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10 Easy Steps & Powerful Techniques to
Select the Right Concept for your Medical
Device




         February 2011
10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device |
February 2011




                                             TABLE OF CONTENTS


                                             Abstract ............................................................................................. 3

                                             Abbreviations .................................................................................... 4

                                             Market trend ...................................................................................... 5

                                             Other Challenges .............................................................................. 6

                                             10 Easy Steps for Concept Selection ............................................... 7

                                             Benefits of Implementing 10 Easy Steps for Concept Selection..... 12

                                             Conclusion....................................................................................... 13

                                             About the Authors ........................................................................... 14




                                             © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device |
    February 2011




                                                 Abstract
                                                 Organizations that consistently struggle to meet the planned project
                                                 schedule and cost, simply cannot pinpoint the product designer on
                                                 why things are not working as they should. The current development
                                                 process may have an issue that needs to be evaluated. For a
                                                 product designer, selecting the right concept out of multiple
                                                 concepts will save a lot of time and project cost, and help
                                                 organization to launch the product to market on time. In many
                                                 projects cost and time lines exceed due to incorrect selection of the
                                                 concepts. This usually ends up in poor quality products and rework.

                                                 This paper provides easy 10 steps and some powerful techniques
                                                 that would help you select the best out of the multiple concepts




                                                 © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
3
10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device |
    February 2011




                                                 Abbreviations


                                                   Sl. No.           Acronyms (Page No.)                                                    Full form

                                                         1           CF (Page-7)                                                            Critical Factor

                                                         2           KT (Page-7)                                                            Knowledge
                                                                                                                                            Transfer




                                                 © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
4
10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device |
    February 2011




             Design outsourcing                 Market trend
             Multinational                      Why should you revisit the current development process?
              development team                   What will happen if you do not have right process for concept
                                                 selection?
             Product launch at right
              time                               Over the last few years, the time taken to market products is
                                                 shrinking considerably when compared to past market development.
                                                 This has forced companies to launch their own high-quality products
                                                 in a short duration sustain their existing market and to improve their
                                                 present level. Now-a-days, business has become heavily dependent
                                                 on the launch of new product at the right time. Additionally,
                                                 companies must meet customer expectations that are changing
                                                 every day.

                                                 On one side, the new product design and development investments
                                                 are very high, and on the other side, the products get outdated very
                                                 quickly due to various reasons. Now, most of the organizations have
                                                 started design outsourcing to reduce timeline and project cost.
                                                 However, complications have increased further due to the
                                                 involvement of the multinational development team and different
                                                 concept selection processes. Therefore, new product outsourcing
                                                 trends need to implement a very successful concept selection
                                                 process.




                                                 © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
5
10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device |
    February 2011



     How to select the best
      concept?                                   Other Challenges
                                                 Additional challenges/questions that point the need of a good
       - 10 simple steps with
                                                 concept selection process for the designer are as follows:
       useful tips and templates
     Are you confused about                           Usually, in most of the projects, the concept generation and
                                                        finalization phases not completed on time when compared to
      selecting the best
                                                        the detailed design phase.
      concept?
                                                       Why do you face project escalation and customer dissatisfaction
       - 10 steps to help you select                    during the concept phase?
       the best concept                                Why are projects terminated after the concept design phases?
                                                       Why are you missing the Water Fall approach in development
     Are you spending a lot of                         phase?
      time and money to select                         Why is it that some projects are doing well while others are not?
      the best concept?                                Why do some selected concepts miss critical requirements of
                                                        the customer?
       - 10 easy steps that could                      How to involve customer or management team during the
       save your cost and time                          concept selection phase?
                                                       How to meet new or unknown customer expectations?
                                                       How to gain customer or management confidence and improve
                                                        the customer relationship from beginning of the project?

                                                 There are several problems or challenges as these that are
                                                 associated with the mishandling of concept phase in new product
                                                 development project.

                                                 If organizations consistently mishandle projects particularly during
                                                 the initial phase of the project, the product launch and costing will
                                                 be affected and the organization loses revenue.

                                                 Fortunately, you have 10 steps for the best concept selection that
                                                 can help your organization to increase the success rate.




