Shaping the future of implants: How hyperMILL® empowers Sigma Surgical for success.
Medical device manufacturing in India is experiencing unprecedented growth, with Gujarat state emerging as a hub and Sigma Surgical at the epicentre. The company has transformed its production capabilities through hyperMILL® CAM software from OPEN MIND Technologies AG.
Sigma Surgical Pvt Ltd's journey began in 1998 when a friend of founder Jayanthi Gothi needed help producing medical devices with a 50% failure rate. At the time, Gothi was manufacturing diamond processing machines. Gothi devised a solution and transitioned his five-employee company into the medical device industry. The company now employs 368 staff and is the country’s largest trauma implant manufacturer, supplying customers worldwide with more than 600 product lines, adding around 10 new lines annually.
"One of the most significant improvement was a 90% reduction in prototype development lead times, dropping from one month to just three days.”
Mehul Gothi, CEO of Sigma Surgical Pvt Ltd, Gujarat
The shop floor is dominated by high-end machine tools from DMG MORI, Hermle, Makino, Chiron and Mazak. However, Sigma Surgical has had to overcome critical manufacturing challenges while positioning for continued growth - it is here that hyperMILL® now plays a pivotal role.
Producing bone plates under its own brand, ‘Sorath Ortho’, Sigma is also a leading international contract manufacturer of medical devices. Sigma Surgical's portfolio includes 615 different implants SKUs (Stock Keeping Units) with variations, amounting to 32,000 different parts. Additionally, there are 1,200 instrument SKUs and 440 variants of general instruments. The company's extensive range demonstrates its market significance. It produces 1.1 million bone plates along with 38,000 instruments and 11,000 general instruments annually in a facility equipped with 63 CNC machines, including 14 five-axis machines, operating 24 hours a day. Explaining these impressive figures and diversity, CEO Mehul Gothi states: “For one customer, we produce knee replacement sets with over 290 different component types, and the next customer will have an additional 120 variants, totalling 16,000 SKUs just for knee replacements. A popular product is Distal Femoral Plates, which we produce in volumes up to 28,000 a month, while a clavicle hook plate may only require 200 parts per month.”
The Sigma Surgical state-of-the-art facility in Gujarat state, Western India
Source: Sigma Surgical
The company is growing rapidly, as Mehul Gothi explains: “We added medical instruments to our portfolio in 2019, and our turnover was 14 Crore Indian Rupees (€1.4 million). We continue expanding our portfolio, including sports medicine, replacement parts, and spinal products, this year. In 2024, we closed at 78 Crore (€7.75 million), and we expect to reach 120 Crore (€12 million) in 2025. We plan product rollouts two years in advance, which means we are already planning our manufacturing investment. To support this, hyperMILL® plays a significant role in our strategy.”
Manufacturing Challenges
Before implementing hyperMILL®, Sigma Surgical faced several challenges that threatened its growth plans. Processes had limitations that became problematic as the product range expanded, with a requirement to obtain CE certification for access to the European market.
The traditional process required significant tooling development, including mould fabrication, sheet metal cutting, press tool bending, and verification cycles. This extended lead times to one month in an industry where design iterations are crucial to meet market demands. The challenges of workforce and process scaling were also significant. Sigma Surgical expanded from 72 employees in 2019 to 368 today, with a large proportion involved in manual post-machining finishing activities such as grinding and polishing. Projections indicate they would need over 4,000 employees by 2030 to sustain growth using traditional methods, making the situation unfeasible. As CEO Mehul Gothi states: "Training skilled workers for manual processes takes six months or more, and we need to invest heavily in each individual. We had to remove manual finishing steps to enable sustainable scaling — our reliance on manual labour was impractical for our growth plans."
Mehul Gothi is the visionary leader and CEO of Sigma Surgical, delivering a strategy for long-term worldwide growth
The limitations of its current software were apparent when moving to more advanced simultaneous 5-axis machining, as the existing CAM suite resulted in long cycle times and required specific machine choices and programming, reducing shop floor flexibility. Sigma Surgical also recognised the need for high-quality surface finishes and accuracy that its previous CAM software couldn’t sufficiently provide.
