Logistics Articles

81. Stop Treating Risk Management & Design Controls As Checkbox Activities 9/1/2015

    Understanding the relationship between product risk management and design controls is critical to the success of a medical device in the marketplace. Both are all too often treated as “checkbox” activities that have to be done because the regulations say so. Read on to see why you should embrace design controls and risk management not just as necessary evils, but as tools to help ensure your medical device is as safe and effective as possible.

82. How To Incorporate Risk Management In Medtech Supplier Quality Management, Part 2 8/24/2015

    In Part 1 of this series, we discussed developing a risk management strategy for supplier evaluation, along with a qualification plan to demonstrate compliance to auditors/regulators. In this article, I will share best practices for implementing a successful risk-based supplier management system, as well as explain the requirements that should be clearly defined in a supplier quality agreement.

83. Value Stream Mapping For Medical Device Companies, Part 2 8/21/2015

    In this edition of Thinking Lean, we are going to complete our two-part series on value stream mapping. In the part one of the series, we addressed the concepts of value stream identification and current state mapping.  In this article, we will talk about mapping the future state and creating a value stream plan.

84. Stryker's MAKO Surgical Acquisition: A Second Look 8/18/2015

    At a time everyone was playing follow-the-leader in consolidation, Stryker took a different approach. With the MAKO acquisition, Stryker was bold enough to sacrifice short-term profit for long-term gain. I talked with Stuart Simpson, VP and GM of Stryker Reconstructive Business, about how that gamble could pay off.

85. 4 Ways Med Device Developers Can Capitalize On The Internet Of Things 8/13/2015

    As connected devices begin to permeate the home environment, they can enable smarter consumer decision-making regarding health matters. What will ultimately drive device developer success is the quality of their new technologies’ connectivity, hardware system design, and comfort, as well as their ability to deliver more meaningful healthcare outcomes. Once you have found a way to fit into a user’s lifestyle, the next big development step is to present content that is relevant not only to the primary user, but to all stakeholders who will use the information.

86. Hacking In Medical Devices: White And Black Hats, Part 1 8/10/2015

    Hacking in medical devices is a sensitive topic. In general, hacking has some deeply negative connotations but, while some hackers are dangerous, others have nobler causes. In this article — the first in a two-part series — we’ll discuss the programmers and engineers who have lifted the hood on medical devices to understand their underlying mechanics.

87. Philips Healthcare: A New Approach To Innovation 8/4/2015

    How can well-established med device companies overcome the internal hurdles that prevent disruptive innovation? It is not a complete lack of structure that promotes optimal innovation. Just loosen the reins. I had the chance to discuss this topic with Ken Berta of Philips Healthcare. Berta works under the Philips Group Innovation umbrella and is the Head of Commercial Operations, North America.

88. The Impact Of Large-Scale Mergers On The European Extremity Reconstruction Industry 7/28/2015

    The small bone and joint device market in the Europe consists of reconstructive implants for the extremities, including the shoulder, elbow, hand, and foot. Significant growth in unit sales of key segments is counteracting across-the-board price cuts that are caused by competition and tendering processes in many EU countries. These price declines are causing many niche markets in extremity reconstruction to shrink, despite otherwise stable unit sales. However, there still is significant potential for growth.

89. New Insights On Med Device Market Consolidation 7/17/2015

    If your company is considering M&A as a solution to the med device market pressures, you need to understand the challenges ahead. I sat down recently with Steve Cottrell, the new president of Maetrics Life Sciences Consulting, to discuss his thoughts on the issue.

90. European Market For Orthopedic Biomaterials Undergoing Rapid Change 6/26/2015

    The market for European orthopedic biomaterials (OB) has undergone dramatic changes over the last two years. Prices, quantities sold, and competitors have been in an almost constant state of flux. While quantities sold are marginally increasing, ASPs (average sales prices) are being driven down by an increase in competition. This analysis includes the markets for bone morphogenetic proteins (BMPs), hyaluronic acid viscosupplementation injections, bone graft substitutes, and autologous chondrocyte implantations (ACIs).