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Introduction

Managers tend to cringe when they hear the word “culture,” because cultures seem so mysterious and organic, and they are one of the parts of the organization that managers can’t control. At least, that’s the myth; but in fact you can design your organization’s culture and

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

then set out to create it in very straightforward ways. The catch is that changing a culture requires time, participation from everyone in the organization, a long term plan and careful monitoring.

Step 1: What Culture Do You Want?

Probably the hardest part of the cultural change pr

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

Examples of combination products may in

cess is deciding what kind of culture you want to have in your organization. Should it be a strict hierarchy, or maybe a democracy, or a loose federation of experts, or something else entirely? How will people make decisions? How will resources be distributed? What are the penalties for failure and the

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

rewards for success? You won’t be able to answer these questions all at once, because they will evolve over time, but you need to think hard about the kind of culture you would like to work in - the culture that is likely to attract the people you need to achieve your goals. This cultural visioning wo

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

ks best if you can engage everyone in the organization and if everyone feels committed to the project and shares the same vision of how they want to work, and how they want to treat each other.

Step 2: What Culture Do You Have? Now, you need to characterize the existing culture - a

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

Combination pro

fter all, you don’t know which way to go if you don’t know where you are. You need to find out what frustrates people, what makes them feel good, what helps them get their job done and what keeps them back. And the only way to get this information is to ask as many people as you possibly can. You can a

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

k people in any number of ways: through surveys, or focus groups, or interviews, or just hanging around the water cooler and talking with people. Write down what you hear and analyze it for common themes - these are your starting point for change.

Step 3: What Needs to Change? Now

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

that you know where you are, and where you want to go, you can start planning the changes to get you from point A to point B. You can plan the changes in two ways: by making the small, easy changes first to get momentum rolling, or by tackling the big, important changes to get dramatic successes early,

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

or a combination of the two. But however your decide to do it, you should identify all the negative aspects of your current culture that you want to stamp out, the positive parts of the current culture that you want to preserve and nurture, and the aspects of your visionary culture that you need to cre

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

ate. If you write these down in detail, you’ll have a road map of the changes you ned to make to create your new culture.

Step 4: How Can You Cause Change? It’s all very well to imagine a new culture, and to prioritize the needed changes, but how do you actually get a culture to ch

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

nge? Well, it’s easy to describe the methods, but harder to implement them. For each cultural change that you want to make, try to identify the top five organizational traits that prevent you from making the change and start trying to eliminate them. And at the same time, identify the five most importa

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

Following aspects would a

nt traits that would encourage the change and start promoting those traits. You’re trying to establish both a push and a pull to get you to the new culture: the push is to stamp out negative practices and the pull is to start rewarding positive practices that get the new behavior started.

Step

dd to the challenges in developing combination products:

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

5: How Can You Measure Change? As you start your program of cultural change, how do you know that you’re making any progress? It’s not enough just to look around and guess - you have to find a way to measure the changes so that you can tell what measures are working. You can get accurate me

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

asurements of the changes in a number of ways: by using employee surveys, by interviewing employees, or by using focus groups. You can also track changes by indirect measures like sick days, or employee productivity, or product quality metrics; all of these are sensitive to cultural issues and will cha

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

ge as your culture changes. And the most important part of your measurement program is to establish a baseline and track the measurements over time. Often the trend of the measurements will give you strong hints about where to direct your efforts.

Step 6: How Long Will This Take? So

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

how long should you allocate for making a cultural change? It depends on the scope of the change, how many people it effects; on the depth of the change, how much they must change their behavior; and on their motivation to change. As a rule of thumb, you should predict in weeks for making changes in

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

Professional from academic institutions, pharmaceutical industries, health care indust

team’s culture, in months for changing a department’s culture, and in years for changing an entire organization’s culture. The rate of change may vary from one situation to another. Some organizations start to change slowly, and then pick up speed as the changes settle in and reinforce each other. Oth

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

er organizations make dramatic changes very quickly, but then require a long time for the changes to settle into the culture and become self-sustaining

Step 7: When Are You Done? Organizations that are in constant cultural change are not healthy - they get exhausted by the energy th

.

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

y expend in the change process. So it’s important to have a goal in mind: a way of declaring, “We’ve reached the culture that we set out to build.” And the only reliable way to decide when you’ve reached the goal is through your measurements. For instance, you might decide that your goal is to increase

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

Companies that provide selfless information through particip

employee satisfaction to 85% for six months, or to lower product defects by 30% for a year. With firm goals like these, you can decide how to allocate your time and resources, predict how the change is going, and decide when it’s time to declare the culture change complete and move on to the next task

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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