Advice You - Business

A quick story:

During the annual meeting, the CEO of a manufacturing company informed her executive team that she wanted to ach

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

ieve a 10% growth during the next 12 months. The VP of Operations made plans to purchase new manufacturing equipment for new pro

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

Examples of combination products may in

ducts while the VP of Marketing & Sales began to implement a plan selling existing products. The CFO decided to cut budgets to c

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

pital improvements and marketing. All three executive team members believed that their actions would help achieve the 10% growth

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

.

And the results of their actions are only symptoms of a greater, real problem – lack of alignment supported by poor communica

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

Combination pro

ion.

Many times in business, symptoms are confused with problems. One area that this is especially evident is within th

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

e area or department of human resource training and development. For example, employees are trained on new skills and rec

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

eive lots of new knowledge for a specific performance issue. Within a short time, performance problems for that same issue re-e

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

erge and training is viewed as not solving the problem. Hence, when a budget crunch arises, HR is one of the first departments t

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

o suffer because this department is viewed as being a problem due to poor results. Yet, the real problem was probably not the kn

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

wledge training. The authentic question to ask is not “Do they know it?” but “Do they want to do it?"

Another sho

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

Following aspects would a

rt story:

During a recent presentation, a business owner received the following challenge. If 10 of his 100 employees named th

dd to the challenges in developing combination products:

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

e top 3 current organizational goals, would he receive the same answers from everyone or would he receive 5, 10 or even 25 diffe

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

ent goals? The business owner shook his head and responded, “No, I am sure that I would receive more than 3 goals.”

Whe

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

n looking at this situation, the symptom is having multiple responses of the 3 current goals. The true problem<

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

b> is again alignment and communication.

One solution to identifying the actual problems is conduct an organizational as

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

Professional from academic institutions, pharmaceutical industries, health care indust

sessment based on known criteria such as Baldrige. Research suggests Baldrige is one of the best predictors for organiza

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

tional success. If you are truly committed to creating a winning business team, then having the ability to clearly separate the

.

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

ymptoms from the real problems will enhance your bottom line.

P.S. Read the previous article elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

eArticles.com/?id=239627"> How to Improve the Management Wins for Winning Business Teams Part 4: Implement Executive Coaching

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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Advice You - How To Improve the Management Wins for Winning Business Teams Part 5: Identify Real Problems

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