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In today’s highly competitive marketplace, the fundamental challenge for most management teams and the #1 reason companies fail to fulfill their annual growth objectives, is their inability to execute the company’s strategic in

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

itiatives as well as anticipated.

Given that many companies tend to run very lean, leadership may have unrealistic expectations about how many projects and/or initiatives the organization can effectively manage while maintaini

; 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 a high level of customer service. As such, an organization becomes spread too thin for the resources available.

Caught in a perpetual state of “firefighting,” employees tend to react to those tasks that author Steven Covey

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

alls urgent tasks while foregoing those that are of more importance. Without having enough time set aside for discussion, prioritization, consensus and planning, organizational change tends to occur rather reactively.

For cha

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

ge to occur systematically within your company, several factors must be present for optimal results including:
• Discussion, agreement and on-going support of the company’s direction and strategic initiatives among senior

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

Combination pro

management
• Link strategic initiatives to tactical execution through planning and on-going communications
• Align and connect the performance management, incentive compensation and training processes for optimal

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

esults
• Emphasize hiring, developing, rewarding and retaining top talent as a key driver of sustained business growth.

To aid you in your efforts to bring about positive organizational change, we’re happy to share

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

our Success Roadmap for Bringing About Effective Organizational Change. The process tends to follow these phases and steps:

Phase One - Management Alignment
• Develop a company-wide vision
• CEO sets the ton

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

& expectations
• Conduct needs analysis
• Development of plan
• Establishment of steering / execution team
• Hold regularly scheduled progress meetings

Phase Two - Establishing & Driving Perfo

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

mance Expectations Throughout the Company
• Leverage service standards into sales expectations
• Develop a performance management system including job competencies, job descriptions, performance based review form

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

and provide management/coaching training to support the desired culture and performance expectations
• Establish goals to support performance metrics
• Evaluate performance tracking systems and upgrade as needed

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

Following aspects would a

> • Align incentive plans to motivate for individual, branch and company performance

Phase Three - Focus on People as a Competitive Advantage
• Provide on-going training and development – management and coaching

dd to the challenges in developing combination products:

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

raining, sales training for lenders and retail staff, product training, operations and regulations training.
• Create consistency and discipline through on-going tracking of results and coaching
• Create regular,

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

n-going reporting mechanisms
• Upgrade employee screening and hiring processes
• Develop a reputation as a great place to work through annual employee surveys, formal and informal recognition programs
• Usi

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

g information to support people and processes
• Adjust strategy based on results
• Focus on daily execution
• Keep the focus on capturing the entire customer relationship

The Goal - Capturing the Enti

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

e Customer Relationship
At the end of the day, we must focus on capturing more of the customer’s relationship if we are to maintain the annual growth rates enjoyed over the past five to seven years. This necessity may cal

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

Professional from academic institutions, pharmaceutical industries, health care indust

for making changes to your company’s strategic direction, internal processes, product and service offerings and the ways in which you recruit, develop, motivate and retain employees. And just as an ocean liner doesn’t change

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

irection on a dime, neither will your company’s culture change over night or within a single quarter. We’re confident however, that this Success Roadmap will aid your company’s management team in discussing and better planning

.

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

whatever changes are deemed necessary to remain competitive in the next five plus years.

*****************************************************************
© 2007 Ray Adler, All rights reserved. You are free to use this ma

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

Companies that provide selfless information through particip

erial in whole or in part in print, on a web site or in an email newsletter, as long as you include complete attribution, including live web site link. Please also notify me at ray@btitraining.com where the material will appear

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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