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Lean is no longer the propriety process and quality management mantra for manufacturing units. The success of Lean management in manufacturing units was bound to percolate to non-manufacturing processes sooner or later. Needle

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

ss to add, success stories about Lean Office abound with many organizations proactively adapting this technique to cut down wastage (also referred to as muda) of time and material and developing processes which are closely kni

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

Examples of combination products may in

t to give the maximum output. Though Lean processes have been around for quite some time along with other quality processes such as Six Sigma, the interest in Lean Office has been recent due to the increase in the services sec

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

or through out the globe.

Benefits of a Lean Office are very easy to gather. However, if you are still not convinced about the benefits of this quality management system, which has shown huge improvements in offices across 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 world, here are some outlined benefits which can convince you in that direction.

Improves efficiency:

The implementation of lean office processes just does not improve the efficiency of the office marginally, it improves i

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

Combination pro

by as much as 90% in some cases! Such a huge improvement by reviewing the processes and making suitable changes and implementing a revised process is the outcome of the process of Lean Office.

Saves costs:

This is really th

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

e reason why many companies find Lean Office of interest. Improved flow of processes results in both direct and indirect cost advantages to the company. Apart from timely responses which results in better results in the overal

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

l performance of the company, a Lean Office process implementation also results in saving direct input or resource costs.

Identifies the wastes:

And gets rid of it from within the organization is the output of Lean Office pr

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

ctices. Many a times, business managers are surprised by so-called hidden activities which are actually quite wasteful in terms of both time and money but would have never been exposed had it not been for implementation of Lea

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

n Office. Some activities might be being undertaken without planning and a leaner process in place of these activities can get the same and maybe even better results when reviewed.

Simplifies the complex process:

Implementat

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

on of a Lean Office study gets many processes under the scanner and managers can look at them in isolation and simplify them for greater productivity from the same set of resources. If you are wondering how does wasteful proce

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

Following aspects would a

dures get active in the first place then it is not the fault of the employees. Processes are usually built one on top of the other which is why they result in becoming slightly cumbersome and with passage of time, it becomes a

dd to the challenges in developing combination products:

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

nti-Lean Office.

Retains the knowledge within the organization:

Lean Office implementation makes the business manager document each process and results in sections of automation as well. Due to this close scrutiny of process

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

s, high level of dependability from employees is removed and greater stress is paid to the process. Knowledge retention within the organization is then implemented as employees are made to work within the framework and informa

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

tion collation takes place.

Faster customer response:

If an organization is dealing with customers on a regular basis, Lean Office processes help the response time to be shortened phenomenally and responses become very promp

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

. Quicker customer responses can only result in better goodwill generation with customers and subsequently more sales and higher profitability. No one can argue with processes which have such direct impact on the bottom line o

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

Professional from academic institutions, pharmaceutical industries, health care indust

f the company!

Lean also allows you to conform to rules and regulations:

Rules and regulations implemented by various bodies which you need to comply with are made easier to follow when you have it built into the process whi

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

ch you plan to implement. This results in smoother output of regulatory reports and faster turn around time.

Once you are convinced about the value proposition which a Lean Office brings to the table in any organization, it i

.

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

very likely that you cannot imagine an office in any other way. There are some technical processes which helps you implement the Lean Office which might require intervention from experts who are well versed with Value Stream

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

Companies that provide selfless information through particip

Mapping and consultants who can provide inputs on various kinds of process flows which can be implemented in an office as well as various kaizen processes which might not be very well known to the average management consultant

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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