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All leaders need to have vision because it is vision that leads leaders. Being a leader is not an appointed position! Being a leader means that there are people who are following you: they may be people on your team, other

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

people in your organization, even clients and customers. As you lead and as people look to you for leadership, a vision gives you the spark that others want to catch.

1. Vision starts with you. Leadershi

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

Examples of combination products may in

p development begins with self knowledge and understanding. It is then important to understand those whose preferred behavioral and communication styles are different from yours. As a leader, you need to understand, respec

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

t, and yes, even enjoy all styles.

A vision is a positive picture of the future and a simple question might be, "What are you building"? Is your vision a part of your motivation? To answer that, you might ask, "What am I

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

passionate about?" "What is my sense of where I want this organization to be in three years and how will I help get us there?" The answers to these questions will lead you to thinking and creating possibilities and explori

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

Combination pro

ng the depth of your vision. Who comes to mind that has clearly led with a passion for his/her vision?

2. Vision draws on your life journey. What has your life/career journey been like so far? What has wo

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

rked well for you and helped you to grow? What kind of employee/customer has followed you in the past? What are the important lessons you have learned? How will these lessons help you to form your vision?

3. Visio

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

meets the needs of those you lead. This is the hard part . Leadership is not about you. It is about the people who follow you! The vision starts with you, of course, and the spark of your vision attracts those wi

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

th similar interests/desires/ motivation. Not all managers are leaders because one of the things leaders focus on is working to meet the needs of their staff/team members. There is a tendency of managers to direct and tell

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

people what they need to do. Their job as manager is to get the work done. Leadership is about influencing people to follow your lead with energy and enthusiasm, to gather input from them and to get the work done, usually

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

more quickly, more effectively and with full engagement. An example: Nancy is an R.N. and has a passion for hospice care. She recognizes that one way to assure the highest quality of care is to build a

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

Following aspects would a

work environment that will support it. Her vision for that work environment includes:
• Harmony, cooperation and collaboration, applied to problem solving for initiating new ideas to improve care, work processes, a

dd to the challenges in developing combination products:

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

nd teamwork.
• People trust each other and all employees are treated fairly; all are recognized as valuable contributors to the success of the organization.
• People are proud of their work and their organizat

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

ion
• There is a sense of enjoyment throughout the organization of each other and of "the work".
• People push themselves to meet challenges with enthusiasm ? even change becomes just another challenge for cr

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

ativity.
• Everyone is encouraged to continue to learn and develop professionally.

To be sure that this vision becomes a reality, there is much for Nancy to do. Patience is a virtue - one step at a

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

time, knowing that her vision is a three-year Implementation process. She needs to plan it carefully, mindful that "failing to plan is planning to fail"!
• Her first step will be to build sincere relationships with

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

Professional from academic institutions, pharmaceutical industries, health care indust

all those in the organization and especially with those she will lead.
• Nancy must be trustworthy, the biggest key to successful leadership.
• She will then share her vision by engaging others in all parts o

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

f her plan.
• Nancy and her followers will move forward with intention. Results Nancy can expect:
• An energetic workplace where cooperation and collaboration are the norm
• Increas

.

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

ed retention of staff at all levels
• A reputation in the community for being the "best place to work" and in the community for providing the highest quality of care
• Increased productivity ? more gets done

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

Companies that provide selfless information through particip

in less time
• Organizational goals are met and the business is thriving.

Take time to reflect on your own leadership skills and identify your vision. The spark will touch your followers and your work will flourish

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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