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Productivity during change can be affected positively and negatively by restraining forces and driving forces respectively. Productivity can reach a state of equilibrium between these two opposing forces. However, this balance can be punctuated by a disturbance in one or b

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

oth of the opposing forces. Therefore, at any given time, the productivity can go up or down depending on the strength or weakness of either the restraining or driving forces. This view of change and transformation is known as punctuated equilibrium.

A leader can use 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

theory in preparing for change in order to evaluate whether the change is possible to implement and/or to plan actions to better implement the change. To do so, the leader should conduct a force field analysis of both the driving forces behind the change and the restraini

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

ng forces against the change. He or she can then estimate if there is a reasonable possibility to implement the change or not.

Restraining forces may include market pressures, internal structures and capabilities or resistance from employees. Resistance can be passive or

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

overt. For example, employees may be unenthusiastic to make a change because they have been through previous change efforts which were not totally successful. Because of this, their will to take up another project may be low. In some cases, employees may totally check ou

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

Combination pro

t of the process, either passively or actively resisting the change. This could include talking negatively about the project with other team members, starting an employee campaign against the project, or other actions which can hurt the successful implementation of the cha

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

ge.

Leaders can do eight steps which will help them manage change efforts more successfully. These include the following:

1. Build an environment of trust with the employees in order to create an environment where employees are more open to ideas and more willing to disc

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

uss possibilities and problems associated with change.

2. Link the change effort to a common team value in order to help employees feel they can relate to the change effort at a personal level. This increases the desire and motivation to change.

3. Articulate and commu

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

icate a clear message about why the change effort is needed and will help the team. This links the facts and figures supporting the change to the team value. Communication should frequent throughout the effort.

4. Establish a vision with the employees regarding the poss

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

ible advantages of making the change in order to help the team define for themselves where the change will take them.

5. Collaborate for solutions with team members so that employees have the opportunity to identify the driving and restraining forces in the change effort

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

nd identify action steps for implementing steps to implement the change and overcome the restraining forces.

6. Establish and celebrate wins along the way. The leader should actively orchestrate wins and celebrations so employees can see that the change effort is importa

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

Following aspects would a

t and see that changes in behavior will lead to positive outcomes.

7. The leader must manage performance around the change. This includes coaching those who need support with the change, disciplining or removing those who continually resist the change or have decided to

dd to the challenges in developing combination products:

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

fight against it, rewarding positive changes, hiring employees who have the new capabilities needed in the change effort, etc…

8. Constantly monitor the process and the results to ensure that the change effort is on track.

References:

Coillet, A., (2005). Changing how

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

eaders lead change. www.accomligroup.com

Beer, M., Eisenstat, R., and Spector, B. (1990). Why change programs don't produce change. Harvard Business Review. November - December.

Catlette, B., and Hadden, R. (1998). Contented cows give better mild: The plain truth abo

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

ut employee relations and your bottom line. Germantown, Tennessee: Saltillo Press.

Connors, R., Smith, T., and Hickman, C. (1994). The oz principle: Getting results through individual and organizational accountability. Paramus, NJ: Prentice Hall.

Duck, J.D. (1993).

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

Managing change: The art of balancing. Harvard Business Review. November - December.

Halpern, B.L., and Lubar, K., (2003). Leadership presence. New York: Gotham Books.

Harvard business review on change, (1998). Boston: Harvard Business School Press.

Hersey, P., B

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

Professional from academic institutions, pharmaceutical industries, health care indust

lanchard, K.H. & Johnson, D.E. (2001). Management of organizational behavior: Leading human resources. Upper Saddle River, NJ: Prentice Hall.

Kotter, J.P. (1995). Leading change: Why transformation efforts fail. Harvard Business Review. March - April

Kotter, J.P. (

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

996). Leading change. Boston: Harvard Business School Press.

Kotter, J.P. & Cohen, D.S. (2002). The heart of change: Real-life stories of how people change their organizations. Boston: Harvard Business School Press.

Lencioni, P. (2005). Overcoming the five dysf

.

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

unctions of a team. San Francisco: Jossey-Bass.

McDermott, L.C., Brawley, N. & Waite, W.W. (1998). World class teams: Working across borders. U.S.A.: John Wiley & Sons, Inc.

Schein, E.H. (1996). Three cultures of management: The key to organizational learning. Slo

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

Companies that provide selfless information through particip

n Management Review - Fall

Stowell, S.J., and Starcevich, M.M. (1996). Win - win partnerships: Be on the leading edge with synergistic coaching. Salt Lake City, Utah. CMOE Press.

Strebel, P. (1996). Why do employees resist change? Harvard Business Review. May - Jun

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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