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Ever been the guy who is put in to stop the bleeding. The Big Kahuna calls you in and says, “We’re bleeding money on this project. It’s still important. But it’

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

s gotta’ get turned around. You’re the man!” How about that … you’re the man.

It’s happened to me several times. It’s fun, if you know what to do. The first ti

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

Examples of combination products may in

me for me (we always remember our first time) was a huge project for a glamour company I was working for at the time. When a partner and I got the news above we

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

were six weeks from launch of a new handheld computer for route salesmen.

We drove to a nearby office to meet with the team. They proudly displayed a balsa 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

od model. That’s right, a balsa wood model at six weeks before launch. Your kids could write the script on this disaster. The train was careening out of control

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

Combination pro

and all we could do was be there for the crash. When we got the project we were told it was right on the money so, it’s a ‘little’ behind but trust us, the IT

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

Director said.

The launch was a debacle and three days into the field sobriety test the handheld was found quite a bit more than legally drunk. Instead of jail

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

we took our new device and all the folks involved back to the FIT lab, the Field Integration Test lab where it obviously hadn’t been tested. It had been releas

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

ed with 287 known defects. Now there is some serious bleeding.

There were many things to get to the bottom of on this one, the first being the truth. We had no

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

time to build trust and team concepts. The patient was bleeding profusely. We told them this is the chance, the time to come clean. There was no time right now

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

for chasing our tail. We needed to look forward. The people responded. They spilled their guts on the issues.

You have to first get to truth quickly and then d

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

Following aspects would a

o a triage on your situation. A triage is what medical people do when overwhelmed in an emergency. As a Marine sniper in Nam I’ve seen it done many times. It wo

dd to the challenges in developing combination products:

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

rks for projects too. They divide the wounded into three categories. Let’s take a look.

1. The mortally wounded: In this category go the people who regardless

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

of treatment will not survive. They make them as comfortable as possible. Then they direct their attention to other people. On your project turnaround this is t

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

he elements that no matter what you do they aren’t going to work. Make the tough call and stop the bleeding, shut the down.

2. The slightly wounded: In this ca

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

tegory are the people who will survive no matter what. You put them aside until time permits. On your project turnaround these are the parts of the project that

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

Professional from academic institutions, pharmaceutical industries, health care indust

are going fine. Let the leaders of this work know you trust them and to carry on.

3. The seriously wounded: In this category are the people who will die if th

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

ey do not have immediate treatment. You place all your energy and skill here. On your project turnaround these are core elements that have the highest leverage

.

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

for success of the overall work and you dive in here and make the fix.

In turnaround work you must make the tough calls. You must do a triage of the project, c

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

Companies that provide selfless information through particip

ut where you need to and reassign resources to the most critical areas. Leadership is doing just that, making the tough calls. There is no substitute.

Ed Kugle

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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Promoting your company does necessarily mean constantly spending money. There are avenues of public relations that cost nothing more than time, effort, and a little ingenuity.

Employer and interviewers expect you to answer tough question during interviews. Take a few minutes to brainstorm on how you might elaborate on the following answers. The answers you give to these questions that will be asked during your interview will be very important in your career prospects. Suppose you were asked these questions right now. Could you give a good answer?

It is always better not to go into litigation. There are no winners in the litigation except the lawyers. But litigation can be the final that drives into the coffin of a dying company. Be very wary and make sure that all paper work and due diligence are done properly in case of litigation

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