The Engineering Core team consists of mechanical, biomedical and materials engineers who focus on research and development related to new medical devices. We have over eighty years of combined engineering experience from a variety of backgrounds. Our team uses state-of-the-art tools to complement our experience, including computer-aided design, digital anatomic reconstruction and rapid prototyping (see Services for more information). We have the unique position of having access to Cleveland Clinic physicians and surgeons and the support and infrastructure of Cleveland Clinic, with the operational flexibility of a small business.
Dave Dudzinski, BS
The Engineering Core is primarily focused on the design and fabrication of new medical device prototypes. We provide mechanical design and materials selection expertise to clinicians and innovators within Cleveland Clinic as well as externally. Our close partnership with Cleveland Clinic Innovations helps guide our projects to develop both functional and commercially relevant devices. These projects typically last 12 - 18 months.
Additionally, the Engineering Core is involved with several multi-year projects and we have a number of collaborations with various institutions. The background of the majority of our engineers is multi-year projects.
The Engineering Core also operates the Rapid Prototyping facilities, which serve as a fee-for-service method to provide prototype models to both internal and external clients. Our turn-around time is exceptional and a quote is always provided up-front.Mechanical Design
CAD Software Packages:
Our primary CAD modeling tool is SolidWorks, however we also have access to Pro/ENGINEER and Solid Edge. Our engineers have expertise in solid modeling, surface modeling, 2D drawings and Geometric Dimensioning and Tolerancing (GD&T).
Digital Anatomic Reconstruction Packages:
Our team also uses TeraRecon, Mimics and Magics in order to work with 3D anatomic data. This allows us to build anatomic models on our Objet Eden 260 rapid prototyping machine as well as use anatomic data in our CAD packages.
Finite Element Analysis:
We use our "in-CAD" FEA software to improve our designs. When in-depth FEA is required, we partner with the experts in CoBi core.
Rapid Prototyping & Prototype Assembly
Our team has access to 1500 square feet of lab space . This serves to house our rapid prototyping, laser cutting and shape setting equipment as we as provide benchtop space for prototype assembly and device testing.
Objet Connex 350 and Eden 260:
Our rapid prototyping machines allows us to manufacture prototypes in a matter of hours and with very high accuracies. The build resolution of these machines is 0.0006" in the z-direction allowing us to build parts with wall thicknesses and/or gaps as low as 0.004". Both machines have a broad selection of materials, including flexible and clear rigid resins. These machines have several key features that make them an ideal took in the prototyping process:
- High Accuracy: 0.017” (40µm) horizontal resolution; 0.0006” (16µm) vertical resolution
- Wide Material Selection: Objet supplies nearly a dozen resins; these can be blended to achieve 51 additional unique material combinations
- Fast Build Times: Most parts are built within a few hours; same or next day turn-around is possible!
- Easy-to-Clean Parts: Provides for short turn-around times, even when builds have numerous parts
- Low-Maintenance: Allows our engineers to focus their efforts on prototype design
Applications of rapid prototyped parts include:
- Demonstration models
- Functional prototypes
- Surgical planning models
- Molds for elastomer molding
- Building parts based on CT and MRI data, microscopy images and protein data bank files
|FullCure720||light yellow||transparent||Lowest cost, good strength|
|VeroWhite||white||opaque||White colored rigid parts|
|VeroBlack||black||opaque||Black colored rigid parts|
|VeroGray||gray||opaque||Gray colored rigid parts|
|VeroBlue||blue||opaque||Light blue colored rigid parts|
|TangoPlus||light gray||translucent||Translucent rubber-like parts|
|TangoBlackPlus||black||opaque|| Black rubber-like parts, enhanced relative
|TangoGray||gray||gray||Gray rubber-like parts|
|TangoBlack||black||black|| Black rubber-like parts, has some unique
|VeroClear||none||transparent||Best resin for transparent parts|
|RGD5160||green||opaque|| Similar to ABS, highest heat-deflection
|DurusWhite||white||opaque||Similar to Polypropylene|
Complex Device Assembly :
Our engineers have extensive experience in assembling complex devices as well as the necessary tools to facilitate assembly. Devices include:
- Blood pumps, including the continuous flow PediPump Ventricular Assist Device and the pulsatile MagScrew Total Artificial Heart
- Customized bariatric staplers
- Small French size, catheter based cardiovascular and peripheral vascular devices
Bench Testing :
Our engineers have a strong background in device testing. When we need to provide data to demonstrate a prototype works, we can use a variety of data acquisition hardware (pressure, flow, force, strain) along with software (LabVIEW and Powerlab) in order to measure acquire both analog and digital data. We also have expertise in designing and building custom test loops or other test setups.
Good project management is a necessity to keep a project on schedule and on budget. We offer project management capabilities for all of our projects.
We use a self-hosted web-based software tool to manage all of our projects. Not only does it provide client access to important project information, it also is a collaboration tool:
- Discussion threads with email integration
- Gantt charts
- Document sharing
- Real-time budget information
PortfolioAdjustable VAD Inflow Cannula
Client: Dr. Kiyotaka Fukamachi, Cardiovascular Dynamics Laboratory
Services Provided: Project Management | Mechanical Design in collaboration with Polymer Lab | CAD Modeling in Pro/ENGINEER
Ventricular Assist Devices (VADs) have become a viable medical treatment in recent years. VADs consist of a pump, inflow cannula, outflow graft, power supply system, and control unit. The second and third generation VADs have typically gone to a continuous flow design. Several investigators have reported multiple issues with the currently available VAD inflow cannulas that necessitated reoperation. This is at least partially due to the unique anatomy of each patient. However, the inflow cannula angle of placement may change after the chest is close, and thus the cannula may become obstructed.
