“Understanding Prototype Development Phases For Medical Products” Article Published

Cooper Consulting Service had an article published about “Understanding Prototype Development Phases For Medical Products”. In the article, Tommy Cooper helps tie together the development goals, time & cost expectations, and design controls needed at each stage of prototyping.

https://www.meddeviceonline.com/doc/understanding-prototype-development-phases-for-medical-products-0001

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LinkedIn:  https://www.linkedin.com/company/cooper-consulting-service/

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Understanding Prototype Development Phases

PDF Version:  CCS Understanding Prototype Development Phases

 

Background

Having a common understanding of the functional utility for each stage of prototype development is essential to managing the expectations for everyone involved in a project, from the designers to the executives and the investors.  Prototypes at each development stage have a utility that needs to be understood to justify the cost and time to develop them.  Here is a chart that presents the prototype development stages and the effective use of the prototypes at each level.

 

Appearance Model

The appearance model may be rendered images from an industrial designer or a physical mock-up made from foam board or 3D printing.  It may look like the final product.  It is used to demonstrate the size, colors, control locations, actuator size/location and other visual features.  In some cases it may be a series of drawings that explores a number of configurations for the product.  It should be done in weeks rather than months.  It may be used to gage investor interest and to get end user feedback.  It is part of the concept design of the system.

Proof of Concept

Proof of concept (PoC) prototypes are bench top physical mock-ups and breadboards.  They are used to evaluate the performance of a subsystem or technical component for feasibility.  For example, a tubing clamp design could be evaluated for pressure withstand or flow control capability or a dc-dc converter could be evaluated for heating under load, noise, and regulation.  PoC prototypes may be used to evaluate the usability of a user interface, such as the operability of an active graphical user interface (GUI) mock-up or the ease of tubing kit loading onto a pump panel mock-up.  These evaluations and feasibility reports assist with component selection and specification development and are part of the design history file for a medical device.  The PoC prototypes designs are 40% to 80% stable for the final design. The PoC prototype stage should be done in a few months.

Alpha

The Alpha prototype is the initial attempt at designing and fabricating the product to meet the Product Requirements Specification (PRS).  It is also the first attempt at making it look like the final product and work like the final product.  The iterative process of designing and building the Alpha prototype will provide the guidance for the next stage.  The Alpha may be constructed with 3D printed enclosures and components for physical fit and performance evaluation.  It will have initial PCB and enclosure designs for internal testing and evaluation of performance, safety, EMC, usability and appearance.  The Alpha development is expensive compared to previous stages, and requires months to iterate and refine the design.  The Alpha design and testing is essential in understanding the limitations of the product and in refining the design.

Beta

The Beta prototype development incorporates the design refinements found in Alpha development and implements them into production tooling, molds, PCBs, subassemblies, enclosures, GUI designs, etc.  Test plans and verification protocols are prepared.  Software is refined and prepared for the first release.  Documentation is updated and prepared for releasing the device master record (DMR).  Production testing and assembly protocols are drafted.  The Beta prototypes are assembled and tested per the production procedures.  The Beta prototypes are ready for verification and preliminary validation testing, safety and EMC testing, and performance testing to verify compliance with the PRS.    There will be refinements that are required after assembly of the Beta prototypes and these refinements should be under configuration control to reflect the reasons for the changes and how they make the Beta prototype overcome any deficiencies in meeting specifications and standards.

Pilot Production

The pilot production phase is where the refinements from the Beta prototype verification and validation testing are incorporated into the design and into the production process.  The design transfer to manufacturing and the implementation of the quality management system is done for pilot production. These units may be used for summative usability testing and clinical trials.  They are suitable for initial release to market.  The design and the production process are relatively stable.

Matured Product

The matured product incorporates the refinements from user feedback and production monitoring.  The design and the assembly process are stable, have high yields and incorporate cost saving measures.

 

Have more questions about the prototyping process?  Contact Us

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IEEE HCN Meeting – Jan 2017

The next IEEE HCN General Meeting will be held on Wednesday January 25th at the Clayton Library Center at 5300 Caroline St., Houston, TX 77004, starting at 5:30pm. There is a no fee parking lot next to the library. The meeting will be in the carriage house across the parking lot from the main library building.

Our speakers will be Brian A. Kilmer, J.D., shareholder at Kilmer Crosby & Walker, PLLC, and Shannon Quadros, MSEE, J.D., shareholder at Kilmer Crosby & Walker, PLLC. Mr. Kilmer and Mr. Quadros will have a presentation titled:

Top Ten Tips for When You are a Creditor in a Business Bankruptcy Case

Following their presentation, we will have a short Q & A with audience participation. Snacks and refreshments will be provided. Attendance at this event may be used for one hour PDH credit for your TBPE continuing education ethics requirement (certificates provided).

Please plan to attend and try to bring an associate that could benefit from the Network. You can RSVP by sending a message on our Contact Us page.

