Medical Devices Blog

Wilson Sonsini Goodrich & Rosati Medical Device Conference

2010-06-11T15:33:00.000-07:00

We will be attending the Wilson Sonsini Medical Device Conference on June 23rd and 24th in San Jose. Here is the website for more information about the conference. We hope to see you there.

Three Ways PADT Medical Help Commercialize Medical Technology

2010-06-04T06:52:00.000-07:00

Our presentation at the Southwest Bioscience Expo last week was based around the following graphic that illustrates how we support the medical devices industry. At our core is Product Development Services. There are plenty of details on our website and blog about our experience in this area.

In the past couple of years we've added two additional levels to help commercialize new medical device innovations. Collocation and Integration is a service that we provide to early stage medical device companies that want the benefits of having a product development team and infrastructure without having to invest time and money to establish them. We currently have one medical device company collocated and we are actively looking for other companies to bring in.

Medical Technology Investments and Partnerships is our latest expansion. We are actively looking for intellectual property that we can license and productize. We are also looking for opportunities to partnership in the establishment of new medical device companies. In fact, we cofounded a new medical device company this spring.

Please contact us if you are looking for medical device Product Development Services, Collocation and Integration, or Medical Technology Investment and Partnerships. We have a rapidly growing expertise in medical device technology commercialization and would enjoy the opportunity to discuss how we can best help you take your innovations to market.

PADT Reaches 60 Employees

2010-05-04T07:49:00.000-07:00

Great customers, exciting projects, and top-notch talent have helped us grow to reach 60 employees for the first time since PADT was started in 1994. Thank you all!

Presenting at AZBio's Southwest Bioscience Expo 2010

2010-04-13T06:09:00.000-07:00

We have been selected to be one of the presenting companies at this year's AZBio conference. Our presentation is an overview of our capabilities and past projects in product development. We will also discuss our investment approach the types of IP we are looking to license. The conference is on May 21st in Tucson, Arizona. Click here from more information on the conference.

Achieving Milestones: PADT Purchases Building to Create Space for Collocating Startups

2010-04-02T06:33:00.000-07:00

PADT is pleased to announce that it is one step closer to achieving its vision to incubate medical device startups within its R&D facility in the ASU Research Park. PADT has purchased the building that it has resided in for the last 8 years. With the purchase of the 48,000 sq ft facilities, PADT Medical can help investment-backed medical device companies reduce time and cost to market by collocating and seamlessly integrating with PADT's product development staff and infrastructure.

"The ASU Research Park is a superb location for us. The purchase lowers our operating costs and enables more freedom to offer incubation space to local startups," according to Ward Rand, President of PADT.

PADT has been working to partner with local startups that fit with PADT's business model and being able to offer space is a part of that effort. Collocating at PADT provides seamless access to the following:

Infrastructural support: Office space, conference rooms, telephone and web service, accounting support, etc.

Engineering support including: Design/engineering expertise, CAD, FEA simulation, prototyping, instrumentation, testing, clean room, and final assembly.

Commercialization support: Funding, strategic planning, manufacturing implementation, access to ISO 13485 compliant quality system.

To learn more about how your medical device startup company can benefit from collocating at PADT, please contact Scott Klopfenstein.

PADT Customer, SynCardia, Receive FDA Approval for IDE

2010-03-30T12:58:00.000-07:00

SynCardia Systems (Tucson, AZ) has received a FDA approval for an Investigational Device Exemption (IDE), which allows them to perform clinical trials using their new Freedom Driver system (full article). Here's a link to PADT's previous posting about supporting SynCardia.

Do I Need to Submit a New 510k for This Change?

2010-03-29T07:35:00.000-07:00

One of the common questions we face when modifying the design of a medical device is whether a new 510k is required because of the change. To answer this question we make extensive use of the FDA 510(k) Memorandum #K97-1 . This document includes a flowchart that helps developers determine if a new 510k is required or if is sufficient to document the changes in the Design History File (DHF).

Understanding this memo can provide valuable insights when developing your original 510k submission so that it cover future design modifications. Please contact us if you are developing a medical device and need support with your 510k submission strategy.

Saving Time with Established Procedures

2010-03-19T08:24:00.000-07:00

One way to help reduce the time and cost of developing a new medical device is to start with established protocols and procedures. When starting from scratch, even the first step of documenting customer/user requirements for a product can seem daunting. Established medical device companies will have a quality system that includes procedures, protocols, and templates that help guide and simplify the product development process. Additionally, established companies have staff that understands these procedures and how all the pieces fit together to make for smooth and controlled development process. However, this is not the case for a medical device startup. So what can early stage device companies do to help navigate the development process without established processes and procedures?

In my view, this is where outsourcing product development to company that has established procedures and development teams can add significant value to a medical device startup. I’ve seen first-hand how startups can struggle through product development because they don’t have established procedures and prior success using them. I’ve also seen how we’ve been able to add significant value to early stage companies by leveraging our established procedures and know-how. For example, we have established procedures for design planning, requirements management, biocompatibility, sterilization, packaging, risk management, electromagnetic compliance, etc.

At PADT Medical, we specialize in working with early stage companies. We are currently working exclusively with investment backed startups. In addition to providing engineering services and human-use prototypes, we can seamlessly integrate your product development in our Quality System to ensure a smooth and controlled development process that satisfies FDA regulatory requirements. Please contact us to learn more about how we work with early stage medical device companies.

See Us at the Arizona Health & Medical Expo

2010-03-17T08:37:00.000-07:00

Come and visit us at the Arizona Health & Medical Expo on March 25th. We will be at Booth 22. Click here for more information about the event.

