medical device design - Faz Business

Top 51 Medical Device Design Companies for New Prototype Engineering Services in the US

Posted on January 8, 2026 by faz_business

With few exceptions, new product development companies almost never specialize in just one product category. For example, if a prototype design firm develops medical devices, chances are it also provides similar services in other sectors, like consumer goods such as home appliances and electronics. Some even offer to develop more sophisticated industrial equipment, like robotics and laboratory instruments, as well. Medical device development is a complex undertaking, often a multidisciplinary effort involving user research, design engineering, safety and risk management, pre-clinical and clinical tests, and interactions with regulatory bodies (FDA in the United States, MDR in Europe, or their equivalents in other regions).

Even well-known medical device brands turn to new product development companies not only to transform ideas and concepts into real products but also to manage regulatory compliance. Apart from design firms, specialized freelancing platforms like Cad Crowd can be an excellent alternative, as they allow you to collaborate directly with pre-qualified engineers and designers at an affordable rate. To help find a competent partner, here is a list of 51 companies providing medical device development services.

In the United States

Working with an onshore design firm simplifies a lot of things in an otherwise intricate project. Maintaining good communication and collaboration isn’t always easy, but you can avoid potential difficulties throughout the partnership in the project by working with a domestic product development firm.

1. Cad Crowd

Perhaps a peculiar name in the list, yet the most likely option for everyday inventors, startups, and small businesses alike. Cad Crowd comes up at the top for its massive range of services, straightforward user interface, and affordability. This isn’t your run-of-the-mill medical device development company; instead, it’s a specialized freelancing platform to help you connect with multidisciplinary engineering and 3D design professionals of any product category.

The “professionals” in question may include mechanical engineers, electrical engineers, industrial designers, firmware developers, and project managers with proven track records in the field of product development. The design and manufacturing services cover such medical applications as surgical devices, dental equipment, orthopedic braces, veterinary equipment, and customized prosthetics. In short, the services are available for the development of medical instruments under FDA classifications, including Class I (low-risk), Class II (moderate-risk), or Class III (high-risk) devices.

One of Cad Crowd’s biggest strengths lies in its ability to match clients (or rather their projects) with 2D & 3D design professionals who have domain-specific expertise. Within the context of medical device development, you’ll be granted access to a massive database of engineers specializing in biocompatible materials, ergonomics design, microfluidics, regulatory-compliant systems, interoperability, user safety, CAD modeling, DFM (Design for Manufacturing), digital and physical prototyping, and so forth.

Cad Crowd gives the options to launch a design contest or work directly with the professionals you choose under NDA to ensure privacy and IP protection. If you want, the platform can function as a project manager to help you on an ongoing basis, practically facilitating an end-to-end medical device development service. Flexibility is another major reason why Cad Crowd makes for an excellent choice. The medical devices design service encompasses the entirety of the project workflow, from ideation and prototyping to product certification and manufacturing support.

But it doesn’t mean you can’t hire professionals from the platform to handle only certain portions of the development stage. Say you’ve already had a 3D model made, and now you need a qualified engineer to fabricate a physical prototype. Cad Crowd can step in at any point in the development and connect you with a professional to handle the task. It also provides complementary services such as patent finding and filing, product licensing, and invention marketing.

Website: Cadcrowd.com

2. Karten Design

An established medical device design company, Karten Design, maintains a long-term partnership with hospitals and clinicians to help inventors get the necessary funding and acknowledgement for their product development projects. The company also serves on boards at accelerators in various healthcare institutes and C-suite committees in the United States. Having been around for more than 30 years, Karten Design is among the most knowledgeable product design companies to recognise some of the biggest obstacles in medical device development overcome the challenges.

Thanks to its deep access into the healthcare landscape, the company has a unique insight into the market, ensuring quicker adoption across the ecosystem. Some of its best works include the Cardiac Science Automated External Defibrillator (AED), the Starkey Livio AI hearing aid, the MedVector Telemedicine Device, and the Bruin Biometrics OrthoSonos monitor. Karten Design is based in Los Angeles, California.

