BIODEGRADABLE FIBERS – Enabling Controlled Pharmaceutical & Biologic Delivery for Next-Generation Medical Applications
Kevin Nelson, PhD, discusses how wet-extruded fiber eliminates the traditional limitations of pharmaceuticals and biologics that may be incorporated into implantable medical devices with melt extrusion or electrospun fibers, microspheres, or nanoparticles.
EXECUTIVE INTERVIEW – Insulet Corporation: Improving Adherence Through Wearable, Patient-Centric Drug Delivery
Michael Graffeo, Vice President of Business Development, Insulet Delivery Systems Group, discusses the importance of optimizing patient adherence to ensure improved clinical outcomes.
Bill Welch says when developing a combination product, there are many things to be considered – relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation.
ADVANCED DELIVERY DEVICES – Sophisticated Connected Wearables: Boosting Biologics’ Compliance, Value & Patient Satisfaction
Michael D. Hooven, MSME, says the new, most advanced wearable large-volume injectors available now for clinical trials and commercial application are designed to address the challenges of formulating biologics, delivery complexity, patient compliance, and cost.
DEVICE STUDY – The Intuitiveness, Ergonomics & Usability of the Credence Companion® Safety Syringe: A Formative Study
John A. Merhige, MEM, and Lisa Caparra, RN, present an informative human factors study to evaluate and assess the intuitiveness, ergonomics, and usability of the Credence Companion® Staked Safety Syringe.
TRAINING DEVICES – Best Practices & Considerations in Developing Effective Training Devices for Injectable Healthcare Markets
Joe Reynolds says training devices are often used to create consistent onboarding experiences for patients through the use of novel technologies and mechanisms that fully simulate the mechanical aspects of the injection experience. And while these devices appear to be fairly simple at first glance, numerous design and engineering challenges must be addressed.
Contributor Cindy H. Dubin spoke with some of the world’s leading device developers about their current injection technologies and how their devices are addressing the current trends and opportunities in the industry.
Lilli Zakarija, MSME, MBA, explains that in order to conduct a successful V&V on the intended combination product, the key is to understand that the V&V testing is not an isolated activity and task.
Lilli Zakarija, MSME, MBA, cautions that while OTS devices are already “developed” and on the market, they should still go through the device development design control process from the perspective of the combination product, and then let the design control process determine if the device meets the specific requirements of the CP.
Bruce K. Redding, Jr, CEO and Founder of TSI, discusses the importance of developing a new tool for enhanced drug delivery, but also a means to reduce the time-to-market for new formulations while also expanding the number of drugs that can be delivered transdermally.
EXCLUSIVE ONLINE CONTENT
Whether it is meeting the needs of a rapidly aging market, blocking drug counterfeiters, or differentiating your pharmaceutical product in the market, a secondary packaging program is an important factor in………
Enable Injections, Inc. recently announced it has entered into a multi-product development agreement with Sanofi S.A.
The Japanese medical device market is set to reach from $54.5 billion in 2018 to $74.7 billion in 2025, growing at a compound annual growth rate (CAGR) of 4.6% says GlobalData, a leading data and analytics company.
Hovione Technology, a specialist in development of innovative inhalation device technology, recently announced it has secured global rights to develop and commercialize a new ultra-affordable, multi-use blister-based dry powder inhaler patented by inventor Dr. Klaus-Dieter Beller.
Peter Soelkner says there will always be a wide variety of trends influencing our industry and we see no reason why this will not continue well into the future.