The Cardiovascular Dynamics Laboratory conceived of an adjustable VAD inflow cannula. Medical Device Soluations worked closely with the lab to develop this device. The original concept used four nitinol wires, each mechanically anchored on the distal end and guided through polymer guide rings, that would be actuated via small linear motors. These four actuators would surround a flexible, reinforced cannula that has been separately designed and developed for the PediPump, a Cleveland Clinic VAD technology.
Our engineers helped to simplify the design. Two flexible threaded rods replaced the four nitinol wires. The threaded rods were rotated via flexible drive-shafts that could be removed once optimal placement was confirmed. We envision that the drive-shafts would be further developed such that they would be removable extracorporeally several days post-surgery.
The Adjustable Cannula was successfully tested in-vivo as assembled to the Cleveland Heart LVAD. The results have been published in The Annals of Thoracic Surgery (2010;90:1682-7).
Client: Dr. Rahul Seth
Mechanical Design | CAD Modeling in SolidWorks | Rapid Prototyping | Machining | Device Assembly & Bench Testing
Dr. Seth recognized a need in the treatment of Middle Ear Effusion, or fluid in the ear space, and came to Medical Device Solutions with a design concept. In his studies, the refraction of laser light emitted on the ear drum could more accurately predict the presence of effusion, which could help prevent frequent mis-diagnoses and prolonged hearing loss.
Medical Device Solutions helped bring his idea to life, by routing power to a 5-milliwatt laser from the battery pack already in place in a common Otoscope model. The laser beam was transmitted via fiber optics up into the viewing piece and aligned such that during a routine ear inspection, a clinician could simply hold down a button and the laser would shine directly onto the patient’s ear drum.
A clinical study is currently in process to determine the efficacy of this design concept. Medical Device Solutions supplied four prototype units for this study.
Micro PET/SPECT Phantom Development
Client: Dr. Frank DiFilippo, Cleveland Clinic Nuclear Imaging
Services Provided: Mechanical Design, optimizing the usability of the device and manufacturing via Stereolithography | CAD Modeling in Pro/ENGINEER | Rapid Prototyping
Dr. DiFilippo approached Medical Device Solutions regarding support of a NIH grant. One of the grant aims was to develop an optimized set of calibration spheres (phantoms) for micro-PET and micro-SPECT nuclear imaging machines. The calibration spheres would need to be part of an assembly that could be rotated within an outer fixture as part of the improved imaging routine that was proposed in the grant.
Medical Device Solutions presented several design iterations to Dr. DiFilippo, each time further optimizing the design. Additionally, the parts were designed such that they could be built via stereolithography without any internal supporting structures. A clear, waterproof resin was chosen to build the parts. This resulted in parts that were very easy to visualize, which was important for the operators who were filled the internal sphere structures with a radioactive fluid.
Results have been published in the journal Physics in Medicine & Biology (Phys. Med. Biol. 55 (2010) 5363–5381)
Navis Guidewire Torque Device
Client: Windcrest, LLC
Services Provided: Mechanical Design | CAD Modeling in Pro/ENGINEER | Rapid Prototyping | Detailed 2D drawings, utilizing extensive GD&T
Cleveland Clinic was approached by Windcrest, LLC, to further the development and commercialization of a novel guidewire torque device, the Navis Torquer. Conventional guidewire torque devices, also known as “torquers” or “controllers,” have to be loaded onto a guidewire from the proximal end. This can be tedious and inconvenient, especially in procedures that involve multiple exchanges of catheters. The Navis Torquer eliminates this issue by adding a cross-slot, allowing it to be loaded onto a guidewire at any position.
Medical Device Solutions and Cleveland Clinic Innovations worked together to develop the device, adding unique intellectual property to the design. Medical Device Solutions in particular optimized the novel design for usability and manufacturability. Nearly two dozen iterations were explored and our access to clinicians on campus aided our efforts to make the Navis Torquer a device that would be accepted by vascular surgeons, cardiologists and other clinical personnel. Medical Device Solutions engineers also coordinated the manufacture of several of the Navis Torquer designs, including machining and injection molding.
Client: Dr. Doanh Nguyen
Mechanical Design | CAD Modeling in SolidWorks | Rapid Prototyping | Machining | Device Assembly
Tonsilloliths (or “tonsil stones”) are growths of bacteria that grow and accumulate within the tonsillar crypts. These growths range from being relatively soft and gel-like to becoming calcified and hard, and while generally not harmful, can cause halitosis and discomfort. Sufferers can sometimes remove the Tonsilloliths by themselves, but many require a doctor visit for removal.
Dr. Nguyen had recognized a need for a device in this specific area and came to Medical Device Solutions with an idea in mind. With the help of his design and initial prototype, Medical Device Solutions designed a sleeker and highly-functional device that uses smooth rollers to massage the affected region of the tonsils in order to harmlessly dislodge the tonsillolith.