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Background

iMedd (Intelligent MicroEngineered Drug Delivery) is an early-stage drug delivery company.  Their business is to leverage micro-engineering technology to develop an implantable drug delivery treatment for patients with hepatitis C.  According to the World Health Organization (WHO), 170 million people (3% of the world’s population) are infected with hepatitis C.  WHO adds that patients with hepatitis C receive weekly shots of interferon, a natural protein that can result in flu-like symptoms such as fever, nausea, sore muscles, joint pain and fatigue.  iMedd hired Speck Design to design a drug implant that would constantly diffuse the medication, interferon, into the body of hepatitis C patients over time.  It was hoped that the new form of treatment would replace weekly visits to the doctor for injections, and instead provide patients with a consistent therapeutic drug dosage for the entire course of therapy.  iMedd chose Speck Design because of our extensive experience designing medical and consumer products, specifically in the area of implantable drug delivery systems.  Our team has designed more than six different implantable osmotic pumps and implantable pump systems for clients including Alza and Durect.  The goals for this project were:

• Redesign an existing proof-of-concept platform into a pre-clinical system and then into a clinical-ready delivery system for clinical trials.
• Design all of the mechanical components including the NanoGate housing, drug reservoir, fixturing, test apparatuses and fixtures for QC and design verification.
• Provide ideation, mechanical design and analysis, prototyping, and fabrication support for the NanoGate development.

Challenge

At approximately 1/8 inch in diameter and 1 inch long, the delicate titanium cylinder containing the NanoGate membrane is surgically implanted into the skin of a patient’s arm.  Unlike routine injections, in which the drug concentration decreases over time, the NanoGate implant containing the interferon drug diffuses at a constant rate into the patient’s body for up to 3 months.  Working against the challenges of cost, environmental effects, failure modes, and membrane mounting, Speck Design was charged with constructing a device that could withstand the impact of a significant force on the casing, which could damage the fragile membrane.  Another challenge for Speck Design was working with the delicate membrane discs which required careful and solid mounting in the housing.  Any inconsistency in the mounting of the thin silicon membrane could create a weak point that could ultimately cause it to fail.

Solution

Speck Design worked with iMedd from the concept design phases to the fabrication and development of the implant.  The initial development phases included visual inspections of the membranes with a microscope, checking for inconsistencies in the membrane surface, and testing the amount of pressure the membrane disc could withstand before breaking.  Speck Design handled the engineering side of the development phases, which included creating the implant components, assisting with the membrane development, and designing special tools for manufacturing.  Speck Design was also responsible for conducting quality testing of membrane integrity on 100% of the assemblies. This was done with a Speck Design built pressure decay test system.  For the fragile membranes to withstand the forces generated during handling, assembly, implantation, and pressure-related thermal effects, Speck Design considered functionality, manufacturability, overall robustness, and impact tolerance.  In order to develop a membrane housing that could be easily assembled and manufactured, Speck Design created and tested several different complete housing designs to identify one that served iMedd’s goals most effectively.

Results

Serving essentially as iMedd’s engineering department, the Speck Design team was able to design an effective housing for this innovative implantable drug delivery system, through frequent meetings with iMedd and their partners throughout the product development stages.  By also supporting iMedd with production, Speck Design assisted in bringing the product forward to the animal testing stage.  The product went on hold for some time due to internal corporate challenges at iMedd.  During that time, new research at Ohio State University, building on work done at Arizona State University on photocapillarity showed promise in further improving a possible delivery option.

PROJECT INFO

• Client:

  iMedd

• Project:

  Implantable Drug Delivery System

• Industry:

  Medical