Product Success Story: Puttycise® Occupational Therapy Tools

2010-03-17T07:55:00.000-07:00

Carolyn Mittelsteadt, inventor and founder of Puttycise® (http://www.puttycise.com/), is a licensed occupational therapist who approached PADT about 18 months ago for product development support. "I first went to PADT with rough concepts of my Puttycise tools and ideas. PADT helped me through the entire product development process, starting with prototyping models, to a pilot production run using silicone molds, and finally larger production runs using injection molding."

The Puttycise® tools are used in the treatment of a wide range of pathologies ranging from burn and traumatic upper extremity injuries to neuro-rehabilitation post cerebrovascular accident (CVA) or traumatic brain injury (TBI). The Puttycise® system consists of 5 tools which all function by inserting the base into a resistant putty. The tool is pushed, pulled or turned through the putty to produce the specified exercise. Each piece is specially designed to maximize function and versatility.

Some of the major challenges associated with this product development dealt with design for manufacturability (DFM). Early prototypes were made using PADT's in-house stereolithography (SLA) capability. Then, pilot production was done using silicone molds and the parts were cast from a thermosetting Urethane. The final product set required certain features and textures but had to be compatible with high-volume production. These designs are injection-molded Acrylonitrile Butadiene Styrene (ABS) and manufactured with steel tooling in Taiwan.

"PADT provided close support and advice during the entire process. It was challenging to decide on the final details, such as plastic type, wall thickness, texture, and gluing method, as these details significantly affected our end product. I appreciate the expertise at PADT for advising me and ultimately producing a high-quality product."

PADT Medical helps entrepreneurs achieve early and critical milestones and supports product commercialization from concept through clinical trials and into production implementation. To learn more about the development of this device or to learn how PADT Medical can help entrepreneurs and inventors commercialize new products, please contact Scott Klopfenstein

Scott Klopfenstein will be chairing a session at the MEPTEC conference at ASU in September.

2009-08-11T08:16:00.001-07:00

MEPTEC:
September 16th - 17th - 2009 Medical Electronics Symposium: Drivers for Technology, Health and the Economy (Tempe)Co-produced by MEPTEC and SMTA, this two-day event will bring together medical and microelectronics experts to cover a spectrum of medical technology and applications. Click Here for more information.

PADT is Looking to License and Commercialize New Technology

2009-07-04T15:21:00.000-07:00

PADT is building on 15 years of success in the energy and aerospace sectors by investing in our medical device group – PADT Medical. Part of this investment involves developing new products founded on concepts provided by Doctors, entrepreneurs, inventors, and tech transfer offices. PADT began building its medical device capability in 2002 and formed PADT Medical as a formal group in 2006. The group has been FDA compliant since 2007 and will be certified ISO13485 in Q3, 2009.

Since late last year, we have been working to find products for PADT Medical to develop and to date we have collected and reviewed ~ 60 concepts. Four of these concepts have made it through our initial investigation and we are now pursuing the next preliminary phase of development. We hope to make it to full scale development on 1 or 2 products each year.

We are looking for two very distinct types of product opportunities: one that is simple enough for PADT to fund largely on our own, or with some Angel level support, and could conceivably be to market in 18 months; and one that is much more technically cutting edge and that we would work to gather government and VC funding for and would take ~ 4 years to bring to market. An example of a simple product that we are funding on our own is a one-piece plastic tool that would be used in hospitals for routine exams. An example of a cutting edge device that we are pursuing is an aortic graft. In the case of this graft, we have partnered with a leading doctor and entrepreneur to apply for an NIH grant to develop a proof of concept.

Simple product IP that we would be interested to review could come from almost any discipline, but cutting edge concepts would best fit us if they were endovascular, endoscopic, laparoscopic, diagnostic, natural orifice, or orthopedic in nature.

We are excited about bringing this business opportunity to doctors and entrepreneurs in Arizona and look forward to hearing your ideas and concepts. If you are interested, we invite you to contact us to further explore the potential of commercializing your IP.

MedApps Receives FDA Approval for Telehealth Solution

2009-06-27T15:18:00.000-07:00

Another PADT customer to recently achieve a significant milestone is Scottsdale-based MedApps, Inc. In its June 5th Press Release, the company reports;

“MedApps, Inc. has been granted a 510(k) market clearance by the U.S. Food and Drug Administration for its expanded, flexible telehealth solution. The MedApps system is designed to link patients, families and healthcare professionals by providing a convenient way to remotely collect, transmit, store and report timely and accurate health information - anywhere. The MedApps system features the HealthPAL, a small portable personal health device, to collect and transmit readings from glucose meters, blood pressure monitors, weight scales and pulse oximeters.”

When MedApps needed to fabricate prototypes and prepare for full-scale production they turned to PADT. Bruce Bowers, VP of Manufacturing at MedApps stated “PADT has helped us with prototyping and small run support of our enclosures. Now we move into the higher volume demand with PADT to enjoy mutual growth. This is getting very exciting for the teams”. PADT is excited about the future of MedApps and we are looking forward to seeing their new technology help reduce healthcare costs and improve compliance.”

PADT Medical helps innovative medical device companies, like MedApps, that are commercializing new products and need rapid prototyping and low-cost manufacturing solutions. Our in-house capabilities, combined with our list of approved off-shore suppliers, provide our medical device customers a one-stop seamless transition from development to production. Contact us to learn more about how you can achieve early milestones with your innovative medical device concept.

SafeStitch Medical Inc., Receives FDA Approval for Its SMART Dilator

2009-06-20T20:00:00.000-07:00

It brings us great satisfaction when we are able to help our medical device customers achieve significant product development milestones. One such milestone was recently achieved by SafeStitch Medical when the FDA approved the Smart Dilator medical device. In its April edition, Gastroenterology and Endoscopy News reports that the SMARTTM Dilator is the “first esophageal dilator that indicates the amount of pressure being applied at the esophageal stricture, hopefully reducing the incidence of esophageal perforation.”

