Save The Date: RP Technologies and Trends

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!

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

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

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:

1. How would you describe your company's current compliance with FDA human factors standards and guidelines?
   
2. What, if any, challenges do you anticipate ensuring compliance with HE: 75?
   
3. What FDA - Human Factors experiences can you share and lessons learned?
   
4. 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

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

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

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

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

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

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

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

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

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

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

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?

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

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

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

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

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

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

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.