Advice You - Business

These days subcontracting, especially in IT, became very common. While I don’t say subcontracting is always a bad thing, it can’t be negated that sometimes it fails. Why is it so? I have several examples 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

o share.

Credibility

We outsourced development of a piece of our proprietary application framework. Guys who took the project were considered as gurus but there were some problems with m

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

Examples of combination products may in

eting deadlines by them earlier. A risk which can be managed. We made a negotiation session, agreed on functionality range, price and deadlines. Then I stated that we want to add statement saying about for

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

feits, if they don’t meet the deadline. Their answer was that they actually could agree but cutting two third of planned functionality. Their credibility went out and hasn’t ever been seen after that.

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

ong>Pricing

Another company developed some software for us. We wanted to add internationalization and the easiest way to do that was to outsource the work to the authors. They should exactly know

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

Combination pro

what had to be done -- hey, they were the authors. Our team didn’t really have a time to take over the code then so they had really strong negotiation position, although they didn’t know about that. Howeve

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

r, first price they gave was reasonable. When they doubled it I didn’t considered it as fair any more, but still wanted to give them the task. Then they tripled the price and rejected to lower it even for

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

buck. That was enough for me. They haven’t earned anything.

Responsibility

A guy was doing some small tasks in one of our projects. His only motivation was to get the money. He did know

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

he wouldn’t support his pieces of code in the future. He did know he would be done after implementing his changes and software running several days without any issues. However, he didn’t take the effort t

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

do his job even fairly. He finished when it looked it could work, and cut the contact (excluding reminding us about money we should pay him). It took a week to clear all crap he developed, as he rejected

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

o correct it by himself. It took many hours to achieve agreement how we should account for his job. It would be few times faster and cheaper if we did it by ourselves.

Cooperation

We had

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

Following aspects would a

a big and important subcontracting company, which was doing a lot of good stuff for us. Whole cooperation was built on some personal contacts and worked rather well. Guys were considered as our mission im

dd to the challenges in developing combination products:

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

ossible team. At least that was the opinion when I joined the company. No one asked if they met the deadline -- it was agreed by acclamation. However their intrinsic motivation to cooperate with us expired

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

. I can guess the reason, yet I can’t be sure about that. Nevertheless after several months it appeared that their effort is much lower and their will to cooperate in the future disappeared. We were planni

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

g another couple of projects to partially outsource to them and we were lucky that we won only one of them. They took it but quality of cooperation was systematically going down and brought some unpleasant

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

situations for both sides.

Attitude

Another project and another subcontractor. Just a piece of code, rather not repeatable. Small risk. But still, there is some. Subcontractor changed hi

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

Professional from academic institutions, pharmaceutical industries, health care indust

s attitude and stopped any cooperation. Another time, I can guess why he did that and he can hardly be blamed for that. However, when a customer asked us for some changes we had to do a lot of archeology w

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

thin the code. Nothing pleasant. Especially when you have some important things to do and you’re not willing to reject your customer.

That’s probably not a full range of reasons why sometimes subcontracti

.

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

ng fails. As I stated on the beginning, that’s not a list which is intended to convince anybody to reject outsourcing at all. That’s rather a list of risks. You can manage them and it doesn’t have to be re

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

Companies that provide selfless information through particip

igning from subcontractors in every case. Often it’s enough to remember that subcontracting brings some additional effort, especially for project and program managers and it’s not a panacea for every issue

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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