SafeStitch Medical approached PADT to help design and develop early prototypes of the SMARTTM Dilator product concept. We worked closely with the SafeStitch’s clinical, engineering, and regulatory team to establish product and design requirements through early prototype testing. The early development work was performed within PADT’s FDA Compliant Quality System and the Design History File was subsequently transferred to SafeStitch for final development and fabrication of the SMARTTM Dilator product.

PADT Medical helps emerging medical device companies, like SafeStitch Medical, that are commercializing new products and need outside engineering expertise to help develop their innovative device concepts. We enable reduced time-to-market by utilizing our established quality system, computer simulation, and rapid prototype testing to quickly converge on design solutions. Contact us to learn more about how you can achieve early milestones with your innovative medical device concept.

Accelerate Your Product Development with Fortus Rapid Prototyping Technology

2009-06-13T15:15:00.000-07:00

Fortus FDM technology, created by Stratasys, can accelerate your product development process by enabling earlier form, fit, and function testing of your medical device.

Engineers at Medtronic’s Sofamor Danek use the Fortus Technology to quickly bring concepts from the minds of Doctors to 3D prototype. “We often see one or two VIP surgeons per day,” says design engineer Richard Franks. “They come in with a problem to solve in the morning. They explain their need to an engineer, the engineer will model a solution on ProEngineer and then make a prototype. “

The Fortus technology enables device developers to rapidly produce components using medical grade thermoplastics. The technology is similar to other FDM machines in that it is an additive prototyping process that melts and extrudes a ribbon of material that is built up one layer at a time. The Fortus offers the following improvements over existing FDM technologies:

Biocompatible (ISO 10993-1 certified) Polycarbonate and ABS materials
Many grades of thermoplastic including Polycarbonate, ABS, Polyphenylsulfone, and Ultem
A production capable process that produces durable parts
Low cost: Polycarbonate is $3.60/in3 and Ultem is $7.00/in3

PADT now distributes the Fortus here in the Southwest and employs the technology to support product development for customers in the medical industry. The Fortus is the latest technologies that PADT has added to its RP resources, which include Stereolithography (SLA), Selective Laser Sintering (SLS), Fused Deposition Modeling (FDM), and rapid injection molding. Contact us for more information about the Fortus technology or how PADT Medical uses RP technology to accelerate your medical device development.

Solvent Bonding Polycarbonate to Polycarbonate - Update

2009-03-25T14:57:00.000-07:00

It didn't work well. Unfortunately, it seems the bond created was very porous (see image below). After curing in a fume hood for 18 hours, the surface was still a bit tacky (after pulling the two pieces apart). The bond surface was abot 1/4" square and held roughly 20 lbf before seperating. It may have been stronger had it cured all the way, hard to know for sure. I only tried a few samples, so perhaps there are process tweaks I could make that would improve the efficacy of the cyclohexanone bond, but at this point it seems a less than ideal solvent for bonding polycarbonate to itself.

Solvent Bonding Polycarbonate to Polycarbonate

2009-03-15T18:29:00.001-07:00

I encountered the need to solvent bond Polycarbonate to itself for one of the projects we're currently working on. After speaking with several vendors and reading various snippets online, I discovered that Methylene Chloride is the solvent of choice for bonding polycarbonate. Great, right? Except not so great. This is why: the method of sterilization we've chosen for our product is EtO (and we can't change it for technical reasons), and apparently EtO sterilization does not react well to anything with chlorine in it. So, the chloride part of methylene chloride presents a challenge. After further digging, a technician at Masterbond recommended a chemical called Cyclohexanone (which, I confirmed, has no chlorine in it). I've got some on order and plan on doing a test this week. I'll fill you in on the results when I have them.

Moral of the story - methylene chloride is the solvent of choice for bonding polycarbonate to itself; however, if you'll be EtO sterilizing your parts, using methylene chloride won't work and you should consider an alternative, possibly cyclohexanone.

Have A Medical Devices Idea? Recovery Act provides Funding!

2009-03-09T13:14:00.000-07:00

If you have a concept for a medical device and need seed stage funding this could be a unique opportunity for you. The NIH recently announced that it will be awarding $200M in additional research funding due to the Recover Act (see RFA for specifics). Small business are eligible for this funding. Contact PADT Medical if you are interested in learning how we can partner with you and advantage of this unique opportunity.

Engineering the Next Generation of Artificial Hearts

2009-02-25T13:32:00.000-08:00

PADT Medical is helping SynCardia Systems Inc. meet the anticipated demand for its artificial heart medical device. SynCardia, a Tucson-based company, manufactures the CardioWest™ temporary Total Artificial Heart (TAH-t). The TAH-t is the only temporary total artificial heart in the world that has both FDA and CE approval for the treatment of severely ill patients with end-stage biventricular failure. SynCardia anticipates increased demand for the TAH-t upon FDA approval of its portable driver technology. Recent shifts in reimbursement policy by the Centers for Medicare and Medicaid Services (CMS) are also anticipated to increase demand for the TAH-t.

SynCardia has contracted PADT to provide engineering services on the development of the next-generation of implants. According to Mike Gaul, Chief Operating Officer of SynCardia;

“PADT is providing engineering expertise to help us develop our next-generation of total artificial hearts. Their medical device testing and CFD fluid-flow modeling capabilities are providing valuable insight into the performance of these products.”

SynCardia has a small 50cc TAH-t, under development, which is targeted for patients with a body surface area (BSA) of 1.0 to 1.7, to complement the existing 70cc TAH-t, which is generally used for patients with a BSA of 1.7 or greater. In addition, SynCardia is developing Pediatric Ventricular Assist Devices (VADs). The 10cc and 30cc VADs are intended to be short term devices that in some cases allows the native heart to fully recover.