Sigma Surgical trialed hyperMILL® on a DMG MORI EVO 40 machining center, focusing on bone plates that had previously been difficult to program. The results surpassed expectations. A notable improvement in programming times, cycle times, surface finishes, and component quality convinced Sigma Surgical of hyperMILL®'s capabilities, leading to their first purchase in July 2024, with a second licence added in March 2025.
Transformative Features and Technologies
Adopting advanced finishing strategies such as 5-axis Tangential Machining from the hyperMILL® MAXX Machining Performance Package greatly enhanced surface quality on curved shapes. Transitioning from multiple processes and setups with plates to 5-axis simultaneous machining with hyperMILL® from solid billets improved throughput, surface finish, and decreased secondary hand polishing and rework.
Barrel Tool Tangent Machining strategies proved particularly effective for Sigma's bone-shaped implant profiles. Programming Manager at Sigma, Mr. Chaitanya Deshpande, notes: "Many of our implants have profiles matching bone shapes, and barrel tools are ideally suited for these applications. Our step-over distances increased from 0.1mm using ball end mills to 1mm with conical barrel tools, dramatically reducing surface scallops, cycle times and improving tool life. This hyperMILL® MAXX Machining HPC strategy delivered a 15% reduction in tool consumption by utilizing the entire flute length rather than just the tip, enabling 24-hour unmanned operation by enabling our 8 to 10 tool changes per implant to last the full 24 hours.”
Additionally, the intuitive interface reduced programming time by over 30 to 40% compared to the previous CAM suite. Additionally, hyperMILL®'s high-speed linking feature within the job linking module connects multiple operations using the same cutting tool, eliminating unnecessary tool retractions to home positions or clearance planes. This shortens cycle times and decreases machine wear with smooth tool movements that further improve surface finishes and machining stability.
hyperMILL®'s robust post-processor features and high-quality G-code generation have enhanced machine performance throughout the entire machine portfolio. Mr Gothi adds: “hyperMILL® has allowed us to implement uniform strategies across our DMG MORI, Makino, Hermle, and other machines, improving consistency and setup efficiency across production lines."
Quantified Production Benefits: reduced programming time by approximately 30%
One of the most significant improvements with hyperMILL® was in programming efficiency. Mr. Chaitanya Deshpande reports: "Programming time was reduced by approximately 30% with toolpath generation for complex bone plates dropping from 6-7 hours to around 4 hours, allowing faster turnaround on new components. This is credit to the intuitive programming interface and efficient 5-axis strategies, which are now freeing up our programming resources to focus on more complex projects and accelerate time-to-production for new designs.”
Cycle time reductions from optimized toolpaths and tool engagement strategies were equally impressive, as Mr. Chaitanya Deshpande states: "Cycle times improved by 20% to 30% with production cycles reduced from 60 minutes to around 40 minutes per bone plate. This enabled us to increase throughput without additional machine hours.”
Mr. Chaitanya Deshpande, Programming Manager at Sigma Surgical programming medical implants with hyperMILL®
This cut lead times from five working days to 3.5 days for batch production of 200 components, while daily machine productivity rose from 38 to 40 implants to 48 to 50 per 24-hour shift. The streamlined workflows enabled a 20% reduction in workforce for the same production output. Training efficiency also significantly improved, with new CAM programmers needing just 40 to 45 hours compared to over two weeks for previous CAM systems.
hyperMILL® has also played a vital role in enabling downstream modifications, as Mr Gothi observes: “Advanced 5-axis finishing strategies have substantially improved surface quality, lowering the need for manual polishing and rework. Functions such as 5-axis Tangent machining have reduced manual finishing from full-time staff effort to minimal material removal after adopting the new robotic polishing technology to meet strict 5-20 micron tolerance requirements.”
Perhaps the most significant improvement was a 90% reduction in prototype development lead times, dropping from one month to just three days. This allows Sigma Surgical to respond quickly to design changes and customer needs, which is vital for success and maintaining a competitive edge in the fast-moving medical device market.