                                                 © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
6
10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device |
    February 2011



    10 Easy Steps
                                                 10 Easy Steps for Concept Selection
        Identification of CF
        Weightage allocation and                For any new product development project, the concept design
                                                 phase commences after the customer requirements are ready.
         ranking on ideas
                                                 During this phase, the project team will be formed and different
        Establish Base concept                  concepts will be generated for evaluation. We have a unique
                                                 template for the best concept selection that will help handle the
        Team formation and KT                   concept phase to achieve best results.
        Generate Concepts
                                                 Step 1: Determine Critical Factors (CF) for Concept Design
        Concept Evaluation
        Concept Ranking                         The concept generation process starts with preparation of the
                                                 criteria or critical concept selection factors based on understanding
        Hybrid Solutions                        customer‟s requirements with respect to the following aspects:
        Re evaluate
                                                                       Critical to performance
        Selection and Sign-off                                        Critical to usability
                                                                       Critical to product cost
                                                                       Critical to reliability
                                                                       Critical to manufacturability and assembly
                                                                       Critical to safety
                                                                       Critical to regulatory

                                                 This list can be customized based on the nature of products. For the
                                                 selected criteria, define the evaluation methods on how to check the
                                                 critical factors. These details will help the team to understand the
                                                 complete expectation on the new concepts.

                                                 Step 2: Weightage Allocation and Concept Ranking Scale
                                                 Definition for CF

                                                                       Weightage allocation

                                                 The next step includes allocation of the weightage in the scale of 1-
                                                 5 for each critical factor (CF). You must assign high weightage for
                                                 the most important CF and low weightage for the least important CF.
                                                 The best practice would involve the team to allocate weightage for
                                                 each of these critical factors. Additionally, the client and other stake
                                                 holders can also be involved in this exercise.

                                                                       “Ranking on ideas”- Create a common
                                                                        understanding

                                                 Once the allocation of weightage for each CF is done, define how to
                                                 rank each concept against these critical factors. The ranking score
                                                 scale can include 1-5 range, similar to CF weightage scale.

                                                 Since the ranking exercise is a collective team effort, the detailed
                                                 definition of ranking score scale is very important, to arrive at a
                                                 common understanding among the team members.




                                                 © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
7
10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device |
    February 2011



                                                 The very important part of this exercise is to get the concurrence of
                                                 both the team members and client on CF weightage and ranking
                                                 score scale. The “weighted score” of each concept is arrived by
                                                 multiplying these two parameters which will be finally used to rank
                                                 the best concept.

                                                 Weighted score = CF scale x Ranking score

                                                 Another best practice is to involve the client team also in this
                                                 process. This will help the team to gain confidence on the process
                                                 of best concept selection. It will also ensure overall agreement on
                                                 the best selected concept.

                                                 Step 3: Establish a Base Concept and Communicate

                                                 The main objective of this step is to demonstrate the basic
                                                 understanding of the design requirements through a base concept.
                                                 This would be a guideline/template for the team members to
                                                 communicate the concepts. This could be in the form of:

                                                                       Hand sketches,
                                                                       Schematics,
                                                                       Storyboard,
                                                                       Process flow chart, and so on.

                                                 This step will ensure that each team member provides identical
                                                 output formats. This will help reduce unnecessary rework during
                                                 concept rating.

                                                 Step 4: Team Formation and Knowledge Transfer

                                                 Once the basic concept is ready and accepted by all stake holders,
                                                 the team will be formed based on various skills required for the
                                                 particular concept generation. The team composition will be arrived
                                                 based on the nature of the product.

                                                 The next activity is to transfer knowledge to the team. The
                                                 knowledge transfer would pertain to the following areas which are to
                                                 be addressed as part the new concepts:

                                                                       Critical new product design requirements and its
                                                                        applications
                                                                       Demonstration of the basic concepts and expectations
                                                                        with respect to new concepts
                                                                       Finalized critical factors for concept selection and
                                                                        rationale behind the allocated weightage
                                                                       Concept rating scale definitions and rationale behind
                                                                        the allocated score

                                                 The best practice is to provide hardcopies of the critical
                                                 requirements list and rating scale to the team along with concept



                                                 © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
8
10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device |
    February 2011



                                                 review checklist to ensure 100% coverage of                                                               the design
                                                 requirements in the new concept.

                                                 Step 5: Generate Concepts

                                                 Now team is ready for new concept generation. You can adapt the
                                                 following methodologies:
                                                          Brain storming - Capture all ideas
                                                          Web search - Understand information on relevant
                                                             patents, latest technologies and development, so on.
                                                          Study similar products in the market - Understand
                                                             factors such as usability, customer expectation, and so
                                                             on.
                                                 The project team also can develop its own methodologies to
                                                 generate new concepts.

