FDA Opening to Simulation Supported Verification and Validation for Medical Devices

FDA-CDRH-Medical-Devices-SimulationBringing new medical device products to market requires verification and validation (V&V) of the product’s safety and efficacy. V&V is required by the FDA as part of their submission/approval process. The overall product development process is illustrated in the chart below and phases 4 and 5 show where verification is used to prove the device meets the design inputs (requirements) and where validation is used to prove the device’s efficacy. Historically, the V&V processes have required extensive and expensive testing. However, recently, the FDA’s Center for Devices and Radiological Health (CDRH) has issued a guidance document that helps companies uses computational modeling (e.g FEA and CFD) to support the medical device submission/approval process.

Phases and Controls of Medical Device Development Process, Including Verification and Validation
 The document called, “Reporting of Computational Modeling Studies in Medical Device Submissions”, is a draft guidance document that was issued on January 17th, 2014. The guidance document specifically addresses the use of computation in the following areas for verification and/or validation:

  1. Computational Fluid Dynamics and Mass Transport
  2. Computation Solid Mechanics
  3. Computational Electromagnetics and Optics
  4. Computational Ultrasound
  5. Computational Heat Transfer

The guidance specifically outlines what form reports need to take if a device developer is going to use simulation for V&V.  By following the guidance, a device sponsor can be assured that all the information required by the FDA is included. The FDA can also work with a consistent set of input from various applicants. 

CFD Simulation of a Drug Delivery System. Used to Verify Uniform Distribution of Drug

Computational Modeling & Simulation, or what we usually call simulation, has always been an ideal tool for reducing the cost of V&V by allowing virtual testing on the computer before physical testing. This reduces the number of iterations on physical testing and avoids the discovery of design problems during testing, which is usually late in the development process and when making changes is the most expensive. But in the past, you had to still conduct the physical testing. With these new guidelines, you may now be able to submit simulation results to reduce the amount of required testing.
Simulation to Identify Stresses and Loads on Critical Components While Manipulating a Surgical Device

Validation and verification using simulation has been part of the product development process in the aerospace industry for decades and has been very successful in increasing product performance and safety while reducing development costs.  It has proven to be a very effective tool, when applied properly.  Just as with physical testing, it is important that the virtual test be designed to verify and validate specific items in the design, and that the simulation makes the right assumptions and that the results are meaningful and accurate.

PADT is somewhat unique because we have broad experience with product development, various types of computational modeling and simulation, and the process of submission/approval with the FDA. In addition, we are ISO 13485 certified. We can provide the testing that is needed for the V&V process and employ simulation to accelerate and support that testing to help our medical device customers get their products to market faster and with less testing cost.  We can also work with customers to help them understand the proper application of simulation in their product development process while operating within their quality system.

Getting to Know PADT Medical: An Interview with Skott Skeleton


PADT Medical has been an established group within Phoenix Analysis & Design Technologies (PADT) for a while now. Over the years it has grown and we have added new employees with new skills and experience. But one “employee” has been a member of the team since the beginning, providing guidance and setting a strong example on a variety of medical device product development projects. Skott Skeleton may not be physically substantial, but his skills are rock solid. If you have been fortunate enough to have toured PADT, you have probably met Skott as he hangs around in the PADT Medical office area.

As we launch this new blog based format for sharing information and news with people interested in what is going on with PADT Medical, we thought it would be a good opportunity to sit down and ask Skott a few questions and learn more.

EM: Skott, why don’t you share with our readers why you decided to join PADT Medical?

SS: I didn’t decide anything. One day I was hanging around with my buddies in a warehouse in China, and someone comes along, shoves me in a box and ships me off to the desert. But once I got here, I really fell in love with the place. PADT is a great company. Everyone here is smart, they have good senses of humor, and they do not judge me because of my body type.

EM: What is your roll within PADT Medical?

SK: Mostly I just watch. I move around in the office and I watch. Everyone knows that I’m there and that I am watching. Another important role that I play is to remind everyone why they are doing what they are doing what they are doing. For many engineers, parts are parts. But PADT Medical works on parts that are used to heal and repair people. There is nothing like a person stripped down to the basics to remind everyone that we are working on devices that can really make a difference in people’s lives. And, if we do it right, a good difference.

