Medical product development involves several key steps – clinical need validation, proof-of-concept, detailed product design, rapid prototyping, pilot batch manufacturing, lab testing, human clinical trials, regulatory compliances, intellectual property rights and business modelling.
BETIC team carries out product engineering, rapid prototyping and basic testing using facilities established at IIT Bombay, COE Pune, VNIT Nagpur and MGMIHS Navi Mumbai. The team works closely with partner hospitals and industry vendors for outsourcing the remaining activities.
The details steps and results are meticulously documented in line with ISO 13485 – Medical Device Quality Management System. The dossier is useful for regulatory approvals.
Product engineering design, simulation and optimization of various components to achieve the desired functionality and quality at the least possible cost. BETIC labs have a range for facilities for product engineering.
3D and X-Ray Scanning: Existing devices or models can be converted into digital replicas using a range of 3D scanners available at BETIC labs ((Steinbichler Comet, PICZA LPX, Artec Spider). Radiographs can also be scanned and converted into digital files (using Medi Plus).
Medical Modelling: Starting from CT or MRI images, the 3D CAD model of patient’s anatomy (region of interest) can be reconstructed using medical modelling software (MIMICS). These models are useful for visualizing and treatment planning. Physical replicas can be created by 3D printing.
Product Design: Medical devices can be designed using CAD software (SolidWorks). The overall structure of product is decided first, followed by detailed design of all components, bill of materials and manufacturing tolerances. Visualization tools enable improving the aesthetic and ergonomics.
Design Optimization: The design is iteratively improved for achieving the desired functionality (such as movements and forces) by simulating various movements, forces and stresses (ABAQUS, ANSYS). Product manufacturability is also assessed and optimized (AutoCAST, UG NX).
In addition to mechanical components, many medical devices also include electronics and software. They are designed to be compatible with each other, as well as follow prevailing international standards of performance and quality.
Rapid prototyping of plastic, metal, ceramic and electronic parts is essential to obtain early feedback from clinicians, users and other stakeholders.
BETIC facilities available at IIT Bombay and other centres include the following.
Plastics Prototyping: Laser cutter (Epilog), tabletop plastic 3D printers (Connex, Dimension BST and uPrint SE, multi-plastic 3D printer (Fortus), electro-spinning (Epsin Nano).
Metal Prototyping: Metal 3D printer (EOS DMLS) for biocompatible titanium-aluminium-vanadium alloy, ultrasonic cleaner, power tools (cutting, grinding, polishing, etc.).
Printed Circuit Boards: Schematic layout and simulation of PCB (Altium Designer), soldering station with fume extraction, PCB drilling machine.
Bio & Tissue Engineering: Hydroxy-apatite 3D printer (Bio-Plotter), Cell culture, bio-safety cabinets, bacteriological incubator, CO2 incubator, ultra-low freezer, refrigerated centrifuge, inverted microscope, hot air oven.
Medical-grade manufacturing facilities are needed to produce small batches of medical devices for lab testing and human clinical trials.
BETIC team relies on facilities in other labs and industry vendors for pilot batch manufacturing.
Metal Processes: Turning, drilling, milling, wire-cut EDM, grinding, polishing, micro-machining, sheet metal forming, deep drawing, bending, cutting, stamping, arc and gas welding, laser welding, anodizing, etc.
Other Processes: Plastic injection molding, vaccum casting, multi-layer circuit board printing, laser marking, label printing, sterilization, painting and packaging.
Quality control and assurance is critical for medical devices. This requires facilities for inspecting part geometry, internal integrity and properties – mechanical and electrical.
Product inspection requires equipment for laser scanning, surface topology, roughness measurement and radiography. Mechanical testing includes strength (static or dynamic load), drop & impact, fatigue & wear, vibration, water ingress and product-specific testing based on relevant standards. Medical devices with electronics need to be tested for electro-magnetic compatibility and electro-magnetic interference. Materials used for medical devices coming in human contact have to be characterized using spectroscopy, scanning electron microscopy and computed tomography as
well as various tests for sterility and biocompatibility evaluation.
Facilities available in BETIC labs are listed here; other tests are carried out in collaboration with other labs, institutes and industry.
Mechanical Testing: Universal testing machine (Instron), digital image correlation system (Correlated Solutions VIC), dynamic mechanical analyser to measure material properties over a range of loads and temperatures (E-Artemis).
Electronics Testing: Digital multimeter, tabletop function generator, mixed signal oscilloscope and triple channel power supply (all from Tektronix).
Gait Analysis: 12 high-end 240 fps optical cameras (Vicon, UK), three force platforms (AMTI, USA), foot pressure analysis system (Pedar), and 8-channel Electromyography (EMG).