Main Subject - Business

Just to review, in our last article we discussed five things to consider when implementing or upgrading an ERP system.

1. Begin with the end in mind. At t

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

he end of your project, you own and will live with the system. You need to control the temporary help you bring in to complete this task.

2. Don’t hand th

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

Examples of combination products may in

keys to the implementation partner and walk away. If you do, you may be surprised when you arrive at a destination very different than what you expected.

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

You are paying for it, not them and you must stay involved every step of the way to ensure that the project stays on track.

3. Use a customer solutions ori

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

nted provider. In other words, use a provider that will listen to what you want and advise on the pros and cons, but ultimately you are the customer.

4. F

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

Combination pro

nd a partner that will extend knowledge transfer to key employees throughout the whole project.

5. Don’t be afraid to make a change in personnel at anytime

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

during the implementation. Often, companies tolerate an ineffective consultant because they are afraid that making a change will slip the project timeline

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

Remember, that no one is bigger than the game. Fixing a personnel problem may be that critical step to keeping your project on time.

To accomplish this

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

ask there are several things to keep in mind.

First you need to provide resources to be full time on the project to oversee your personnel and to be your a

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

vocate to the partner

Second, you are going to want people who want to be a part of the project both from your side and your partners. Choose your team wi

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

ely; our most successful implementations and upgrades have come when the client and the partner have used what is referred to as “best of breed”. That mean

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

Following aspects would a

s you only settle for the very best. This may seem obvious, but the truth is that the very best does not always come on the first try. Sometimes, like any

dd to the challenges in developing combination products:

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

good coach, you need to change your starting line up.

Third, use your team’s ability to find the best talent. Good people attract other good people. Do n

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

t be afraid of using your team to investigate a potential candidate. In the end this is a small industry so chances are very good that someone on your team

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

knows someone who knows the candidate or they have had direct contact with them

Fourth, when picking who to lead the team from the partner’s side, you want

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

to find someone who has been a part of several upgrades that have succeeded and failed. That’s right, I said FAILED. As long as they have also been succe

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

Professional from academic institutions, pharmaceutical industries, health care indust

ssful; they will have learned from their failures. When choosing this leader, do not be afraid to ask about their mistakes and what they would have done di

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

ferently. This may save you a trip down the same path.

Fifth, have a plan for knowledge transfer. Don’t assume it will happen, schedule it and insist tha

.

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

it happen. Make sure your team is ready to take over the system when your partner walks out the door.

In the end, the partner is there to lead you throug

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

Companies that provide selfless information through particip

the upgrade or implementation to the other side. Their job is to remove the fear and to help you avoid the pitfalls they have seen other clients fall into

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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Main Subject - My ERP Implementation Was a Failure, Now What? (Part II)

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