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Where do we in manufacturing find the “edges” that make or break our profit margins? Where do we make the changes in process, the tweaking, that maximize returns on investments (ROI)? More often than not the edges that reac

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

h both output and quality goals are found in the efficiencies we make in the manufacturing technique. Today, in many job shops, make-to-order, or mixed mode manufacturers, those efficiencies in production are found in the eliminat

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

Examples of combination products may in

ion of waste—a technique commonly referred to as lean. In a lean system the manufacturer seeks maximized ROI by attempting to eliminate the waste of resources commonly found in physical production processes. In effec

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

t, the greatest and most fixed resource available to any manufacturer is that of time, and the control of time is something that we in manufacturing are always striving for.

In the performance assessment of any job or

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

work center set-up, we first need to ask ourselves: Does the ROI justify the time, effort, and cost of leaning a particular process? For example, common sense will dictate that it’s not worth the expense of thousands of dol

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

Combination pro

lars to fix a process that will take a year or more to recover. Indeed, the ROI in manufacturing set-up improvement is directly related to the expected and/or actual use and output of the process. To truly lean a process, t

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

he improvement must be both significant in terms of time and productive in terms of output—a positive ROI. However, as any lean expert will point out, most set-ups can easily be reduced to ten minutes or less.

What, th

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

en, are the factors we must consider when looking to lean a set-up? First, as mentioned, volume of output is a key concept in assessing a set-up redevelopment. How many of a particular component do I expect to make in a yea

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

r? Related is the notion of customer requirements—how often might this process be set-up during this same period? In short, how often will I run the part and in what quantities? It is only in the review of the answers to these que

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

stions that we begin to understand the importance of a particular process to our bottom line. With the awareness of value of a process in these terms, we can then begin to look at these cost in longitudinal terms; that is to say,

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

ur real costs for a particular set-up over time.

It is true that most shops underestimate real hard set-up costs, leading managers to include “soft costs” (e.g., the value of improved customer satisfaction, etc.) to ju

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

Following aspects would a

stify the meager ROI in leaning a process. To truly validate the cost of a set-up, managers should engage a value stream analysis in which every step of the set-up is listed and measured in terms of time spent. Indee

dd to the challenges in developing combination products:

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

d, even the time (and cost) spent in breaking down the set-up on the backend must be included. This data is then compared against the average hours collected in the set-up performance information in the manufacturing database.

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

Of course, there are several more general steps you can take to help in ensure speedier set-ups—all common sense notions that are, surprisingly, overlooked by many manufacturers. In the world of lean we call it the “low h

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

anging fruit”. For example, have a well organized fixture/tooling area. Always have a dedicated place for each fixture and make sure it is clearly identified. If at all possible, create multiple locations within the plant to store

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

fixtures and store fixtures closest to where they are used.

Another great application is the use of shadow boards to place and store fixtures. Shadow boards provide a simple visual cue in the form of an outline or solid shap

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

Professional from academic institutions, pharmaceutical industries, health care indust

e that quickly guide the set-up person to where a fixture should always go after breaking down. Some argue that this could be an expensive undertaking, creating dozens of shadow boards to store hundreds, sometimes thousands

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

of fixtures. However, it certainly cannot be as expensive as having a $25 per hour person walking around for an hour looking for a $10 wrench ten times a week—week in and week out. Furthermore, while the set-up person is in searc

.

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

h of the wrench the machine needing set-up is not producing parts.

Ultimately, the leaning of a set-up, a process, and even an entire work center involves the simple use of what is often the most basic of common sense

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

Companies that provide selfless information through particip

observations. Plan and cost the set-up with realistic scenarios in mind. Remember, in leaning a set-up for a truly maximized ROI is to a large degree the controlling of that highly uncontrollable manufacturing resource—time

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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