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A Knowledge@Wharton article based on joint research with the Harvard Business School says now may be the time to re-evaluate the corporate efficacy of process management and tailor them to the right

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

applications. Studies show that misapplied process management can hinder companies and dull innovation. "In the appropriate setting, process management activities can help companies improve efficienc

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

Examples of combination products may in

y, but the risk is that you misapply these programs, in particular in areas where people are supposed to be innovative," notes Mary Benner–management professor at Wharton.

Process management methodo

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

logies focused on continuous improvement such as TQM (the work of Dr. Deming), surfaced in the 1980s in the US after the Japanese adopted it successfully. In 1960 the Emperor of Japan awarded Dr. Dem

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

ing the Second Order Medal of the Sacred Treasure for his help in transforming Japanese industry. Six Sigma started at Motorola and became popular in the mid-1990s due to GE’s visible efforts. The ba

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

Combination pro

sic premise is to improve quality to only three defects per million through systematic in processes improvement, and careful statistical measurement of outcomes.

The ISO 9001:2000 international stan

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

dard specifies requirements for a Quality Management System overseeing the production of a product or service. It is not a standard for ensuring a product or service is of quality; rather, it attests

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

to how well processes work, and how they will be managed and reviewed. Earlier incarnations of the standard were heavily criticized for the internal focus on extensive documentation, but like all th

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

ings worth doing the standard evolved to the current 2000 much improved version. Continual improvement, leadership involvement, and customer satisfaction are pivotal components of the standard.

Six

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

Sigma is similar to TQM in its focus on techniques for solving problems and using statistical methods to improve processes. But whereas TQM emphasizes employee involvement organization-wide, the Six

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

Sigma approach is to train experts (known as green belts and black belts) who work on solving important problems while they teach others in the company. The publicized success of GE after Jack Welch

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

Following aspects would a

adopted Six Sigma (to which he devotes a chapter of his book "Winning"), more than a quarter of the FORTUNE 200 followed suit. Yet not all firms were able to find the same magic.

In fact, of 58 larg

dd to the challenges in developing combination products:

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

e companies that have announced Six Sigma programs, 91 percent have trailed the S&P 500 since, according to an analysis by Charles Holland of consulting firm Qualpro http://www.qualproinc.com/ . Crit

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

ics say that one of the chief problems of Six Sigma is that it is narrowly designed to fix an existing process, allowing little room for new ideas or an entirely different approach. All that talent–a

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

ll those best and brightest–were devoted to, say, driving defects down to 3.4 per million and not on coming up with new products or disruptive technologies.

An inward-looking culture can leave firms

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

vulnerable in a business world that is changing at a breakneck pace–whether it's Craigslist stealing classified ads from local newspapers or VoIP threatening to make phone calls virtually free. Inno

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

Professional from academic institutions, pharmaceutical industries, health care indust

vation is "a meta-stable entity," says Vishva Dixit, Vice President for research of Genentech, who oversees 800 scientists at a company that has created some of the most revolutionary anticancer drug

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

s on the market. "Nothing will kill it faster than trying to manage it, predict it, and put it on a timeline."

No business can afford to focus its energies on its own navel in that environment. "Get

.

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

ting outside is everything," says GE's Immelt (who still deploys Six Sigma). From the day he took over as CEO, he says, he knew the company would need to be "much more forward-facing in the future th

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

Companies that provide selfless information through particip

an we ever were in the past." He explains: "It's not about change. It's about sudden, abrupt, and uncontrollable change. If you're not externally focused in this world, you can really lose your edge.

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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