 Submissions)
Design History File (DHF) Remediation
FDA inspectors, ISO auditors and internal quality and regulatory personnel are scrutinizing design history files more than ever, and the consultants at Engineering & Quality Solutions, Inc. have seen this first-hand while assisting clients with QMS audits and FDA inspections. DHF deficiencies are a major source of 483 letters in the medical device industry, and we’ve helped many clients remediate their DHFs and update procedures to ensure future design control compliance.
DHF deficiencies may be related to products which have been on the market a long time and the documentation practices from many years ago just aren’t sufficient today. In new development projects some personnel or comapnies simply don’t have the expertise, capacity or procedures in place to fully comply with regulations. If a company has identified DHF deficiencies, they may be dedicating resources to remediating DHFs for existing products, reviewing current in-process development efforts more carefully, and revamping design controls procedures to make sure design files are compliant. The internal effect of the DHF remediation effort is a slowing of new development as resources attend to legacy products, improve their documentation and answer corrective actions.
It may seem somewhat painful to go through, but the ultimate effect of strong DHFs (and also the intended effect of the regulations) is a better product with fewer problems. Applying proper design controls helps ensure that the product does what is intended, is safer, is more reliable and predictable, has fewer problems, and meets market needs.
If you need expert help to get your DHFs remediated quickly and efficiently, and to free up internal resources, call us today!
I really enjoyed contributing to this ODT article on the latest tends and technology in orthopedic product development. It's great that ODT magazine researches and talks with industry professionals like myself to find out what's happening and get a preview on the orthopedic products that may be under development and launched soon. I appreciated the opportunity to give my experience and perspective. Check out the full article at this link:
https://www.odtmag.com/issues/2019-08-14/view_features/designing-complexity-simply/
Engineering & Quality Solutions, Inc. is the perfect resource for medical device start-ups and business ventures. Contact us today to get started.
Part 4 – Transitioning to Internal Resources
This is the final installment in a four-part series on how Engineering & Quality Solutions, Inc. can help business ventures and start-ups by consulting on product development, quality systems, manufacturing and transitioning to internal resources if needed. We consult on-site or remotely and can work in a small or large capacity, as company inside resources or outside consultants, whatever works for your company model and stage. Many start-ups operate entirely in the cloud with resources living in different states, and this is a great model to reduce overhead and attract the best personnel. As the company and business evolves and grows, we adapt and provide the resources you need at the exact time you need them!
When business grows and matures, start-ups may decide to remain remote and cloud-based or to transition to a central office. The consultants at Engineering & Quality Solutions, Inc. have worked with all sizes and stages of medical device companies and we understand how businesses function at different stages. We can help streamline transitions by managing growth phases, training new employees, and continuing to support your company as needed.
We can help with:
- Transitioning from External to Internal Resources
- Training New Employees
- Continued Support for Product Development, Quality System and Manufacturing as needed
Engineering & Quality Solutions, Inc. is the perfect resource for medical device start-ups and business ventures. Contact us today to get started.
Part 3 – Manufacturing
This is the third installment in a four-part series on how Engineering & Quality Solutions, Inc. can help business ventures and start-ups by consulting on product development, quality systems, manufacturing and transitioning to internal resources if needed. We consult on-site or remotely and can work in a small or large capacity, as company inside resources or outside consultants, whatever works for your company model and stage. Many start-ups operate entirely in the cloud with resources living in different states, and this is a great model to reduce overhead and attract the best personnel. As the company and business evolves and grows, we adapt and provide the resources you need at the exact time you need them!
Once the device is designed, product manufacturing needs to be addressed. Many medical device start-ups need help finding manufacturing resources and ensuring they’re qualified to work on medical products. The consultants at Engineering & Quality Solutions, Inc. have worked in medical device manufacturing and quality assurance and we have a network of qualified resources. We’ve toured, evaluated and audited many contract manufacturers, so we can efficiently identify and qualify vendors for your new products. We can act as your resource to manage all aspects of contract manufacturing.
We can help with:
- Identifying and Qualifying Suppliers
- Maintaining Supplier Documentation
- Supplier and Incoming Product Inspection
- Quotes and Proposals
- Manufacturing Technical Problem Solving
- Purchasing Controls
- Supplier Quality Audits
- Acting as Manufacturing & Supply Chain Manager
Engineering & Quality Solutions, Inc. is the perfect resource for medical device start-ups and business ventures. Contact us today to get started.