                                                 Step 6: Concept Evaluation

                                                 Before getting on to the concepts evaluation, it is proposed to filter
                                                 or eliminate the ideas which are not potential for further concept
                                                 evaluation. This activity could be done as team deliberations. If the
                                                 number of concepts is not sufficient, then step 5 can be repeated to
                                                 generate some more potential concepts.

                                                 Once the required number of potential concepts is ready, the
                                                 following activities can be performed for concept evaluation:

                                                 1. Ranking on ideas

                                                        Ranking of ideas is a team activity. Here, each potential concept
                                                        is ranked on the scale of 1-5 based on the understanding of the
                                                        detailed definition of ranking score. Generally, rank 1 represents
                                                        Minimum and rank 5 represents Maximum. Higher the score,
                                                        better the advantage (For more details, refer to step 2).

                                                 Best practices:

                                                                       Get the same exercise carried out by the client team or
                                                                        the management team separately.

                                                                       Capture the understandings and assumptions made
                                                                        while ranking concepts against each CF, which could
                                                                        be discussed and agreed with the client team.

                                                 2. Concept Average weighted score calculation

                                                        During this stage, the individual weighted score for the each CF
                                                        will be calculated automatically based on the ranking of each
                                                        concept. Once it is done, the total average weighted score for a
                                                        particular concept will be populated automatically.




                                                 © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
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10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device |
     February 2011



                                                         The same exercise will be performed for the rest of the
                                                         concepts and the total average weighted score for each concept
                                                         will be calculated.



                                                  Step 7: Concept Ranking

                                                  1. Concept Average Weighted Total Score- Team Review

                                                         Before concluding on the final average weighted total score for
                                                         the each concept, it is proposed to have a team walkthrough
                                                         along with the client on the outcome. This exercise will give a
                                                         common understanding and acceptance among the team
                                                         members about the concept ranking.

                                                  2. Select 2-3 best concepts based on weighted totals

                                                         Here, all the concepts will be ranked based on the total average
                                                         weighted scores (Highest rank = Max average weighted score
                                                         and Least rank = Min average weighted score). Once this is
                                                         done, the first two or three highest ranked concepts will be
                                                         considered for the next stage.

                                                  Step 8: Look for Hybrid Solutions

                                                  1. Prepare CF profile for the selected concepts

                                                  The purpose of this step is to highlight the ranking of each CF for all
                                                  concepts that can be represented in a single chart. This can be
                                                  done using a Web chart. This graphical representation will give a
                                                  better understanding on performance of each of the concepts
                                                  against each CF.




                                                  © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
10
10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device |
     February 2011




                                                  2. Mix and match the best features of the selected concepts

                                                  Based on the Web chart representation, the best features among
                                                  the concepts can be selected and implemented in the maximum
                                                  ranked concepts. This will add more value to the concepts and may
                                                  reduce the cost. The suggested feature information can be captured
                                                  in the individual concept tab in the concept selection template.

                                                  3. Generate Hybrid Solutions

                                                  New concepts can be generated by using the best features of all
                                                  concepts. These concepts can be evaluated based on the CF to
                                                  address the advantages and disadvantages of combining the best
                                                  features. This evaluation will be carried out in the next step.

                                                  Step 9: Re-evaluate Ideas

                                                  After implementing the suggested improvements on the concepts,
                                                  the concepts can then be re-evaluated against the CF.


                                                  Step 10: Best Concept Selection and Sign-off

                                                  Based on the ranking, the highest ranked concepts can be selected
                                                  for further development.




                                                  © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
11
10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device |
     February 2011




         Product time to market                  Benefits of Implementing 10 Easy Steps for Concept
         Avoid reworks in design                 Selection
          implementation                                                Enables the project team to complete their concept
         Documented in single file                                      design phase successfully in every project
                                                                        Improves the new product time to market success rate
         Visual communication of                                       Enhances the project team contribution and customer
          concepts                                                       confidence during the concept design phase of the
                                                                         project
         Easily adaptable                                              Enables systematic validation of concepts
                                                                        Maximizes organization‟s value among competitors
                                                                        Reduces project expense during concept design phase
                                                                        Reduces organizational risks on the best concept
                                                                         selection for new products
                                                                        Simplifies the concept selection process
                                                                        Avoids reworks during the design implementation
                                                                         phase
                                                                        Easily adaptable for any new product development
                                                                         process
                                                                         All the generated concepts are documented in a single
                                                                         file that can be referred for future purpose
                                                                        Acts as a visual communication tool for the evaluation




