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IN PART 1 of this two part article, we looked at Quality of the Product and Friendliness of the Service. In Part 2 we will consider alignment to particular requirements, responsiveness to needs, ability to deliver to schedul

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

e, and cost to the purchaser. Let’s get started.

ALIGNMENT TO REQUIREMENTS

A big part of competitiveness is found in the alignment of the product to the customer’s requirements -- if it does what it’s supposed to do, they’

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

Examples of combination products may in

e gonna consider buying it. This was discussed back in Quality of the Product, but it also means that you, as the producer, have to consider needs that the customer has in keeping his/her own costs down. You will have done

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

that, of course, when you set up initial sales with the client, but it should be done on an ongoing basis, too.

RESPONSIVENESS TO NEEDS

Do you know what your customer is dealing with, and what new challenges are being faced

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

by that company? Worthington Steel, based out of Columbus, Ohio actually makes it a point to send front line staff out periodically to client facilities to see how the product is being used. What good is that? It allows W

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

Combination pro

orthington to make small changes in either construction or delivery that mean a big difference to the client. And often it’s ONLY the front line staff who can identify these types of requirements – sometimes the client doesn

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

t even know the opportunity is there. Staff can recognize this, and bring the ideas back to your plant where changes can make your product even more valuable to the client. What’s the outcome? Let’s look: Worthington is a

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

leading diversified metal processing company with $3 billion in sales, and 8,000 employees in 63 facilities. You can review their results at www.worthingtonindustries.com.

Get your staff involved in improving your responsiv

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

ness to customer needs.

ABILITY TO DELIVER TO SCHEDULE

Believe it or not, this is the area where an American company has the best opportunity to compete with offshore. Here’s why. When production is moved to another count

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

ry, the lead time on getting that product back here to the U.S. moves to an average of 8 to 10 weeks. That’s 2 ? months, most of which is transportation and loading time. And here’s the kicker – all of that new product has

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

o be inspected. Now that may not sound like a big deal, but if your client is bringing a shipload of new product in (which is often necessary to keep transportation costs manageable), the inspection time alone is a very sign

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

Following aspects would a

ificant investment in time and manpower. And what happens if something is wrong? THEN there have to be plans and facilities in place for either shipping it back OR for fixing the problem back to spec. Can you honestly say

dd to the challenges in developing combination products:

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

here isn’t opportunity here for you to provide a much more competitive product? American companies should be able to very significantly reduce lead times; and errors in manufacturing can be much more quickly rectified when t

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

hey do occur.

COST TO THE PURCHASER

This is the second area of great opportunity for you, the producer, because it has to do with your cost of production – something that is mostly within your control. Now you will holler

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

hat you can’t control the cost of supplies and labor. But the fact is that you CAN control the cost of production, and there is very often ample opportunity for improvement here. Have you used the four process mapping appro

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

aches? Do you know where in your line the value and non-value steps are? Have you applied the Lean principles relative to the Five Ss, Preventative Maintenance, and Predictive Maintenance. Most business owners have at leas

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

Professional from academic institutions, pharmaceutical industries, health care indust

put these last three in place, but often a systematic review of processes has not been done – and there is a lot of opportunity in process mapping! Edwards Deming felt that as many as 70% of process steps are waste steps, a

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

nd identifying and eliminating them can drastically reduce your cost of producing a product. This is a prime area for investment in outside help, because the return on investment potential is so high. Look into it, you will

.

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

not be sorry.

IN SUMMARY…

There are six areas where a domestic company can improve its competitiveness with offshore. They are:
1. Improving the quality of the product
2. Improving the friendliness of the service

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

Companies that provide selfless information through particip

3. Securing better alignment to customer requirements
4. Enhancing responsiveness to customer needs
5. Providing better delivery to schedule
6. And reducing cost to the purchaser through Lean applications

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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