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Wikipedia states that “Change management is a structured approach to change in individuals, teams, organizations and societies that enables the transition from a current state to a desired future state.”

So, why is it that the implementat

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

ion of change breaks down so often in organisations?

Kurt Lewin postulated that there are 3 broad stages to change; these being:

· Unfreezing (i.e. planning and preparation)

· Change implementation, and

· Refreezing (consolidation and

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

Examples of combination products may in

refinement)

The language of “freezing” is illustrative of reality in organisations. People do naturally become “frozen” into familiar patterns, environments and behaviours. Life does need to have a degree of predictability in order for us

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

to function. However, herein lays a major challenge for a significant change.

Effectively implementing organisational change is clearly a management responsibility. However, human beings throughout an organisation need to “feel” the need

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

for change. Even an intellectual understanding that things could be done better is not enough to engage individuals in a change process. Nothing beats the proverbial WIIFM (“What’s In It For Me”) factor!

This is a major reason that consu

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

Combination pro

ltation is so important in working toward change. The WIIFM factors for individuals will vary widely, but the sense of being included and listened to are fundamental in motivating people toward change.

Remember, Lewin’s theory tal

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

ks about “unfreezing”. Change is not about creating an ice sculpture. Change management can take this approach, but the organisation risks breaking off critical pieces well into the change management process. This is a wanton wast

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

e of precious time, resources and opportunities. Melt the ice with education about the rationale and the benefits of change. Do not ignore the costs, both human and financial. Make sure consultation is honest about potential difficulties a

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

nd gives all stakeholders an opportunity to suggest refinements. It is possible to do this and still hold on to the vision.

The second stage of Lewin’s change model also poses some challenges. Even with a critical mass of

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

support, implementation can be severely hampered by bad decisions and missed opportunities. For example, if the change requires a change in physical facilities, equipment or tools of trade, how are decisions made on how these are assessed

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

for suitability and acquired?

An organisation recently implemented a significant systems change within a key area of the organisation. Not only did management neglect the unfreezing process, but the “tools of trade” introduced to support

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

Following aspects would a

improved business outcomes actually caused and exacerbated injury to a number of the staff. Subsequently a range of remedial (and not particularly effective) strategies were introduced at great cost.

Never underestimate the negative impa

dd to the challenges in developing combination products:

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

ct of such a scenario on the trust between employees and management. Management can be so dedicated to implementing a change that any constructive criticism is dismissed as the product of “dinosaur mentality”. Employees will readily recogn

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

ise this response for what it is, as management step up the promotional activity and dabble half-heartedly with minor variations to the change strategy. In turn, disenfranchised employees tend to confirm the management view that “the o

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

nly way to get things done round here is to crack the whip”. Whip cracking is sustainable for a few days, weeks, or maybe even months. When whip cracking becomes the norm to sustain business outcomes, it is a burden on everybody in th

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 organisation and ultimately undermines productivity.

The third stage, Refreezing, is the least demanding IF stages 1 and 2 have been well managed. Nevertheless, it would be na?ve to think that this stage does not need t

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

Professional from academic institutions, pharmaceutical industries, health care indust

o be actively managed. Under the very best of change strategies, organisations will bring with them a body of the unconvinced, the uninformed or simply the hostile and unwilling. Refreezing should capitalise on the success of the majority

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

in achievements to date. Celebrate success both corporately and for individuals and teams that have contributed “above and beyond”. At this stage of the change process organisations need to consolidate new “norms”. Who is better placed to

.

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

do this, if not an engaged and supportive body of employees who recognise solid and inclusive change management practices?

In summary, for better or worse, change is a shared process. Organisations must acknowledge and understand this. Mo

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

Companies that provide selfless information through particip

re importantly, organisations need to demonstrate a genuine commitment to a shared approach right from the beginning, ensuring the change vision is well conceived, articulated, consulted and managed. Remember, organisations are people too!

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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