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FDA Presentation on Design Controls for Medical Devices

Design Controls for Medical Devices:
Check out this presentation on Design Controls, published by the FDA. They've been publishing educational presentations and videos on many relevant topics for years; this can act as a primer on the subject, help resolve questions or confusion, and the best part is that it comes from the source!
 
If your team needs expert help with design controls - creating, maintaining or remediating design history files, contact the experts at Engineering & Quality Solutions, Inc. today.
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Part 4 – Transitioning to Internal Resources

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
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Part 3 - Manufacturing Management for Start-ups

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
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Part 2 – Quality System Development for Start-ups

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
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Part 1 – Product Development for Start-ups

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.

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Attending the 2019 AAOS Annual Meeting in Las Vegas, Nevada

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!

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Tips for a successful business relationship with a consultant

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.

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FDA Announces Potential Overhaul to Medical Device Review Process

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

 

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Pedicle screw usage to increase globally

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

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Finite Element Analysis, FEA, Computational Modeling, Computer Simulation…what is it and how can you use it to improve medical device product development?

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.

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Design Verification and Validation

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.

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Engineering & Quality Solutions, Inc. will be attending the North American Spine Society (NASS) 2018 annual

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!

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Need to complete internal audits on time and with useful feedback?

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.

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Attending the 2018 AAOS Annual Meeting

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!

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Managing & Maintaining Medical Device Design History Files (DHFs) and Design Controls

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.

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Article on Design Challenges in the Orthopedic Industry

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/

 

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Orthopedic Design & Technology Article on R&D

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/

 

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Attending AAOS 2017 Annual Meeting

Engineering & Quality Solutions will be attending the 2017 AAOS annual meeting March 14 – 17 in San Diego, CA.  This will be EQS's fourth year attending the AAOS annual meeting and we look forward to meeting with our current and prospective clients.

The AAOS annual meeting also provides great opportunities to meet with peers, 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 meet your medical device product development goals in 2017 and beyond!    

 

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Long PD Timelines Delaying Market Launch?

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

Orthopedic and spinal device systems typically contain many implant versions with multiple sizes, geometries and options. If you can identify the worst case version early and design that size first, you can get to prototyping and testing sooner. Then design the remaining versions after the critical one is completed.

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PD Bottlenecks Impacting Your 2017 Launch Plans?

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

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