Main Subject - Business

It is a common business axiom – change or die. As a small or mid-sized business owner or a manager, there will be times you will need to make changes in your organization but m

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

ay not be sure how to go about it.

Change is hard to implement and even harder to sustain. Think about all of the people who have trouble sticking to a diet or quitting smokin

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

Examples of combination products may in

g or keeping up with an exercise program, let alone just starting. If changing yourself is hard, how can you change an entire business, organization, process or department?

As

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

a Certified Business Coach, one of the biggest challenges my clients face is this issue of change. Did you know there are eight reasons why organizations fail to change from a

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

lack of urgency to underestimating the power of vision to failing to create short-term wins? The eight reasons are:

Lack of a sense of urgency
Failing to create

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

Combination pro

a sufficiently powerful guiding coalition

Underestimating the power of vision

Not communicating the vision

Allowing obstacles to block the new vision

Faili

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

ng to create short-term wins

Declaring victory too soon

Neglecting to anchor changes firmly into the corporate culture

Take the third reason, for example, und

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

restimating the power of vision. A clear vision helps direct, align and inspire actions on the part of large numbers of people. Lack of vision, on the other hand, leads to lots

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

of debate and confusion. Think about the organizations you have worked for or know. When everyone understands the vision, work gets done, employees are energized, and processe

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

s get put into place. Without a guiding vision, employees lose passion, urgency and focus. And, it is just as critical to communicate your vision – reason number four – instead

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

of keeping it in your head. Communicate your vision to your employees, vendors and clients – often.

How can a business leader do it all – create and communicate a vision, get

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

Following aspects would a

the work done and make a profit? Business coaches help business leaders step back and create the processes necessary to communicate and sustain their vision for their organizat

dd to the challenges in developing combination products:

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

ions by focusing on sales, marketing, systems and team building. One strategy I use is to facilitate a team alignment day. I often start out with a number of traditional and no

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

n-traditional teambuilding exercises. Then, I introduce a game called “Leverage: The Game of Business,” in which employees learn the five key areas to impacting the bottom line

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

By playing the game, each employee learns how he or she plays a pivotal role in making the business work and impacting its cash flow. By the end of the day, the team is align

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

ed with the business owner’s goals as well as the team and the business manager being aligned as people. When everyone is on the same page, change can take place and things hap

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

Professional from academic institutions, pharmaceutical industries, health care indust

pen more efficiently and effectively.

A recent article in Fortune Magazine, entitled, Executive Coaching – With Returns a CFO Could Love, stated, "Asked for a conservative est

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

mate of the monetary payoff from the coaching they got, these managers described an average return of more than $100,000 or about six times what the coaching had cost their com

.

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

panies."

My goal as a business coach is to help business owners step back and think about new and innovative ways to achieve profitability and business growth … and to do it i

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

Companies that provide selfless information through particip

n a way that provides a good return on investment of a business manager’s time and money. The ability to change, while remaining focused, is an integral part of this philosophy

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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Most authorities agree that there is room for improvement in business ethics. One of the most problematic questions raised in relation to business ethics is whether or not businesses can become more ethical in the real world.

Successful business owners pay careful attention to the culture of their organization. They know that by doing this they build high performance into the very fabric of their business. They relentlessly drive the culture that they want to achieve the results envisaged. Knowing the character of the business is an imperative in achieving high performance.

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