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PDTS is hosted by the Central University of Technology, Free State

MEDICAL DEVICE
PRODUCT DEVELOPMENT

WHO SHOULD ATTEND?

Medical & Allied health Professionals, Mechanical Engineers, Students.

TOPICS TO BE DISCUSSED:

  • Medical device product development process
  • Industrialization
  • Patient-Specific medical devices by Additive Manufacturing
  • Commercialisation and opportunities of medical devices in South Africa
  • Case studies on Medical device development and products
  • Introduction to Medical device registrations and ISO 13485
  • Introduction to intellectual property and IPR act

For more information and bookings contact Moqhaisa Mzwake

Email: mmoqhaisa@cut.ac.za

INTRODUCTION TO SKETCHING AND DRAWING

Communicate ideas and concepts using lines and contours, covering the basics of sketching for concept development.

OBJECTIVE

Learn to communicate ideas and concepts using lines and contours with a pen and paper and no other tools, but freehand.

DURATION OF THE TRAINING

The full course runs over two days from 09h00 to 15h00. Participants complete practical exercises during the training sessions.

TRAINING CONTENT

The course covers the basics of sketching and drawing for concept development and includes topics like, drawing techniques, project planning, shading and linework, isometric drawing, perspective, shadows, contour lines, enclosure design, using colour and application of skills.

The application of skills are adapted to the industry the training is presented to e.g. radiography or engineering.

On completion of the training and its practical components, participants will receive a certificate of completion.

ADDITIONAL INFORMATION

The course is compiled of lessons and exercises. Notes and exercise sheets are provided. Participants must bring along their own drawing equipment. No equipment will be shared.

Interested individuals can communicate with us via email for additional information & bookings: mkotze@cut.ac.za

RODENT RADIATION APPARATUS

The Department of Medical Physics at the University of the Free State (UFS) makes use of radiation apparatus when doing research on rodents. This is done with a medical linear accelerator (LINAC) machine. The Product Development Technology Station (PDTS) assisted the department to manufacture these jigs through Additive Manufacturing (AM). The original device was manufactured many years ago from acrylic with an in-house process.

The acrylic sample was reverse engineered and the design was adapted for the AM process. The PDTS then 3D printed the device from SLS nylon and other materials.

The design of the existing apparatus was improved and AM technology makes it possible to easily customise according to the client’s specific needs. The AM process also significantly reduces manufacturing time.

The rodent radiation device assists with more effective and efficient research. The availability of more jigs also reduces the testing period and improves the standard of radiology and cancer treatment.

RUST INOCULATOR

The Department of Plant Sciences at the University of the Free State (UFS) uses an instrument, called the inoculator, in research of rust on cereal crops. It requested the Product Development Technology Station (PDTS) to help manufacture this instrument for research on plant fungi. The inoculator, which was originally designed in 1971 and never updated, is used to apply collected rust spores onto uninfected plants to accelerate the spreading of rust.

The original design was very complicated and required special skills and numerous manufacturing processes. The PDTS made use of Additive Manufacturing (AM) that requires no additional processes. Through this a product was designed that costs a fraction of the price of the original model and is also much less time consuming to assemble.

The station did research on the theory behind the inoculator’s systems and learned it is based on pilot tubes, much the same as a spray paint applicator. The inoculator was redesigned and based on the design of an air brush and prototypes 3D printed in nylon.

The product performed exceptionally well – to such an extent that the UFS patented the design in the United States of America and South Africa and commercialised the inoculator.

ADDITIVE
MANUFACTURED RIFLE SIGHTS

The Product Development Technology Station (PDTS) assisted a client to design and manufacture cost effective rifle sights for sharpshooting as new sights were very expensive. The station used various iron sights as reference and decided on the Additive Manufacturing (AM) process to manufacture certain components of the product.

A new unique design was made for this purpose and therefore differed from existing iron designs of rifle sights. AM gives more freedom of design, which no other manufacturing technology provides.

The PDTS chose nylon for its durability, light weight and lower cost. The design was based on a brass railslide system and tried to keep most of the moving parts low profile in order to keep a low centre of mass.

The rifle sight was 3D printed in nylon and features 5 mm brass round bars for the rails and two M4 threaded rods for adjusting the slides. The adjusting dials rotate on spring-loaded bearings that divide the rotation in increments. Each increment gives an adjustment of only 0.07 mm. The rest of the hardware is stainless steel for durability.

This AM produced rifle sight is one of a kind and the client was satisfied to such an extent that he can commercialise the product.

DYNAMIC HAND SPLINT

Stroke patients often experience unusual stiffness of the hand, which is also referred to as spasticity. Therapists make use of dynamic hand splints as part of the rehabilitation process of these patients.

The Product Development Technology Station developed a patient specific Dynamic Hand Splint produced by Additive Manufacturing (AM).

