Getting to Know PADT: Medical Device Product Development

 This post is the thirteenth installment in our review of all the different products and services PADT offers our customers. As we add more, they will be available here.  As always, if you have any questions don’t hesitate to reach out to info@padtinc.com or give us a call at 1-800-293-PADT.

The development of medical devices is difficult.  The regulatory challenges, quality requirements,  and technical hurdles of dealing with the complex system that is the human body make the processes required to bring products for this industry to market unique and difficult. That is why PADT has a team in our Engineering Services department that is focused on one thing: Medical Device Development.

If you read our article on Product Development Services or watched the flashy video then you know how we do product development differently.  That our processes and staff are proven, that we are all about solving problems and using project management intelligently, all geared towards to deliver a complete solution.  Every one of those characteristis is true for our Medical Device team as well, we just add more on top to give our customers the confidence to work with us on their product development.

We sometimes get involved in projects all the way from defining specifications to coordinating with manufacturing. We also provide assistance at every step along the way: testing, concept modeling, trade studies, material evaluations, quality consulting, design for manufacturing, and testing to name just a few areas that we can help.  That is one of the things that makes PADT unique in this particular industries. Most companies will only do the full product development, whereas we serve as an outside resource for the whole thing, or only where our customers need additional help.

Solving the Tough Problems

There are a lot of medical device design companies out there.   We often get asked how we can stay busy in this industry, especially when we are not located in a hot-bed of device design and manufacturing like California, Boston, or Minneapolis.   The answer is simple.  Customers from those locations and other markets come to Tempe to work with us because we are good at solving the difficult problems.  Most of this capability comes from the skill and experience of our staff.  They know their stuff and they know how to systematically investigate and solve the most difficult problems.  They also have access to advanced tools like 3D Printing and world-class simulation in-house. Combine this with solid project management and a well-provisioned lab, and you have a winning combination.

Understanding Medical Devices

The other key requirement for anyone doing medical device product development is a thorough understanding of Medical Devices themselves. Every industry has its buzzwords and acronyms, but medical devices are in a category all their own. They are a bridge between the world of mechanical engineering and medicine, so they terminology and operating environment are different then say aerospace devices or consumer products.  To work on medical devices you have to understand all the physics, manufacturing, software, and electronics that every mechanical device needs. You also need to understand biology and treatment.  PADT’s staff walks that fine line between the two worlds and often serves as a translator between the end user (doctors and nurses) and engineering, even within our customer’s organizations.

Quality Centric

Quality is the most important, and least understood, unique aspect of Medical Device Product Development.  Any team attempting to bring a product to market who does not know ISO 13485 and the FDA requirements will fail.  We also know that Quality is a tool, not a barrier.  We understand the client’s quality system and adapt our processes as efficiently as possible to get value from the entire quality process.

Let us Engineer your Medical Device Innovations

Here is a powerpoint we put together last year with even more information:

Product development for medical devices is something we are just plain good at.  Large corporations and startups come to PADT to because we get the job done.  You can see some great case studies here that tell the story in the words of our customers.  Reach out to us via email (info@padtinc.com) or give us a call at 480.813.4884 and we can talk about how our team can help engineer your medical device innovation.

PADT-Medical-Overview-Portfolio-2018_02_13-1

Exploring the Value of Multi-Print 3D Models for Medical with Stratasys & Intermountain Healthcare

PADT’s Salt Lake City office has been involved with fulfillment of medical 3d Printing of several cases where customers are exploring the value of multi-color and multi-material medical 3D models by using the Stratasys J750 or the Connex 3. One of those cases was presented at the Mayo Clinic’s Collaborative 3D Printing in Medical Practice 2018 course, which was held in Arizona this year.

An Intermountain Healthcare facility in Salt Lake City needed help with 3D printing a patient-specific anatomy, as they were looking to better their understanding of the value of 3D printing using multi-color printer beyond their existing in-house capabilities. In the picture below, Rami Shorti, PhD., a senior Biomechanical Engineering Scientist at Intermountain Healthcare, wrote:

“A patient with a horseshoe kidney and multiple large symptomatic stones, who had failed Extracorporeal Shock Wave Lithotripsy and Ureteroscopy Treatment, was used to evaluate the benefit of using different imaging modalities intraoperatively.” 