EM: PADT has been doing product development for over 15 years, including many Medical Devices, why create a special group and brand it apart from PADT?

SS: After doing a couple of medical projects two things become clear. First, the development process for medical devices is different because of the quality requirements, the material issues, the regulatory environment, and the difficulties in designing things that go inside of or interact with human bodies. Second, medical device customers know that they need specialists. PADT Medical customers know that generalists might be able to do some things very well, but that engineers in this space really need to know what is required for medical devices. So we formed a group dedicated to nothing but medical device product development. And to convey that specialization and focus to people inside and outside of the company, we created the PADT Medical brand.

EM: There are a lot of people out there doing medical device product development, what sets PADT Medical apart?

SS: I’d say their engineering skills and their ability to simply get stuff done. When I’m standing in the corner and no one remembers I’m there, I hear customers talk. The main thing they say over and over again is how impressed they are with the breadth and depth of engineering knowledge within PADT Medical. The other thing they say is that when the PADT Medical team signs on to a task, they get it done. They get it done efficiently and with a minimal amount of delay and floundering, especially with difficult tasks.

I also think there are a few other things that set PADT apart but I could go on and on about it, or you can read the PADT Medical part of the website. Let me list the most important bits:

  • Access to world class FEA and CFD simulation, right here at PADT
  • In house rapid prototyping, injection molding, and machining
  • A flexible and robust product development process
  • Established and proven processes

That is just the tip of the iceberg.

EM: That is very impressive. PADT Medical really seems to have a lot of unique skills, experience and tools. But no group can do everything themselves, what do you do when you can’t do what you need in house?

SS: Ah yes, our vendors. We love our vendors. We have over 350 vendors and 65 are approved for medical device work. You are exactly right when you say that we can’t do everything ourselves. So we have spent a lot of time finding and qualifying lots of different vendors. We use our quality system to make sure they can deliver what our customers need, exactly the way they need it. Then we continually work with them to make things better and more affordable.

I should also add that not the way a lot of companies do it this way. We don’t have a purchasing department that beats up our vendors on price and schedule. Our engineers and technicians work directly with our vendor network as partners to come up with a reasonable win-win-win solution for everyone. We want our customers to win, we want PADT to win, and we want our vendors to win.

EM: I’ve heard that PADT Medical is well known as a team that works very closely with vendors and customers. How close?

SS: So close that sometimes I get wheeled out of my comfortable corner to make room for our customers and vendors to actually move into our space here. Only a few partners end up collocating, but even if they are visiting for a day or a few weeks, we make room, and we work side by side till the project is complete.

EM: Skott, we are running out of time and you probably need to get back to the PADT Medical room. But before you go, is there anything else you would like to share with our readers about PADT Medical?

SS: Wow. That is a tough one. There are so many things that we do here, so many success stories. So many difficult challenges that we have identified and overcome.

When I think about it, I guess the only thing I can say is that if anyone out there is thinking of using PADT Medical for their medical device development project, you should meet with us to really understand all we have to offer. Some of it can be put down on paper or explained in a PowerPoint, but much of the value that PADT Medical adds is intangible. Things like experience, problem solving, perceptiveness, mechanical intuitiveness, and organizational skills. If you want to learn more, let us do a proposal for you, or better yet, let us work on a small project where we can show you first hand.

EM: Well thank you very much Skott. It has been a bit creepy talking with you, but it has been informative. I hope we can do this again soon.

SS: Anytime. I am looking forward to the new blog. I hope to meet some of the readers when they come in for a tour.


[Editors Note: Yes, we know this is a silly way to do an article about what sets PADT Medical apart, but let’s be honest – if I had written an interview with one of the mangers here you would not read it. This way we can have some fun and you might learn a thing or two about what sets PADT Medical apart.  Or you will at least get to roll your eyes a few times.  Share your thoughts in the comments below. – EM]