                                                  © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
12
10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device |
     February 2011




                                                  Conclusion
                                                  Over the years, HCL has developed some very good tools for the
                                                  selection of concepts. These tools enable us to identify good
                                                  concepts easily. Depending on the types of product, the selection
                                                  process needs to be customized. It is imperative to develop a
                                                  process based on the product type. With rich experience in
                                                  developing products for different fields such as Aero and Medical
                                                  Devices, and a range of products within the Medical Devices field
                                                  such as Orthopedics and Diagnostics, HCL was able to implement a
                                                  proper and easy way of selecting good concepts.




                                                  © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
13
10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device |
     February 2011




                                                  About the Authors
                                                                                               •        Tamilnambi N A – has over 11 years of
                                                                                                       experience in new product design and
                                                                                                       development on electro mechanical products that
                                                                                                       include 4 years of medical product design. He has
                                                                                                       worked in Patient Monitoring VAVE project, Breast
                                                                                                       Biopsy Device development, and Cryo Ablation
                                                                                                       System development. He is a PMP certified
                                                                                                       professional.


                                                                                               •       Sivaprakash S – has over 6 years of experience
                                                                                                       in new product design and development on
                                                                                                       electro- mechanical products including 2 years of
                                                                                                       medical product design. He has worked in Cryo
                                                                                                       Ablation System development and Nerve
                                                                                                       monitoring systems.




                                                  © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
14
Hello, I’m from HCL’s Engineering and R&D Services. We enable
technology led organizations to go to market with innovative products &
solutions. We partner with our customers in building world class
products & creating the associated solution delivery ecosystem to help
build market leadership. Right now, 14500+ of us are developing
engineering products, solutions and platforms across Aerospace and
Defense, Automotive, Consumer Electronics, Industrial Manufacturing,
Medical Devices, Networking & Telecom, Office Automation,
Semiconductor, Servers & Storage for our customers.
For more details contact eootb@hcl.com
Follow us on twitter http://twitter.com/hclers            and    our   blog
http://ers.hclblogs.com/
Visit our website http://www.hcltech.com/engineering-services/



About HCL
About HCL Technologies
HCL Technologies is a leading global IT services company, working
with clients in the areas that impact and redefine the core of their
businesses. Since its inception into the global landscape after its IPO in
1999, HCL focuses on „transformational outsourcing‟, underlined by
innovation and value creation, and offers integrated portfolio of services
including software-led IT solutions, remote infrastructure management,
engineering and R&D services and BPO. HCL leverages its extensive
global offshore infrastructure and network of offices in 26 countries to
provide holistic, multi-service delivery in key industry verticals including
Financial Services, Manufacturing, Consumer Services, Public Services
and Healthcare. HCL takes pride in its philosophy of „Employee First‟
which empowers our 72,267 transformers to create a real value for the
customers. HCL Technologies, along with its subsidiaries, had
                                                                           st
consolidated revenues of US$ 3.1 billion (Rs. 14,101 crores), as on 31
December 2010 (on LTM basis).For more information, please visit
www.hcltech.com

About HCL Enterprise
HCL is a $5.5 billion leading global technology and IT enterprise
comprising two companies listed in India - HCL Technologies and HCL
Infosystems. Founded in 1976, HCL is one of India's original IT garage
start-ups. A pioneer of modern computing, HCL is a global
transformational enterprise today. Its range of offerings includes
product engineering, custom & package applications, BPO, IT
infrastructure services, IT hardware, systems integration, and
distribution of information and communications technology (ICT)
products across a wide range of focused industry verticals. The HCL
team consists of over 77,000 professionals of diverse nationalities, who
operate from 29 countries including over 500 points of presence in
India. HCL has partnerships with several leading Global 1000 firms,
including leading IT and technology firms. For more information, please
visit www.hcl.com

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HCLT Whitepaper: 10 Easy Steps Powerful Techniques to Select the Right Concept for your Medical Device

