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Advice You - How To Recognize Bottlenecks In Six Sigma Implementation
Identifying Six Sigma roadblocks and bottlenecks is essential for eliminating them for effective deployment and to reap the benefits of applying advanced versions o
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
f Six Sigma for higher productivity. Of late, Six Sigma professionals are increasingly identifying bottlenecks. The dawning of the reality that the voice of the cus
; 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
tomer is a ‘moving target’ has posed challenges in the face of growing competition. But this is not to say that there are no bottlenecks on the implementation side.
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
Six Sigma Bottlenecks
One major bottleneck in Six Sigma deployment can be attributed to errors in decision making which invariably leads to higher COPQ. The bott
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
enecks are critically different for small and companies from large corporations because of their contextual differences. Further, they may result from any or all ph
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ases of the deployment process.
Bottlenecks In Low Cost Deployments: Often, small and medium sized companies take to Six Sigma circles with limited resources and a
Bottlenecks In Low Cost Deployments: Often, small and medium sized companies take to Six Sigma circles with limited resources and a
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 a consequence, expose themselves to additional limitations.
• Owing to resource limitations, human and financial, more personnel are often found working overtime
• Owing to resource limitations, human and financial, more personnel are often found working overtime
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
• Difficulty in hiring the Belts on a full-time basis due to reasons other than financial; for example, uncertainties including the commitment to deployment
• Que
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
stion of survival of the business owing to lack of innovativeness in product or service development and introduction to the market
• Procrastinating over decision-
• Procrastinating over decision-
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
making on capital expenditures even against justified ROI projections
The above roadblocks result in problems such as:
• Non-availability of methods and tools req
The above roadblocks result in problems such as:
• Non-availability of methods and tools req
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ired for efficient and timely Six Sigma deployment
• Risk of generating outdated, irrelevant and incompetent solutions for re/design and development of product or
• Risk of generating outdated, irrelevant and incompetent solutions for re/design and development of product or
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
service
• Prolongation of project cycle time
• Expensive errors at the early stages triggering a series of multiple errors
Overview of Bottlenecks Arising From D
• Prolongation of project cycle time
• Expensive errors at the early stages triggering a series of multiple errors
Overview of Bottlenecks Arising From D
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
eployment Phases
Poor selection of projects is often found to be the biggest stumbling block. Let’s take a critical look at this:
Define Phase
o Lack of options
Poor selection of projects is often found to be the biggest stumbling block. Let’s take a critical look at this:
Define Phase
o Lack of options
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
for potential changes or innovation
o Underestimation of subsequent secondary problems
o Lack of failure analysis
o Unclear definition of alternative causes and
o Underestimation of subsequent secondary problems
o Lack of failure analysis
o Unclear definition of alternative causes and
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
ffects
o Failures due to wrong direction and narrowing of scope
Measure Phase
o Variability of measurement or lack of measurement systems
o Time lost in data
o Failures due to wrong direction and narrowing of scope
Measure Phase
o Variability of measurement or lack of measurement systems
o Time lost in data
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
collection
Improvement or Design Phase
o Shortcomings in innovative design improvement ideas
o Unjustified consumption of DOE by labor and time
Control or Verif
Improvement or Design Phase
o Shortcomings in innovative design improvement ideas
o Unjustified consumption of DOE by labor and time
Control or Verif
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
ication Phase
Failure to simulate design and prototype against the ‘voice of customer’ resulting in poor and non-exhaustive failure projections and profiles can be
Failure to simulate design and prototype against the ‘voice of customer’ resulting in poor and non-exhaustive failure projections and profiles can be
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
mostly expected in this phase.
What immediately gets affected by the bottlenecks are not just time losses but a newfound increase of COPQ. Other pitfalls include r
What immediately gets affected by the bottlenecks are not just time losses but a newfound increase of COPQ. Other pitfalls include r
.
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
epetitive idea and data collection, never-ending discussions and meetings and examining alternatives that significantly hamper the outcome. All of these factors so
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
metimes push the Six Sigma methodology to the threat of losing support for future deployment plans. Error removal, even if not routine, must be practiced inherently
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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