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Digg It - Superior Performance: What's Holding Your Organisation Back?
Business Process Revisited:
We have previously defined a business process as a sequential series of interrelated tasks triggered by an event, and undertaken to provide valued outcomes to customers.
Dependent Activities - Critical Chai
We have previously defined a business process as a sequential series of interrelated tasks triggered by an event, and undertaken to provide valued outcomes to customers.
Dependent Activities - Critical Chai
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
n:
When we combine the ideas of sequence and interrelatedness, we reach the conclusion that the process steps are dependent on one another. Subsequent steps cannot be carried out until prior steps have been done.
Statistical (i.e. unpredictab
When we combine the ideas of sequence and interrelatedness, we reach the conclusion that the process steps are dependent on one another. Subsequent steps cannot be carried out until prior steps have been done.
Statistical (i.e. unpredictab
; 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) Fluctuations:
Almost every business process contains statistical fluctuations. While average figures can be given for the time it takes a call centre representative to resolve a customer issue, or the hourly production of a manufacturing line, or t
Almost every business process contains statistical fluctuations. While average figures can be given for the time it takes a call centre representative to resolve a customer issue, or the hourly production of a manufacturing line, or t
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
he time it takes a restaurant to serve a dinner, in each of these cases, the actual value can vary widely around the stated average. To appreciate the nature of fluctuations, consider a die thrown a large number of times. While individual throws will vary from 1 to
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
6, the average outcome will be 3.5. Stating the average throw as 3.5 masks the wide variation in actual outcomes.
Constraints:
The dependent nature of process steps creates enormous leverage when considering improvements. Like a chain that is
Constraints:
The dependent nature of process steps creates enormous leverage when considering improvements. Like a chain that is
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
only as strong as its weakest link, the process throughput is wholly determined by the capacity constrained resource. The speed of a marching file of soldiers depends on the speed on the slowest man. There are two main types of constraints. These include physical
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
space, time, capability, market) and policy constraints.
The combination of dependent processes and statistical fluctuations leads to escalating work in process inventory (where an internal process is the constraint) or finished goods inventory (where the market d
The combination of dependent processes and statistical fluctuations leads to escalating work in process inventory (where an internal process is the constraint) or finished goods inventory (where the market d
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
emand is the constraint), and eventually lower throughput.
1. Locating Performance Constraints:
The foregoing discussion makes it obvious that the only way to improve the performance of a system is to improve the performance of the constraine
1. Locating Performance Constraints:
The foregoing discussion makes it obvious that the only way to improve the performance of a system is to improve the performance of the constraine
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
resource. The first step in improving the process is to identify the constraint. For each value chain, there can only be a single constraint at any time (weakest link in the chain).
To identify a constraint, simply ask, "What is it that limits the system throughp
To identify a constraint, simply ask, "What is it that limits the system throughp
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
ut? What limits the amount of money we make? What stops us from satisfying the entire demand? Where do we find inventory piling up?" Assume you were to attempt to gradually increase throughput from zero by increasing the inputs into the process. The resource in fro
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
t of which you begin to have a significant and sustained build up of inventory is your constraint.
2. Exploiting Performance Constraints:
Having located the constraint, the next step is to exploit the constraint. This means optimising the per
2. Exploiting Performance Constraints:
Having located the constraint, the next step is to exploit the constraint. This means optimising the per
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
formance of the system based on a proper understanding of what is going on. According to Goldratt, inventor of the Theory of Constraints, most constraints that at first glance seem to be physical, on closer examination turn out to be the result of invalid assumptio
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
s and harmful policies. For example a change in product mix (arising from a change in policy) could significantly increase throughput (revenue less costs) obtained from a given production facility, even with the same constraints intact.
The constrained resource mu
The constrained resource mu
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
st operate at or close to full capacity at all times. Non-constraints must then operate at a level of capacity utilisation necessary to only supply the requirements of the constrained resource. Anything more creates unnecessary work in process inventory and reduces
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
throughput.
3. Subordinating Everything Else to the Above Decision: All policies and decisions must align with a proper exploitation of the constraints. For example having decided on the product mix which maximises throughput, the reward system f
3. Subordinating Everything Else to the Above Decision: All policies and decisions must align with a proper exploitation of the constraints. For example having decided on the product mix which maximises throughput, the reward system f
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
or the sales force must not encourage sales persons to push a different mix.
4. Elevating the Constraint:
At the last step, we have obtained as much improvement as we can without any added investments. The next step is to turn the constraint
4. Elevating the Constraint:
At the last step, we have obtained as much improvement as we can without any added investments. The next step is to turn the constraint
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
nto a non-constraint by increasing its capacity. For physical constraint, expense or investments may be required to elevate the constraint. To elevate a policy constraint will require a different sort of investment - that of political capital.
5. Return to
5. Return to
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Step 1 while Avoiding Inertia:
Once a constraint is broken, by definition a new one is created. Thus we must return to the first step of identifying the constraint.
It is important to avoid inertia at this point. According to Goldratt, a number of r
Once a constraint is broken, by definition a new one is created. Thus we must return to the first step of identifying the constraint.
It is important to avoid inertia at this point. According to Goldratt, a number of 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
les and policies are in place in the system that is consistent with the existing set of constraints. Once any of these are broken, then the underlying assumptions for these policies should be examined to determine their continuing relevance. Otherwise, these polici
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
es through mental inertia, become constraints in themselves. To continue our previous example, the breaking of a constraint may dictate a new product mix to exploit the new constraint, and a new reward system to align sales force behaviour with the new requirements
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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