R & D product development; Strategies for a successful IVD product

BMA Messenger, 1999

Getting a new product from the drawing table to the lab bench has never been easy. More often than not. efforts are frustrated by delays, cost overruns and reliability problems. With the tightening of profit margin it will be tougher than ever. In the decade ahead, there will be little room for errors in design, timing or cost. New product development — like everything else — will simply have to produce more for less.

Improving the chances for success depends as much on marketing as it does on R&D. Marketing talent and resources can no longer be reserved for the latest stages of development and product launch. Some of the most important contributions marketing can make to a new product occur long before it reaches the launch stage.

Here are just a few ideas of how marketing can improve the chances for new product success by getting more involved in the product development process.

1. Turn IVD Product Concepts Into Product Opportunities

Hundreds of decisions are made in the process of developing a new product. These decisions build upon one another and can often be reversed only at a considerable cost. but they all begin with a product concept.

The product concept ~ a new chemistry analyzer — is not a sufficient base for a successful product launch, however. Marketing can turn that concept into an opportunity by adding more detail. A product opportunity outlines a rationale for the product and clearly describes the customer benefits: it immediately establishes development priorities and guides future decisions.

Be thoughtful in selecting an opportunity target, however. Do your homework. It is the single most important decision made on a product... and it will need to weather many challenges.

Be timely in communicating your thoughts. A development team with upfront knowledge of how you want to position their new product when it gets to market will be much more likely to create a marketable product.

2. Eliminate Non-Critical IVD Product Features

"Do-it-all" product designs attempt to incorporate the best features of every product on the market. In the real world, "do-it-all" designs often don't do enough. They result in "me-too" products that enter the market too late or lackluster products that offer no significant benefits. In short, asking for too much actually can produce too little,

Forget about do-it-all designs and perfect products. Instead, focus on outperforming the competition in areas that are truly important to the customer,

Balance the customer needs with a realistic appraisal of the marketplace and your corporation. including:

Competitive Evolution — what is on the market today and how fast are things changing?

The State of the Art — do your product requirements push or exceed existing technology?

Corporate Strengths — does the new product align with the proven expertise of your corporation?

By identifying critical features, marketing can fine tune product design and help the development team select the basic requirements necessary to meet business objectives.

3. Create an Early Vision of the "Final" IVD Product

Most participants on a development team are responsible for only a small pan of the final product; Mechanical engineers design mechanisms. chemists design reagents; software engineers - and so on. Each of these groups faces unique challenges and uses different problem-solving techniques. They often enter the development process at different times. This is not unlike different vehicles leaving different countries at different times with the hope of meeting at some point in the middle of the ocean.

In both cases- success depends on a map and good communication tools. For new product development, the design goal document can serve these functions.

A good design goal document has three characteristics. The first is completeness - Two or three lines is not enough. Work out all the details. For an automated analyzer, this document could easily be 25 pages long.

Next , a rationale, Why a 100-test kit? Is it the common size? Is it the number of tests done in one day? Is it the number of tests done before the reagents expire? If you establish "rationale" early on, many tradeoffs and alternate implementations can be considered without necessarily sacrificing important product benefits.

Finally, an understanding of the "spoilers." Spoilers are features that will make your product unacceptable no matter what else it has going for it. Overnight incubation would definitely be a spoiler for a pregnancy test. Other spoilers might be excessive cost-per-test or a procedure with too much hands-on time.

Marketing can use a design goal document to create a vision of the final product and to guide the product team toward that target.

4. Start at the Beginning... Where it Counts

Late in the development game. options are extremely limited. A change that may have had minimal impact early on could devastate the project at a later stage. If marketing wants to influence what the final product looks like. they need to get involved with R&D right from the start.

5. Become Part of the In Vitro Diagnostics R&D Process

New product development groups evolve into a close-knit team. They share a common goal. They solve problems together. They challenge one another. They gain each others' respect and trust. As time goes on. the communication level inside the group differs from the communication with outsiders. Within the group, there are few surprises; others may not be so well-informed.

When marketing is close to the R&D process, it can anticipate or learn about issues early and provide timely and accurate feedback. This can help to head off mistakes and avoid delays and setbacks caused by lack of information. In too many cases, effective communication to and from the group is difficult.

To be a part of the process, you must be a part of the team.

6. Make An Effort to "Cross-Communicate"

In most new product groups, there is no common language. The engineers, scientists and the marketers each come to the table with very different expectations. Marketers who make an effort to translate their needs into language that others will understand are much more likely to get their ideas assimilated into the final product design.

This task is easier said than done. If you want an analyzer that is twice as fast as the competition. for example, expect questions such as "how do you measure speed?"; "in random access or batch?"; "which analytes?"; "best case or worst case?"; and "how much can we increase the manufacturing cost?"

To answer the question, the mechanical engineer will need to know all assay protocols to design the mechanism, the scientist will then need to know., etc., etc. The list is endless.

Be careful not to misinterpret these questions as a failure to take responsibility or a "run around." Systems are complex. Communications about systems are even more complex. It lakes time to communicate in a way that is meaningful.