PADT is well equipped to develop innovative cardiovascular medical devices. These devices have a host of challenging design requirements including biocompatibility, fluid dynamics, and difficult geometric constraints. PADT’s experience with these challenges is proving valuable to customers like SynCardia. Contact us for more information about PADT’s expertise in the development of cardiovascular related medical devices.

Join us for the next Council Connect event on Rapid Prototyping at PADT on 2/26/2009

2009-02-23T09:17:00.000-08:00

Here is the Agenda:

7:30AM – Registration & Continental Breakfast
8:00AM – Welcome & Introductions
Steven G Zylstra, President & CEO, Arizona Technology Council
8:10AM - Presentation: Rapid Prototyping Product Innovation
Presenter: Eric Miller, Principal, Director, Analysis & Design Technologies (PADT)
9:00 – Panelist Questions
Moderator: Eric Miller, Principal, Director, Analysis & Design Technologies (PADT)
Panelist: Rey Chu, Director of Rapid Manufacturing Technologies, PADT, Inc.
Panelist: Brad Palumbo, RP Expert, PADT Inc.
Panelist: Renee Palacios, FORTUS Channel Manager, Stratasys, Inc.
9:15AM - Tour of Rapid Prototyping Systems
9:30AM – Conference ends, Steven G Zylstra

Click here for more information and to register for the event.

Shape Setting Nitinol for a Medical Device Prototype

2009-02-13T14:02:00.000-08:00

This week I enjoyed the excitement and frustration of shape setting Nitinol tubing for a prototype medical device used for a demonstration. I obtained samples from NDC and Memry . Both provided free samples within days. Nitinol is commonly used in medical devices because of its superelastic or shape-memory characteristics. In my application, I am taking advantage of the superelastic properties.

Shape setting Nitinol is a quick and easy process provided you have the appropriate equipment. To shape set the Nitinol, I created a fixture to securely hold the Nitinol to the desired shape. I then pre-heated an oven to 500-550°C. Next, I placed the part in the oven for 1 minute. I then removed the part and immediately quenched it in water. If you overheat the part it will reduce its superelastic properties.

The key to designing parts with Nitinol is to obtain material and start testing as soon as possible. Nitinol is NOT an easy material to design with because it does not have a linear stress-strain curve like stainless steels. Hence, most design formulas are not applicable. This week I learned that even though think-walled Nitinol tubes are flexible, they will splinter when compressed axially.

By Margaret Koga

PADT is Celebrating 15 Years of Service

2009-02-10T19:39:00.001-08:00

PADT is celebrating 15 years of service by inviting all who are interested to join us on March 12th for an open house and celebration. Here's a flyer. Come and celebrate with us!

Posted by: Scott Klopfenstein

Developing Next-Generation Surgical Devices

2009-02-05T08:13:00.001-08:00

PADT Medical has a growing expertise in the development of "non-invasive" and Natural Orifice Transluminal Endoscopic Surgury (NOTES) medical devices. PADT Medical was contracted to by SafeStitch Medical Devices to develop and deliver a transoral sugical device for the treatment of obesity (shown below).

This device is patented by SafeStitch Medical Devices. SafeStich offers the following description on there website about this device:

The Obesity Device is introduced through the mouth and esophagus and works by suctioning two sides of the stomach lining into position for suturing, impaling the mucosa or stomach lining, placing a row of sutures through the two sides of the stomach, as commonly done during gastric surgery, injecting adrenaline into the mucosa to elevate it for excision, excising the top layer of the entrapped stomach wall, releasing this tissue, removing the device and tightening the sutures. [link]

Here is a news article that provides additional discussion and links on the future of surgery using NOTES techniques and medical devices.

Posted By: Scott Klopfenstein

Injection Molded Parts in Days

2009-01-26T09:01:00.001-08:00

PADT has now has the capability to deliver your injection molded prototypes in just days using “NanoTooling”. This new capability is made possible using a new Stereolithography material from Somos called NanoTool™ , which is heavily filled with non-crystalline nanoparticles.

PADT Medical recently used this approach on a Medtronic program to injection mold components made from Ticona Vectra, a biocompatible Liquid Crystal Polymer (LCP).
This new capability is another way that PADT Medical helps innovators reduce time-to-market. Parts made using NanoTool are ideal for early development testing and iterations to allow for faster convergence on design solutions.

The process to fabricate molded parts starts with a solid model of the component to fabricate. The tool is then designed by PADT engineering. The injection mold tool is then “grown” using Stereolithography prototyping equipment. Next, the tool is processed and fitted into the injection mold machine where the parts are made from any number of thermoplastic resins. This entire process is performed in house at PADT.

If you are interested in exploring this capability to accelerate your development program please contact us.

Posted by: Scott Klopfenstein

Save The Date: RP Technologies and Trends

2008-12-02T07:58:00.000-08:00

AZ Tech Council Connect Event: Overview of Rapid Prototyping Technology and Trends

February 26th, 2009 Morning , more details coming.

Rapid Prototyping has grown in the past 15 years to become a mainstay of product development. And every year there are new technologies, system refinements and material improvements that enable faster turnaround, stronger prototypes and reduced cost. PADT is pleased to host a seminar to update people involved in the development of physical products on where the industry is, where it is going and how to get the best return on investment in Rapid Prototyping. A presentation will then be followed by a Q&A session with industry leaders, a member of the Product Design community and PADT’s own in-house experts. Contact us for more information regarding this event.

Happy Thanksgiving!

2008-11-28T18:30:00.000-08:00

The day before Thanksgiving we captured a picture of this rainbow. The building is PADT. Happy Thanksgiving everyone!