This allows for local production of complex hand splints that are tailored to the patient’s specific needs and this is done in a cost and time effective manner. Traditional dynamic hand splints are expensive and have extensive manufacturing lead times due to the patient specific and complex nature of the devices.

The ability of AM to produce on demand and custom medical devices has made it an attractive technology in the medical orthoses and prosthetics environment.

AM design principles such as mass customisation, compliant mechanisms and part consolidation were utilized to produce a novel Dynamic Hand Splint. This improved functionality, replicating hand biomechanics which allows motion in a specific direction while also restricting and supporting undesired motion.

The use of AM therefore made it possible to produce an aesthetically pleasing low cost durable Dynamic Hand Splint which can be easily customised according to patient’s requirements.

STAGED PROTOTYPE APPROACH

In the product development process it is essential to confirm design concepts and ideas. A physical prototype can answer a lot of questions with regards to the product’s functionality, look and feel. Prototypes are also an effective means of securing funding or conducting early market tests.

Each product however requires a unique prototyping approach. The Product Development Technology Station (PDTS) therefore tailors each product’s prototype strategy to ensure a low risk and cost effective product development process.

The station for example assisted in developing a commode attachment for a walking frame. A major problem facing retirement homes and care centres are elderly patients falling at night on their way to the toilet. The proposed device was a cost effective clip-on commode for a standard walking frame.

To confirm the initial viability of the device, the PDTS produced a simple laser cut wood prototype. It was tested by occupational therapists to obtain the necessary feedback. Testing confirmed that the product could add value and make a practical difference. A cost effective limit run rotor mould prototype was produced to be tested by patients and to confirm the strength of the device.

Thereafter the device was redesigned for mass manufacturing and a 3D printed prototype produced.

VACUUM CASTING

Silicone mould tooling and vacuum casting enables the production of components in a wide range of available polyurethane resin, specifically chosen to mimic properties of the intended thermoplastic mass-production materials.

The process is an economical way of producing near production parts for exhibitions, market research and batch prototyping or in some instances low volume production. It furthermore enables the reproduction of sculptures and statues in exclusive limited batches.

Polyurethane vacuum cast components provide valuable feedback in terms of design, intended production material and actual look and feel. The process is ideal when requiring limited quantities of a product or final prototypes in need of specific material properties, colours, translucency and other general aesthetics. 

The Product Development Technology Station makes use of the process to give innovators and product developers access to limited functional batches of their newly developed products, which in-turn allows for testing, market exposure and final re-design prior to full scale production and official market entry.

RTV silicone moulds are produced by means of a master pattern responsible for creating the required component geometry and finish. If a master pattern does not yet exist, a suitable high resolution 3D printed prototype is hand-finished to the required specifications. Limited run production requirements are made possible via multi-cavity or multiple sets of silicone mould tooling. Depending on the specific component geometry and chosen polyurethane, moulds can normally produce 20 – 40 castings per impression.

CONVENTIONAL MANUFACTURING

Conventional manufacturing is a way of manufacturing parts of or a product by using manual machining processes. Standard machines, that operate manually, are used as part of the production process and no computer numeric control programming is utilised.

Milling and turning is one of the methods used by the Product Development Technology Station in conventional manufacturing. This is ideal for manufacturing smaller quantities of a product and also when manufacturing large and long scale components. It is more cost effective when manufacturing products for these purposes.

Another example where conventional manufacturing is used, is with frame manufacturing and the main structures of products. Raw material such as sheet metal, mild steel sections or stainless steel sections are used and cut to desired sizes. Bending, rolling, drilling or punching of the material forms part of this process.

Assembly of the different parts of the product follows and this can be done by welding, such as Arc-, MIG-, TIG welding and brazing or fasteners.

3D PRINTING

Additive manufacturing, commonly known as 3D printing, produces objects by selectively adding material layer by layer. This is a method of rapidly producing prototypes or complex final parts.

The Product Development Technology Station (PDTS) utilizes desktop printers, Fused Deposition Modelling, to quickly test design concepts and create physical models to determine user experience and functionality of products. This allows multiple design changes to occur rapidly and cost effectively. Once the design is finalized, high quality samples of the product can be produced on high end 3D printing systems or used as masters for silicone mould tooling and vacuum casting.

This allows clients to make informed decisions and interact with the product in all phases of development, reducing the risk and cost of product development.

The PDTS works closely with the Centre for Rapid Prototyping and Manufacturing (CRPM) at the Central University of Technology, Free State, in Bloemfontein, to create tailored additive manufacturing solutions for clients. This interaction with the CRPM allows access to a range of EOS selective laser systems that produce parts in nylon, Alimide, PrimeCast, titanium and tool steel (MS1), as well as an Objet Connex system that can produce prototypes of varying hardness.