Working with us in Salt Lake City, Rami Shorti, PhD, prepared the patient-specific medical imaging segmentation, post-processing of the patient anatomy, and finally generated for us a 3D printable CAD model that we were able to print using a Stratasys Objet 260 Connex 3. Since our office is located just around the corner from the hospital, we were able to work closely with Rami to identify the colors and finish of the final part.

The Connex 3 printer was introduced in 2014 as the only printer in the world that could combine three different model materials in a single print pass. Most 3D printers can only print with one material at a time, which is one of the main reasons why this technology is preferred for medical use cases along with its added precision. In 2017, Stratasys introduced the J750, which again is an industry first, becoming the only printer in the world that can print 6 different materials at the same time.  Combinations of hard plastics and rubber materials allow for a range of shore hardness values along with the ability to mix three primary colors to print 500,000 different colors.

With a quick turnaround needed, we decided to use the Connex 3 and were amazed that we were able to print the parts in two batches. Within 48 hours of receiving the STL files from Dr. Shorti, we were able to 3D print, post-process, and deliver the parts in time for the surgeon to review the time-sensitive surgical planning guides using the mockup. To enhance the transparency of the parts, we simply applied a few coats of Rust-Oleum Clear Gloss to the 3D printed part.  Now we were able to relax and wait for it to dry.  Below is a picture of the finished products displayed at the Mayo Clinic event.

 “3D printing added a level of benefit because of its ability to showcase the stones, renal pelvis, and renal arteries and veins simultaneously through the image fusion step done in Mimics software and with the use of specific materials and contrasting colors.  In addition, its ability to be held and manipulated in space was observed to be beneficial especially for patient education.”

– Rami Shorti, PhD., senior Biomechanical Engineering Scientist, Intermountain Healthcare

PADT is excited to continue our work with Intermountain Healthcare, and grow this relationship as new opportunities arise to leverage multi-material printing.

Introducing the Stratasys J750 – Webinar

Introducing the Stratasys J750 – Webinar

August 30th, 2017 – 11:00 AM – 12:00 PM MST

The Stratasys J750 3D printer delivers unavailed aesthetic performance including true, full-color capability with the texture mapping and color gradients. Create prototypes that look, feel and operate like finished products, without the need for painting or assembly, thanks to the Stratasys J750’s wide range of material properties.

With this, students can easily experience both the prototyping and testing stages of the manufacturing process, helping to prepare them for what they will experience once they enter the workforce. The high quality materials available with the J750 also allow for the creation of highly intricate and realistic models, perfect for helping medical students with research.

The wide color spectrum, combined with the fine-finish, multi-material capability, let’s the Stratasys J750 produce parts with an incredible array of characteristics. Prototypes that need to look, feel and function like future products are possible in a single print operation, with minimal to no finishing steps, like painting, sanding or assembly.

With such an innovative machine comes a variety of user applications, such as:

  • Image Rapid Prototyping
  • Concept Models
  • Medical Models
  • Jigs & Fixtures
  • Colored Textures

Join PADT’s Sales executive Jeff Nichols and 3D Printing Application Engineer James Barker from 11:00 AM – 12:00 PM MST AZ for an in depth look at how the Stratasys J750 stacks up against it’s competition, and how it’s various attributes help to make it the perfect fit for institutions such as yours!

 

Don’t miss this unique opportunity to bring the future of manufacturing into your classroom or workplace, secure your spot today!

  

Phoenix Business Journal: Why medical startups should not focus on patients

It sounds counterintuitive, but it is one of those positions where you sometimes have take a different path to end up where you should. I  “Why medical startups should not focus on patients” in order to in the end, deliver better products and better outcome to their patients. I’ve observed too many good ideas fail because the creators are not paying attention to the people who will pay for and deploy the solution.

New: PADT’s Medical Device Capabilities and Portfolio Presentation

We recently updated our slide presentation on PADT’s Medical Device product development capabilities that includes some examples of past work.  Our team applies proven processes and deep industry experience across a wide spectrum of products.  Please take a look to learn more about how we help companies engineer their medical devices.

PADT-Medical-Overview-Portfolio-2018_02_13-1

You can learn more here and if you have any questins, simply email info@padtinc.com or call 480.813.4884.

MD+DI: 3-D Printing Applications Changing Healthcare

md+di-logo-13-D Printing is having a significant impact on healthcare technology. In “3-D Printing Applications Changing Healthcare” PADT’s Dhruv Bhate gives real world examples of how this technology is enabling never-before-seen breakthroughs.