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It always seems to happen when you're in the most vulnerable spot. The worst possible situation, the worst possible place, The worst possible time. The sickening feeling goes through you; you know what is about to happen. You are out...the outcome is inevitable. You're stuck, in a jam. The situation is embarrassing. Your t

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

houghts race. " How could I ever let this happen.? What will I tell others?" Your thoughts immediately begin to focus on recovery. How will you get out of this predicament?

Out of gas? No such thing--you wish you were. You outsourced your parts overseas, you're out of a critical component, and you can't make delivery to

; 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 key customer. So, what do you do? You make something you don't need...to keep the shop busy. Unusual? By no means...it happens all the time...and it's sad, because in this day and age, with all of the tools that we have, MRP, JIT, TQM, CIM, it shouldn't happen. As a matter of fact, in most companies, it's a way of life. Thi

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

nk about it.

Most production schedules in the U.S. today are driven by material availability. What you have in stores or on the receiving dock determines what you produce today. You can regard this as scheduling by default, or.... running on empty.

Water in Our Tanks?

It's not too hard to figure out what's wrong. If

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

you step back for a moment and look at the way that we have organized ourselves over the years: component plants located states and countries away from assembly, corporate purchasing located away from the key hub of activity, spaghetti factory flows to confuse what materials are needed and when,..... poor communications, phy

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

Combination pro

sical walls, functional walls, etc. have all strangulated our efforts to run smoothly. Plus, the results of the way that we work(or don't) with our suppliers drives the rest of the service chain and stifles our ability to deliver quickly and cheaply.

Consider that our tendency in the past has been to get many suppliers to qu

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

ote items on a unit price basis. We order in volume taking unit discounts, then pound our supplier for expedited deliveries. Purchasing's focus has been only on the cost of materials rather than the total operational costs of a company and the effect that product quality and timely delivery have on production costs. The most

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

common practices are supplier "jumping" and price negotiation, which result in a cost escalation beyond any saving that occurred at the purchasing level.

High Octane for the Future

It's no secret that competition is tough and will get stiffer in the next decade, as a global resegmentation of markets emerges. The winn

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

ers and leaders in the 21st Century will be world-class competitors, organized to respond to a dynamic market with precision and unprecedented speed in delivery and new product introduction. Those companies will have refocused and redesigned their businesses--both physically and logically--to meet the demands of the market.

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

This will require a smooth flow of materials and information, and velocity within the service chain: that chain of events that occur from the time that a customer inquires about an order, through complete satisfaction of the order: distribution, assembly, manufacture, and supply. All of the physical events must be enacted swi

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

ftly, accurately, and effectively. The faster parts, information, and decisions flow through the service chain, the faster the response to demand.

Radical Change

To accomplish this, we will need to make some dramatic changes in the way that we work with our suppliers. First, we will need to develop closer, long-term

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

Following aspects would a

agreements to motivate suppliers to make the changes critical to achieving our goals. We should think in terms of working out a mutually beneficial operating arrangement:

• Provide incentives to motivate the supplier to induce velocity within his own facility

• Buy capacity instead of a few parts at a time: negotiate long-t

dd to the challenges in developing combination products:

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

erm agreements with high volume incentive

• Provide forecasts to your new partner with a window with which to operate:
- long-term forecasts to arrange raw materials
- shorter term forecasts to produce longer lead time items
- line schedules to meet your real demand

• Involve your partner in the design pr

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

ocess, he most likely can tell you how to produce a better part

How Radical is Radical?

Physical proximity is extremely important in inducing velocity. Distance makes it hard to respond quickly or to have regular face-to-face contact to form a good solid long-term relationship. We need to physically close the distanc

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

e, locating supply close to component manufacture and assembly. A supply facility should operate as an extension of your own facility; as, a remote cell producing and delivering upon real demand.

Quality must be part of the focus to detect an error as early as possible in the manufacturing process: certification is a goal Th

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

e result should be less rework, less scrap, and less schedule disruption.

To support physical activities, the agile supply chain structure also requires emphasis on velocity throughout, eliminating and simplifying natural points of delay. The supply information chain must be streamlined and electronically linked, so that the

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

Professional from academic institutions, pharmaceutical industries, health care indust

flow is direct--without interruptions and delays--again eliminating queues and excess paper. The supply cycle time must be reduced to the time it actually takes to efficiently process information, supporting the fast movement of physical parts, and not inhibiting them.

Good Mileage For Your Efforts

In turn, you shou

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

ld require the changes that allow you to induce velocity and lower cost in your facility, and operate as planned, and not by shortage:

• Improved cost targets
• On-time JIT deliveries to the point of use
• Exact delivery quantities
• Supplier certification for consistency in high quality
• Packaging in ne

.

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

gotiated quantities
• Long-term Contracts
• Minimal paper(electronic releases, instead)
• Reduced lot-sizes

The vision of future supplier relationships with the agile supply chain is one of a strategic alliance that promotes a mutual objective: satisfying the supply chain as quickly as possible. Working han

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

Companies that provide selfless information through particip

d-in-hand, these partners will be world-class competitors, organized to respond to a dynamic market with precision and unprecedented speed in delivery and new product introduction. Each company will be developed uniquely to suit its particular needs, but one characteristic will fit them all--they won't be running on empty

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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