Expanding Market Opportunities
Following the successful implementation of the bone plate, Sigma Surgical expanded hyperMILL® usage to the production of surgical instruments. The company now manufactures comprehensive surgical kits containing specialised instruments for specific bone plate applications. Each kit requires unique tools adapted to particular bone types and surgical procedures.
A particularly notable application was the implementation of hyperMILL® for targeting devices, which feature tight tolerances, multiple contours, and complex 3D surfaces. Mr. Chaitanya Deshpande explains: "Using hyperMILL®, we applied advanced 3+2 and 5-axis strategies to handle multi-face machining in a single setup.”
The targeting devices are machined from aluminum blocks (250 by 150 by 120mm) with 85% material removal. Previously, 180-degree component rotation created manual finishing marks requiring skilled handwork. As Mehul Gothi explains: "The tool comes to center, the entire component rotates 180 degrees and moves forward, making small marks we had to manage manually. With hyperMILL®'s Smooth Overlap strategy, we eliminated that situation - we get finished components straight from the machine."
Bone plate manufactured by Sigma Surgical for its Sorath Ortho brand
Source: Sigma Surgical
One of the Sigma Surgical bone plates manufactured for its Sorath Ortho brand. The plate demonstrates not only the number of holes required, but also the plane orientation, positioning and precision required
Source: Sigma Surgical
Service Excellence and Support Integration
Mr Gothi emphasises the critical role OPEN MIND’s support has played: "The service and support have been a key part of the successful integration of hyperMILL® into our operations."
“During the initial training period, OPEN MIND provided practical, application-specific training tailored to our implant and instrument manufacturing needs. Their team offered hands-on, tailored training that helped our programmers quickly build confidence with the software and apply it effectively to real production parts. The ongoing support - both technical and strategic - has been just as valuable. Whether it's post-processor customisation, toolpath optimisation, or clarifying specific machining strategies, the OPEN MIND team has been highly responsive and proactive.”
Sigma Surgical has successfully integrated hyperMILL® VIRTUAL Machining into its workflow, leading to notable process enhancements. As Mr. Chaitanya Deshpande reports: "We have already incorporated the Virtual Machine extension into our workflow, which has significantly enhanced our manufacturing process. The ability to utilise hyperMILL®’s NC-Code simulation to simulate exact machine kinematics and verify complex 5-axis programmes has greatly reduced setup errors and collisions. It has also improved machine utilization, minimised downtime, increased confidence in running complex parts such as bone plates and surgical instruments.”
OPEN MIND Technologies India Sales Director Hemang Panchal (left) with Sigma Surgical’s Mr. Chaitanya Deshpande on the shop floor
Future Growth and Strategic Vision
Looking ahead, hyperMILL® plays a central role in Sigma Surgical's expansion plans, Mr Gothi comments: "I strongly believe you can always win when your technology is better than your competitor. Our engineers' confidence after introducing hyperMILL® opens the opportunity to take on complex projects. As we develop more intricate surgical instruments and patient-specific implants, hyperMILL®'s advanced 5-axis strategies will be vital for efficiently machining complex geometries, and it will help us accelerate our R&D process by enabling faster toolpath generation and simulation, allowing quicker turnaround on design changes and new product introductions."
As for hyperMILL®'s automation capabilities, Mr Gothi concludes: "We see significant potential in using the automation technology within hyperMILL®, such as templates and feature-based programming, to reduce programming time. One example is the planned application of automation to introduce variable hole programming, enabling single NC files for bone plates with 3 to 21 holes, depending on selection. This will increase programming efficiency, reduce human error, and support high-volume production with consistent results. Implementing more feature-based programming and template-driven workflows will further reduce programming times, standardize processes, and increase efficiency. Additionally, there is strong potential for integrating tool database management and process libraries more deeply with hyperMILL® to streamline tooling decisions, enhance tool life monitoring, and promote consistent machining strategies across all our machines.”
This industry-leading medical device manufacturer has experienced transformative benefits from hyperMILL® since its relatively recent adoption, and it seems the journey is only beginning.