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.

https://www.odtmag.com/contents/view_breaking-news/2018-10-18/pedicle-screw-system-market-forecast-to-grow-to-7242-million-by-2023/48608

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.

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.

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.

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.

http://www.odtmag.com/issues/2017-10-01/view_features/back-to-the-drawing-board-designing-orthopedic-devices/

It was my pleasure to contribute, along with other industry professionals, to the latest ODT article looking at the state of R&D in the orthopedic industry. Some topics discussed are: development trends, challenges and FDA regulations in orthopedic devices. See the full article here:

http://www.odtmag.com/issues/2017-03-01/view_features/out-of-ideas/

Long PD Timelines Delaying Market Launch? Tips to reduce PD timelines

Are your medical device PD time lines getting longer? If you have a high impact project or a critical launch window, this can seriously jeopardize revenues. Consider these top four tips to reduce PD timelines. It’s no secret that the sooner your medical device is launched, the sooner revenues begin rolling in. And some products have a specific launch window where introduction time is critical to realizing sales and gaining market share. But medical device product development takes time, especially for orthopedic and spine devices where design controls and FDA regulations are non-negotiable. So what can you do to launch sooner while maintaining quality on critical projects? Check out these four tips to reduce medical device product development timelines:

1) Reduce distractions and multi-tasking

If development team members work on multiple projects and sustaining engineering tasks, consider removing these other duties and allowing team members to work on only the high impact project. They will be more productive and efficient and tasks will be completed faster.

2) Identify and work on the critical design first

PD Bottlenecks Impacting Your 2017 Launch Plans? Tips for Successful Management of Outsourced Engineering

As product development ramps up in the medical device industry, many companies are considering ways to increase PD capacity in order to meet aggressive and exciting goals; utilizing outsourced product development can be a great solution, with a little smart management. Here are the top four tips we at Engineering & Quality Solutions, Inc. have found ensure success between you and your design firm. These tips hold true whether you’re outsourcing a full project from start to finish or getting outside help with certain portions of the project.

1) Select resources with experience and skill that match your project

For medical device companies, engaging a PD resource who knows the industry is critical. Medical device projects require different considerations such as raw material specs, cleaning & sterilization, testing, submission considerations, design history file creation and FDA regulations. Make sure your design partner understands these requirements in order to avoid delays and design revisions due to missed requirements.

2) Start with detailed project plans with inputs and outputs

If you’re thinking about adding design engineering resources for a development project, first check out this comparison of the impact of hiring an employee versus using outsourced development resources.  See our Case Study titled "Outsourced Product Development" at the following link. http://www.e-qsolutions.com/case-studies#outsourced-product-development-click-to-open-close.  If you're interested in getting cost estimates for your specific project, please contact us and we'll be happy to help you!

"Maximizing Margins with DFM" is an article by Orthopedic Design Technology magazine looking at the DFM trends in the medical device industry. I feel analyzing DFM & DFA is an important step in the product development process that EQS applies to almost every project, and I was so pleased to be able to provide insight for this article.  We're also glad to see that more MedDev companies are applying these principles, as it helps everyone succeed and ultimately leades to better outcomes and lower costs. Please see the whole article at the link below.

http://www.odtmag.com/issues/2016-11-01/view_features/maximizing-margins-with-dfm/

It's understandable that changes sometimes need to be made to improve devices that are already cleared and being marketed.  Are you wondering if it's necessary to submit a new 510(k) for a device in this situation?  There are draft guidance documents issued by the FDA to help companies navigate these questions, and recent updates have been made to the recommendations.  So if you're unsure how changes affect your device status, make sure to revew the guidance documents.  See the recent press release from the FDA about this topic at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm515174.htm

Is your team thinking of using additive manufacturing for a medical device?  Additive manufacturing, or 3D printing, has become a reality in many industries including orthopedics.  Several devices that leverage this technology are now on the market.  They were the first to pave the way and navigate the FDA clearance process.  The FDA has been researching and following the developments in additive manufacturing and now they’ve released draft guidance which covers many relevant topics including manufacturing and processing, cleaning and sterilization, testing, and more. This document titled “Technical Considerations for Additive Manufactured Devices - Draft Guidance for Industry and Food and Drug Administration Staff” is available to the public at the link below.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf

If your team needs assistance with a medical device project involving additive manufacturing, don’t hesitate to contact Engineering & Quality Solutions, Inc.   We have experience with 3D printing applications for orthopedic devices and can help you understand the unique requirements of using this technology.

Engineering & Quality Solutions also does technical training.  We’re happy to share our expertise and experiences with your team to help them become experts and increase productivity and efficiency.  Common course requests are GD&T, Medical Device Design Verification & Validation, and Medical Device Quality System Compliance.  If you have training needs like these or other similar topics, contact us to find out how we can help you.

Engineering & Quality Solutions, Inc. often gets asked about FDA registration and listing…Which companies needs to register and list devices? When should a new or start-up device company register? Should a contract manufacturer be registered? The rules have changed over the years and the answer depends on the company, its products & services, and other factors. The link below to the FDA website provides guidelines on this sometimes complex subject. If you’re wondering about FDA registration and device listing for your company, feel free to contact us and we can help you determine the best path.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm#contractmanufacturer