Part 2 – Quality System Development
This is the second installment in a four-part series on how Engineering & Quality Solutions, Inc. can help business ventures and start-ups by consulting on product development, quality systems, manufacturing and transitioning to internal resources if needed. We consult on-site or remotely and can work in a small or large capacity, as company inside resources or outside consultants, whatever works for your company model and stage. Many start-ups operate entirely in the cloud with resources living in different states, and this is a great model to reduce overhead and attract the best personnel. As the company and business evolves and grows, we adapt and provide the resources you need at the exact time you need them!
Once a medical device start-up has completed the concept and is conducting final product development, it’s time to start implementing a quality system. This will help ensure activities are completed in compliance with FDA 21 CFR 820 and the company is poised to move to manufacturing and distribution as soon as possible. The consultants at Engineering & Quality Solutions, Inc. have developed, implemented, and streamlined dozens of quality management systems for start-ups. We know the regulations and we have worked in the trenches ourselves, so we can implement a system which is compliant and functional without being cumbersome. We’ve also been through many FDA inspections and helped companies recover from FDA warning letters.
We can help with:
- Developing a Complete Quality System
- Updating, Finishing or Streamlining an Existing Quality System
- Conducting Internal Audits
- Maintaining QMS Records
- Acting as Quality Manager
- Preparation and Representation for FDA Inspections
Part 1 – Product Development
Engineering & Quality Solutions, Inc. is the perfect resource for medical device start-ups and business ventures. Contact us today to get started.
This is the first installment in a four-part series on how Engineering & Quality Solutions, Inc. can help business ventures and start-ups by consulting on product development, quality systems, manufacturing and transitioning to internal resources if needed. We consult on-site or remotely and can work in a small or large capacity, as company inside resources or outside consultants, whatever works for your company model and stage. Many start-ups operate entirely in the cloud with resources living in different states, and this is a great model to reduce overhead and attract the best personnel. As the company and business evolves and grows, we adapt and provide the resources you need at the exact time you need them!
New business ventures and start-up companies need concepts and products developed quickly and efficiently, which means experienced engineers with the right tools are a must. The consultants at Engineering & Quality Solutions, Inc. have decades of medical device development experience and have the software, instruments and resources to produce concepts and designs in very short timeframes. We can source prototypes and make design modifications in just days, keeping your projects on track.
Most medical devices need an accompanying design history file with appropriate design controls. Our engineers know the FDA regulations and can create the necessary design files for you. Therefore, your product will be designed and the documentation will be compliant with FDA 21 CFR 820.
Engineering & Quality Solutions, Inc will have representatives attending the 2019 AAOS annual meeting March 12 – 16 in Las Vegas, Nevada. This will be EQS's sixth year attending the AAOS annual meeting and we look forward to meeting with our current and prospective clients.
The AAOS annual meeting provides great opportunities to meet with peers, share perspectives keep track of industry trends and form successful partnerships.
Please contact us to set up a time to meet in person and discuss how we can help you meet your medical device product development, quality system and training goals in 2019 and beyond!
Thinking of hiring a consultant for a short or specialized project? Here are a few tips to make the relationship a success.
Consultants allow clients to complete specialized tasks and gain extra capacity easily without hiring a full-time person. A good consultant is professional, reliable, honest and efficient but the client-consultant relationship still needs to be a good fit for both sides. The truth is, it’s best to use the same screening and evaluation process for a consultant as you would for an employee. Here are four key tips to success when working with a consultant.
Interview
Always interview a consultant as you would a prospective employee. Consultants are not employees, but they ultimately work for you! Therefore it’s best to conduct a thorough interview and find out about their technical qualifications, work experience and communications style.
Get References
The FDA announced it intended to overhaul the new medical device review process with the intent to improve device safety. See the AP article at the link below for more details.
The review system, which includes the 510(k) submission and is the pathway used to clear most devices, has been in place for decades and may well need an overhaul in some capacity. The article states that the process needs improvement to keep up with technological advancements in devices. True, technology has made major advancements since the substantial equivalence pathway was adopted in 1976, but not all devices have had such rapid technological advancements. Compare a cannulated bone screw to a diabetes glucose meter and that point is clear. It may make sense to apply stricter criteria to a complex device such as one including software and electronics versus an orthopedic device where the basic technology hasn’t changed much since the original device was cleared.
It will be interesting to see how this overhaul moves forward. Typically, it has taken a long time for the FDA to make changes to practices on a much smaller scale. And this overhaul may involve congress and a long list of government and civilian officials. I certainly hope that if this moves forward, they group devices based on technology or application or complexity for different pathways, rather than making the clearance pathways more strict for all devices. The industry absolutely needs to be dedicated to providing safer devices, but that also has to be balanced with getting those safe devices to market in a reasonable time.
https://www.apnews.com/58820e1d2cff448181073d05eb56c1a6
Market research projects a 35% increase in revenue from the use of pedicle screws for the global market over the next 5 years. See article below from ODT magazine. The consultants at Engineering & Quality Solutions have designed pedicle screw systems that have received FDA clearance in the past year for our clients. If you need product development help with a pedicle screw system please contact us to discuss how we may help you achieve your goals for your system.
