Posted on Wed, Feb 08, 2012
In anticipation of his upcoming presentation at the Medical Design and Manufacturing conference in February, Medical Product Manufacturing News has published an interview conducted with Richard Meyst, President and CEO of Fallbrook Engineering. In the interview Mr. Meyst discusses some of the topics he and Dr. Stephen Coulter, his co-presenter, will cover during their MD&M presentation entitled "Bioresorbable Polymers in Medical Devices - A (Still) Emerging Field."
Click here to read the full article at MPMN online.
Richard and Steve will present at MD&M West on Monday, February 13, as part of the "Advances in Medical Polymers for Medical Devices" session. Click here to view the 2012 MD&M West conference agenda.
Posted on Fri, Jan 27, 2012
Mr. Karl J. Hemmerich, President of Ageless Processing Technology and a Fallbrook Engineering Senior Associate, has over 35 years of experience in medical device product design, development, sterilization and operations. He specializes in sterilization method selection and program development with emphasis on component material selection, process development and sterilization process validation. His experience in product design and process development includes injection molding, RF, ultrasonic and solvent assembly, multivariate process analysis and statistical process control.
In 2004 Medical Device and Diagnostics Industry selected Mr. Hemmerich as one of the 100 Most Notable People in the medical device industry. He holds numerous medical device patents and is a member of American Society of Mechanical Engineers, American Society for Quality Control and the Society of Plastics Engineers. He has written and presented papers on radiation sterilization and materials selection for many corporations, universities and professional organizations, including MDDI, SPE, FDA, HIMA, & ASQC, and his paper on radiation effects on polymers published in Medical Device and Diagnostics magazine remains an industry standard. He has presented short courses in Radiation Sterilization of Medical Polymers and Preventing Plastic Part Failure through the College of Engineering, University of Wisconsin. He is a contributing member of the SWG96/ISO11137 “Radiation Materials Working Group” that developed Technical Information Report # 17 as the guidance for materials selection, qualification/validation test techniques (i.e., accelerated aging), and quality processing methods for all common sterilization methods. Mr. Hemmerich is a member of the Editorial Advisory Board for MDDI magazine where he offers forward looking guidance as well as technical review for state-of-the-art articles prior to publication.
In addition to working with Fallbrook Engineering as a Materials and Sterilization Specialist, Mr. Hemmerich has held various responsible positions in medical product R&D and sterilization operations with Becton-Dickinson, Cutter Laboratories, IVAC Corporation and Steris Isomedix. He holds a Bachelor of Engineering degree from Stevens Institute of Technology, a Masters of Bio-Medical Engineering from the Polytechnic Institute of New York University, and a Masters of Business Administration from Fairleigh Dickinson University.
Click here to read Mr. Hemmerich's article on radiation effects on polymers at MDDI online.
Posted on Fri, Jan 20, 2012
On February 13, 2012, Fallbrook Engineering President and CEO Richard Meyst and Dr. Steve Coulter, Senior Research Associate at Fallbrook Engineering and Principal of SLC Consulting, will present "Bioresorbable Polymers for Medical Devices - A (Still) Emerging Field" at the Medical Design and Manufacturing conference in Anaheim, California. Theirs will be the final presentation in the Advances in Medical Polymers for Medical Devices session, and will follow presentations given by research scientists and executive management from companies such as Dow Chemical Company, Abbott Cardiovascular, Teleflex Medical OEM, Innova Dynamics, NuSil Technology, Momentive Performance Materials, Eastman Chemical Company and BASF.
In their presentation Richard and Steve will discuss how the selection of various classes of bioresorbable materials must conform to Design Control, as well as share their recent discovery that there are very limited options for commercial bioresorbable polymer sources.
Fallbrook Engineering would like to thank Len Czuba for inviting Richard and Steve to present at this year’s conference. Please visit MD&M West’s website to view the entire conference agenda: http://www.canontradeshows.com/expo/west12/conference_104.html.
Posted on Tue, Jan 03, 2012
Dr. Stephen Coulter, a Senior Research Associate at Fallbrook Engineering, is a biomaterials scientist with over 25 years of experience in the design, product development, process development, package engineering, manufacture, regulatory clearance and business development for medical devices. His experience ranges from surgical implants (wound healing, biomaterials, biodegradables, orthopedics, cardiovascular surgery, urology, neurosurgery, ophthalmics and gastroenterology) to consumer products (family planning, oral care, skin care and consumer packaging). He has been involved in the development of products for the U.S. as well as international markets. Dr. Coulter is well-versed in the requirements and implementation of design control, ISO 13485 and CE marking. He has technical expertise in the arena of materials science, especially biomaterials, materials compatibility, materials processing, surface modification techniques and materials characterization, both for product development and for failure analysis.
