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A change management programme succeeds only when the change in processes and outcomes become embedded in day-to-day business. For a change programme to be embedded into day-to-day business, a critical mass of employees and managers must be emo

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

tionally tied to the change in business outcomes and the change in processes which deliver the change in outcomes.

What does it mean to be emotionally tied?

The old metaphor of the chicken and the pig demonstrating the difference between com

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

Examples of combination products may in

mitment (emotional attachment) and involvement suffices to explain.

The metaphor goes, "What's the difference between commitment and involvement?"

"Ask whether the contribution of a pig and a chicken to a breakfast of bacon and eggs is commi

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

ment or involvement." The answer is, "The chicken is involved, the pig is committed."

When a critical mass of people shows the commitment of the pig, a change management programme will be embedded into day-to-day life.

When too many people 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

re, at best, demonstrating the involvement of the chicken, a change management programme is doomed to stop as soon as the driving force behind it is removed.

What ties people emotionally to a change programme? "What's In It For Me?" (WIIFM),

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

Combination pro

s the answer. Whilst a few people may be altruistic about change, the major motivator is WIIFM.

Whilst the elements of a change programme that provides sufficient incentive for people to become committed rather than just involved is different

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

from person to person, the elements tend to be the same, programme to programme.

Career advancement/remuneration:

Career advancement is a strong incentive to most people. It appears as the first or second item in the list o

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

work motivators in most studies. When it is second, the prime element is usually money. Career advancement, usually a driver of future income, is therefore either the first element, or a strong driver of the first element, in most surveys.

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

strong>Personal pride in a job well done:

Career advancement comes from demonstrated personal development. That is, development of the behaviour, skills and knowledge to execute one's tasks well. Being able to do a job well consisten

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

ly leads to pride in a job well done, another strong motivator.

Recognition:

Thanks for that job well done from colleagues, customers and supervisors cements the perception, creating a sense of pride.

If the sense of pride

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

and the competence to execute a job well is prevalent, people will be recognised and their career opportunities will unfold in front of them.

Standards of performance:

Providing new standards of performance that are known by

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

Following aspects would a

all is a first step in creating clarity about what changes are required. Standards of performance additionally make it clearer what behaviour, skills and knowledge are required to execute a job well.

Low tolerance for non-performance

dd to the challenges in developing combination products:

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

It is insufficient, however, to develop and communicate standards of performance. An important step is the establishment of obvious low tolerance by supervisors and managers for below standard performance. Another important step is

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

to train people to improve their behaviour, skills and knowledge.

Coaching, training and counselling people when their performance or behaviour does not meet clearly communicated standards, is a must in executing a change management plan. It

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

rives the realisation that this is serious. Further, it becomes clear what behaviour, skills and knowledge are required to do a good job.

Low tolerance for non-performance is a key element to build critical mass.

Building trust:
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
ong>

However, even when the WIIFM's are established and the processes for people to gain an advantage out of the change programme are clear, the change programme may still fall over if trust has not been developed between the proponents of th
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
change programme and those being affected.

Trust can be built several ways. However, the simplest way is to always say what you will do and do what you say. An ability to build rapport is very helpful, but is insufficient without constancy o
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
f purpose and consistency of application. Communicating early and often using a variety of channels is necessary to reduce the risk of surprise.

Building trust by communicating early and often, establishing standards of performance as part of
.

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
the change programme, training, coaching and counselling people to enable them to execute to the standards of performance and setting a low tolerance level for non-performance will build pride in a job well done, leading to career advancement.
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

This approach has built self sustaining momentum in a change programme every time I have used it. Many organisations think they do it when instituting change. However, most organisations do not. Most change programmes fail the longevity test

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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Advice You - Building Critical Mass in a Change Management Programme

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