Website: Kartendesign.com

3. Whipsaw

Throughout 25 years of history, Whipsaw has completed more than 1,000 projects for clients of all sizes and accumulated over 700 patents to its name. Whipsaw also boasts a strong history of partnerships with early-stage companies as well as international corporations in popular projects like the Dell Precision computers, the Dropcam home security cameras, the Google Chromecast and OnHub router, and the TP-Link networking devices, among others. In the medical device category, some of Whipsaw’s project highlights include the Aescape Fully Automated Massage Experience, the Omnicell Syringe Dispenser, and the Empatica EmbracePlus Health Smartwatch. The company is situated in San Francisco, California. It’s spearheaded by Dan Harden, who, in 2014, was listed in Fast Company’s 100 Most Creative People in Business.

Website: Whipsaw.com

4. StarFish Medical

Every new product development project must deal with the challenges in market adoption, and even more so if the product is a medical device from a relatively unknown brand. StarFish Medical is a new product design and development company with a strong focus on commercial launch. More than just creating a new product based on an idea, the company helps you tackle the potentially complex regulatory landscape and navigate the intricate path to compliance.

It provides a comprehensive range of services for clinical trials and even facilitates tech transfers if needed. Based in Irvine, California, StarFish Medical is powered by a multidisciplinary team of experienced product engineering professionals and in-house capabilities to transform a mere concept of a design into a fully functional product. It has state-of-the-art facilities in the United States and Canada, equipped with everything you need to handle not only rapid prototyping, but also Verification and Validation testing and pilot-scale manufacturing.

Website: Starfishmedical.com

5. Delve

For more than 55 years, Delve has been a prominent name in the product development sectors, specializing in medical devices, commercial and industrial equipment, and consumer products. Along the way, it has earned more than 200 design awards and more than 1,500 patents. Delve maintains four locations in the United States, including Boston (Massachusetts), Madison (Indiana), Philadelphia (Pennsylvania), and San Francisco (California). Some of its best-known works in the medical device category are the BK Ultrasound’s Sonic Window, the Dexco G6 Continuous Glucose Monitoring System, and the Phlex EDGE goggle-worn fitness tracker. In fact, the Sonic Window earned a gold recognition in the Radiological and Electromechanical Devices category from the Medical Design Excellence Award (MDEA) in 2016.

Website: Delve.com

6. Goddard Technologies

As an industrial design and low-volume manufacturing company, Goddard Technologies provides new product development services not only for medical devices but also for consumer products, robotics, and automation as well. It caters to both an end-to-end 3D design service and an on-demand engineering assistance at any phase of the development of new medical devices and launching them to market. Goddard Technologies is an ISO 13485:2016 certified company, meaning it has put in place internationally recognized standards for safety, efficacy, and regulatory compliance in the design and manufacturing of medical devices. Some of its best works include the Guard Medical Negative Pressure Wound Therapy and the Arthrex MIS Hip Distractor System. Goddard Technologies is based in San Diego, California.

Website: Goddardtech.com

7. Battelle

Gordon Battelle founded the institute in 1929. The institute initially focused on contract development and research projects in material science, but quickly expanded the specializations to cover the larger scope of applied science and technology. As it stands today, Battelle is a private nonprofit company that offers its services in the development and commercialization of technologies as well as the management of laboratories.

Around the 1960s, Battelle added medical technology to its service portfolio, offering expertise in medical device designs, life science research, and chemical and biological countermeasures. Since then, the institute has amassed over 100 patents (granted and pending) in related fields of study. Some of its most notable works in the medical field are the COVID rapid test equipment and the N95 respirator decontamination. Battelle is headquartered in Columbus, Ohio, with satellite offices across the United States.