All of these terms refer to the creation and use of computer models to analyze performance of a design. For orthopedic medical devices, these methods could help in predicting failure loads and locations, comparing performance of several design options, determining mechanical performance ranges within a product family, comparing performance of one device to a competitive (predicate) device, and more. Several examples of these applications are shown below.
ASTM/ISO Mechanical Testing
Any orthopedic device submitted for FDA 510(k) must undergo some kind of mechanical testing, usually according to an applicable ASTM or ISO test standard. FEA can be used to simulate the tests and get a preview of performance and results, before time and money has been spent on prototypes and lab testing. The simulation can also be applied to a competitor’s design as a preview of mechanical equivalence testing, or even used in lieu of mechanical testing when test specimens are limited or unavailable.
Design Family Analysis
Many medical devices contain various sizes in a product family, but it’s impractical to prototype, evaluate and test every variation. FEA can be used to quickly analyze the whole family to determine the range of performance, and which versions should be used for physical testing.
Design verification and validation is a critical part of every medical device design project, and is required by the FDA and by ISO 13485:2016. By completing design verification, you confirm that design inputs were indeed met in the final design. And by completing design validation, you ensure that the final design meets user needs and intended uses. Planning, carrying out and documenting design verification and validation can be a cumbersome task but it doesn’t have to be. The engineers at Engineering & Quality Solutions, Inc. have extensive experience in completing design V&V for a variety of medical products. We can help your product development team with V&V from A to Z, whatever level your needs; you can hand off the project to EQS for full V&V planning, documentation and completion; or EQS can carry out some aspects of the V&V tasks as needed. Contact us today to discuss your design verification and validation needs.
Engineering & Quality Solutions, Inc. will be attending the 2018 NASS annual meeting on September 26 & 27 in Los Angeles, CA. We missed last year's meeting but are looking forward to meeting with our current and prospective clients, industry peers and contacts in Los Angeles.
Please contact us to set up a time to meet in person and discuss how we can help you meet your product development, Finite Element Analysis (FEA), Quality Management System (QMS) and training goals for 2018 and beyond!
Many small to mid-sized companies have issues completing their internal audits or getting real insight from their audits. Since employees are responsible for many different areas, there may be few options for unbiased internal auditors. Or employees may not be qualified to perform thorough audits to ISO 13485 and FDA 21 CFR 820 standards. If your company falls into either of these categories, Engineering & Quality Solutions, Inc. can help. We can complete your internal auditing and give you real, useful feedback. We understand the latest regulations and standards and how to apply them efficiently. Contact us today to discuss your internal audits.
Engineering & Quality Solutions will be attending the 2018 AAOS annual meeting in New Orleans, LA. This will be EQS's fifth year attending the AAOS annual meeting and we always look forward to meeting with our current and prospective clients.
The AAOS annual meeting also provides great opportunities to see the latest industry trends, share perspectives and form successful partnerships. Please contact us to set up a time to meet in person and discuss how we can help you attain your medical device product development goals in 2018 and beyond!
Many medical device companies find themselves uncertain of how to meet FDA design control regulations, and overwhelmed with the associated DHF workload. Lean start-ups are focused on product innovation and launch, and therefore have few resources to dedicate to DHF documentation. Established companies have legacy product DHFs that were created years ago and are in need of an update. Many companies are faced with audit findings and corrective actions related to insufficient DHF procedures and files, and they don’t know where to begin the improvement process. No matter what the scenario is, EQS can help get your DHFs and procedures in order.
EQS can ease your DHF burden by:
- Creating DHFs for new products
- Reviewing & updating existing DHF documents to meet current regulations
- Updating & expanding DHF documents for line extensions
- Updating QMS procedures to streamline DHF processes and meet regulations
- Training employees on understanding DHF documentation and regulations FDA 21 CFR 820.30
Contact us today to discuss your project!
Our goal is to help you meet yours.
 and Design Controls)
Check out the recent story in ODT magazine, titled "Back to the Drawing Board: Designing Orthopedic Devices". EQS was pleased to provide our inside perspective on orthopedic and spine design, and hear what others in the industry are experiencing. It's a dynamic time in orthopedic R&D right now and this article sheds some light on some of the issues and solutions.