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Main Subject - ROI and Six Sigma - Improve Your Bottom Line!
Very easily, Six Sigma is your best bet for maximizing return on investment, more so in troubled economic times. However, the success of implementation depends much on its
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
achieved degree of alignment with the problems. Ifs and buts not withstanding, there are stories to support both sides of the issue. First let’s consider the negative sid
; 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
e of the story.
Why Do We Hear Failures To Achieve Projected ROIs On Six Sigma Investments?
We hear failure stories not just because they are reported but because they o
Why Do We Hear Failures To Achieve Projected ROIs On Six Sigma Investments?
We hear failure stories not just because they are reported but because they o
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
cur. Now, why do they occur so much as to be heard in the open? The first reason any practitioner can give is the lack of support from the top management. Considering long
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
implementation periods, commitment levels sometimes wither away and consequently the effects percolate down the line of the organization. And project implementation turns
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
into a ritual exercise. The claims of $1 million per Black Belt in ROI can appear more and more unrealistic.
It is not enough to blame top management alone. Champions and
It is not enough to blame top management alone. Champions and
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
Master Black Belts on their parts could scale down the projects that result in slashed expenses. High returns can be realized in this scenario by driving projects initial
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
ly through the internal market to gain much-needed support. Things are subjective to multiple aspects but a complete turnaround is not impossible.
What Critical Factors H
What Critical Factors H
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
lp Bring About Satisfactory ROI?
There are three more critical factors barring project selection that play a role in ROI. Obviously, these are:
1. Lowering the investmen
There are three more critical factors barring project selection that play a role in ROI. Obviously, these are:
1. Lowering the investmen
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
t
2. Maximizing the returns
3. Reducing the time to return
But things are more complex than meets the eye! Interrelated variables such as quality of personnel a
2. Maximizing the returns
3. Reducing the time to return
But things are more complex than meets the eye! Interrelated variables such as quality of personnel a
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
d training, support of management and magnitude of the opportunity, function in unison. Apart from these, aligning the management (and stakeholders’) initiatives to the Si
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
x Sigma initiatives must be given due importance. All good programs will launch from a project on revenue maximization that potentially becomes an instant hit.
How to Mea
How to Mea
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
sure ROI in A Six Sigma Initiative?
Return on investment simplistically means the cost of implementation over time compared to return for the corresponding period after d
Return on investment simplistically means the cost of implementation over time compared to return for the corresponding period after d
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
scounting inflation and risk adjusted rates. For reasons of practicality, return on investment is measured in terms of hard and soft returns. Hard returns are those which
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
are tangible and can be measured; for example, the savings achieved on reduced personnel and wastage. Whereas soft returns are mostly intangible like the advantage derived
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
from the reduced cycle time.
Soft returns vary hugely from company to company and from project to project, unlike hard returns, which are measured almost by the same yard
Soft returns vary hugely from company to company and from project to project, unlike hard returns, which are measured almost by the same yard
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
stick universally. So clearly, the soft returns are relative in nature, depending on accepted interpretations at that time, thus making quantification a difficult exercise
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
. Errors in calculation of reduced capital employed or cost of financing leaves tremendous room for debate.
As a rule, most successful companies don’t differentiate betwe
As a rule, most successful companies don’t differentiate betwe
.
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
n hard and soft returns. What is more interesting is the recurring returns in terms of all around savings. Add to it the value creation by increases in the growth rates an
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
d defeating competition, which all result in higher shareholder value.
More sophisticated tools such as Economic Value Analysis may help quantify intangible value created
More sophisticated tools such as Economic Value Analysis may help quantify intangible value created
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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