Advice You - Business

One of my favorite moments on any project is the moment when, after spending hours investigating a process, an exhausted interviewee gives an exasperated gasp and says “Well,

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

that’s the way we’ve always done it!”

Most companies with a long and storied corporate history have a similarly colorful story behind their internal processes. System limita

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

Examples of combination products may in

ions, management fads and product introductions have shaped everything from invoice generation to marketing campaign design. In many instances, over a matter of time these pr

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

cesses become a source of pride, and are even seen by some as a source of competitive advantage. People in the company that know the nuances of these processes, and are able

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

to “finesse” a new product or management dictum into the confines of the current practice are highly regarded, and many an intelligent person is relegated to hammering square

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

Combination pro

egs into round holes, albeit to much acclaim.

When a new system is implemented, there is a golden opportunity to simplify and redesign processes. Unfortunately this chance 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

start anew is overlooked, and much effort is expended to once again find creative ways to maintain self-inflicted problems. While competitors apply innovative talent to thei

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

r product and service offerings, companies implementing new systems spend their creative efforts maintaining rather than redesigning. Whether it is due to self-inflicted time

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

constraints, political problems or the sense of pride around the homegrown practice, “that’s how we’ve always done it” becomes a mantra and excuse to hammer the old ways of bu

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

iness into new systems.

The marketplace is increasingly demanding highly specialized products, unique in the problems they solve, and equally specialized in their marketing a

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

d customer value statement. The Apple’s and Google’s of the world have shown what can be accomplished through product innovation, and by extension, offer a lesson in how dram

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

Following aspects would a

atically a company will be left behind if it is not innovating. While there is an increasingly compelling case to apply corporate creativity to product design, foolish compan

dd to the challenges in developing combination products:

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

es expend this “creative capital” to arbitrarily prolong the life of legacy processes even while implementing new systems.

With a sense of unwarranted pride, these companies

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

egard themselves as “beautiful flowers,” assuming they have a better design for rudimentary aspects of operations like calculating product prices or shipping product than thos

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

e provided in purchased software. While “industry standard best practices” is touted as a key contributor to buying packaged software, too many companies immediately throw ou

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

these practices to maintain their own. Make your products speak for themselves, and seek unique positioning and customer value. No customer will care that your billing proc

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

Professional from academic institutions, pharmaceutical industries, health care indust

ss can support over 372 exception processes, and would likely seek a different supplier if they knew the actual cost of supporting these exception processes. Not only are the

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

re hard costs associated with convoluted processes, but there is an immense opportunity cost lost by keeping the “smart folks” on cleanup duty rather than developing competiti

.

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

e advantage.

The analogy of the beautiful and unique flower should be the analogy your company strives for when customers regard your product and service offerings. Internal

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

Companies that provide selfless information through particip

processes however, should elicit a resounding yawn for their simplicity, standardization and ability to “just work” without the care and feeding of your most capable resources

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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