Main Subject - Business

Measuring Return on Investment (ROI) is a solid business principle that helps guide corporate decisioning. However for purposes of this blog post I want you to think of ROI as return on imaginati

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

on, ideas and innovation. It is the return on innovation that will allow companies to maintain their competitive edge and create sustainable growth. Peter Drucker said, "An established company wh

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

Examples of combination products may in

ch, in an age demanding innovation, is not able to innovate, is doomed to decline and extinction."

Drucker’s quote mirrors my sentiments exactly…I have seen too many companies forget about the n

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

eed for, and power of innovation (more classically referred to as R&D). Without a dedicated focus on innovation it is only a matter of time until a business cannot attract or retain talent, suff

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

rs from obsolescence due to the innovation of others and watches their brand fall into decline.

Does you company suffer from the lack of innovation or does it reap the many benefits of innovatio

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

Combination pro

? The answer can likely be found by examining your company’s organization chart…Who is in charge of innovation management? If you don’t have a dedicated C-suite position focused on innovation you

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

might really want to reevaluate your direction. While I’m not typically a fan of “title inflation” I have rarely witnessed a company with a chief strategy officer, chief innovation officer, chie

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

imagination officer, chief idea officer, chief thinking officer, etc. who are not experience sustainable growth and increases in brand equity. It is these companies who have a positive culture a

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

nd who are attracting and retaining the best talent.

Innovation is not the same thing as process engineering. Implementing Six Sigma or other process engineering programs to achieve short-term i

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

cremental gains in existing processes is not the same thing as adopting an innovation management approach which looks for long term gains in new areas which may require completely new business pr

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

cesses to be adopted. While both process engineering and innovation management are necessary and can and should overlap, they are not the same thing.

Simply open up any business magazine and loo

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

Following aspects would a

k at the companies receiving the majority of the news and editorial coverage…They represent the best in innovative organizations. These companies realize the value received from innovation and ch

dd to the challenges in developing combination products:

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

ose to be market leaders as opposed to market lagers.

So how do you adopt an innovation management approach for your business? Begin by considering the following best practices recommendations:

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

1. Make innovation a full time initiative: Part time efforts yield part time results and even worse zero effort yields zero results. Externally hire or promote from within the best creative thin

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

er and innovative strategist you can afford. Equip this individual with resources and watch your company grow. Nothing catalyzes growth and change like innovation.

2. Gain “active” leadership su

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

port: Innovation doesn’t work in isolation. It is one thing for your executive team talk the talk, but quite another to have them walk to walk. Form a “thinkubator’ facilitated by your chief inno

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

Professional from academic institutions, pharmaceutical industries, health care indust

vation officer and comprised of department heads, business unit leaders and other senior executives to regularly brainstorm about innovation Great ideas come from great minds and if your leaders

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

ip isn’t involved in the practice of innovation your business will suffer.

3. Get your head out of the sand: Avoid the DITWLY (Did It That Way Last Year) syndrome. It has been said that the defi

.

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

nition of insanity is to continue doing things the same way that you always have while expecting different results. Attend trade shows, conferences, continuing education workshops and other event

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

Companies that provide selfless information through particip

that expose your leadership team to the latest thinking. Hire an executive coach, bring in consultants, outsource or do whatever is necessary to drive new ideas, creative thinking and innovation

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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