  • 1. 10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device February 2011
  • 2. 10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device | February 2011 TABLE OF CONTENTS Abstract ............................................................................................. 3 Abbreviations .................................................................................... 4 Market trend ...................................................................................... 5 Other Challenges .............................................................................. 6 10 Easy Steps for Concept Selection ............................................... 7 Benefits of Implementing 10 Easy Steps for Concept Selection..... 12 Conclusion....................................................................................... 13 About the Authors ........................................................................... 14 © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
  • 3. 10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device | February 2011 Abstract Organizations that consistently struggle to meet the planned project schedule and cost, simply cannot pinpoint the product designer on why things are not working as they should. The current development process may have an issue that needs to be evaluated. For a product designer, selecting the right concept out of multiple concepts will save a lot of time and project cost, and help organization to launch the product to market on time. In many projects cost and time lines exceed due to incorrect selection of the concepts. This usually ends up in poor quality products and rework. This paper provides easy 10 steps and some powerful techniques that would help you select the best out of the multiple concepts © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved. 3
  • 4. 10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device | February 2011 Abbreviations Sl. No. Acronyms (Page No.) Full form 1 CF (Page-7) Critical Factor 2 KT (Page-7) Knowledge Transfer © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved. 4
  • 5. 10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device | February 2011  Design outsourcing Market trend  Multinational Why should you revisit the current development process? development team What will happen if you do not have right process for concept selection?  Product launch at right time Over the last few years, the time taken to market products is shrinking considerably when compared to past market development. This has forced companies to launch their own high-quality products in a short duration sustain their existing market and to improve their present level. Now-a-days, business has become heavily dependent on the launch of new product at the right time. Additionally, companies must meet customer expectations that are changing every day. On one side, the new product design and development investments are very high, and on the other side, the products get outdated very quickly due to various reasons. Now, most of the organizations have started design outsourcing to reduce timeline and project cost. However, complications have increased further due to the involvement of the multinational development team and different concept selection processes. Therefore, new product outsourcing trends need to implement a very successful concept selection process. © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved. 5
  • 6. 10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device | February 2011  How to select the best concept? Other Challenges Additional challenges/questions that point the need of a good - 10 simple steps with concept selection process for the designer are as follows: useful tips and templates  Are you confused about  Usually, in most of the projects, the concept generation and finalization phases not completed on time when compared to selecting the best the detailed design phase. concept?  Why do you face project escalation and customer dissatisfaction - 10 steps to help you select during the concept phase? the best concept  Why are projects terminated after the concept design phases?  Why are you missing the Water Fall approach in development  Are you spending a lot of phase? time and money to select  Why is it that some projects are doing well while others are not? the best concept?  Why do some selected concepts miss critical requirements of the customer? - 10 easy steps that could  How to involve customer or management team during the save your cost and time concept selection phase?  How to meet new or unknown customer expectations?  How to gain customer or management confidence and improve the customer relationship from beginning of the project? There are several problems or challenges as these that are associated with the mishandling of concept phase in new product development project. If organizations consistently mishandle projects particularly during the initial phase of the project, the product launch and costing will be affected and the organization loses revenue. Fortunately, you have 10 steps for the best concept selection that can help your organization to increase the success rate. © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved. 6
  • 7. 10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device | February 2011 10 Easy Steps 10 Easy Steps for Concept Selection  Identification of CF  Weightage allocation and For any new product development project, the concept design phase commences after the customer requirements are ready. ranking on ideas During this phase, the project team will be formed and different  Establish Base concept concepts will be generated for evaluation. We have a unique template for the best concept selection that will help handle the  Team formation and KT concept phase to achieve best results.  