Dr. Coulter has held a number of technical management positions with Baxter Healthcare, Carter-Wallace and Church & Dwight, as well as two start-up companies for female incontinence and chemical/biological sensors. In this role he has expertise not only in product/business development, but also technology assessment, compliance and regulatory reviews and cost-improvement programs.
Dr. Coulter earned joint PhDs in Organic Chemistry and Polymer Engineering from the University of Michigan. He has been granted 6 patents in different product fields. Most recently his work with Fallbrook Engineering includes research and selection of materials, processing methods and sterilization methods for a bioresorbable stent, as well as polymer characterization and research for an IDE submission. In February he and Richard Meyst, President and CEO of Fallbrook Engineering, will present together at MD&M West.
Posted on Tue, Nov 08, 2011
Fallbrook Engineering is pleased to announce a recent addition to our team. Mr. Scott Thompson is a graduate of the University of California San Diego who has been working as an Associate for Fallbrook Engineering since April 2011. Until now his efforts have been focused on providing technical support to the senior associates and project managers for various ongoing projects.
Now, as Project Engineer, Mr. Thompson will mainly be responsible for new product concepts and designs, as well as maintaining our lab and purchasing new equipment and supplies, testing new products and writing protocols and engineering documentation.
Mr. Thompson received his Bachelor of Science in Mechanical Engineering from the Jacobs School of Engineering, University of California, San Diego. While at UCSD he was the design lead for a National Geographic Society sponsored project that created a stereo panorama image capture electromechanical system currently used by National Geographic Society scientists in Mongolia to aid in the discovery of the tomb of Genghis Khan. He also participated in the data collection and analysis for determining the feasibility of LEED certification for various structures on the UCSD campus. His studies included hands on experience with part machining, data collection and analysis, computer programming and prototyping.
Mr. Thompson is a member of the Order of Engineers and a receipt of the Eagle Scout Award in Boy Scouts and the Jane Goodall Institute Peace Action Award for Schools program. Although he is a recent university graduate, he already possesses the skills and experience to set him apart as an exemplary engineer. States Richard Meyst, Fallbrook Engineering President and CEO, “We are excited to have a youthful addition to our team to provide for our clients’ satisfaction and our company’s success.”
Posted on Wed, Sep 28, 2011
We knew it was time for something different…time for something out of the ordinary…
So, we decided to offer up a little humor on our website alongside the traditional e-business faire. For a little fun, I invite you to check out our new Engineering Humor page at http://www.fallbrookeng.com/links/engineering-humor. And, after you have had a chuckle or two, please visit our recently updated Portfolio page showing some of our project case studies as well as a link to an article featuring our Master Model Maker and CAD designer extraordinaire, Bill Gould: http://www.fallbrookeng.com/portfolio/mechanical-engineering-magazine
Bill has been working closely with Fallbrook Engineering for over twenty five years and is one of our esteemed Senior Associates. I know you will enjoy Bill’s use of CAD and advanced rendering to enhance the field of industrial archaeology.
Posted on Fri, Jul 29, 2011
Recognizing user error as one of the greatest factors contributing to patient and health care worker injury from medical devices, recent guidance from the FDA stresses the importance of human factors and usability engineering in the design and risk analysis of new medical devices.
The guidance document details how to apply human factors and usability engineering in design of medical devices in order to optimize safety and effectiveness. Medical device design engineers are reminded to focus on thoroughly analyzing all users who will be handling the device, as well as the settings and conditions in which they will be working. All aspects of the design must be considered to create a device that facilitates correct actions and prevents or discourages incorrect actions by the user.
In response to this document, Fallbrook Engineering is encouraged in our efforts to provide our clients with the most current and effective risk analysis and management services. We offer the expert services of our Risk Specialist, John Slate, PhD., for every project. Our President and CEO, Richard Meyst, is a guest lecturer on the benefits of Risk Management at both the University of California San Diego and San Diego State University, as well as at industry events. Mr. Meyst has presented for the Overview of FDA Regulations for Medical Device Professionals course and Current Good Manufacturing Practices: Advanced Topics course.
The new guidance from FDA reminds all businesses in the medical device design industry that considering human factors and usability engineering is extremely important in the risk analysis and management of a project. Patient and user safety is a critical goal of all medical device design. A product that was designed to comply with the most effective risk analysis properties will likely have fewer recalls, updates and extensive modifications, and will have a competitive edge over other products in the marketplace.
