Tuesday, January 4, 2011

A Better Way: Incorporating Human Centric Design In Drug Delivery and Drug – Device Combination Products

By Reade Harpham
Manager, Human Centric Design

The importance of human centric design (HCD) considerations in the development of drug delivery devices and drug – device combination products has become vital for companies striving to succeed in an increasingly competitive and rapidly evolving market.

By gathering end users’ input at the outset of every project, we are able to reduce time and cost associated with the development process. This proactive approach to device development means faster time to market, better safety and quality and more effective solutions to the challenges that arise within drug delivery and drug – device combinations. Here at Battelle, our emphasis on HCD and the integration of multiple science, engineering and regulatory disciplines enables us to deliver innovative drug delivery and drug – device combination solutions for biopharmaceutical and device companies.

How do we do it? Our HCD approach involves gathering input from clinicians, such as nurses, physicians and medical technicians, as well as patients, in a clinical context to help guide the development of drug delivery-enabled biopharmaceuticals and drug – device combination products. This allows us as designers to create a safe, effective solution that is easy to use and ultimately improves patient care. It is crucial to gain insight into the unique needs and behaviors of end users through direct observation, surveys and interviews before we even begin the design phase.

Currently, Battelle is applying its HCD expertise to develop autoinjectors for the delivery of biologics. Patients can make all kinds of mistakes when using autoinjectors: using the wrong end of the device, injecting into the wrong part of the body, pushing or pulling on the wrong spot or failing to leave the device in long enough for proper dosing. Sometimes, this happens when patients fail to read or misinterpret directions. Sometimes, the device itself has poor visual or tactile clues that mislead patients. Sometimes, the device was designed without consideration for the patient’s physical limitations, as commonly encountered in autoimmune diseases.

Battelle’s HCD specialists have watched hundreds of patients using a variety of autoinjector devices and developed design solutions to minimize potentially dangerous mistakes. Often, these solutions can be implemented with minimal cost and without any changes to the physical engineering of the device itself. Designing instructions or changing the color of the active end of a device may seem like simple things, but when you are talking about critical therapeutics, compliance can save lives.

HCD streamlines the development process by eliminating the need for multiple revisions based on after-the-fact feedback. This saves biopharmaceutical and device companies money and improves the safety and efficacy of all drug delivery-enabled biopharmaceuticals and drug – device combination products.

At Battelle, we provide a one-stop shop that utilizes HCD in our end-to-end process. We begin with comprehensive research and development and end with manufacturing capabilities and regulatory compliance counsel. Our team here at Battelle is committed to providing the safest and most cost-effective drug delivery and drug – device combination solutions in the industry.

We’d love to talk to you more about HCD, so please feel free to stop by our booth (No. 302) Jan. 26-28 at the 2011 Drug Delivery Partnerships event at the Doral Golf Resort & Spa in Miami, Fla.

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