How YOU Can Create Value In Your Business By Understanding And Managing Risk!

By Christian Haller, MPR Product Development
 
Risk is often not about what you think it is. Its insidious nature means you often won't see it until it is too late. This paper originally presented at the 2011 Advamed Entrepreneurs Boot Camp addresses the real world issues faced in all new development projects.

Download this white paper and you will learn:

·  How to mitigate the effects of risk that come from outisde influences, market instability, even your own team.

·  How to understand the differences between the "S-Curve" and the "Risk Curve".

The 5 Best Secrets for Managing Risk in Product Development

By Ralph Paul, MPR Product Development 
 
The best way to manage a development project is to manage risk - risks that will keep your project from being successful.   
 
By focusing on risk, you concentrate your critical thinking, problem solving, and actions towards the most critical aspects of your project. 
 
Download this white paper and you will learn: 
 
•  5 Simple ways to Reduce Risk and Make Your Project More Successful. 
 
Don't Miss Out on Learning These Key Industry Secrets

How to Cut Solid Modeling Design time by 50%:
Use 3 Simple Techniques While Becoming an Extraordinary Designer   
 
By Chuck Luddy, MPR Product Development

Projects need to go fast, advancing to the next milestone as soon as they can.

Solid modeling, depending on the situation, can become a bottle neck, slowing your project down from light speed to standstill in an instant, making solid modeling tasks the giant turtle of the project animal kingdom; slow and inefficient.

Developing good modeling practices are critical to helping designers learn the most efficient modeling techniques to move projects forward quickly.

Sign up to receive this white paper, and you will learn: 
・  The three most important FREE solid modeling practices to employ that require no special software or tools to implement.

All that is required is a willingness to learn and the desire to save time!

The 5 Things You Must do to Solve Your Product Development Problems:
Kill Your Backlog and
Develop Products People Want
 
By Marcus Hadley, MPR Product Development
& Brian Scrivens, MPR Product Development

With cost-saving initiatives and time pressures more important than ever, product development teams are forced to innovate and create more value with fewer resources. Achieving efficiency has evolved into organizations adopting high-level lean lingo, donning personnel with a rainbow of six-sigma belts, and establishing design for excellence centers that take years to catch hold. While the foundations of these industry-accepted improvement practices are sound, the real name of the game for successful product development is reducing risk. Only when risk is sufficiently and effectively reduced, will further development be profitable. This paper explores the classic pitfalls of product development that fail to prioritize reducing risk - technical, market, business, or otherwise - at all phases of development.

Off-the-Shelf or Do-It Yourself:
The Real Cost of Using Commercial
Off-the-Shelf Products.

By Chris Rice, MPR Product Development
& Craig Mauch, MPR Product Development

The perceived benefits of Commercial Off-the-Shelf (COTS) components are well-understood. Often with COTS components, less effort is required to integrate previously developed componenets. They are usually at least passably reliable, allowing your system to be up and running more quickly.  This, combined with the fact that most medical device developers are comfortable with FDA requirements to document and justify the use of COTS components, demonstrates why the use of COTS devices is common. This paper explores a few of the often overlooked disadvantages of COTS components. These disadvantages have a large impact in the development cycle and can turn the benefits of COTS into "fools gold" for the systems architect.

Aligning Medical Device Design Development and Regulatory Efforts to Save Time and Money

By Helen Mayfield, MDCI
& Eric Claude, MPR Product Development

Navigating the complex maze of regulations in today's global medical device marketplace isn't always easy, especially in light of recent FDA CDRH uncertainty, and more specifically the agency's increased emphasis on the incorporation of human factors into the device design process. Too often, a company's regulatory submission strategy is developed closer to the end of the product development process, rather than early on.

This white paper outlines how, by aligning a regulatory strategy informed by FDA interaction with appropriately timed product development and design activities, companies can better navigate the complex web of activities that are needed to efficiently bring a new medical device to market. You will learn the importance of early FDA interaction, how to determine when to reach out to partners with key expertise, key FDA regulations and requirements to consider, and the value in integrating user input into the design process early and often.

HCP-h: Beyond the Petrie Dish:

By: Dr. John Brekke, Founder, Bioactive Regenerative Therapeutics & Christian Haller, VP Product Development, MPR Associates

Researchers have established that there are quantifiable differences in cell differentiation, gene expression, protein synthesis, metabolic processes, and response to stimuli in cells cultured in a 3-D environment (in vivo) compared to a 2-D environment (in vitro). These differences present major advantages in integrating unregulated research markets with regulated health care markets as scientists and clinicians translate cell culture data into therapeutic agents for regenerative medicine.

This white paper will cover these advantages and will introduce a truly unique biomimetic extracellular matrix, the HCP-h, that provides researchers with a novel artificial tissue capable of bridging the
in vitro-to-in vivo chasm within a single system producing an enormous cell payload.

Concurrent Industrial Design & Engineering: Reduce Development Time & Improve

By Leon Marucchi, Director- Industrial Design, MPR Associates

Developing new products for release to mass markets today poses greater challenges than at any earlier time since the establishment of production methods in the 20th century. To be successful in transforming a great idea into the hands of consumers in the form of a product takes a highly experienced and knowledgeable development team. The development process this team instills from the onset of the project will well define the success they will achieve upon delivery of the final solution.

As Leon Marucchi addresses in this month's white paper, great success requires the development team to move forward in harmony resolving the challenges at hand. Addressing the fundamental requirements of today's consumer, production and regulatory issues is an enormous task. A concurrent means of communication between all team disciplines will provide the greatest opportunity for success of a product development plan.

The Application of iPhones and iPads to New Medical Services

By Craig Mauch

The Apple iPhone and iPad have taken the world by storm, becoming the favorite smartphone technology in just a few years and is in use in over 80 countries. As soon as it was released, developers began to find ways to apply these devices to medical applications.

This paper provides examples of medical device
software and medical devices that use the iPhone technology available from Apple. The paper also provides guidance on how to determine if your application or device is a medical device and if so, what steps are required to comply with FDA regulations. Finally, pros and cons of using this platform for medical
devices are discussed along with best practices for development of these devices and software applications.

The Application of iPhones and iPads to New Medical Services

By Craig Mauch

The Apple iPhone and iPad have taken the world by storm, becoming the favorite smartphone technology in just a few years and is in use in over 80 countries. As soon as it was released, developers began to find ways to apply these devices to medical applications.

This paper provides examples of medical device
software and medical devices that use the iPhone technology available from Apple. The paper also provides guidance on how to determine if your application or device is a medical device and if so, what steps are required to comply with FDA regulations. Finally, pros and cons of using this platform for medical
devices are discussed along with best practices for development of these devices and software applications.