• Integrating Usability Engineering into Your Medical Device Design Process

    In 2016, the FDA finalized their guidance on how human factors and usability engineering should be applied in the design process for medical devices. While this may be new to some, practitioners of user-centered design have known for years that these practices not only improve product safety, they also result in a better product. For those who find themselves in unfamiliar territory, we revisit why usability engineering is so important and how the fundamental elements of usability engineering can be integrated into the design process. Read More

  • Best Practices for Preventing Water Hammer in Combined Cycle Attemperation Systems

    Attemperation systems are used in power plant steam systems to control steam temperature by injecting sub-cooled water into superheated steam lines. Also known as desuperheaters, these systems reduce the amount of superheat present in the steam but are designed to avoid reducing temperatures all the way down to the saturation point where saturated water may occur in the piping. These systems rely on the enthalply difference between the high pressure, sub-cooled water and the superheated steam to reduce the outlet steam enthalply and the outlet steam temperature through evaporation of the injected water. Read More

  • Design Verification Testing: The FDA Cares, You Should Too

    Design Verification is the process used by medical device manufacturers to ensure that the outputs from the design process meet the requirements specified in the design inputs. Activities such as Tests, Inspections, or Analyses provide objective evidence that the specified requirements have been fulfilled. This paper will examine three categories of design verification test failures and discuss what can be done to prevent them. Read More

  • The 10 Commandments of Product Development

    Product design and development is a journey with unexpected twists and turns. People often ask, "how can I make my design process more predictable?" In our 25 years of experience designing medical devices, we've found that you can't always predict all the twists, but there are things that can be done to increase the certainty in a successful outcome. Read More

  • Five Considerations for Outsourcing Medical Product Development

    Development of world-class products for the medical device industry requires a significant number of resources - regulatory, marketing, design and engineering, manufacturing, etc. Your organization may not have the full scope and bandwidth of resources to address all aspects of product development - so you look for strategic partners that can help with areas of need. Read More

  • How To Spend Your First $100,000

    Imagine you are an early stage entrepreneur with a breakthrough technology, some promising intellectual property, and $100K is on the way from a new investor. What do you need to do to maximize your chances of success? Early stage device start ups are more likely to gain access to seed capital rather than a large investment, but they often have a problem figuring out how to spend the money in a way that will lead to more funding. Read More

  • Top 3 Reasons To Outsource Product Development

    Things used to be simpler, an R&D group within an organization would develop an internal team, prioritize the projects on hand, and then get to work. But in today's environment, almost every element of a business faces a "make or buy" decision - and development is no different. In today's market, R&D groups tend to be stretched to their limits and still asked to do more. New cross product and platform technologies create a challenge to have expertise in all the areas you need to develop a modern product. Read More

  • Wind Energy in Mexico: Development and Execution Best Practices

    Development of wind projects in Mexico presents several challenges and opportunities that are unique to the Mexican marketplace. High PPA tariffs and a growing energy market attract developers to the Mexican wind market. However, seizing these opportunities requires developers to understand the needs of stakeholders such as Off-takers, CRE (Energy Regulatory Commission), and CFE (State Owned Utility). Some of the critical development challenges include: identifying viable Points of Interconnection, securing PPA's, working with limited small scale wind data, and managing the substation engineering design, review, and approval process. During the construction phase, some of the important challenges include: major equipment importation, EPC planning and reporting, and site safety, security and theft. Lastly, it is important to appreciate the positive influence of the Spanish workforce during Wind Turbine Generator (WTG) installation and the support from CFE during substation testing and start-up. Read More

  • The Secrets to Implementing M2M Communication in Your Medical Device

    MPR Associates is currently working with healthcare companies to create medical devices that incorporate innovative M2M technology. Our M2M solutions are suitable for companies that are designing new products or product refreshes. This paper presents an overview of the basic components required for a M2M solution, lessons learned from MPR's experience with developing M2M enabled medical devices, and key takeaways to consider during product development. Read More

  • Continuous Blood Glucose Monitor

    An MPR client desired a medical device capable of automated glucose monitoring using a conventional in-line intravascular (IV) catheter. The device was to be designed specifically for patients undergoing intensive insulin therapy in critical and intensive care units. It was required that the monitoring system would automatically sample the patient's blood, test the blood for glucose levels, and reinfuse the blood into the patient, ensuring the entire fluid pathway was kept clean for extended periods of time (up to our days). In addition, the device was required to operate in an automatic unattended fashion and report any abnormal readings. Read More