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What is the cost to not having a strategic plan? To honestly answer this question requires proactive behavior, but most business ow

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

ners and executives are in reactive behavior. And reactive behavior is a symptom of stress.

According to a recent report by the Cen

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

Examples of combination products may in

ter for Disease Control and Prevention suggested that workplace stress is costing the U.S. economy $300 billion each year or $7,500

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

er employee. The question is how much of this stress can be directly tied to not having a strategic business plan?

When business ow

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

ners are so busy working in the business and not on the business, they are in 100% reactive behavior. This behavior drives the beha

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

Combination pro

vior of all the other employees. People are working harder because they are in reactive mode instead of smarter which is a proactiv

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

mode.

For example, the president or CEO of XYZ company states that the goal is to increase bottom line revenue by 10%. The VP of

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

Sales quickly convenes a meeting of all sales people and tells them to sell more of existing products. The VP of Marketing decides

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

to launch a new product. The VP of Finances cuts the budget for Marketing and Sales. From the top down everyone is working to increa

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

e sales and reduce costs and their actions are counter productive. Stress quickly surfaces.

However, if an executable strategic pl

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

an had been created including clearly articulated and measurable goals, then everyone would be more in a proactive behavior instead

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

Following aspects would a

of reactive behavior. Additionally, if all employees knew how to consistently set and achieve their own personal goals, a high perf

dd to the challenges in developing combination products:

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

rmance culture would be a natural outcome. Unfortunately, many strategic plans are not executable and many employees do not achieve

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

their own personal goals. One of the non-desired results is increased employee stress.

Using the annual figure of $7,500 and estima

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

ting that 25% of the stress in your organization is because of a lack of a strategic action plan and goal achievement, then what wou

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

d happen if you reinvested $1,875 per employee into afforda

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

Professional from academic institutions, pharmaceutical industries, health care indust

ble business coaching and employee development? Of course, you may believe that you don’t have the dollars to invest, but how m

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

uch is stress costing your bottom line specific to:

Poor attendance?
Sick days?
Wasted time or mistak

.

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

s in overall performance from selling to shipping?

Increase in health insurance premiums?

Employee turnover?

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

Companies that provide selfless information through particip

Non-returning clients?

As the old adage goes, "If you think you can, you can; if you think you can't, you won't.

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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