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.