7. Exploit Good Industrial Design

Good industrial design can go a long way toward communicating the attributes of a product to the customer. Time spent designing the produces human interface so that it reflects the produces capabilities will communicate more effectively than any sales brochure. "Easy-to-use" instruments should have self-explanatory keyboards. "Low-cost" reagents should not be in four-color boxes.

Conversely, poorly designed features may make selling tougher and may have to be explained away. Since a human interface design must be done, why not get involved and make it a part of the marketing campaign?

8. Set Up a Jury to Help Evaluate Marketing Decisions

There are two good reasons to establish a system for decision review.

First, the development process is so diverse, no one person can be best qualified to make all decisions.

Second, if you establish yourself as an expert, the team will either design the product to meet your needs (instead of the customers) or they will begin to discount your decisions as opinions.

By using customer consultants, focus groups and other impartial audiences, marketing can get the development team invested in an upbeat, market-oriented process.

9. Anticipate Change

Unless the market is totally stable or you have the uncanny ability to predict the future, you will have to deal with change at some point in the development process. Unanticipated change can be ugly, particularly at late stages in the development cycle.

You can reduce risks of change by identifying the three or four areas where change is likely to impact your competitive position. For example. you may believe that "closed tube" sampling does not justify the added reliability burden and time cost. Its absence "could" become a very significant liability if regulatory guidelines change. however. Therefore, the instrument could be designed with this feature as an option later. More importantly, design decisions that will eliminate the possibility of ever incorporating their capability in the product can be avoided. Often this is no problem if identified early.

You can help hedge the bet. Very few major changes develop overnight.

10. Avoid "Creeping Elegance"

Over time. the new product development process lakes on a life of its own. It is easy for the team to get caught up in the excitement of new technology and "add-on" possibilities. Including more "bells and whistles" can be very tempting.

Nobody on the team is in a better position than marketing to put a lid on these elegant extras. You're going to pay for them in some way so if in doubt say "No."

A very long time ago. Machiavelli said, "There is nothing more difficult to plan. more doubtful of success, nor more dangerous lo manage, than the creation of a new system." He could have been talking about new product development. There is simply no way to avoid every setback or problem associated with such a complex undertaking. More marketing involvement, however, may go a long way toward improving the chances of success.

Next time you evaluate the costs of having an active marketing participant on a major development program, remember to look at the economics of product failure and product delays.



