SPR Therapeutics’ $10 million from the US DoD; other medical device design, manufacture news

SPR Therapeutics’ $10 million from the US DoD; other medical device design, manufacture news

Emergo by UL’s medical device research, design facility; B. Braun’s safety engineered needle; Instrumental’s manufacturing intelligence; Freudenberg Medical's device, design solutions

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October 6, 2018
Elizabeth Engler Modic
#WhyMFG

SPR Therapeutics Inc. has been awarded two new grants and one new contract from the U.S. Department of Defense totaling $10 million to further develop its percutaneous Peripheral Nerve Stimulation (PNS) therapy. The SPRINT PNS System offers a non-opioid pain relief therapy that is FDA-cleared for the treatment of acute and chronic pain.

In addition to a previous contract and grants from the National Institutes of Health and Department of Defense, these latest awards from the Defense Department bring the total amount of grants and contracts to $30 million to support the advancement of SPR’s neurostimulation technology for pain.

The largest of the awards, a grant totaling $6 million, will support a randomized controlled trial (RCT) comparing the SPRINT PNS System to conventional medical management, to reduce pain and opioid use while enabling improvements in function among Service members, Veterans and civilians with chronic back pain. Chronic back pain interferes with function and daily activities (such as walking, work and personal care), and decreases quality of life. As the leading cause of morbidity in the U.S. military, back pain is the most commonly diagnosed injury or reason for seeking medical care and has the highest 5-year risk of permanent disability.

A second RCT, supported by a $3 million grant, will focus on improving pain management following surgery for combat and non-combat related orthopedic trauma. Designed based on encouraging results of a previous study, it will further evaluate the use of percutaneous PNS to relieve pain, reduce or eliminate use of opioids, and accelerate functional recovery.

A $1 million contract will fund continued advancement of the company’s PNS platform while enhancing the system’s ability to support independent use by healthcare providers. These improvements are intended to enable a wider range of interventional pain management physicians to offer the system with minimal training and enable simpler self-management of therapy, thereby allowing more patients to receive effective, non-opioid pain relief.

 

Emergo by UL has just opened a new, state-of-the-art facility to support medical device research and design efforts in downtown Chicago.

Chicago Studio was established by Emergo by UL's Human Factors Research & Design (HFR&D) team, which integrates the consulting groups formerly known as UL–Wiklund and Medical Device Usability. Using Chicago Studio, medical device companies can focus on developing robust and user-centered design concepts for medical devices and related healthcare products and technologies. Establishing the facility in Chicago will also foster close collaboration between local and regional incubators, universities, technology developers, and medical device manufacturers.

Chicago Studio provides an 8,000-square-foot facility where clients may consult with Emergo by UL HFR&D experts as well as UL Healthcare professionals on device design issues as well as cybersecurity, interoperability, biocompatibility, and electromagnetic compatibility (EMC). The new facility supports product research, development and design for medical devices, combination products, wellness products, and medical software such as electronic health record systems.

Clients will have access to on-site HFR&D staff in Chicago as well as remote access to additional medical device human factors and product development experts (e.g., industrial designers, biomedical engineers, technical writers) based in the U.S., Europe, and Japan.

 

B. Braun Medical Inc. has introduced its Surecan Safety II Port Access Needles, a safety engineered needle for accessing implanted intravenous ports. The safety mechanism offers a unique visual confirmation when successfully engaged. The non-coring port access needles are suitable for power injections to 325psi. 

The Surecan Safety II has a manually activated safety mechanism that is designed to provide visual confirmation with a green dot that is visible through the clear bottom plate. The Surecan Safety II also is designed to provide tactile confirmation upon activation. The safety mechanism is designed to reduce the risk of accidental needlestick injuries by shielding the needle tip during and after removal.

The single-use Surecan Safety II is intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling. The needles are available in sizes from 19 gauge to 22 gauge and have a useable needle length ranging from 0.5" to 1.5" (12mm to 38mm). They are available with or without a Y-site and the Y-site version includes a pre-attached CARESITE luer access device.

In addition to the green dot safety mechanism, Surecan Safety II’s features include:

  • A low profile and foam pad, designed to assist with the placement of a securement dressing.
  • Flexible and ergonomic wings, designed to provide secure handling during insertion and removal of the needle.2
  • A small, transparent, round base plate, designed to help increase stability and help visualize the placement of the needle.

 

Instrumental has expanded its customer base from quality leaders in the consumer electronics space to include multiple vehicle and medical device manufacturers. With customer demand for rapid expansion, for both development and mass production lines, Instrumental has hired Keith Lucas as COO to help scale the organization to meet the demand for Instrumental.

In May 2018, Instrumental released Intercept, which identifies defects in real time, saving brands and manufacturers significant money in rework, scrap and returns.

 

Freudenberg Medical offers several new options for medical device companies looking to accelerate time to market. The new Composer XL Deflectable Catheter Handle Platform provides a commercialization ready interface designed to provide integrated control and sized for large bore structural heart and endovascular devices such as transcatheter tricuspid and mitral valve delivery systems. The HyperSeal XL, a new member to the hemostasis valve family, adds a robust design option for vascular access applications up to 30Fr and 40Fr. Also making their debut at this year’s TCT are the 8.5F and 12Fr Composer Steerable Introducers, new finished device solutions for private label development and customization across a wide range of electrophysiology, structural heart, and vascular applications.

“Building on the strong market response of our Composer Deflectable Catheter Handle Platform and Hemostasis Valve Family, Freudenberg Medical’s new Composer XL and HyperSeal XL were developed to address the unique challenges with large bore vascular access and device delivery in the rapidly evolving transcatheter valve and endovascular space. The significantly larger size of these emerging therapeutic devices is demanding innovative and unconventional solutions to reduce risk and improve outcomes,” says Bernie Kaeferlein, director of portfolio management at Freudenberg Medical. “As a partner for innovation, we are committed to proactively addressing unmet clinical needs and offering our medical device customers a growing portfolio of finished device, design, and process solutions to help improve efficiency and accelerate their time to market.”