Ergonomic Medical Design

Abyrx: Prolieve HEMASORB® Rosorbable Hemostatic Bone Putty Apply 

A precise delivery instrument designed to apply resorbable hemostatic putty to reliably stop bone bleeding. Our user research revealed surgeons want to have precise dose and application control without taking any time. TKDG design team created a simple yet patented elegant solution for dose control utilizing the tactile and audible feedback that orthopeadic surgeons are accustomed. TKDG provided all engineering design with supporting material specifications and manufacturing management.

Medical Device Design Consulting

Boston Scientific: Prolieve Thermodilatation® System, a transurethral microwave thermotherapy (TUMT) system for treatment of benign hyperplasia in the prostrate

Medical Instrument Design Challenge: Redesign and package the engineering prototype. Develop an easy-to-use console that integrates the computer, electronics, and heat exchanger system for catheter, disposable treatment catheter, display interface, and information display into a handsome space-efficient mobile cart.

A proprietary technology, made in USA

Tri-Medics® Precision Surgical Instruments:  Upper extremity orthopedic surgery requires precise dissection and cutting.  TKDG worked with Tri-Medics® on a new scissor technology and manufacturing process that is patented.  This scissor design will provide over 5000 precise cuts without dulling or tearing tissue during dissection. Surgeons have praised this elegant scissor for being lightweight and balanced; the scissor feels as though it was an extension of their hand.  The scissor is available in three sizes and styles. TKDG developed all engineering and final CAD models and followed through with documentation package for production, working with the US manufacturer  to perfect production process.   This scissor cost 60% less than conventional competition.

Multidisciplinary Industrial Design

DePuy Spine: The SYMPHONY® Graft Delivery System, a sterile disposable kit used in orthopedic spinal surgery to create a biologically and mechanically enhanced bone graft, pre-mixed with platelet concentrate for implantation in spinal surgery

Surgical Device Design Challenge: Simplify a complex, multi-stage procedure into easy-to-complete tasks. TKDG applied ergonomic design principles to analyze the clinical procedure in the conceptual design process and then radically reduced the complexity of the surgical device, making it possible for surgeons to complete a sophisticated procedure in less than five minutes. The application of materials analysis in the product design process ensured that the graph material would be suitable for one-time use.

Award Winner: Industrial Design Excellence Award (IDEA)

Orthopedic Device Design Consulting

Orthovita: Vitoss™ Bone Graft Substitute Delivery Device

Disposable Surgical Device Design Challenge: Design a disposable funnel/syringe and plunger to permit the repair of bone voids and other imperfections during a minimally invasive surgical procedure. TKDG’s innovative surgical device design delivered significantly more clinical-based features to allow for clearer visualization under fluoroscopy. TKDG also identified manufacturing design requirements that significantly improved manufacturing efficiency and reduced costs.

Medical Device Design Prototyping

Micromedics: EarPopper™ Middle Ear Pressure Relief Device, a clinically proven prescribed device for relieving Eustachian Tube Dysfunction without invasive surgery or antibiotics

Medical Device Design Challenge: Develop engineering prototype designs for validation in clinical trials. The TKDG design was guided by four design objectives: 1. Clinical efficacy. 2. Ergonomic design. 3. Simplicity. 4. Elegant engineering. TKDG developed the first miniaturized prototype and initial production samples for clinical trials. After successful clinical trials, TKDG provided the detailed design for the client’s successful full production phase.

Medical Device Design Consulting

BD: Iontophoretic Lidocaine Delivery System, a proprietary system that uses a transdermal patch pre-filled with lidocaine to deliver small controlled quantities of the drug using iontophoresis. The first generation was designed specifically for pediatric applications

Medical Device Design Challenge: Identify appropriate films and adhesives that were compliant with the skin as well as design the electro-mechanical aspects of the controller. Develop a fully compliant patch suitable for the intended user, including design of the disposable patch, and the micro-controller packaging and system components. TKDG’s innovative medical device industrial design was instrumental in helping the client overcome significant technical obstacles identified in clinical trials.

Disposable Surgical Device Design

Ethicon: Disposable Laparoscopic Instruments, a disposable surgical instrument system for general use in laparoscopic surgery

Surgical Device Design Challenge: Design a minimally invasive surgical instrument that alleviated shoulder, wrist, and elbow pain reported by surgeons performing laparoscopic surgical procedures. Based on direct observation in the operating room and other design research processes, TKDG developed an innovative ergonomic design that replaced the small ring handles that were ideal for open surgery, but ill-suited for the laparoscopic procedures. The design research conducted by TKDG was instrumental in helping the client resolve a significant ergonomic design problem that previously had not been recognized by the medical device industry.

Orthopedic Device Design Consulting

Stryker: Alta® Orthopedic Femoral Plating Instruments and Sterilization Tray

Orthopedic Device Design Challenge: Design instruments and a sterilization tray for orthopedic trauma surgery to create an organized workstation that simplified the selection and use of medical instruments. TKDG’s orthopedic tray system provided the client with a complete design program that included working drawings, engineering prototype designs, and production quotes.

Dermatological Product Delivery Design

MELA Sciences: MelaFind® is designed to provide software driven image analysis of clinically atypical pigmented skin lesions to dermatologist during melanoma examinations.

Medical Device Challenge: Design the MelaFind® diagnostic cart, including hand-held probe, patient-information processing and storage system. Design packaging and mechanical systems to create a stable and aesthetically appealing cart. Design helped MELA Sciences overcome significant technical challenges and make the breakthrough technology suitable for all types of dermatology practices.

Innovative respiratory medical products

Mergenet Medical: HiFLO2® non-invasive ventilatory support systems delivering warm humidified respiratory gases (up to 100% oxygen) without a face mask.

Medical Device Challenge: Many HFT products in the market today require expensive disposable accessories that could cost approximately $100 per use & require complex installations to prepare each time they are used.

TKDG designed the HiFLO2  compact and self-contained, and the disposable accessories can be easily assembled using simple push or pull connections. The simple design also enables caregivers to easily control & monitor vital statistics such as upper airway pressure, temperature, humidity, respiratory & flow rates.

Ergonomic driven medical products

C. R. Bard: Precisor® biopsy forceps 

Surgical Instruments Challenge: Obtaining tissue specimens from the pulmonary or gastrointestinal tract is a delicate procedure requiring teamwork between the assisting nurse and physicians. TKDG's observations and insight resulted the one of the very first injection molded plastic product. The new Precisor® three ring handle design handles provide greater control and tactile fee. Designed to cut tissue not tear. Larger jaw sample capacity with the greatest cutting force as jaws close helps maintain channel integrity.