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Just Other Articles - Outsourced Product Development - Rising Phenomenon
Outsourcing today is no longer seen as an option only for repetitive, non-innovative, and non-strategic functions; it is increasingly bei
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
ng evaluated and regarded as a viable option for more strategic business functions. One such area that has seen new and growing interest
; 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
in outsourcing is outsourced
product development.
In the backdrop of speedily changing business environment, stiff competition
In the backdrop of speedily changing business environment, stiff competition
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
and declining market shares, companies have been challenged to expand into new
markets, introduce new and innovative products, and app
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
y the latest product development technology to their development work.
In such highly competitive environment, time to market ha
In such highly competitive environment, time to market ha
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
become the critical differentiator. Companies’ efforts to achieve better time to market have, however, been challenged by following facto
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
s:
- Shorter product life cycles
- Technological obsolescence
- Rapid advances in design and engineering technolo
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
gies
Increasing design and engineering complexity
Necessary infrastructure changes required with new technology applic
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
tion to product development
The cited challenges and the more pressing requirements to innovate and introduce new products hav
The cited challenges and the more pressing requirements to innovate and introduce new products hav
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
only caused product development costs to shoot up further.
Consequently, companies have recognized quickly that working with th
Consequently, companies have recognized quickly that working with th
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
rd party specialists through an outsourcing engagement can help them reduce design cycle times, achieve better time to market, reduce co
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
ts, minimize risks, access the latest technology without owning it, improve return on their product development investment, and, in the p
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
ocess, improve the overall competitiveness of their products.
Major outsourcing driving factors:
Major outsourcing driving factors:
- Cost efficie
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
cy
Focus on core business
Reduce/manage risk
Solve business process issue
Access to technology
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
>
Optimize application investment
Headcount reduction
Transfer management and maintenance
Achieve cost
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
ariability
Asset reduction
Access to global expertise
Derive incremental revenue
Bottom
Bottom
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
Line
Today, outsourcing is no longer seen as an option only for repetitive, non-innovative, and non-strategic functions; it is inc
Today, outsourcing is no longer seen as an option only for repetitive, non-innovative, and non-strategic functions; it is inc
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
easingly being evaluated and regarded as a viable option for more strategic business functions.Factors such as cost efficiency, focus on c
.
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
re business, access to technology, time to market, access to global expertise, among others are the reasons for 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
://www.outworx.com"> outsource product development that leverage quality and development discipline to the product as well.
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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