IEEE HCN General Meeting on Wed, Sept 28th at Clayton Library Center

The next IEEE Houston Consultants Network (HCN) General Meeting is on Wednesday September 28th at the Clayton Library Center at 5300 Caroline St., Houston, TX 77004, starting at 5:30pm. There is a no fee parking lot next to the library. The meeting will be in the carriage house across the parking lot from the main library building.

Our speaker will be David Howell, P.E., Deputy Executive Director for the Board of Texas Board of Professional Engineers. Mr. Howell will have a presentation on:
– Texas Board of Professional Engineers
– Professional Practice Update/Ethics Update

Following his presentation, we will have a short Q & A with audience participation. Snacks and refreshments provided. Attendance at this event may be used for one hour PDH credit for your TBPE continuing education ethics requirement. Certificates will be provided.

Please plan to attend and try to bring an associate that might want to join the Network.

Tommy Cooper of CCS is on the board of IEEE HCN. You can RSVP on our Contact Us page.

Tommy Cooper published in Medical Design Briefs

CCS founder and president Tommy Cooper wrote “Lasers: The Next Generation of Fetal Monitoring” for the January 2016 edition of Medical Design Briefs. The article discusses the cerebral oxygen monitoring device CCS developed for Noninvasix, which is able to make non-invasive measurements of cerebral blood parameters.  This real-time data lets hospital staff identify adverse conditions immediately.  Quick actions can prevent brain damage and other serious conditions, and this device enables those actions.

This is the second time the project has been published in a technical journal article.  We are very happy it has been getting exposure and we would like to congratulate our client on their pioneering work in this field.

Visit our contact page and let us help you make your ground-breaking device idea a reality!

IEEE HCN Meeting – February 2016

The IEEE Houston Consultants Network (HCN) General Meeting will be on Monday February 1st at the McGovern-Stella Link Houston Public Library at 7405 Stella Link, starting at 6:00pm. There is a no fee parking lot next to the library.

Shannon Quadros, MSEE, JD, shareholder – Kilmer Crosby & Walker, PLLC , will be the speaker. Mr. Quadros will give a presentation: Non-Competes, Non-Solicits & Non-Disclosures – The Three Horsemen of Employment Law Every Engineer Should Know. Following his presentation, there will be a short Q & A session.

Snacks and refreshments will be provided. Attendance at this event may be used for one hour PDH credit for your TBPE continuing education requirement. Certificates will be issued on request.

Please plan to attend and if possible, bring an associate that may want to join the Network. You can also the IEEE HCN website for more information.

CCS helps run the IEEE HCN group.  You can RSVP to the meeting through our contact page.

CCS Project Wins NASA Award

Cooper Consulting Service (CCS) is currently working on an exercise and health monitoring device with NASA. In December, we had the opportunity to present the project at the EISD Poster Session at the Johnson Space Center (JSC).  Approximately 50 current NASA projects (including ours) made displays and gathered in the collaboration center.  We had the chance to give brief presentations to all of the NASA staff members who stopped by, including JSC Director Dr. Ellen Ochoa.

We were very honored that CCS and our NASA team were given the Director’s Choice award, which was voted on by senior NASA staff members. We look forward to continuing work on this project and helping the space program improve physiological monitoring of our astronauts in orbit.  Thanks again to our NASA team!nasa-bldg-1 nasa-poster nasa-session-2 nasa-present

CCS device used on TV show

The LifeSync device designed by Cooper Consulting Service recently had a cameo appearance on CW’s TV series The Flash, based on the DC Comics character. Here is a picture of the character wearing the device on his arm:

lifesync-flash

CCS is always happy to see our projects in use in the field, or at least representing their use on television (it does look like it is hooked up properly).  Tell us about your device idea and perhaps you will see it in the bright lights of Hollywood… but more likely, the bright lights of a hospital or doctor’s office.

CCS Project Published in Medical Design Technology

Cooper Consulting Service worked with Noninvasix to develop their prototype cerebral oxygenation monitor.  The project was published recently in Medical Design Technology, which focused on how it can be used to prevent brain damage in infants and neonates using a novel non-invasive monitoring technique.  You can read the full article here.

CCS would be glad to help you make your life-changing device a reality as well.  Visit our contact page and let us know how we can help you.

IEEE HCN – October 2015 Meeting Notice

The next IEEE Houston Consultants Network (HCN) General Meeting will be on Monday October 12th at the McGovern-Stella Link Houston Public Library at 7405 Stella Link at 6:00 pm. There is a no-fee parking lot next to the library.

This meeting’s speaker will be C. W. Clarke (P.E.), Director of the Compliance & Enforcement Division of the Texas Board of Professional Engineers.  Mr. Clarke will be presenting on recent rule changes, board initiatives, enforcement statistics, sealing requirements, and the continuing education program/requirements.  The presentation will be followed by a round-table discussion.

Snacks are provided during the networking session, which begins the meeting. Attendance may be used for one hour PDH credit for your TBPE continuing education requirement. Certificates provided.

CCS is on the HCN board & encourages you to bring an associate that may wish to join the Network.

You can RSVP on our Contact Us page.