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Advice You - Purchasing Outsourcing
Businesses compete in the real world with core competency. The core competency can be, for instance, excelle
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
nce in design and low cost manufacturing. The purpose of businesses is to satisfy customers. Businesses, wit
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
h its number of functions and process flows, have to add value to the product in order to satisfy customers.
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
The satisfaction of customers is attained by providing value for money experience.
The value addition in e
The value addition in e
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ach stage of the process flow is dependent on the cost of that particular process and the perceived value ad
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
dition. If the cost exceeds the perceived value or the perceived value is not significant, businesses have t
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
o look at that process. Outsourcing is one of the ways to solve a business problem. It is a process by which
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
a process flow is given to the third party, thereby utilizing the resources for any other value added activ
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ity.
The value addition in purchasing depends upon the criticality of the items purchased. In the Bill of M
The value addition in purchasing depends upon the criticality of the items purchased. In the Bill of M
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
aterials, usually 80% of the items are recurring and non-critical. The remaining 20% of the items are critic
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
al because of their high cost-low volume nature, which means large inventories are not necessary. In industr
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ies such as automobiles, where early stage supplier involvement is necessary for design and modular manufact
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
uring, outsourcing of purchasing will not make sense.
Outsourcing saves cost by eliminating costs of purcha
Outsourcing saves cost by eliminating costs of purcha
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
sing such as processing and labor costs. This is possible for the third parties because their core competenc
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
y is in purchasing and they excel at it. Some of the outsourced activities are proposal management, contract
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
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
management. Proposal management includes preparing proposals, bids and qualifying bidders by inviting bids
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
for projects. Contract management helps manage third parties who provide non-critical items such as office s
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
upplies, prepare contracts and negotiations.
Outsourcing works well in private as well as government enterp
Outsourcing works well in private as well as government enterp
.
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
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
rises. Most of the service providers have consulting services and purchasing services. Their fee structure i
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
s based on flat management transaction fees and/or retainer fees plus profit sharing on the savings accrued.
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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