Enable Injections Achieves ISO 13485:2016 Certification To Meet Mounting Demand for Drug-Delivery Device Combination Products

January 9, 2018


BioOhio is excited to share news on behalf of member company Enable Injections.

Enable Injections, Inc., developer of the advanced enFuse™ large volume wearable injectors (LVWI) platform for subcutaneous delivery of biologics, has been awarded the International Organization for Standardization’s 13485:2016 certification for its Quality Management Systems.

The new certification verifies that across the company’s operations and manufacturing, Enable Injections’ quality system and processes meet the rigorous regulatory requirements and comprehensive reviews of ISO 13485:2016 certification for medical devices and related services. These include design, development, production, manufacturing, storage and distribution at all device life-cycle stages.

“As demand for our enFuse™ drug delivery platform accelerates, our pharma partners can be assured that Enable Injections is committed to designing and manufacturing the highest quality, most advanced and most patient-friendly biologics delivery technology,” said Michael D. Hooven, Enable Injections President and CEO and BioOhio Board Member. “With our pharma partners, we are dedicated to radically improving the patient infusion experience to increase compliance, improve outcomes, and reduce health system costs.”

Biologic drugs dominate pharmaceutical company pipelines but due to their viscosity and the large doses required, at present most require intravenous (IV) administration in a costly healthcare facility.

Enable’s wearable devices, while supporting delivery of life-saving products in the hospital, have the greater potential to shift treatment to the patient’s home or office by providing easy and comfortable patient self-administration of doses as large as 50 ml. For the pharmaceutical companies developing biologic therapies, enFuse’s automated functions can reduce drug development time by months or years.


In other Enable Injections news, Dr. Jeannette “Jeannie” Joughin has been named Executive Vice President and Chief Commercial Officer.

A global pharmaceutical executive and long-time champion of a patient-focused approach to treatment, Dr. Joughin joined the company as Vice President of Corporate Development in 2015. In her new role she will support the CEO and Board with investment strategy and remains responsible for business development, strategic pharma partnerships, alliance management, as well as aiding in selection and prioritization of Enable Injections’ global portfolio.

“Jeannie has exceptional experience and a proven track record of developing mutually-beneficial partnerships with pharmaceutical companies who share our passion for radically improving the patient infusion experience,” said Michael D. Hooven, Enable Injections’ President and CEO. “Today we are recognizing her leadership in helping to drive the next phase of growth for Enable Injections.”

Prior to joining Enable Injections, Dr. Joughin was Vice President, Business Development at drug maker CSL Behring, with global responsibility. The Australian native also served as Marketing Manager at Mayne Pharma, as General Manager of Medimark International, and held clinical and commercial roles at Bristol-Myers Squibb.

About Enable Injections, Inc.

Founded by medical device industry veterans, Cincinnati, OH-based Enable Injections develops and manufactures wearable devices that allow easy, comfortable patient self-administration of large volume/high viscosity drugs in doses from 4 ml to 50 ml. The Enable body-worn enFuse™ drug delivery platform utilizes any standard container closure system, including syringes or vials; automatically warms and can automatically mix lyophilized solutions. Enable’s devices are available for pharmaceutical and biotechnology industry investigational use. For more information please visit www.enableinjections.com and follow us on www.twitter.com/EnableInjection.

Media contact:

Edna Kaplan

KOGS Communication