry one more feather?"

Strange q

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

Examples of combination products may in

uestion, right? At six years old I exclaimed, "sure why not, it's just a feather". My father would simply shake his head—no. It wasn't until years later that I realized I had been misap

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

plying the principle. I had set up the problem all wrong.

Logic told me that feathers didn't weigh much, so the weight of one more feather would be insignificant. I only thought about t

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

he weight of the feather and not the capacity of the camel.

This is what we do in the workplace. We overlook people as a critical part of the performance equation. When demand is high

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

Combination pro

we raise expectations, giving them more work to do and think little about whether they have everything that they need to do it.

Everyone carries different loads. And, no matter the job

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

or the level of responsibility, we are all limited by our individual capacity. Combined our abilities represent the full capacity of the organization.

How much extra weight are your pe

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

ople carrying? Is is possible for them to take on one more project, work late into the evening, or keep working themselves in circles?

There are limits to everything and at some point e

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

ven one single feather is too much too carry. It is important that everyone in the organization carry their own weight, but there are more effective ways to increase organizational perf

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

ormance. So, if you want the best performance from the camel, watch how you stack the load.

What are you doing to lighten the load? How are you going to grow their capacity?

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

If you really want to move further faster, you need to grow the capacity of your employees. Rather than continuing to pile on, maybe you should look for ways to share the load.

The cap

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

Following aspects would a

acity of your people is dependent on your ability to:

Lead the way with a clear vision, purpose and map of where you’re headed and how you expect to get there. Commitmen

dd to the challenges in developing combination products:

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

t starts at the top, but needs to flow down and through every level of management and across every business unit to create a culture of trust, respect and accountability.

Communi

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

cate strategy, clear job expectations, and measures of success to employees. Provide them with timely and appropriate feedback about their performance.

Support performanc

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

e by creating and aligning systems, processes and policies. Provide tools needed for better productivity and access to a wide variety of quality resources and people.

Honor

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

their contributions, dedication, hard work, long hours and efforts with fair reward, recognition, incentives, and compensation. Appreciation goes a long way toward building relationship

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

Professional from academic institutions, pharmaceutical industries, health care indust

s and bridges between the needs of the business, customers and the spirit of employees.

Connect the line from strategy to jobs; from systems to performance; from performance

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

management to daily work activities; from efforts to results; and from business results to their own advancement and growth opportunities.

Develop the skills and full capabil

.

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

ity of all employees to participate. Create the success you want by developing the right skills and knowledge that will aid them now and carry them into the future.

Today

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

Companies that provide selfless information through particip

’s employee needs more than technical skills and job knowledge. They need to understand the business, the market, its customers and most importantly how to learn at the speed of change.

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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