For more information please see FDA’s Applying Human Factors and Usability Engineering to Optimize Medical Device Design
Posted on Fri, Jun 24, 2011
Having joined the Designers Accord, an organization that promotes sustainability in design, and in a continuing effort to increase our focus on sustainability in the medical device industry, Fallbrook Engineering is eager to utilize the experience of one of our newest Senior Associates, Mr. Robert Dutchik.
Bob has been developing, commercializing and sustaining medical products in the device, diagnostics and pharmaceutical industry for over 25 years. He has extensive packaging experience for medical device and pharmaceutical products and is well versed in cold chain and third party management. Having worked in technical and management positions for a number of the top tier healthcare firms, his work has taken him across the globe to locations in the US, Puerto Rico, Europe, Malaysia, Costa Rica and Mexico.
Bob’s experience in design sustainability comes from his previous position working at Baxter Healthcare. Bob frequently communicated with buyers the necessity of packaging and shipping alternatives for purchased medical products. While still maintaining the integrity of the product and meeting shipping schedules, Bob was largely responsible for implementing packaging options to reduce waste and promote sustainability. For strictly regulated medical products that typically cannot be made with reuse or recycling in mind, improving device packaging and shipping methods is key to reducing waste in our industry.
“Fallbrook Engineering is delighted to have Bob join our team,” states Richard Meyst, Fallbrook President and CEO. “Bob previously was our client at several medical device companies, and now his years of experience and expertise are available to help our clients with their products. He will be managing projects for us as well as acting as a technical resource in the areas of barrier materials, packaging and sterilization. He is an essential resource for Fallbrook Engineering and bringing him on to our team is another step we are taking to support and enhance our offerings to our customers.”
Posted on Fri, May 13, 2011
Fallbrook Engineering is proud to announce it is now a member of the Designers Accord, a non-profit organization that aims to create positive environmental and social impact in the design industry.
The Designers Accord was founded in June 2007 with the primary goal of increasing sustainability awareness in the creative community. It is now a global coalition of designers, educators and business leaders working together to share methodologies, resources and experiences around environmental and social issues in design.
As a member of this organization, Fallbrook Engineering has joined 749 other design firms that are dedicated to sharing their best practices and case studies in order to facilitate new sustainability initiatives in the design community. Like all designers who focus on medical and biotech devices, Fallbrook Engineering faces the challenge of striving to create sustainable products while still meeting the demands of a rigidly controlled market. This market often requires the production of single use products made from non recyclable materials both to ensure cost efficiency and, most importantly, patient safety. Fallbrook Engineering will focus on discussing sustainable manufacturing options with our clients and design teams, such as designing for reuse and less energy intensive assembly, optimizing tool design and molding protocols to reduce waste and exploring alternative packaging options.
All at Fallbrook Engineering agree that focusing on sustainability in engineering design is an important issue for every company. States Vice President Bill Atkinson, “Working to create a more sustainable world has never been an option. It is a necessity. Joining the Designers Accord is an excellent step towards expanding our efforts.”
For more information: www.designersaccord.org
Posted on Tue, Apr 26, 2011
Fallbrook Engineering is pleased to announce that John Slate, Ph.D., has joined our team as Senior Associate.
Dr. Slate has over 30 years experience commercializing medical device products. His extensive background in research and development includes managing projects and leading design teams to develop software-controlled electromechanical systems and associated disposable components. His considerable expertise will be available to FEI clients from the individual inventor to large cap, multi-national corporations.
“We are pleased to be able to offer John’s unique skills and experience, which further strengthens Fallbrook’s team and our continuing commitment to helping our clients discover innovative solutions to their product development challenges,” states Richard Meyst, President and CEO of Fallbrook Engineering.
Dr. Slate has the critical experience in project management, patent reviews, feasibility demonstration, prototype development and quality system implementation to bring success to our clients’ efforts. His technical contributions include defining system architecture, performing risk analyses, sensor and actuator selection and algorithm design including feedback control systems. He has created documentation required by the FDA for design controls and quality systems, and is very experienced with drug delivery technology, including drug infusion modeling and control, infusion pumps and hand-held medication injectors, both needle-free and needle-based.
Prior to joining Fallbrook Engineering, Dr. Slate held Vice Presidential positions with MiniMed, Siemens Infusion Systems and VIA Medical. As cofounder and Vice President of Operations at Avant Medical, he led a team to develop and test four self-injection devices. Dr. Slate has led teams from product conception through manufacturing, including clinical studies and regulatory approvals.
Dr. Slate received his Ph.D. in Electrical Engineering from the University of Wisconsin, Madison. He has been awarded fourteen U.S. patents and published more than a dozen technical articles.