Main Subject - Business

Imagine a river. Then visualize all that the river carries with it. Apart from the water and fish, there are other elements which form the river. Processes are very much like a river. They flow in a natural direction and carry informa

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

tion with them from one point to another. The process of Value Stream Mapping is a by product of the Lean Manufacturing process pioneered by Toyota and the core fundamental is to identify the areas of waste which can be avoided within

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

a manufacturing or office process. Apart from identification, Value Steam Mapping also helps streamline the process for higher productivity. Developing the Value Stream Mapping for any organization is a very scientific process. If yo

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

u plan to implement the Lean Manufacturing quality system in your organization, you will need to employ consultants who specialize in Value Steam Mapping.

Method to Map the Value Stream:

The first steps in this process are to map th

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

e current flow of the various flows of production and supply. A detailed analysis will give you a flow chart for various departments on how communication, information, or goods flow from one end to the other. This requires inputs from

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

various business heads as well as floor managers. Once this is done, a documentary chart of the organization’s flow is ready to be analyzed. It is required that the information also maps the quantities of items in this flow chart as

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

that is the key to identify where wastes or inconsistencies are happening. Apart from quantities, the diagram also requires time inputs.

The diagram put together to map the current state of Value Stream Mapping has some specific icon

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

s which highlight the various processes. A thumb rule is that the more complicated looking the diagram, the higher level of simplicity is desired by the organization.

After the present status has been mapped the next step is quite lo

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

gical. Lean Manufacturing Consultants that review each step with the management and identify areas of waste and how these can be smoothened out and optimized for greater productivity. This evaluation and implementation of revised proc

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

edures is known as Future State Value Stream Mapping. A number of methods can be used to optimize processes here. A good match has to be found between the method and industry.

Cellular Manufacturing is one of the methods which can be

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

applied during the development of a future Value Stream Mapping process. Though the concept is simple, the implementation has to be done with adequate planning and with the correct definition of a cell.

Takt Time is a measurement whi

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ch is required to evaluate the lead time in the manufacturing process and is useful when implementing Lean Manufacturing processes. Takt time is even more critical in time bound deliveries of services or products.

Kanban is a method

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

of measuring movement of goods within a system and is probably most used in the case of a retail outlet. One of the most popular terms in quality control and business process management circles is Kaizen which signifies constant impro

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

vements which can be done to a process in order to make it work more efficiently. Though Kaizen is a process, it can be so ingrained in an organization that it can become a way of life within the organization. The above terminologies

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

are all related to the Lean Manufacturing process though they may be used loosely to describe various types of business thinking in organizations and offices.

Value Process Mapping has been found most effective is large assembly line

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

manufacturing processes and one of other most commendable products are cars. Toyota has adapted kaizen to a large extent and can boast about their cars being very high on the technology scale while keeping a check on the costs of man

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ufacturing. Other leading car manufacturers such as Ford are also on the same page when it comes to quality control and process improvement.

However, Value Stream Mapping cannot be the only item in consideration when it comes to impl

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ementing Lean Manufacturing. VSM is more of a technical tool, where Lean Manufacturing is almost like a culture within an organization. VSM terminologies are also more concentrated towards the automobiles industry and non-auto industr

.

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

ies may get a bit confused when implementing VSM word by word. Some consultants feel that though VSM is a required procedure, it might sometimes be over-hyped by people and the benefits may be exaggerated to a large extent.

VSM also

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

requires detailed training within the organization to make it effective. In case you are planning to implement Lean Manufacturing in your organization, Value Stream Mapping will continue to form an important part of the entire process

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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Merchants and providers of services should be in the market to make money: as much money as possible.

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