Posted by Scott Klopfenstein

Incubate Your Startup Company at PADT

2008-11-17T08:08:00.001-08:00

If you’re an entrepreneur looking for product development expertise and facilities to launch your company, consider incubating here at PADT. We are actively looking for startup companies that need a partner to develop and commercialize their innovative products. Specifically, we are looking for startup companies that will benefit from locating at our facility and taking advantage of the full spectrum of our product development expertise. If you are interested, we invite you to contact us to further explore this opportunity.

Since 1994, PADT has provided engineering and prototyping. However, to fuel our growth and support the commercialization of new technologies, PADT now is additionally looking for - and investing in - emerging companies. In the last year PADT has invested in two strong, local companies - KMI and Celerative. We are now looking to expand the way we help startups succeed by offering to incubate them here at our facility in the ASU Research Park.

This is a great opportunity for technology based startups that have an exciting business concept, enabling intellectual property, and the management expertise to make it happen. We will invest in your startup and partner in your success by providing the following support:

Infrastructural support: Office space, conference rooms, telephone and web service, accounting support, etc.
Engineering support including: design/engineering expertise, CAD, FEA simulation, prototyping, instrumentation, testing, and final assembly
Commercialization support: Funding, strategic planning, manufacturing implementation, access to ISO 13485 compliant quality system.

To be considered, your company will have the following characteristics:

An experienced management team with strength in marketing and financing
A need for product development and engineering expertise.
A clear business plan and rollout strategy for entering a substantial market.
Attracting angel level investment in addition to PADT’s contribution.
A product or medical device that has significant technical challenges - ideally one that benefits from our FDA compliant quality system.

We are excited about bringing this business opportunity to entrepreneurs in Arizona and look forward to hearing your ideas and concepts. If you are interested, we invite you to contact us to further explore the opportunity of incubating your startup company with us.

Join us for a Lunch discussion on Human Factors

2008-11-04T07:29:00.001-08:00

PADT is sponsoring the next AZBio Peer to Peer Luncheon on Thursday, November 13. The topic is on the FDA's growing emphasis on human factors.

Next year the FDA is expected to adopt its newest and most comprehensive human factors standard. Patricia A. Patterson, CPT, President of Agilis Consulting Group and a Certified Performance Technologist, will provide a basic introduction to the topic including:

The FDA's position on human factors and use error
The 7 Common Mistakes the FDA sees manufacturers make regarding human factors
What we can expect in HE 75: Human Factors Design for Medical Devices

Discussion questions include:

How would you describe your company's current compliance with FDA human factors standards and guidelines?
What, if any, challenges do you anticipate ensuring compliance with HE: 75?
What FDA - Human Factors experiences can you share and lessons learned?
How has human factors influenced your bottom line?

This is your opportunity to interact with colleagues and to have your questions answered by experienced peers in your industry. Space is limited - reserve your seat by registering here.

Key Points from Peer2Peer Discussion Group

2008-10-13T21:10:00.001-07:00

We met last week to discuss how best to work with contract service providers in our AZBio Peer-2-Peer luncheon. The session took two perspectives – utilizing services and providing services. The following outline captures some of the key points that were brought out in the discussion.

What important factors do you consider when selecting a service provider?
- Clear needs?
- Good capability match?
- Cost competitive?
- Delivery speed?
- Total service offering (i.e. "package")?
- Partnership opportunity?
- Culture match?
How do you maintain good communication with a contract service provider?
- Verbal communications (face-to-face where possible)
- Frequent communication
- Open and transparent with issues
- Multilevel communication
- Taylor to match personal style/preferences
- Be flexible with communication approach
How do you ensure that service providers deliver on schedule?
- Establish series of deadlines/milestones
- Document expected deliverables
- Do a good job defining the scope of work
- Establish clear specifications
- Document agreements
- Use tools (online and email) to keep schedule visible
- Establish contingencies
How do you ensure service providers satisfy your quality expectations?
- Set expectations at the outset
- Keep Quality Control people in the loop
- Perform audits along the way
- Utilize certifications
- Establish a quality agreement
- Work with first with a good reputation
How do you build long-term relationships with service providers?
- …. Ran out of time.

Many of these ideas are common sense but it's good to be reminded of them. Feel free to add your comments to this list.

Simulating Your Next Back Surgery

2008-10-07T14:49:00.001-07:00

The day is coming when your spine surgery will be performed virtually using advanced computer simulation to practice and plan for the real thing. PADT Medical is currently working with Neil Crawford, PhD at the Barrow Neurological Institute (BNI) to develop the Virtual Spine Surgeon software system. The program, which is funded by the National Institute of Biomedical Imaging And Bioengineering (NIBIB), has the ultimate goal to "improve the outcome of surgery, shorten the time under anesthesia, and improve the confidence of the patient and surgeon". PADT is providing software development, finite element modeling, and rapid prototyping expertise to help construct a system that will convert pre-operative images (CT or MRI) into a patient specific model that can be used to suggest refinements to the surgery and ultimately create templates and drill guides for intraoperative use.

Screen Grab from Virtual Spine Surgeon program.

Increasingly, finite element modeling is being used to predict surgical outcomes and device performance. Contact us If you are interested learning more about how we can help you accelerate your medical device development program using finite element modeling.

Join Our Team

2008-10-02T20:55:00.001-07:00

Interested in joining the PADT Medical team? We are looking to build our local network of medical device development engineers. Click Here if you're interested in learning more.

Working with Contract Service Suppliers

2008-09-30T22:00:00.001-07:00

Please join us next week at Dave & Buster's for the monthly Peer-to-Peer luncheon. We will be participating in the discussion about Contract Service Providers. The first luncheon received positive reviews and we look forward to making it even better. Here is more information about the event.