Generate Concepts Step 1: Determine Critical Factors (CF) for Concept Design  Concept Evaluation  Concept Ranking The concept generation process starts with preparation of the criteria or critical concept selection factors based on understanding  Hybrid Solutions customer‟s requirements with respect to the following aspects:  Re evaluate  Critical to performance  Selection and Sign-off  Critical to usability  Critical to product cost  Critical to reliability  Critical to manufacturability and assembly  Critical to safety  Critical to regulatory This list can be customized based on the nature of products. For the selected criteria, define the evaluation methods on how to check the critical factors. These details will help the team to understand the complete expectation on the new concepts. Step 2: Weightage Allocation and Concept Ranking Scale Definition for CF  Weightage allocation The next step includes allocation of the weightage in the scale of 1- 5 for each critical factor (CF). You must assign high weightage for the most important CF and low weightage for the least important CF. The best practice would involve the team to allocate weightage for each of these critical factors. Additionally, the client and other stake holders can also be involved in this exercise.  “Ranking on ideas”- Create a common understanding Once the allocation of weightage for each CF is done, define how to rank each concept against these critical factors. The ranking score scale can include 1-5 range, similar to CF weightage scale. Since the ranking exercise is a collective team effort, the detailed definition of ranking score scale is very important, to arrive at a common understanding among the team members. © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved. 7
  • 8. 10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device | February 2011 The very important part of this exercise is to get the concurrence of both the team members and client on CF weightage and ranking score scale. The “weighted score” of each concept is arrived by multiplying these two parameters which will be finally used to rank the best concept. Weighted score = CF scale x Ranking score Another best practice is to involve the client team also in this process. This will help the team to gain confidence on the process of best concept selection. It will also ensure overall agreement on the best selected concept. Step 3: Establish a Base Concept and Communicate The main objective of this step is to demonstrate the basic understanding of the design requirements through a base concept. This would be a guideline/template for the team members to communicate the concepts. This could be in the form of:  Hand sketches,  Schematics,  Storyboard,  Process flow chart, and so on. This step will ensure that each team member provides identical output formats. This will help reduce unnecessary rework during concept rating. Step 4: Team Formation and Knowledge Transfer Once the basic concept is ready and accepted by all stake holders, the team will be formed based on various skills required for the particular concept generation. The team composition will be arrived based on the nature of the product. The next activity is to transfer knowledge to the team. The knowledge transfer would pertain to the following areas which are to be addressed as part the new concepts:  Critical new product design requirements and its applications  Demonstration of the basic concepts and expectations with respect to new concepts  Finalized critical factors for concept selection and rationale behind the allocated weightage  Concept rating scale definitions and rationale behind the allocated score The best practice is to provide hardcopies of the critical requirements list and rating scale to the team along with concept © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved. 8
  • 9. 10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device | February 2011 review checklist to ensure 100% coverage of the design requirements in the new concept. Step 5: Generate Concepts Now team is ready for new concept generation. You can adapt the following methodologies:  Brain storming - Capture all ideas  Web search - Understand information on relevant patents, latest technologies and development, so on.  Study similar products in the market - Understand factors such as usability, customer expectation, and so on. The project team also can develop its own methodologies to generate new concepts. Step 6: Concept Evaluation Before getting on to the concepts evaluation, it is proposed to filter or eliminate the ideas which are not potential for further concept evaluation. This activity could be done as team deliberations. If the number of concepts is not sufficient, then step 5 can be repeated to generate some more potential concepts. Once the required number of potential concepts is ready, the following activities can be performed for concept evaluation: 1. Ranking on ideas Ranking of ideas is a team activity. Here, each potential concept is ranked on the scale of 1-5 based on the understanding of the detailed definition of ranking score. Generally, rank 1 represents Minimum and rank 5 represents Maximum. Higher the score, better the advantage (For more details, refer to step 2). Best practices:  Get the same exercise carried out by the client team or the management team separately.  Capture the understandings and assumptions made while ranking concepts against each CF, which could be discussed and agreed with the client team. 2. Concept Average weighted score calculation During this stage, the individual weighted score for the each CF will be calculated automatically based on the ranking of each concept. Once it is done, the total average weighted score for a particular concept will be populated automatically. © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved. 9
  • 10. 10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device | February 2011 The same exercise will be performed for the rest of the concepts and the total average weighted score for each concept will be calculated. Step 7: Concept Ranking 1. Concept Average Weighted Total Score- Team Review Before concluding on the final average weighted total score for the each concept, it is proposed to have a team walkthrough along with the client on the outcome. This exercise will give a common understanding and acceptance among the team members about the concept ranking. 2. Select 2-3 best concepts based on weighted totals Here, all the concepts will be ranked based on the total average weighted scores (Highest rank = Max average weighted score and Least rank = Min average weighted score). Once this is done, the first two or three highest ranked concepts will be considered for the next stage. Step 8: Look for Hybrid Solutions 1. Prepare CF profile for the selected concepts The purpose of this step is to highlight the ranking of each CF for all concepts that can be represented in a single chart. This can be done using a Web chart. This graphical representation will give a better understanding on performance of each of the concepts against each CF. © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved. 10
