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

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.

Build the “Right” Product

Successful product commercialization is achieved when the product development process is integrated with customer development and is executed by an experienced team and organized by an effective process. At PADT we have spent the last 20 years building our team, establishing our infrastructure, and honing our processes. One of the key processes that strongly affect the outcome of a product development effort is the process of establishing product/market requirements. The idealized product development process that we use is shown below and the establishment of requirements is shown as the first development activity box.

product-development-process

Establishing requirements insures that we develop the “Right” product. Building the “Right” product means working closely with clients to understand what the end customers want and are willing to pay for. It also means testing the market by building prototypes early and validating design choices with end customers.

At PADT we have found it very effective to get with customers from the very first meeting to establish these market and product requirements. Even if you are part of a large organization and do not work directly with external customers, we recommend that you adopt a methodology that captures and documents market and product requirements as early as possible, and that you evaluate your design against these requirements through the development process. 

 One way we do this is by asking questions about the product from many perspectives as illustrated by the wheel below. By looking at the product from each of these perspectives, we capture important requirements, avoid late stage product revision, and end up with the “Right” product.

product-development-questions

A question based approach is effective because it opens up everyone involved to looking beyond their initial assumption. The more traditional method of making a list of requirements, often results in requirements from the point of view of the person making the list. By questioning the customer, or proxy customer, from these different points of view, the team looks at things in new and different way and this captures more realistic and comprehensive requirements.

product-development-examples-PADTVisit our case studies page to see examples of how our approach has been used across a wide variety of industries.

The best way to understand the benefits of properly building the right process by establishing product/market requirements is to partner with PADT on your next product development project.

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.

FDA-Medical-Device-Design-Process-Verification-Validation
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. 

drug-delivery-1-large
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.
mm_model_stresses
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.

Humbling Feedback from PADT’s Product Development Customers

Case-Studies-Screen-ShotWhen we decided to redo our website we were told by all of the experts that you need case studies and you need testimonials.  Being engineers, we immediately pushed back saying that none of our customers will give us the input we need.  We are happy to report that we were wrong. So wrong that we are humbled by the fantastic response.

Our initial effort is focused on documenting some of the projects we have done in our Product Development and Medical Device Development groups.  You can see the eleven case studies we currently have on our Successes page.  There is some good information there on how PADT helps companies develop their products.

But what we are most proud of are the awesome testimonials we have received directly from our customers.  We are usually not ones to brag and toot our own horn… but we were proud enough of these testimonials to where we felt it was OK to let them toot our horn for us.

“PADT did a great job translating our prototype ideas into a fully-designed, manufacturable product. From multi-disciplinary engineering to project management to fabrication, PADT did it all. PADT worked collaboratively with our team to understand requirements and to solve technical hurdles in order to deliver a product that best fit our expectations.”
– Garrett Beauregard, Senior VP of Engineering, ECOtality Inc.

“I found there to be great benefit in going through PADT’s disciplined steps for the development of an updated prototype of our device. Restarting with a more systematic approach, and analyzing each component fresh, made me feel confident about every aspect of the new design.”
– Neil R. Crawford, PhD Associate Professor, Spinal Biomechanics Barrow Neurological Institute

“PADT’s Design Team was instrumental in working with Orthosensor throughout the design and development activities of the Orthosensor Knee Balance. Their commitment and flexibility to our business needs allowed us to bring our product to market in a significantly shortened period of time.”
– Juan C Fernandez, COO, Orthosensor Inc

“SynCardia has chosen to work with PADT based on their ability to develop close personal relationships, to create and implement engineering solutions rapidly, and to support SynCardia’s innovative drive for our life-saving technology.”
— Douglas A Nutter, COO, SynCardia Systems, Inc.

“PADT has provided a number of valuable services for Ulthera ranging from design work and ergonomic improvements, to manufacturability and V&V testing. Over the past 18 months, PADT worked closely with our engineering staff to ensure the successful launch of our redesigned Deep See Handpiece. Our successful collaboration allowed us to focus our internal resources on our core competencies while leveraging PADT’s skill sets. Ulthera also benefited from PADT’s adaptable, customer-specific, Design Control process to minimize the QC documentation requirements on the Ulthera staff”
— Michael Peterson, Vice President, R&D, Ultherea, Inc

“For the last 2 years we have worked with PADT to develop our ClearView technology. Their team has helped us with many aspects of product development and commercialization. They have been a very valuable asset and I would highly recommend them to any startup that needs to navigate the pathway to market.”
— Tom Blondi, President, EPIC Research & Diagnostics

“PADT has demonstrated strong concept creation and development testing abilities – and have done so with very short time schedules. PADT was in charge of a key component development for our Fuel Cell System, and accomplished it as planned. Owing to PADT’s challenging spirit, Nissan was able to lease the 2005 model FCV’s to some customers in the early period of 2006. In addition, Nissan has been able to continue the FCV leasing program for five years with PADT’s reliable support.”
— Arai Takayuki, Senior Manager, EV Systems Laboratory, Nissan Motor Company

“The PADT experience was a positive one from my first phone conversation with them to the delivery of the end product. The engineers delivered a prototype that was exactly what I envisioned in a short 8 weeks. PADT will be my choice in the future.”
— Bob Rife, R.R.T.

“For the last 3 years I have worked with PADT Medical as a physician-inventor of medical devices. Their engineering team is professional, punctual, and responsible. Their management is exemplary. I recommend PADT Medical to any potential Client.”
— Charles J. Filipi M.D., Medical Director, SafeStitch Medical, Inc.

At PADT “We Make Innovation Work” and these fantastic testimonials give specific examples of how we have done that for others. If you would like to learn how PADT’s products and services can help you, please do not hesitate to contact us.