AZBio's Greater Phoenix Peer2Peer Lunch Series

On the second Thursday of each month, senior representatives of bioscience companies are invited to participate in round-table discussions at Dave & Buster's in Tempe. This is your opportunity to interact with colleagues, share your experiences and/or have your questions answered by experienced peers in your industry.

Thursday, October 9: How do bioscience companies select and manage contract service providers to maximize their value to the organization?

Increasingly bioscience companies rely on contract service providers to perform a range of specialized services. According to Drug Development and Discovery Magazine, "The forces driving the decision to outsource research services are the lack of in-house technology, the desire to accomplish the project more quickly, and the lack of in-house staff. A lack of in-house technology and expertise, along with the need to accomplish research quickly spurs the decision to outsource projects."

Unfortunately, bioscience companies often fail to realize the potential benefits of working with a contract service provider. Why does this happen and what can we do about it? The purpose of this luncheon is to share and discuss methods that you have found helpful when selecting and managing contract service providers.

Here are some questions for discussion:

1. What important factors do you consider when selecting a service provider?
2. How do you maintain good communication with a contract service provider?
3. How do you ensure that service providers deliver on schedule?
4. How do you ensure service providers satisfy your quality expectations?
5. How do you build long-term relationships with service providers?

This is your opportunity to interact with colleagues and to have your questions answered by experienced peers in your industry. Please email questions you would like to get covered during this lunch to natascha@azbio.org or call 602-495-2938.

Space is limited - reserve your seat by registering here or visiting our website at http://www.azbio.org/

See you there.

10+ Years of Bioscience Success

2008-09-30T21:52:00.001-07:00

PADT Medical was recently recognized at the AZBio Annual Awards Dinner for over 10 years of participation in Arizona's Bioscience Industry. We are proud of this accomplishment and we look forward to many more years of helping innovators take their medical device concept to market. To learn more about ways we support bioscience companies visit our website at www.padtmedical.com.

PADT Invests in Kinetic Muscles

2008-08-27T14:09:00.001-07:00

Last month, PADT invested in an exciting emerging company called Kinetic Muscles Inc. (KMI). KMI is a Tempe based medical device company that has been working to develop a more effective treatment for stroke survivors. Founded in 2001 by Jim and Ed Koeneman, KMI has been working steadily to develop and prove its technology and has received several prestigious awards - including Medical Device Company of the year from the Arizona Bioindustry Association.

In 2007, KMI conducted a nationwide launch of their the "Hand Mentor Pro™". The Hand Mentor™ helps stroke survivors regain use of their hand and wrist by engaging them in a series of game-like repetitive exercises that increasingly challenges the patient to move their hand on their own. The product is based on the principal of neuroplasticity - which simply implies that a stroke impaired brain can relearn how to control the muscles with proper stimulation, effort, and time.

KMI is now developing a number of additional rehabilitation products all targeting the $65 Billion dollar stroke market and based on the same technology resident in the Hand Mentor. Simultaneously, KMI is expanding its marketing effort in the US and overseas to generate rapid growth. To support this expansion, KMI is now accepting Angel and Venture Capital funding. For more information, please contact KMI's CEO, Grant Farrell, gfarrell@kineticmuscles.com.

It’s Show Time

2008-08-20T23:08:00.001-07:00

PADT Medical will be exhibiting in two medical device conferences this fall and we encourage you to come and visit us. On September 10^th and 11^th we will be exhibiting at the BIOMEDDevices conference in San Jose, CA. This conference is a comprehensive resource for medical device and biopharmaceutical development and manufacturing.

On October 29^th and 30^th, we will be exhibiting at the Third Annual Annual California Medical Device Forum in Orange County, CA. This conference is expected to draw over 500 participants from across the U.S. The past two years have been an exciting mix of entrepreneurs, start-ups, large companies, venture capitalists, the university sector and strategic advisors. The conference is organized by OCTANe, an organization is fueling "innovation development" in Orange County and Southern California. By connecting people, capital and technology, OCTANe accelerates entrepreneurs and company development for Orange County's biomedical and information technology community.

We hope to see you there.

PADT Medical Sponsors AZBio Peer-2-Peer Luncheon Series

2008-08-20T22:39:00.001-07:00

PADT Medical is sponsoring a Peer-2-Peer Luncheon series focused on issues faced by Bioscience companies based in Arizona. Every first Thursday of the month, senior representatives of bioscience companies are invited to participate in round-table discussions. The topic for September 11th centers on "Developing your Target Product Profile". The luncheon will be hosted at Dave & Buster's in Tempe. We encourage you and your colleagues to participate in the series. To learn more about the luncheon series and to reserve your seat click here.

PADT Medical is an active member of the Arizona BioIndustry Association (AZBio). AZBio seeks to unify, empower and advance its member organizations, who collectively form Arizona's bioscience community. As the unified voice of the bioscience industry in Arizona, AZBio strives to make Arizona a place where bioscience companies can grow and succeed. Click here for more information about AZBio.

Phase 1: Planning – Plans You Can Plan On

2008-08-20T22:14:00.001-07:00

When it comes to developing medical devices there are several plans that you can plan on. The second phase of our Product Development Process (See previous blog, Link) is the Planning Phase. We use this stage of the PDP to help our customers establish that all important "Guidance Documents". We rely on a trio of planning document to establish the roadmap to market. These documents are the Quality Plan, Design Plan, and the Risk Management Plan.

It is tempting to think that establishing these documents only delays the development process. We have found that, if done right, these documents can ultimately lead to a shorter time to market by defining clear roles and responsibilities, design strategy and priorities, and ground rules for risk mitigation activities. These documents also outline how the FDA Design Control regulations will be satisfied.

