Design Documentation

1. Design Documentation Joel Gerber Zachary Reaver Kurt Schilling

2. Why? • Provides physical proof of development • Maintains product design knowledge base • Meets government and corporate requirements • Communicates design planning and implementation • Enables smooth project transitions

3. What needs to be documented? • Collaboration • Meeting minutes • Phone calls • E-mails • Technical • Preliminary design sketches • Calculations • Tolerance stack-ups • Testing records

4. Collaboration Documentation • Date and time • Parties present • Discussion summary • Action items

5. Technical Documents • Drawings • Design Changes • Design and Process Validations/Verifications • Risk Management Documentation • Process Routers • Inspection Criteria • Design Control Plans • Material Specifications • Sterility and Cleaning Process Verifications • Tolerance Stack-ups • Device Master Record (DMR) • FDA Submissions

6. Documentation Methods and Examples • Engineering Notebooks • Preliminary sketches • Meeting notes • Concept ideas and development • Microsoft Word and Excel documents • Engineering Analysis • Summaries • E-mail messages • Design discussions

7. Good Documentation Practices

8. Design History File (DHF) • Compiles records describing the design history of a finished device • Complies with FDA requirements for marketing medical device • Specific to each company FDA Requirement: “Each manufacturer shall establish and maintain a DHF for each type of device. The Device shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approval design plan and the requirements of this part.” Code of Federal Regulations, Title 21 – Food and Drugs, Chapter I – Food and Drug Administration Department of Health and Human Services, Subchapter H – Medical Devices.

9. Design History File (DHF) • Items can include: • User Needs • Design Inputs • Design Outputs • Design review meeting information • Design Verification • Design Validation • Design Transfer • Design Changes

10. Design Planning • Outlines the activities to be taken during the design control process • Sets target dates for finishing each stage of development, as well as design reviews • Gantt Chart • Identifies team members from each necessary department

11. User Needs • Customer Requirements • Defines the use for the product in the market • Drives the development process • Typically gathered by marketing team

12. Design Inputs • Translate customer’s needs into design • Reduce miscommunication between engineering and marketing teams if used effectively • Improve efficiency of the design process • Require documentation and approval • Define performance and function requirements

13. Design Inputs • Functional requirements • Lists all functions the final product must perform • Lists compatibilities with mating parts • Performance requirements • Benchmarks the final product must meet • Include strength, durability, and lifespan

14. Design Inputs • Sterilization Method • Defines how product will be cleaned • Packaging/Labeling requirements • Defines specifications that labeling/packaging must meet • Human Factors • Specialized inputs to define how people interact with a medical device

15. Design Outputs • Bring design inputs to life • Outline what happened in design process • Items include: • Product specifications, drawings, packaging, labeling, instructions for use, design rationale

16. Risk Management • Evaluates all risks of product and production process • Identifies actions to manage unacceptable design and process risks

17. Risk Management • Design Failure Mode Effects Analysis (DFMEA) • Process Failure Mode Effects Analysis (PFMEA) • Potential product failures • Effects of product failures • Causes of failures • Corrections of failures

18. FMEA Example: Toothbrush • Other Examples: • Predicate Device • Testing Standards • Clinical History • Engineering Analysis • Surgical Technique • Intra-op feedback • Design Controls

19. Design Review • Identifies and evaluates design at several stages of the development process (Design Review I, II, III, etc.) • Each review has a series of checklists and criteria that must be met • Utilizes knowledge base of multi-function team representatives concerned with the design stage • Approved by multiple departments in order to proceed with development • Packaging, Labeling, Product Development, Quality, Regulatory, etc.

20. Design Change • Communicates and documents changes • Creates links between revisions • Traces development of new product • Approved by appropriate departments during development

21. Design Verification/Validation • Validation – “Are you building the right thing?” • Make sure product meets user needs • Verification – “Are you building it right?” • Ensure that final product meets initial design specifications • Ensures that outputs conform to inputs • Consists of tests, inspections, and analyses • Requires documentation of acceptance criteria and protocols

22. Device Master Record (DMR) • Compilation of records containing the specifications and procedures for a finished device • The DMR for each device should include or refer to the location of: • Device specifications including appropriate drawings, composition, formulation, component specifications, and software applications • Production process specifications including appropriate equipment specifications, production methods, production procedures, and production environment specifications

23. Device Master Record • Other items include: • Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment used • Packaging and labeling specifications, including methods and process used • Installation, maintenance, and service procedures and methods

24. Device Master Record

25. Design Transfer Documentation • Facilitates transfer of product from design engineering to manufacturing engineering • Includes detailed production specifications • Increases efficiency and quality of production

26. Summary • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122416.htm

27. Summary • Assume everything you hear, say, think, write, read, and create is important no matter how insignificant, trivial, irrelevant, immaterial, or inconsequential you might think it may be • Record, date, sign, and save everything • Document as though an audit will occur • Include timestamps and revision numbers on all documents

28. QUESTIONS?