  • 11. 10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device | February 2011 2. Mix and match the best features of the selected concepts Based on the Web chart representation, the best features among the concepts can be selected and implemented in the maximum ranked concepts. This will add more value to the concepts and may reduce the cost. The suggested feature information can be captured in the individual concept tab in the concept selection template. 3. Generate Hybrid Solutions New concepts can be generated by using the best features of all concepts. These concepts can be evaluated based on the CF to address the advantages and disadvantages of combining the best features. This evaluation will be carried out in the next step. Step 9: Re-evaluate Ideas After implementing the suggested improvements on the concepts, the concepts can then be re-evaluated against the CF. Step 10: Best Concept Selection and Sign-off Based on the ranking, the highest ranked concepts can be selected for further development. © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved. 11
  • 12. 10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device | February 2011  Product time to market Benefits of Implementing 10 Easy Steps for Concept  Avoid reworks in design Selection implementation  Enables the project team to complete their concept  Documented in single file design phase successfully in every project  Improves the new product time to market success rate  Visual communication of  Enhances the project team contribution and customer concepts confidence during the concept design phase of the project  Easily adaptable  Enables systematic validation of concepts  Maximizes organization‟s value among competitors  Reduces project expense during concept design phase  Reduces organizational risks on the best concept selection for new products  Simplifies the concept selection process  Avoids reworks during the design implementation phase  Easily adaptable for any new product development process  All the generated concepts are documented in a single file that can be referred for future purpose  Acts as a visual communication tool for the evaluation © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved. 12
  • 13. 10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device | February 2011 Conclusion Over the years, HCL has developed some very good tools for the selection of concepts. These tools enable us to identify good concepts easily. Depending on the types of product, the selection process needs to be customized. It is imperative to develop a process based on the product type. With rich experience in developing products for different fields such as Aero and Medical Devices, and a range of products within the Medical Devices field such as Orthopedics and Diagnostics, HCL was able to implement a proper and easy way of selecting good concepts. © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved. 13
  • 14. 10 Easy Steps & Powerful Techniques to Select the Right Concept for your Medical Device | February 2011 About the Authors • Tamilnambi N A – has over 11 years of experience in new product design and development on electro mechanical products that include 4 years of medical product design. He has worked in Patient Monitoring VAVE project, Breast Biopsy Device development, and Cryo Ablation System development. He is a PMP certified professional. • Sivaprakash S – has over 6 years of experience in new product design and development on electro- mechanical products including 2 years of medical product design. He has worked in Cryo Ablation System development and Nerve monitoring systems. © 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved. 14
  • 15. Hello, I’m from HCL’s Engineering and R&D Services. We enable technology led organizations to go to market with innovative products & solutions. We partner with our customers in building world class products & creating the associated solution delivery ecosystem to help build market leadership. Right now, 14500+ of us are developing engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor, Servers & Storage for our customers. For more details contact eootb@hcl.com Follow us on twitter http://twitter.com/hclers and our blog http://ers.hclblogs.com/ Visit our website http://www.hcltech.com/engineering-services/ About HCL About HCL Technologies HCL Technologies is a leading global IT services company, working with clients in the areas that impact and redefine the core of their businesses. Since its inception into the global landscape after its IPO in 1999, HCL focuses on „transformational outsourcing‟, underlined by innovation and value creation, and offers integrated portfolio of services including software-led IT solutions, remote infrastructure management, engineering and R&D services and BPO. HCL leverages its extensive global offshore infrastructure and network of offices in 26 countries to provide holistic, multi-service delivery in key industry verticals including Financial Services, Manufacturing, Consumer Services, Public Services and Healthcare. HCL takes pride in its philosophy of „Employee First‟ which empowers our 72,267 transformers to create a real value for the customers. HCL Technologies, along with its subsidiaries, had st consolidated revenues of US$ 3.1 billion (Rs. 14,101 crores), as on 31 December 2010 (on LTM basis).For more information, please visit www.hcltech.com About HCL Enterprise HCL is a $5.5 billion leading global technology and IT enterprise comprising two companies listed in India - HCL Technologies and HCL Infosystems. Founded in 1976, HCL is one of India's original IT garage start-ups. A pioneer of modern computing, HCL is a global transformational enterprise today. Its range of offerings includes product engineering, custom & package applications, BPO, IT infrastructure services, IT hardware, systems integration, and distribution of information and communications technology (ICT) products across a wide range of focused industry verticals. The HCL team consists of over 77,000 professionals of diverse nationalities, who operate from 29 countries including over 500 points of presence in India. HCL has partnerships with several leading Global 1000 firms, including leading IT and technology firms. For more information, please visit www.hcl.com