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Question: ERPs seem like a good idea, so why is return on investment so low?

Answer: Resistance often kills many of these new systems. Even though the promise of

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

what an ERP can do is high, the planners often fail to look at how the users are likely to view this “improvement.” ERPs take away the old tried-and-true ways of wo

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

Examples of combination products may in

rking. Even though some of these cobbled together systems aren’t all that good, people understand them. When they are asked to give up what they know and what they

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

can rely on, you often get resistance to using a new software system.

ERPs also threaten the fragile balance of power and control. The old system allows department

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

and some individuals to control the type of information that gets out – and control the way data gets disseminated. The new system destroys all of that and that ca

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

Combination pro

n be threatening.

One manufacturing plant has spent millions on an ERP, and kept throwing money at the technical parts of project, with no success. What they faile

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

d to see was that the technical problems they faced were minor compared to the human reactions against these changes.

Question: What are the biggest pitfalls when

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

planning an ERP?

Answer: The biggest pitfall by far is assuming that ERP implementation is solely a technical and financial challenge. The human side of change is

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

he most neglected, and consequently most likely to result in cost and time overruns, or failure to meet the intended goals.

Question: How can we increase the odds

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

in our favor?

Answer: Plan for the human part of the ERP. There are three major reasons why people resist a change. They don’t get it (Level 1), they don’t like it

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

(Level 2), or they don’t like you (Level 3). Any one of those can stop the ERP dead in its tracks. And what you need is the opposite of all three: people need to g

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

Following aspects would a

et what it’s all about, they need to like it and be willing to take part in making sure it is a success, and they need to have confidence in you.

Create strategies

dd to the challenges in developing combination products:

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

that speak to people in their own language to help them understand why these changes are critical to your organization. Spend a lot of time building the case for th

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

e change before you get into the often mind-numbing details of the ERP process itself. This attention to Level 1 is necessary but not sufficient for success. You mu

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

st attend to the other two levels as well.

If people react against the change, find out why. It is usually fear. In some cases people are afraid that the new ERP w

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

ill cost them their job. If that’s the case, why would they support it? You need to find ways to engage people to help you address the downside of the change. For e

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

Professional from academic institutions, pharmaceutical industries, health care indust

ample, if people are afraid that the new system will not allow them to customize and be as responsive to customers, invite them into the planning to ensure that the

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

new system provides the features they need.

And if they don’t have confidence in you or your team (Level 3), you must do everything you can do demonstrate that yo

.

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

u are worthy of their trust. This probably won’t happen over night. One meeting won’t do it. You need to prove yourself time and time again. No, it’s not easy, and

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

Companies that provide selfless information through particip

working on Level 3 issues can be exhausting, but it may be the only game in town if you really want people to make a commitment to you and the new system. Good luck

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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