Services: Medical Device Life Cycle

How you manage the early phases of your medical device life cycle determines if your product will bring your company commercial success on-time and on-budget. Walk through the device discovery and development processes to learn how we can help you achieve your success:

Early Phases of Your Medical Device Life Cycle
(Roll your mouse over each phase to learn more; click for detailed info)

DISCOVERY PROCESS:

The Discovery Process reveals your new Market Opportunities

WHAT YOU’VE DONE:

• Determined a need for new medical devices or systems to grow your business

WHAT YOU NEED US TO DO FOR YOU:

• Identify your customers’ problems & needs
• Research your targeted market situation revealing key issues, trends & developments
• Reveal competitor intelligence through investigation and analysis
• Screen your opportunities using selection criteria customized to your needs
• Create solutions to your customers’ problems & needs
• Evaluate and recommend the best pathways for capitalizing on your opportunities

Contact us directly to discuss how we can help you discover new opportunities for your company

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DEVELOPMENT PROCESS

After successfully Discovering your product opportunities, your medical device is ready to be developed. The early phases of your Device Development Process guide you through product evaluation and Definition to produce the device design your customers require.

Concept Phase:

WHAT YOU’VE DONE:

• Identified new medical devices or systems to help you grow your business
• Targeted specific medical applications or indications for your technology
• Confirmed your technology’s application with early R&D benchtop studies - in vitro benchtop and in vivo model studies
• Prepared a Project Control Plan

WHAT YOU NEED US TO DO FOR YOU:

• Refine research on your targeted market situation revealing key issues, trends & developments
• Refine your competitor intelligence through investigation and analysis
• Assist you with technology transfer or product acquisition
• Investigate and assess your device’s “marketability”
• Prepare your Market Requirements Definition (MRD) including market specifications, customer performance requirements, clinical applications and possible risks
• Value your product and business (market potential and financial analysis)
• Analyze and recommend your most effective Regulatory Approval pathways and strategies
• Recommend your optimal clinical development plan
• Prepare your initial business plan and investor presentation materials to obtain early stage seed investment

Contact us directly to discuss how we can help you define your product and its best development pathway

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After you have successfully Defined your product characteristics – market specs, performance and clinical uses – you are ready to test its Feasibility or Concept in simulated situations.

Feasibility Phase:

WHAT YOU’VE DONE:

• Prepared your product’s engineering design
• Prepared and are installing your Design Control System
• Produced alpha prototypes
• Testing alpha prototypes in pre-clinical studies (for selected device classifications)

WHAT YOU NEED US TO DO FOR YOU:

• Refresh research on your targeted market situation revealing evolving issues, trends & developments
• Refresh your competitor intelligence through investigation and analysis
• Refine your device’s “marketability” assessment
• Confirm your product and business valuation
• Verify your Market Requirements Definition (MRD) based on pre-clinical studies
• Plan for your product design risks assessment
• Optimize your regulatory and clinical research plans
• Manage your pre-clinical studies
• Prepare your refined business plan, adding operational strategies, and investor presentation materials to obtain your next round of investment or partner with other life sciences companies
• Create and promote your business identity or “brand”

Contact us directly to discuss how we can help you achieve your product’s proof-of concept and assess its full market potential

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Achieving Feasibility or Proof of Concept is a major milestone, your gateway to substantially larger investment and partnering opportunities. At this point your medical device is ready for further verification through early clinical studies and/or general user evaluations.

Pre-Pilot Phase:

WHAT YOU’VE DONE:

• Produced beta prototypes
• Operating within your Design Control System
• Verifying your product’s engineering design
• Assessing your product design’s “manufacturability”
• Evaluating beta prototypes in early clinical studies (for selected device classifications)

WHAT YOU NEED US TO DO FOR YOU:

• Refresh research on your targeted market situation revealing evolving issues, trends & developments
• Refresh your competitor intelligence through investigation and analysis
• Refine your device’s “marketability” assessment
• Confirm your product and business valuation
• Verify your Market Requirements Definition (MRD) based on clinical trials
• Evaluate product packaging and labeling options through user research
• Identify possible product design risks with early human factors risk assessment
• Manage your regulatory activities and early clinical research
• Refine your detailed business plan and investor presentation materials for reporting and to secure additional investment
• Refine and promote your business image or “brand”

Contact us directly to discuss how we can help you develop your product to achieve its full market potential

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Advancing beyond the Pre-Pilot Phase is your second major milestone, your gateway to even larger investment and partnering opportunities. At this point your medical device is ready for refined verification through pivotal clinical studies and/or refined user evaluations.

Pilot Phase:

WHAT YOU’VE DONE:

• Scaling-up production to commercial-grade product
• Operating within your Design Control System
• Re-verifying your product’s engineering specifications
• Validating your product via pivotal clinical studies (for selected device classifications)
• Evaluating near commercial-grade product and packaging

WHAT YOU NEED US TO DO FOR YOU:

• Refresh research on your targeted market situation revealing evolving issues, trends & developments
• Refresh your competitor intelligence through investigation and analysis
• Confirm your product and business valuation
• Validate your Market Requirements Definition (MRD) based on pivotal clinical trials
• Finalizing user research on product packaging and labeling
• Perform final human factors user risk assessment to purge remaining product design specifications risks
• Manage your regulatory activities and pivotal clinical research
• Refresh your detailed business plan and investor presentation materials for reporting and to secure final development stage funding
• Refresh and promote your business image or “brand”

Contact us directly to discuss how we can help you fine-tune your product development to reach its full market potential

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Advancing beyond the Pilot Phase one of the last major milestones. At this point your medical device and its production process are ready for final verification and regulatory clearance/ approval to go to market.

Commercialization Phase:

WHAT YOU’VE DONE:

• Locating and starting-up commercial-grade manufacturing facilities
• Validating your product and its manufacturing process
• Establishing sales and distribution networks
• Preparing for your product market launch

WHAT YOU NEED US TO DO FOR YOU:

• Refresh your competitor intelligence
• Perform final human factors user risk assessment to assure your product meets users’ needs and intended uses
• Refresh your users’ needs research to develop marketing messaging
• Manage your regulatory activities
• Re-launch your business image or “brand” promotion
• Develop your product marketing and promotional plans
• Prepare your product’s collateral materials

Contact us directly to discuss how we can help you finalize your product development to reach its full commercial potential

Market Launch: Success! Your product is entering the marketplace.

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Contact us if you are

Ready for growth... Ready for The Next Phase

Last modified November 4, 2003

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