At PADT Medical, we help our customers establish these documents in accordance with your business and product development objectives. We have existing protocols and templates that we can draw from to streamline the planning process and help you take your product to market in a controlled and well-planned process.

DFM: Beginning With the End in Mind

2008-07-22T07:58:00.001-07:00

We are going to take a breather from blogging about Product Development Phases to write about Design For Manufacturability (DFM). DFM often comes up in our discussions regarding product design. Why should DFM be important to our customers? And, what are some ways that PADT Medical can help with DFM?

Start With the End in Mind

We understand that DFM is arguably the largest contributor to the total cost of your device or product. Perhaps most important to understand is the fact that changes which take place early on in the design process are relatively inexpensive. Once a product has been developed, it is very expensive to change the design to reduce manufacturing costs.

In fact, "cost reduction" initiatives often fail to pay for themselves. The following table (taken from "Design For Manufacturability", by Dr. David M. Anderson) emphasizes the effects of design changes on total development cost based on when the changes are incorporated:

Level of completion	Cost to find and repair defect
The part by itself	X
Subassembly	10X
Final assembly	100X
At the dealer/distributor	1000X
At the customer	10,000X

Stakeholders, Gather Around

Another way that PADT Medical reduces the likelihood of future design changes is to pull together a cross-functional team early in the product development. An ideal team could include personnel from a wide range of areas such as:

Design engineers
Manufacturing engineers
Service reps
Marketing managers
Customers
Finance reps
Industrial/product designers
Quality/testing personnel
Purchasing reps
Suppliers
Regulation compliance experts
Factory workers

We help our customers by assembling representatives from many of these functions. Our employees and expert network provide a diverse background that can be the source of cost saving input for the development process.

Follow Lessons Learned

We help our customers by applying design and manufacturing solutions that we and others have learned over the years. Here are a few rules of thumb that we keep in mind when designing medical devices for our customers:

Design the most pivotal and challenging parts first
Use the minimum number of fasteners and the same kinds of fasteners
- Fasteners may represent only about 5% of the products direct material cost, but all the associated labor costs can reach 75% of total assembly costs ("The Best Engineered Part is No Part at All," Business Week, May 8, 1989).
Order assembly so the most reliable parts go in first and the most likely to fail go in last. This is important for both factory assembly and field repair.
Design parts to be symmetrical
- Design parts to be symmetrical from every possible view so that the part does not have to be specially oriented for assembly
- If symmetry cannot be achieved, make the parts very asymmetrical
Keep tolerances as loose as possible
- A good rule of thumb is .002". When tolerances dip down below .002" price and time go up exponentially.

Bottom line: It Rarely Pays To Cut-Corners on DFM

Phase 0: Concept Design - Set Your Trajectory

2008-07-11T16:48:00.000-07:00

One of the ways we help our customers is by effectively performing the first and most important phase of the development process - the Concept Design.

In my last post, I described the importance of an established Product Development Process (PDP). The first phase in the process is the Concept Design Phase. The trajectory of the program is set in this phase and studies show that the outcome of the development project is significantly influenced by this initial trajectory.

At PADT Medical, we approach the Concept Design phase with a clear focus on achieving the following tasks:

· Research and define the users requirements
· Select a design concept with the best potential of meeting the requirements
· Identify the critical risks associated with the design and the program
· Establish the feasibility of overcoming those risks and launching the product

The successful execution of the Concept Design phase requires a constant focus on answering these questions in a cost effective and timely approach. Doing this requires the right combination of expertise and tools that enable a quick convergence on the right concept solution. The concept design phase should not conclude without a physical demonstration of the feasibility of the device. Significant value is added once a product concept is reduced to practice. It is very difficult to understand the risks in the development prior to building a medical device prototype.

At PADT Medical, we help our customers set the right trajectory by utilizing in-house expertise and tools to select the best concept options and evaluate them through functional testing. We do this by using a combination of an experienced development staff, advanced computer simulation, and rapid prototype testing. We work closely with our customers to quickly converge on design solutions that have the best chance of success in the market.

If you have questions regarding this topic or if you need help with converging on a concept design, don’t hesitate to contact PADT Medical. We can help Set the Right Trajectory for your medical device concept.

Who Needs A Product Development Process?

2008-06-17T16:35:00.000-07:00

One of the ways we add value to our customers to help them understand the Product Development Process (PDP). Established medical device companies have proven PDP's that have been tested and refined through numerous product developments. Small and early stage medical device companies often enter into a development program without the benefit of an established process. This is where we can help. PADT Medical has an established and refined PDP that we utilize with companies that do not have one of their own.

A well defined PDP provides a high level road map that helps development teams understand how to navigate the medical device development process. Our PDP satisfies the FDA Design Control regulations while at the same time providing the efficiency and flexibility that meets the needs of companies developing innovative new medical devices. There are always surprises, detours, and hurdles in development. The PDP is the all important tool thats keep a program on track and the focus on the finish line.

When we meet with prospective clients, one of the first things we try to understand is where the medical device is on the product development roadmap. We have found that having a one-page overview that highlights the development phases, documentation, and procedures is an invaluable tool for communicating progress to-date and the work remaining.

Here is a link to PADT Medical's one-page PDP overview.

If you are developing a new medical device and you are unsure about the steps required to take your concept to market, feel free to contact PADT Medical. We can help you understand the process and provide tips on how to avoid some of the most common pitfalls encountered by device developers. In the coming blog posts, we will elaborate on various pieces of the PDP that we use at PADT Medical.

Two More Lessons On Requirements

2008-05-21T16:26:00.000-07:00

On the path to helping our clients achieve success with their medical device developments, here are two more lessons we have learned about requirements.

