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Every growing and even some stagnant door and window manufacturers and their suppliers are constantly striving to develop new products and / or services, so they say. These new products are often develop

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

ed in the manufacturer’s facility by a team including sales, marketing, distribution and manufacturing personnel. Some companies have new product development teams while others have a new product develo

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

Examples of combination products may in

pment manager. Regular meetings are held to decide which products merit new tooling / purchasing and eventually going to market.

The process usually begins by the sales team asking for a product they s

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

aw on a competitor’s product, and without which they will be at a competitive disadvantage. This isn’t really new product development in its true sense but rather “copy product development.” Generally

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

speaking there are no patent infringements, and suddenly the new “copy” products are part of the market ante that every manufacturer has. There was no margin or sales lift to the manufacturer or any oth

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

Combination pro

er players in the distribution chain, and in fact, the new “copy” product is soon a non-issue.

Some firms are becoming more inventive and really starting the new products process where it should start –

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

in the market. Does this mean that persons with new product development titles and engineers should go way? Not at all. But in most companies in this fenestration business, they should be redeployed.

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

As anyone sits down to write a great novel or make a great meal, they need and are influenced by factors outside of their office or kitchen. These factors can not be experienced surfing the web or spe

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

aking over the telephone with field contactors (sales persons). They have to be seen, smelled, evaluated, tried, retried and finally established as something that is truly going to make a difference and

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

provide the manufacturer and their customer a competitive edge. A sustainable competitive edge places a company as “top of mind” in the markets they serve for at least 6 months, until the copy innovato

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

s do their thing. Manufacturers can make the copy process more difficult and longer by making the copier’s entry fee higher.

More and more true innovators are conducting market research at job sites, c

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

Following aspects would a

onsumer’s homes and retailers to discover what the market wants, needs and is willing to pay for. Making installation easier and better is one place where the window and door industry is starting to gra

dd to the challenges in developing combination products:

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

sp the concept, and in some cases this is paying large dividends. Some manufacturers of windows and doors are even installing their products in new builds. Some are even installing in remodeling or rep

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

lacement applications. What is the upside? Fewer product warranty claims since the install is “factory installed,” window packaging is removed from job sites cutting down on the contractors waste bills

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

. These services were not developed in the factory. They were developed through field observations known as ethnographic studies, focus groups and one-on-one discussions and were fined tuned through a

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

process called triangulation.

Ethnographic research is the same thing as the late Diane Fossi did when she observed the great apes. Teams including a qualitative researcher, new product development per

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

Professional from academic institutions, pharmaceutical industries, health care indust

son and an engineering / manufacturing person conduct between 12 and 16 in-field observations. One may ask…”do I need an outside qualitative researcher?” An outside researcher brings no bias to the eff

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

ort. If only company people are involved, the entire process is likely to be compromised.

Next ideas and products are tested through focus groups, and more one-on-one discussions. This may need to be

.

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

repeated several times to get the right product for that competitive advantage. The immediate reaction by most company leaders is this process is too expensive. But wait! How many new products did not

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

Companies that provide selfless information through particip

work out and how much money was spent on those in marketing and manufacturing efforts?

That’s triangulation. Conducting several tests to discover and zero in on where the competitive advantage truly is

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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