Introducing
Elevator

An innovative approach to commercializing medical-device technology in the information-based regulatory environment through fully-integrated, comprehensive life cycle management and proven quality management systems

How It Works

  • The ELEVATOR™ is an iterative, dynamic process, requiring input from each workgroup involved in the development process.  An emphasis is placed on the sharing and evaluation of information throughout the product/project lifecycle.
  • Process and quality management systems (QMS) are critical more than ever to ensure that development activities are effectively conducted in this cross-functional environment. Why? Proper documentation in various forms now accounts for well more than 50% of the development of a medical device.
  • QMS therefore forms the backbone of successful development, and a significant part of the development budget

Four Types of Elevators

Fully Incubated
Partially Incubated – Spec Developer
Partially Incubated – Contract Manufacturer
Non-Incubated – Traditional Consulting

Fully Incubated

This type of client utilizes all NAGLREITER™ service types including creation and maintenance of the client’s quality system, full Initial Equipment Access and Use, and Workforce Services for all departments.

This is the highest level of service NAGLREITER™ provides where the client’s company is created and administered fully in NAGLREITER™ facility and utilizing NAGLREITER™ associates. The client remains the spec developer and manufacturer, but all certified activity is conducted in the NAGLREITER™ facility utilizing NAGLREITER™ associates for as much of the activity as the client needs.


Partially Incubated – Spec Developer

This type of client has development projects that may require systems, equipment and workforce services, but at a lower level than a fully incubated client. The client is the spec developer and manufacturer and the client company is not being fully created or maintained by NAGLREITER™.
The client company is only partially incubated for the purposes of running a development project.

Development projects are conducted either in the client’s own quality system (administered by them that NAGLREITER™ associates work within) or in the NAGLREITER™ QMS. The client will not be provided with its own quality system. The client will be provided with the equipment services, but all annual equipment requirements are conducted under the NAGLREITER™ system. The equipment access and use requirement is reduced.


Partially Incubated – Contract Manufacturer

This type of client has contract manufacturing needs that may require systems, equipment and workforce services, but at a lower level than a fully incubated client. The client is the spec developer and manufacturer and the client company is not being fully created or maintained by NAGLREITER™. The client company is only partially incubated for the purposes of running manufacturing in the NAGLREITER™ facility.

The manufacturing activity is conducted either in the client’s own quality system (administered by them that NAGLREITER™ associates work within) or in theNAGLREITER™ QMS. The client will not be provided with its own quality system. The client will be provided with the equipment services, but all annual EQMT requirements are conducted under the NAGLREITER™ system. The EQMT access and use requirement is reduced.


Non-Incubated – Traditional Consulting

This type of client has product development needs that may require systems, and workforce services, but at a much lower level than a fully incubated client. The client is the spec developer and manufacturer and the client company is not being fully created or maintained by NAGLREITER™.

The client company is not incubated at NAGLREITER™ and any physical services are conducted at the client facility. The activity is conducted either in the client’s own quality system (administered by them that NAGLREITER™ associates work within) or in the NAGLREITER™ QMS. The client will not be provided with its own quality system. The client will not be provided with the equipment services.



Building Your Business’ Elevator

At NAGLREITER™, we take a “bottom up” approach to incubation that efficiently uses capital and resources while avoiding risk mitigation at each and every floor (phase) of the project.

The Roof
Phase P: Production
Phase 3: Validation
Phase 2: Design and Development
Phase 1: Definition
Phase A: Proof of Concept

The Roof

  • High volume manufacturing
  • Sales and Marketing insertion
  • Market Validation
  • Clinician support
  • Funding+

Phase P: Production

  • Ongoing Production / Operations support
  • Physician Training & cont’d sales effort
  • Product improvements, as needed
  • Post-market Surveillance / MDR
  • Process Improvements, as needed
  • Update Design Control Docs, as needed
  • Quality Audits
  • Continued Clinical Validation

Phase 3: Validation

  • Train and certify employees to manufacturing and quality processes
  • Tool Qualification, as determined by the Validation Plan
  • Process, Product Validations and reports
  • Perform Accelerated Aging
  • Real Time Aging Protocol
  • Design Change review
  • Complete final Design Verification
  • Complete final Design Validation
  • Final Risk Management Report
  • Market Evaluations (as applicable)
  • Market Evaluation feedback (as applicable)
  • Regulatory submission approval or concurrence as required or “Letter to File”
  • Response to process, ergonomic, health, safety, and environmental issues
  • Final review of design plan, market specification and product specification
  • Conduct supplier evaluation/approval activities per Design Plan requirements
  • Address all open action items from previous design reviews
  • Final design outputs

Phase 2: Design and Development

  • Adjusted PDT Roster
  • Continue prototype design evaluation
  • Biocompatibility testing
  • Market evaluations (as applicable)
  • Market evaluation feedback (as applicable)
  • Revised market specification (MTS) (if needed)
  • Revised product specification (PRS) (if needed)
  • Revised design plan (if needed)
  • Update risk analysis
  • Labeling/Packaging development
  • Manufacturing process documentation/Control Plan
  • Validation Plan
  • Sterilization method development and validation Develop initial design outputs
  • Tool qualification for DV and lot release tooling, as determined by the Validation Plan
  • Equipment to be calibrated
  • Complete initial Design Verification
  • Complete Initial Design Validation
  • Manufacturing scale-up /production release resource requirements
  • Process, ergonomic, health, safety and environmental issues
  • Accelerated/real time aging, if possible
  • Conduct supplier evaluation/approval activities per Design Plan requirements
  • Address all open action items from previous design reviews

Phase 1: Definition

  • Market Specification (MTS) and other design inputs
  • Product Specification (PRS)
  • Legal Issues
  • Produce and test functional prototypes
  • Product/procedure preliminary risk analysis
  • MDRs/complaints/failures and/or other historical and/or marketing data.
  • PDT Team Roster
  • Marketing Strategy
  • Regulatory and Clinical Strategy
  • Supplier development plan
  • Biocompatibility test plan
  • Processes required to manufacture product
  • Manufacturing process Ergonomic, health, safety, and environmental issues.
  • Design plan
  • Risk Management Plan
  • Target average sales price and margin

Phase A: Proof of Concept

The Only Unregulated Floor

  • Technology Evaluation
  • Financial Review
  • Market Analysis
  • Competitive Assessment
  • Initial Marketing Specification (MTS)
  • Early Risk Assessment
  • IP Analysis
  • Regulatory / Clinical Path
  • Reimbursement Path