Phoenix Business Journal: How the International Business Climate in the Medical Device Industry is Changing

pbj-phoenix-business-journal-logoAfter attending the Medica/Compamed 2015 shows in Dusseldorf, Germany, we summarized the experience in this article for the Phoenix Business Journal.  As the title says, it covers “How the International Business Climate in the Medical Device Industry is Changing.” and what companies need to do to keep up with the changes.

Presentation: Leveraging Simulation for Product Development of IoT Devices

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Yours truly going over the impact of Simulation on IoT Product Development

The local SEMI chapter here in Arizona held a breakfast meeting on Monetizing Internet of Things (IoT) and PADT was pleased to be one of the presenters. Always a smart group, this was a chance to sit with people making the sensors, chips, and software that enable the IoT and dig deep in to where things are and where they need to be.

The event was hosted by one of our favorite customers, and neighbor right across the street, Freescale Semiconductor.  Speakers included IoT experts from Freescale, Intel, Medtronics, ASU, and SEMICO Research.

Not surprisingly I talked about how Simulation can play a successful role in product development of IoT devices.

You can download a copy of the presentation here: PADT-SEMI-IOT-Simulation-1.pdf

UPDATE (11/9/2015): Great write-up by Don Dingee on this event in the SemiWiki. Click here to read it. It includes a great summary of the other speakers.

You can also see more details on how people use Simulation for this application on the ANSYS, Inc. website here.  We also like this video from ANSYS that shows some great applications and how ANSYS is used with them:

A couple of common themes resonated across the speakers:

  1. Price and size need to come down on the chips used in IoT (this was a semiconductor group, so this is a big part of their focus)
  2. Lowering power usage and increasing power density in batteries is a key driver
  3. The biggest issue in IoT is privacy and security. Keeping your data private and keeping people from hacking in to IoT devices.
  4. Another big problem is dealing with all the data collected by IoT devices. How to make it useful and how to store it all.  One answer is reducing the data on the device, another is only keeping track of what changes.
  5. It is early, standards are needed but they are still forming.

If you look at this list, the first two problems are addressable with simulation:

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PADT has a growing amount of experience with helping customers simulate and design IoT devices as well as the chips, sensors, and antenna that go in to IoT devices.  To learn more, shoot us an email at info@padtinc.com or call 480.813.4884.

 

Two Fantastic Events for Start-Ups: Synapse Med Device Workshop and Star-Up Lifecycle Lunch and Learn

shutterstock_startups1As a further sign of the growth in the Phoenix Start-Up community, there are two high value events for Start-ups that everyone should be aware of, and it doesn’t hurt that PADT is a key participant in both.

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The first is a lunch and Learn: “The Start-Up Lifecycle – Key Strategies for Success at All Stages of Development.” This event is being presented by the Maricopa Corporate College and AZTC’s Startup + Entrepreneurship Committee and will be held at CEI’s fantastic facilities. Most technology-based start-up companies go through a similar growth lifecycle: validation; product development; commercialization; scale. In this presentation, CEI will discuss the basic principles of business development for companies at all stages. Topics that will be covered include:

  • Lean Startup / Customer Discovery
  • Prototyping and Minimum Viable Product
  • Go-to-Market Strategies
  • Growth Management
  • and more!
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The presenter are experienced entrepreneur’s who will share the lessons they have learned in their own companies and while helping others:

  • Jeff Saville, Executive Director, CEI
  • Nate Curran, Entrepreneur-in-Residence, CEI
  • Hart Shafer, CEO/Founder, Theraspecs & Lean Startup/Innovation coach
  • Eric Miller, Principal, Phoenix Analysis & Design Technologies (PADT)

Learn more here or register here.

The Details:

Location
CEI Gateway
275 N. Gateway Dr
Phoenix, AZ 85034
Date & Time
Thursday June 25, 2015
11:30AM – 1:00PM
Cost
AZTC Members, Free
Non-Members, $15

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PADT is also honored to be a participant in SYNAPSE 2015.  This unique event is a 3-day workshop aimed at medical professionals with a product idea.   The event will be an opportunity for them to work with industry professionals, like PADT, to turn those ideas into something real and tangible.  This is being lead by Medicoventures and will also be held at CEI.

synapseworkshop-1At the end of the three days attendees will have a prototype, secure intellectual property, and a vetted business model. They will also have a new network of resources and an invaluable education in the realities of Medical Device Start-Ups.

Other Resource sponsors besides PADT currently include: PipelineDesign; Global Patent Solutions; Knobbe-Martens IP Law; Schmeiser, Olsen & Watts IP Law; VA Angels; DLA Piper, and MedicoLabs.

