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Main Subject - Outsourcing Strategies and Trends
Outsourcing was the topic in the 1990's and quite frankly it was a feared discussion. Outsourcing was introduced to business as a way to take cos
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
t out of the daily operational budget. Quickly, outsourcing rose to be viewed as a possible partner to application development, marketing and lab
; 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
or augmentation. Early in the 1990's and even now we see it morphing it's way to become more and more transparent within companies in the Fortune
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
500 and below. Examples of new and innovative thought leadership regarding outsourcing is emerging every day at companies like CISCO™,IBM™, AT&T™
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
etc.
When outsourcing first became relevant it was viewed from two distinct directions. Fear and hope depending which side of the bench you happ
When outsourcing first became relevant it was viewed from two distinct directions. Fear and hope depending which side of the bench you happ
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ened to be deployed. As an employee the trend was to fear the word but as a shareholder it became something of a competitive weapon and earnings
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
per share friend going forward. If you could move operational requirements to another company/service provider and still get the same quality and
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
service level agreements the logic flowed that this was a good practice to endorse and clearly use to hold back rising costs. Quickly the compani
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
es that offer outsourcing like:
EDS™ IBM Global Services™ CSC™ Northrop Grumman™ etc
began to look at market
began to look at market
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
ing tiers to strategize their domain expertise. Today, you see defense contractors like Northrop Grumman, Boeing and others providing complete tu
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nkey operations from staff augmentation to full lights out support for Cities, Counties and State government requirements. A natural branch to th
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
eir traditional Federal markets bread and butter. If they can build a B2™, 777™ or and F/A 18™ I'm sure they can lend a helping hand to both Stat
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
e & Local government as well as the commercial markets they are trending to. Of course, they must measure up and early deployments on outsourcing
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
were mixed from a scorecard perspective. Actual savings, depending on the PowerPoint/excel spreadsheet, were generating lots of second glances a
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
to whether or not outsourcing was providing as advertised. This was a double edged sword too. The very companies providing the outsourcing were
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
often caught up on post sales implementation challenges not always anticipated nor covered in their original bids. This is the ouch in outsourci
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
ng. On the one hand you have the customer is king attitude and on the other you have a contract/agreement whereby both parties signed up to a del
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
verable. But, given the exposure politically the two sides would venture off the agreement to preserve the integrity of their announced relations
.
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
hip and try and work it out. This is where the separation of powers collapsed around the profits and loss on a budget. We will have more on this
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
topic in later updates regarding outsourcing as it is truly stabilizing across niche markets with varying degrees of success and challenges.
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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