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Li fe Scie nce s

Delivering accuracy and traceability in

the medical device sector

By Dr. Mahesh Kailasam, SVP Business Development Hexagon MI

The medical device industry is a uniquely challenging space for manufacturers, with demanding regulatory requirements reinforcing the need for functionally flawless medical devices produced in absolutely hygienic conditions. Add to this the variety of sizes needed for every type of technology, increasingly customized patient solutions, and the variety of challenging materials medical industry manufacturers now work with; not to mention the responsibility they have to patients around the world and the industry’s exacting quality standards, it is a challenging industry indeed. Today, critical business and product testing issues facing the medical device industry include:

• Increasing product complexity demands with a need to design innovative devices that are small and fail-safe so they don’t need replacement or recall,

• Prototype and test processes are time consuming and expensive. Being late to market can lead to

major loss in market share and profits,

• Building confidence in ever-increasing Clinical Trials,

• Increasing risk inherent in new medical product development projects while testing biocompatibility, performance,

and behavior of new materials is critical but complicated,

• Increasing pressure to respond to rapidly changing surgeon needs and requirements for new implant designs, and

• Compliance to Quality System Regulations.

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Simulation in life sciences - model, make, measure, & monitor

Hexagon’s Manufacturing Intelligence Division supplies predictive design & engineering software, production software and metrology measurement equipment that provide manufacturing data that support the high regulatory demands of the medical industry. We view our technologies helping device manufacturers and their supply chain achieve the 4M’s – Model their devices before they are built, Make them better, Measure the manufactured product to see if it is within tolerances and Monitor it during its deployment and lifecycle to see if it is performing to the right standard (see Figure 1). Our philosophy is always to provide high quality and high productivity solutions to the medical device industry that are backed up by AI, Machine Learning and Manufacturing Analytics to help customers get the most of their manufacturing facilities. We have metrology technologies and reporting solutions designed specifically to meet the high standards of medical technology companies. Our ultra-high accuracy coordinate measuring machines (CMMs) are used to inspect high-precision metal parts such as surgical supplies, while non-contact laser scanning and optical measurement techniques ensure the fast and accurate measurement of small or fragile parts, including highly-polished or malleable surfaces that are

not suitable for tactile measurement. Our metrology software packages feature customisable reporting that enables manufacturers to meet regulatory demands, while our CAD/CAM software helps design the complex tooling required to shape the freeform components that mimic the human body. With computer-aided engineering software from MSC Software after its acquisition in 2017, Hexagon’s predictive design & engineering solutions are permitting biomedical engineers to gain a competitive advantage by reducing risk, lowering costs, and accelerating innovation. Hexagon Manufacturing Intelligence’s quality products and solutions are helping support medical technology businesses and ultimately end patients enjoy a better quality of life around the world.

Metrology & production software – delivering custom orthopedic patient specific solutions

Hexagon’s customer, DESS, used our CMMs to improve their dental implants

(see Figure 2). They may have a simple appearance, but they require complex manufacturing technology that has propelled the ortho-prosthetic industry to require very high standards. Our Hexagon CMMs can scan dental impressions of teeth and using our reverse engineering capabilities we can supply files to WorkNC Dental software which recognizes the implant connect and position in the prothesis. WorkNC then automatically applies optimized toolpaths for efficient milling of the prosthetic teeth. WorkNC Dental’s high level of automation and specialization optimizes production time with high quality results. And Hexagon’s solution is key in the process of obtaining design information and quality control of the complex shapes.

In terms of Computer-Aided Manufacturing (CAM), our ALPHACAM software has been used by Joint Medica in America for Class 3 orthopedic implants such as knee replacement and hip resurfacing (see Figure 3). These devices necessitate

Figure 1: Hexagon’s ecosystem for medical devices design & manufacture

Figure 2: Dental implant: (a) Dental impression (b) Hexagon WorkNC Dental Software (c) CNC machines in action

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the manufacture of custom-made prosthetic devices for specific patients all created directly from CT scans. The use of ultra-high molecular weight polyethylene in this process helps incorporate new materials and explore innovative new designs driving advancements in the orthopedic hip and knee replacement market. The workflow involves CT scan images of the patient’s hip feeding CAD models that are then supplied to ALPHACAM’s 3+2 system to develop 3-axis and turning toolpaths manufacturing the custom-made devices into simpler, axisymmetric products. ALPHACAM kept material wastage to a minimum and implants are of the highest precision and are right first time every time. It delivers industry expected tolerances and a bearing surface finish of 0.8mm. Roughness Average analysis for one-offs confirm quality is achieved within the specified critical dimensions.

Cutting edge of CAE simulation software solutions for medical devices

MSC has been a trusted engineering simulation and analysis partner to the medical device industry for over 25 years (see Figure 4). Our consulting services and solutions are used by medical device companies during the design process to predict mechanical performance, durability, stress, materials, acoustics, fluid dynamics and fatigue of medical products using computational modeling and analysis methods. By optimizing designs upfront, biomedical engineers can reduce time to market and increase product reliability while meeting budgetary and regulatory requirements. Computer aided engineering analysis results in support of the approval process for medical

devices. Our computer modeling and analysis solutions are helping device manufacturers enter clinical trials and experimental testing stages with more confidence. Typical benefits of utilizing CAE for medical device design include:

• Shorter development cycles• Reduced risk• Faster FDA and CE approval• Enhanced patent protection• Improved quality management• Increased performance and

mechanical reliability• Increased product life and

durability• Improved patient effectiveness

Hexagon | MSC Software has a plethora of modern medical device multi-physics simulation solutions today ranging from Digimat for development of new exotic polymer and plastic materials to Cradle CFD for multiphysics-focused simulation of blood flows in fluid-structure interactions. The Adams multibody dynamics simulation tool is being used in exoskeleton designs for accident recovery scenarios as well as medical device mechanism dynamics, and MaterialCenter is in the center of our customer’s medical device data management simulation workflows.

MSC’s Marc non-linear FEA structural solver is still acknowledged to be one of the best for cutting edge medical device design, and Actran is the gold standard in acoustic structures simulation. Our partnership with CADLM for AI and ML as well as Reduced Order Modelling has opened up avenues for our customers to simulate 100s of design explorations orders of magnitude faster than ever before. Our Cradle CFD software has been tried and tested in cleanroom and hospital built environment scenarios and gained international recognition during the COVID-19 pandemic for its work on droplets and mask wearing on public transport. Finally, today, eloquent and innovative new 3d printed medical devices can be designed in our pioneering MSC Apex Generative Design software along with Simufact Additive for metals and Digimat Additive for polymers.

Conclusions

We are truly entering a brave new world of medical device design and manufacturing with increasing patient centricity and ever tougher regulatory demands. With the advent of Industry 4.0, autonomous manufacturing and digital transformation to transform the sector, Hexagon is very well placed to meet the needs of this important medical and Life Sciences sector. Do check out Engineering Reality Magazine in future for more insights into how our smart manufacturing solutions will transform this industry sector in the 21st century.

Figure 3: Hip Replacement Process from CT Scan to ALPHACAM and Final Customised Product

Figure 4: Selection of medical device CAE simulations area for MSC Software tools