Main Subject - Business

We must first emphasize that here we are talking about outsourcing CAD projects, which is significantly easier than outsourcing software development or IT services (earlier articles of mine have explained why).

This article also assumes that selection of the CAD

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

providers has been completed with due diligence (the methods are described in an earlier article).

As I mentioned in those prior articles, one of the most important ingredients for successful outsourcing is management of the ongoing project by you, the client.

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

Examples of combination products may in

o quote from those articles (here 'outsourcer' means 'provider'):

"This may sound obvious, but probably the biggest stumbling block to offshore outsourcing is that after all the contracts have been signed, companies abdicate responsibility for projects to

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

he provider..."

--- Deepak Khandelwal, McKinsey, Worldwide

TASKS IN OUTSOURCING MANAGEMENT:

(1) You have to assume moral responsibility for the project.

A very senior executive should be made the champion of the CAD project. S/he will need technical and

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

administrative people to help with the project, and these people should be informed of their induction explicitly. Let's call this group of people "the task force".

(2) The task force should define the objectives of the proposed CAD outsourcing.

Subjects to add

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

Combination pro

ress:

Which input documents will you be giving the provider? (Consider rough, dimensioned sketches, specifications and photographs of included objects, written instructions on what you want in the output, libraries of CAD symbols, design rules for elem

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

nts not in the libraries of CAD symbols, drawings or sketches showing how the objects in the target area interface with the immediate environment, sample output documents).

Which CAD platform do you want the work done on?

Which output documents to you e

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

pect?

What is the weekly project schedule?

At what interval do you want the provider to send you the work in progress?

What is the procedure for acceptance of the product?

What is your payment schedule?

What is the payment method? (Check,

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

credit card, wire transfer?)

(3) The task force should put the above documents into a contract.

The contract should also contain non-disclosure clauses. The provider should sign and return the contract.

(4) Put robust communication mechanisms in place.

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

Email is fine provided mailbox capacities are large. Without a doubt the provider should have a broadband connection, and if your CAD files are large and frequent, so should you.
Instant messenger programs are good for discussion sessions.
Fo

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

frequent large volume transfers, one of you should have an ftp server.

If voice communication is required, try Skype (free).

Both you and the provider should have access to a scanner for digitizing sketches.

You must also have each other's postal

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

Following aspects would a

ddress and telephone numbers.

(5) Have a procedure in place for conflict resolution.

(6) As far as possible, do not let go of existing staff because you are outsourcing.

Identify unfulfilled skill needs in your organization when you first think of outso

dd to the challenges in developing combination products:

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

rcing. Explain to the relevant staff that you plan to outsource and that you will train them in those skills. If nevertheless some want to leave, they are responsible for their departure and not you.

(7) Be ready with support services and materials for your prov

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

iders.

For instance, you might have to send the provider files that are in a format for which they do not have the opening application. You should have the software and staff to convert the document into a format compatible with the provider's applicat

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

on.

At the beginning of the exercise, the provider will typically have many technical questions. The task force should include staff whose time is specifically reserved for providing the answers.

Be readily available to help as much as you can. This bui

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

ds confidence in the provider's mind as well as a relationship between you and the provider.

(8) Develop a partner relationship with the provider.

You should be partners in achieving the overall goal... this could be cost reduction, process imp

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

Professional from academic institutions, pharmaceutical industries, health care indust

ovement, more time for your core business, expertise, flexibility and so on.

Discuss this goal with the provider, ask for their views and treat them like a department of your company.

More research facts: In the first year, the important issues are the

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

contract, performance measurements and relationships (in that order); by the third year, it's performance measurements, relationships, the contract.

(9) Budget for the outsourcing exercise.

Use this valuable observation to help you plan:

" ... end

.

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

users engaged in outsourcing indicate that, on average, users spend from 5 to 12 percent of the total contract value on managing the relationship"

--- The Yankee Group (in a recent study)

CONCLUSION

What we've just described represents the late

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

Companies that provide selfless information through particip

t thinking on managing a CAD outsourcing project.

The ideas are state-of-the-art and custom-made for today's world.

We hope you use them and that thereby your business experiences a significant increase in efficiency, earnings and competitiveness.

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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