Main Subject - Business

I was speaking to group in Atlanta recently and this phrase was stated to me after my speech by one of my audience members….”Culture eats strategy for lunch”.

I was compelled

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

by what this meant, especially as regards processes such as customer service. Simply put, the statement implies that companies who establish a particular culture in their bu

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

Examples of combination products may in

siness will be superior in practice than those who forsake culture for strategy or process. Culture will win every time.

Take a look at the finest companies in providing ser

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

vice, such as LL Bean, Nordstrom, The Ritz-Carlton, Chick-fil-A and others. A close look will reflect an actual culture that permeates throughout the entire organization from

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

top to bottom. It is not their process that sets them apart, it is the way that they deliver their product or service; it is their culture.

You buy the same stuff at Nordstro

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

Combination pro

m that you do anywhere else; their culture sets them apart. You get fast food at Chick-fil-A, cooked on the spot, served with a Coke, but it’s not the cooking process or the

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

food that sets them apart; its their culture. The Ritz-Carlton checks you in, gives you a room, and feeds you just like hundreds of other hotels; their culture of service set

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

s them apart. Note that the process and strategy of each of these companies is the same as their competition. It is their culture, their people, which separates them.

The q

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

estion here is “How does a company establish a culture?” The answer is the same way a culture is established in a home. Not by having a meeting with the kids and explaining 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

hat this is what the family believes in regard to spirituality, manners, religion, etc. and expecting this culture to “take”. Instead, you show by example, discuss what is go

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

ing on, compassionately correct the kids when they err, and encourage them when they do things right. This creates a culture. The result is what is called “constancy of purpo

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

Following aspects would a

se”, a never-ending focus on an end-result.

The same is true in business. When a leaders of a company establish what is important, lead by example, discuss these values ofte

dd to the challenges in developing combination products:

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

(if not daily), coach for correction and recognize when done correctly, a culture permeates throughout the organization.

Here are some ways to make that happen.

1) Esta

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

blish in detail how you want your customers to be treated. Make it clear and concise, remembering that your employees have internal customers as well as external customers.

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

r> 2) Make sure your managers understand these basics down pat. Clearly. Also make sure they know the importance of this employee/customer treatment.
3) Reinforce

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

these with management constantly. This results in the above described “constancy of purpose”.
4) Teach the basics to all employees and require management to coach and

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

Professional from academic institutions, pharmaceutical industries, health care indust

nforce the practices.
5) Hire employees who “fit” the new culture.
6) Remember that the way we treat employees is the way they will treat our customers.

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

7) Talk about the culture every day.

The result will be a shift towards a culture that will be observable, as with the leading companies I mentioned earlier.

I have seen

.

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

this happen in companies and can attest for its impact. When leaders in a company make it clear what is important to them regarding their values and culture, it permeates th

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

Companies that provide selfless information through particip

roughout the entire organization. When it spreads, it becomes unstoppable and powerful. Culture is an attraction for both employees and customers….it eats strategy for lunch

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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A business plan is a very important part of any business. It is usually drawn up before the business launches, but can also be developed after a business has already taken off. A good plan can take some time to develop but the effort you put into it will be well worth it to make your business succeed. Not many people know exactly what goes into a good business plan. What alot don't realize is that each business plan is unique to each business.

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