This event is September 17, 18, and 19th.

This post only summarizes what will happen at the workshop, so please visit the website here to get the full details.

Ulthera Purchased by Merz

Ulthera-Hand-Piece-SmallWe love to see our customers succeed – everyone here that has worked with Ulthera knew it would only be a matter of time before a large player recognized the value of this company. And, we just learned today that the German pharmaceutical company Merz is buying Ulthera for $600,000,000.  

Here is a link to an article on the sale, and here is a link to the press release

PADT worked with Ulthera to help them redesign their hand-piece design.  The process, called Ultherapy, is a non-surgical, non-invasive procedure for the face that uses high density, focused, ultrasound and the body’s own natural healing process to lift, tone, and tighten loose skin. Some of our employees also volunteered to test the device and pose for marketing material.  

Read about the work we did in a case study we published a while back.

Congratulations to everyone at Ulthera and we can’t wait to work with them again to help improve and grow this device and others in the future.

Seven Case Studies on Product and Medical Device Development

This morning we added the seventh case study highlighting some customer stories to PADT’s new website.  These short documents highlight a project that our product and medical device development teams worked on with a variety of customers, from Nissan to a medical device inventor. 

You can view them under the Successes portion of our website, or browse the list below:

Clearview Diagnostic TechnologyTHE WORLD’S FIRST AND ONLY FDA APPROVED TOTAL ARTIFICIAL HEART

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.

SynCardia turned to PADT Medical to carry out a comprehensive series of product verification testing within a very challenging timeframe.  Continuous and successful collaboration between PADT and SynCardia professionals guaranteed the program’s success.

READ FULL STORY

Clearview Diagnostic TechnologyCLEARVIEW: A NOVEL MEDICAL MEASUREMENT DEVICE

“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

From 2010 – 2012, PADT worked with EPIC to help them develop their ClearView diagnostic technology. PADT provided engineering, quality, manufacturing, and regulatory support. During this period, EPIC was able to raise over $6 million in private investment, achieve 510(k) submission, conduct a clinical trial at a Johns Hopkins affiliate with devices delivered by PADT, and transfer the product to manufacturing with a local contract manufacturer.

READ FULL STORY

High Pressure Hydrogen Pump A COMPACT HIGH PRESSURE HYDROGEN PUMP

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

PADT worked with Nissan for 4 years to develop a high pressure, high performance hydrogen pump. We have now delivered over 200 working systems and have supported fielded vehicles since 2006.

READ FULL STORY

Germicical Light for Tracheal TubeGERMICIDAL LIGHT FOR ENDOTRACHEAL AND TRACHEOSTOMY TUBES

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.

In 8 short weeks PADT Medical transformed a recently patented invention into a functional prototype. This novel Endotracheal Tube includes a germicidal light to reduce the risk of pneumonia in patients requiring prolonged airway intubation. This device is a good example of PADT’s ability to quickly convert an inventors ideas into a working, functional prototype.

READ FULL STORY

Portable Fuel Cell Power SupplyPORTABLE FUEL CELL POWER SUPPLY

PADT worked with PolyFuel for 18 months to develop a fuel cell based, laptop power supply that was powered from a methanol fuel stock. We started with a blank sheet and developed a POC system that included the fuel cell stack, all of the custom components and controls, and was hybridized with a Lithium-ion battery pack. During that period Polyfuel was able to raise Venture Capital to develop their product.

READ FULL STORY

Portable Fuel Cell Power SupplyCLINICAL SPECIMEN COLLECTION SYSTEM

The ReadyFreezer will rapidly freeze biospecimens collected from any tissue, using any surgical retrieval device, and in any hospital or clinical setting to preserve key biomarkers.  This project took full advantage of PADT’s internal simulation and analysis capabilities as well as our in-house rapid prototyping services.

READ FULL STORY

Endoscopic Obesity Treatment ToolAN ENDOSCOPIC TOOL FOR THE TREATMENT OF OBESITY

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.

In 2006, PADT was approached by a physician who had developed intellectual property that centered on endoscopic treatments for obesity and was founding a new company called SafeStich Medical. PADT served as SafeStitch’ engineering team for several years, developed a suite of related products, helped them achieve 510-k status on their first product, and supported their effort to build a permanent engineering organization. In June of 2010, SafeStitch raised $5 Million of capital to help commercialize their technologies.

READ FULL STORY

If you are interested in learning more about our Product Development team or PADT Medical, contact us and we will be more than happy to discuss your needs.

Getting to Know PADT Medical: An Interview with Skott Skeleton

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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.

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[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]