Lesson 3: Focus on what-not-how

Perhaps the biggest potential mistake in the design process is to focus prematurely on the "how" characteristics in the requirements document. The attention early on should be on what the product does, achieves or could be. Don't focus on how it will achieve it. The requirements should focus on the what-not-how of the product.

One way to support success in this area is to make sure requirements and specifications are "independent" measures and not dependent measures. For example, in a potential medical device, actuation rate would be an independent variable that would depend on the design of the mechanism and power source that powers the actuation. These how's should not control what your medical device could achieve.

Lesson 4: Release and track changes

Requirements change. The goal is to make sure that changes are clearly communicated to the design team in order to facilitate success. We quickly complete a requirements document and release it. Any changes that occur go through an approval process, and the act of changing and disseminating the revised requirements document is an effective communication tool. We make it easy for clients to design, communicate and reach their ultimate goals.

At PADT Medical we work closely with clients to help in every aspect of getting their idea to market, including developing medical device requirements that enable success.

Two Lessons Learned on Requirements

2008-04-24T16:26:00.000-07:00

On the path to helping our clients achieve success with their medical device developments, here are two lessons we have learned about requirements.

Lesson 1: Capture them

From the moment you begin discussing the details of a new product, begin describing its requirements and specifications. There are many creative ways to gather these. The key is to "set the trap" and start recording. This is a mindset and reaction. When you hear of a requirement, capture it by recording it on the fly into a document. We'll get this information into the Product Requirements Document. Over time you will have an impressive list of requirements that you can review to create clarity on the goals.

Lesson 2: Don't get distracted

It's easy to get distracted by focusing on the organization of the requirement document, the wording of requirements or going out of scope and focusing too early on the specifications. We help our clients avoid this. The goal should be to capture the requirements and refine them later. One thing to keep in mind is that there is no ideal organizational method, so don't get hung up on that. Also, specifications can remain unclear until significant development testing is conducted. Don't get too excited about defining detailed specifications before their time.

The requirements process can seem onerous, and so at PADT Medical we work closely with clients to help in every aspect of getting their idea to market, including developing requirements that enable success.

Medical Device Requirements vs. Specification

2008-04-01T16:25:00.000-07:00

There is occasional confusion when discussing what it means to establish "requirements" for a medical device project. The word is so generic that few people agree to its meaning. One thing we have found to be helpful is to define the difference between a requirement and a specification.

We define a requirement as a medical device characteristic that would be described by the end-user or customer. It is typically a general statement of "want" about the product. We define a specification as a "metric" that measures how well that requirement is satisfied.

In an ideal world, each customer requirement would have a single measurable specification. For example, the customer might state that the medical device must be lightweight. The obvious specification (or metric) would be product weight. This is something that we can measure in the lab, compare to a competitive product and track over the course of development.

So a requirement uses customer language and a specification uses engineering language. We'll be discussing four lessons we have learned about requirements in our next posting.

Making it Easier: Requirements

2008-03-20T16:25:00.000-07:00

Our process makes it easier for innovators to take their concepts to market. One factor is how we work with clients to develop clear "requirements" in the beginning of every project. It's one of the keys to our clients' success.

In our experience, unclear design requirements are the most frequent source of misdirection in a project. When time-to-market is critical, a detour in the project development path can significantly threaten the life of a product.

This is why at PADT Medical we make requirements a requirement. No joke! The good news for our clients is that we guide them through it, so rather than an onerous process, it's one they recognize as value-adding and on the path to success.

There is a reason why ISO, MIL Specs, textbooks, and other professional publications insist on starting with defining and documenting design requirements. When this "best practice" is skipped the cost to the program is realized in the end.

There are numerous books and sources available to describe the process of collecting customer requirements. A book we refer to is "Product Design & Development" by Ulrich and Eppinger. The FDA Quality System Manual also offers some good insights into some of the questions that should be asked when collecting requirements. We highly recommend becoming familiar with the Requirement Engineering in order to successfully develop new products.

Don't worry: we'll take you through the requirements process and whatever it takes to succeed!

Track Record of Success

2008-03-13T16:24:00.000-07:00

We thought we'd start by providing some background on us. First of all, I'm Scott Klopfenstein, and I'm a project manager at PADT Medical. I'll be joined in this blog by others on the team who are similarly dedicated to your success.

It takes an experienced and balanced development team to develop new medical and biomedical devices. The regulated medical device market imposes unique requirements and challenges on those who are developing new products. Our clients have told us that working with people who understand these challenges is essential to their success.

Developing this expertise is one of the key drivers behind PADT Medical. We are totally dedicated to our clients' success.

We are a specialized group within Phoenix Analysis & Design Technologies (PADT) that is dedicated to medical device development. PADT has been involved with medical device programs from 1994 with the goal of becoming the premier engineering services company in the Southwest.

Our experience and expertise are instrumental in helping our clients succeed. We also provide other support that we'll be discussing as we go along that sets us apart from all others.

As you consider working with companies to help bring your innovations to market, be sure to evaluate their level of experience in medical devices. Ask these questions: (1) What percent of their business is related to medical devices, and (2) do they have a mature quality system?

If the company has a track record of success in medical devices and their quality system is reportedly QSR compliant, then evaluate them further to see if they are good fit. We always aim to be a great fit with our clients!

Getting Started

2008-03-06T16:21:00.000-08:00

Welcome to the PADT Medical Devices blog. Our purpose is to provide useful information about the development of medical devices to emerging medical device companies that are commercializing new products.

Our entire team at PADT Medical is focused on reducing time-to-market by utilizing computer simulation and rapid prototype testing to quickly converge on design solutions. This enables our innovative clients to better achieve design goals, implement manufacturing and more rapidly take their concepts to market.

In the coming posts we hope to provide commentary, tools, and tips that highlight how we help make this possible.