	Improving the Chances of Success in In Vitro Diagnostics New Product Development

	BMA Messenger, 1999 Getting a new product from the drawing table to the lab bench has never been easy. More often than not. efforts are frustrated by delays, cost overruns and reliability problems. With the tightening of profit margin it will be tougher than ever. In the decade ahead, there will be little room for errors in design, timing or cost. New product development — like everything else — will simply have to produce more for less. Improving the chances for success depends as much on marketing as it does on R&D. Marketing talent and resources can no longer be reserved for the latest stages of development and product launch. Some of the most important contributions marketing can make to a new product occur long before it reaches the launch stage. Here are just a few ideas of how marketing can improve the chances for new product success by getting more involved in the product development process. 1. Turn IVD Product Concepts Into Product Opportunities Hundreds of decisions are made in the process of developing a new product. These decisions build upon one another and can often be reversed only at a considerable cost. but they all begin with a product concept. The product concept ~ a new chemistry analyzer — is not a sufficient base for a successful product launch, however. Marketing can turn that concept into an opportunity by adding more detail. A product opportunity outlines a rationale for the product and clearly describes the customer benefits: it immediately establishes development priorities and guides future decisions. Be thoughtful in selecting an opportunity target, however. Do your homework. It is the single most important decision made on a product... and it will need to weather many challenges. Be timely in communicating your thoughts. A development team with upfront knowledge of how you want to position their new product when it gets to market will be much more likely to create a marketable product. 2. Eliminate Non-Critical IVD Product Features "Do-it-all" product designs attempt to incorporate the best features of every product on the market. In the real world, "do-it-all" designs often don't do enough. They result in "me-too" products that enter the market too late or lackluster products that offer no significant benefits. In short, asking for too much actually can produce too little, Forget about do-it-all designs and perfect products. Instead, focus on outperforming the competition in areas that are truly important to the customer, Balance the customer needs with a realistic appraisal of the marketplace and your corporation. including: Competitive Evolution — what is on the market today and how fast are things changing? The State of the Art — do your product requirements push or exceed existing technology? Corporate Strengths — does the new product align with the proven expertise of your corporation? By identifying critical features, marketing can fine tune product design and help the development team select the basic requirements necessary to meet business objectives. 3. Create an Early Vision of the "Final" IVD Product Most participants on a development team are responsible for only a small pan of the final product; Mechanical engineers design mechanisms. chemists design reagents; software engineers - and so on. Each of these groups faces unique challenges and uses different problem-solving techniques. They often enter the development process at different times. This is not unlike different vehicles leaving different countries at different times with the hope of meeting at some point in the middle of the ocean. In both cases- success depends on a map and good communication tools. For new product development, the design goal document can serve these functions. A good design goal document has three characteristics. The first is completeness - Two or three lines is not enough. Work out all the details. For an automated analyzer, this document could easily be 25 pages long. Next , a rationale, Why a 100-test kit? Is it the common size? Is it the number of tests done in one day? Is it the number of tests done before the reagents expire? If you establish "rationale" early on, many tradeoffs and alternate implementations can be considered without necessarily sacrificing important product benefits. Finally, an understanding of the "spoilers." Spoilers are features that will make your product unacceptable no matter what else it has going for it. Overnight incubation would definitely be a spoiler for a pregnancy test. Other spoilers might be excessive cost-per-test or a procedure with too much hands-on time. Marketing can use a design goal document to create a vision of the final product and to guide the product team toward that target. 4. Start at the Beginning... Where it Counts Late in the development game. options are extremely limited. A change that may have had minimal impact early on could devastate the project at a later stage. If marketing wants to influence what the final product looks like. they need to get involved with R&D right from the start. 5. Become Part of the In Vitro Diagnostics R&D Process New product development groups evolve into a close-knit team. They share a common goal. They solve problems together. They challenge one another. They gain each others' respect and trust. As time goes on. the communication level inside the group differs from the communication with outsiders. Within the group, there are few surprises; others may not be so well-informed. When marketing is close to the R&D process, it can anticipate or learn about issues early and provide timely and accurate feedback. This can help to head off mistakes and avoid delays and setbacks caused by lack of information. In too many cases, effective communication to and from the group is difficult. To be a part of the process, you must be a part of the team. 6. Make An Effort to "Cross-Communicate" In most new product groups, there is no common language. The engineers, scientists and the marketers each come to the table with very different expectations. Marketers who make an effort to translate their needs into language that others will understand are much more likely to get their ideas assimilated into the final product design. This task is easier said than done. If you want an analyzer that is twice as fast as the competition. for example, expect questions such as "how do you measure speed?"; "in random access or batch?"; "which analytes?"; "best case or worst case?"; and "how much can we increase the manufacturing cost?" To answer the question, the mechanical engineer will need to know all assay protocols to design the mechanism, the scientist will then need to know., etc., etc. The list is endless. Be careful not to misinterpret these questions as a failure to take responsibility or a "run around." Systems are complex. Communications about systems are even more complex. It lakes time to communicate in a way that is meaningful. 7. Exploit Good Industrial Design Good industrial design can go a long way toward communicating the attributes of a product to the customer. Time spent designing the produces human interface so that it reflects the produces capabilities will communicate more effectively than any sales brochure. "Easy-to-use" instruments should have self-explanatory keyboards. "Low-cost" reagents should not be in four-color boxes. Conversely, poorly designed features may make selling tougher and may have to be explained away. Since a human interface design must be done, why not get involved and make it a part of the marketing campaign? 8. Set Up a Jury to Help Evaluate Marketing Decisions There are two good reasons to establish a system for decision review. First, the development process is so diverse, no one person can be best qualified to make all decisions. Second, if you establish yourself as an expert, the team will either design the product to meet your needs (instead of the customers) or they will begin to discount your decisions as opinions. By using customer consultants, focus groups and other impartial audiences, marketing can get the development team invested in an upbeat, market-oriented process. 9. Anticipate Change Unless the market is totally stable or you have the uncanny ability to predict the future, you will have to deal with change at some point in the development process. Unanticipated change can be ugly, particularly at late stages in the development cycle. You can reduce risks of change by identifying the three or four areas where change is likely to impact your competitive position. For example. you may believe that "closed tube" sampling does not justify the added reliability burden and time cost. Its absence "could" become a very significant liability if regulatory guidelines change. however. Therefore, the instrument could be designed with this feature as an option later. More importantly, design decisions that will eliminate the possibility of ever incorporating their capability in the product can be avoided. Often this is no problem if identified early. You can help hedge the bet. Very few major changes develop overnight. 10. Avoid "Creeping Elegance" Over time. the new product development process lakes on a life of its own. It is easy for the team to get caught up in the excitement of new technology and "add-on" possibilities. Including more "bells and whistles" can be very tempting. Nobody on the team is in a better position than marketing to put a lid on these elegant extras. You're going to pay for them in some way so if in doubt say "No." A very long time ago. Machiavelli said, "There is nothing more difficult to plan. more doubtful of success, nor more dangerous lo manage, than the creation of a new system." He could have been talking about new product development. There is simply no way to avoid every setback or problem associated with such a complex undertaking. More marketing involvement, however, may go a long way toward improving the chances of success. Next time you evaluate the costs of having an active marketing participant on a major development program, remember to look at the economics of product failure and product delays.

	CaseBauer has 5 practices: Market Modeling, Strategy / Business Development, Benchmarking, Market Research and Business Services.

Improving the Chances of Success in In Vitro Diagnostics New Product Development