Useful Advices - Business

1. Give employees the conceptual tools needed to think strategically: An operations em

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

ployee who doesn’t understand how profit is measured will have as much trouble with thi

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

Examples of combination products may in

s as an accounting person who doesn’t understand your operation. Make sure that employ

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

ees are trained to understand your business from all perspectives, not just that of the

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

ir department.

2. Make sure employees understand your strategy: There is no substitut

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

Combination pro

e for clear, concise communication of your strategy to your employees. If you are targ

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

eting high-end customers who value service, you will best succeed when your employees u

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

nderstand this.

3. Structure your company around your strategy: Departments and funct

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

ional job responsibilities should be structured to make it easier to follow your compan

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

y’s strategy. Be very wary of departmental structures and metrics that may drive peopl

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

e in the opposite direction.

4. Structure jobs to support your strategy: The most com

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

Following aspects would a

mon mistake companies make here is to measure things that drive counterproductive behav

dd to the challenges in developing combination products:

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

iors. If you want strong margins, don’t focus on measuring sales volume – measure marg

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

ins. Of course, if you compensate for sales volume, don’t be surprised if profitabilit

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

y suffers.

5. Use participation and communication to increase “buy-in”: Employees are

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

more supportive if they have participated in creating the strategy. This doesn’t have

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

Professional from academic institutions, pharmaceutical industries, health care indust

to be as big as it sounds – even providing information to your strategy team can creat

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

e a sense of participation. In addition, you will get far better support for your stra

.

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

tegy if employees really understand the reasoning behind it. Make sure this is well-co

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

Companies that provide selfless information through particip

mmunicated to those employees whose support is critical to the success of your strategy

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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