best-path emt presentation

A division of

How Outsourcing ensures Medical Device Startups make the Right Product in addition to making the Product Right

Advanced Medical Operations

2 Advanced MedicalOperations

The Wrong Product Never WinsIt’s an old joke but it’s particularly true in medical devices . . .


Business Plans often fall terribly short

• Reasons are numerous but seldom have to do with product execution

– Lack of “real world” experience– Not focusing on must haves

versus nice to haves– Falling into common pitfalls

particularly dealing with FDA regulatory requirements

– Missing key technical hurdles upfront that are expensive to resolve later

• Outsourcing can provide an insurance policy for early stage business plans

Source: Gerry Langeler. OVP Venture Partners


Utilizing Outsourcing to enhance business plan development

• Outsourcing companies have traditionally only become involved after a business plan is complete and the company is funded

• The trend is to utilize outsourcing much earlier• Outsourcing companies bring a wealth of “real world” experience

that can prevent Startups from making commons mistakes– Improves time to market– Helps identify issues that may be expensive to correct after

development begins– Anticipates FDA and other regulatory issues

• Product development and introduction proceeds smoothly and efficiently– Outsource company is “up to speed” from the start– Technical relationships speed issue resolution


Outsourcing Provides Upfront Resources

• Demonstrate that the concept has the technical feasibility to enable it to serve a large, rapidly growing opportunity– Provides real world experience from the start– Identifies significant technical hurdles

• Help to identify elements that are truly differentiable in a sustainable way– Brings focus to “must have” versus “nice to have”– Broad view of the market helps identify true differentiators

• Provide a strong understanding of the competition– Often have experience with the direct competition– Can bring an understanding of other forces competing for the same

customer budget dollars


Outsourcing helps all phases of business plan development

• Initial phase of business plan development– Clarification of the compelling market need– Identify key technical areas requiring research

• Companies seeking funding– Incorporate concepts developed from initial discussions with potential

customers– Modify the plan based on comments from Venture Capitalists

• Funded companies– Accelerate development product requirements– Identify critical development concerns


Ensuring the Right Product

Business Plan Review

TechnicalAnalysis

Differentiation Competition

-Best Path EMT


Business Plan Review

• Not consulting• Puts highly motivated, talented, technical people together to discuss

state of the art technology• A framework where new and exciting concepts and insights emerge • Begins with development of “elevator speech” focusing Startup on

the customer and benefits• Encourages Startup to identify market segments that the product

has the potential to dominate• The concept is discussed with a view to whether a broader potential

exists which might make it easier to obtain funding


Technical Feasibility

• Begins the process of developing a comprehensive list of product requirements– Identifying Must Haves rather than not Nice to Haves– Identifying design unknowns– Identifying required prototyping– Developing a critical requirements list– Developing a risk control measures list

• Goal is to identify key requirements and issues early in the process when the impact is low– Entire process is outside of FDA review

• The process is completed within a complete Best-Path Program


Differentiation

• Startups must understand that their concept must address not just a need, but a compelling need

• Helps avoid “gee whiz” features that are not compelling differentiators

• Helps identify technology that is better acquired than developed• Example: HEI Embedded Processor Development Framework

– A Processor Family and Development Environment– Software Modules– Connectivity Modules– DSP Modules


Competition

• Outsourcing companies are unique in seeing new design concepts across the medical device market

• Competition is not just other medical device companies but anything or anyone that competes for precious budget dollars and the staff needed to evaluate, recommend, and utilize the product.

• Encourages a dialog about who the client believes is the likely competition and how their concept can win in the market

• Process brings competitive depth to a Startup’s business plan – Startups often lack the broad view of the medical device market – Outsourcing companies are extremely sensitive to trends in the market

that may not be evident to a Startup


Mental Acuity Product

• Initially targeted to demonstrating ongoing brain acuity• Best-Path EMT process identified other opportunities such as

potential in Alzheimer’s and also in monitoring the results of medication on brain function as a POC (point of care) product

• Helped Startup present a larger potential market during the funding process

Brain Activity

HistoricalAnalysis


Hardware/Software/Internet Product

• Medical device captures patient data• Data sent unencrypted over the Internet to a computer• Results compared against expected norms stored in a database on

the Internet• Best-Path EMT process identified likely HIPAA (Health Insurance

Portability and Accountability Act) concerns• Changing the architecture at the concept stage was simple• Would have been extremely difficult after design start

MedicalDevice Internet

Database

Results Analysis


Automated Cell Counting

• Technology is not new and is well understood

• However, Startup’s concept required detecting very small variations in very small cells

• Locating an optical system that could meet the need at a reasonable cost was key to the business plan

• Best-Path EMT process identified this critical need

• A technology provider was identified giving confidence to move forward to attract funding


Making the Product Right

• Complete Best-Path program is a structured methodology for developing the strategies and associated documentation for a product launch that meets user and FDA requirements, at the target cost, and within a predictable schedule.

• Minimizes risk for medical instrumentation companies giving confidence to proceed to formal product design and market deployment strategy

• Going from Best-Path EMT to a complete Best-Path program provides a seamless means of ensuring the most rapid time to market.


Conclusion

• Startups benefit with Best-Path EMT by bringing forward key analyses of the business plan, technical feasibility of the concept, differentiation, and competition. Issues and concerns are raised and solved much earlier in the process saving both time and money for the startup

• Best-Path EMT gives the startup the opportunity to have a larger view of the technology. This can lead to recognizing that the technology has broader applicability than originally anticipated which can provide a stronger case for funding

• Best-Path EMT can be combined with an entire Best-Path program. Best-Path leads the client through the process inside of the FDA QSR guidelines to productization

• Best-Path EMT and Best-Path work together to confidently know that it’s the right product for the market and that you’re developing the product right

best-path emt presentation

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