Website: Battelle.org

8. Veranex

Although a relatively new company founded in 2021, Veranex has a respectable history spanning more than 20 years in the industry. It has been around long enough to oversee the development of more than 1,000 products and get involved in over 2,500 preclinical and clinical trials. Veranex claims to be the industry’s first global Innovation Contract Research Organization (iCRO), which operates with a profoundly different approach compared to traditional CRO. In a typical medical device development workflow, there might be multiple companies involved in the process to handle separate stages of development, including design and engineering, preclinical research, clinical research, commercialization, regulatory affairs, pathology, quality management, and manufacturing.

Because each specific task is handled by a separate team, the entire workflow is interrupted by frequent handoffs that decelerate progress. Veranex takes care of all eight distinct phases under one roof for better efficiency. According to Veranex, an integrated team can cut development time by up to six months per phase compared to silo practices and increase the regulatory clearance rate to 96%. Veranex specializes in microfluidics, optics, sensing systems, artificial tissue, and advanced analytics. The company is based in Raleigh, North Carolina.

Website: Veranex.com

9. MED Institute

The medical device engineering experience of MED Institute’s medical device designers covers the studies of orthopedics, cardiology, urology, endoscopy, biologics, and endovascular. Its range of services includes concept development, product planning, and therapeutic device design. The company also offers comprehensive design controls for a range of Class II and Class III medical devices. Like many other product development companies specializing in medical devices, MED Institute is ISO 13485 certified. But the biggest promise revolves around the claim that the company has what it takes to help slim down the budget for early R&D phases to accommodate small businesses and startups, who often have limited funding. MED Institute is based in West Lafayette, Indiana.

Website: Medinstitute.com

10. DeviceLab

Situated in Tustin, California, DeviceLab offers a comprehensive medical device development service that encompasses early research and study, design and engineering services, prototyping, and pre-production. The company is known for its expertise in developing medical devices and instruments for home use, point of care, and hospital environments. DeviceLab maintains a strategic collaboration with Microchip’s 32-bit MPU Design Partner Program, LabVIEW, and Texas Instruments to speed up product development in most projects. The ISO 13485 certified company is also a recipient of the gold medal from MDEA. Some of its best works include the Zoom Dental UV Lamp designed for Philips, the TracPatch developed for Consensus Orthopedics, and the ARGOS optical biometer built for Santec.

Website: Devicelab.com

11. RKS Design

While RKS Design doesn’t explicitly mention that it specializes in medical device development, it’s an industrial design company that builds physical products of various categories across all industries, including healthcare. The company is known for its “Psycho-Aesthetics” approach, which focuses on how a design makes users feel about themselves rather than asking users about how they feel about the product.

Having been around for more than 45 years, RKS Design has developed a number of innovative medical devices, including the ViSi Mobile wearable continuous vital monitoring platform for Sotera Wireless, a wearable stroke detector for StrokeDx, composite resin syringes for Dental Discuss, CleanTech EVO Automated Handwashing Station for Meritech, cardiac ablation platform for Synaptic, and Juvederm Syringe for Allergan. RKS Design makes clear that the clients have complete ownership of the IP of the device, unless the company makes a significant contribution to the final design, in which case there might be shared ownership of the patents. RKS Design is based in Thousand Oaks, California.

Website: Rksdesign.com

12. Paragon Medical

A turnkey medical device development company, Paragon Medical, boasts a massive rapid prototyping center and a separate manufacturing facility reserved for complex products. Apart from making high-precision surgical instruments, the company also caters to the development of drug delivery devices, implants, and cases and trays. The end-to-end service covers medical device design and development, testing and validation, contract design engineering services, contract manufacturing, and even product assembly and packaging. That being said, Paragon Medical is willing to lend its expertise at any stage of your product development project; whether you’re still in the early stages or already approaching the commercialization phase, the company can help bridge the milestones to reach full market launch. Paragon Medical is an ISO 9001:2015 and AS9100D certified company, situated in Pierceton, Indiana.

Website: Paragonmedical.com

13. Frog Design

An industrial design company with a long history, Frog Design made a name for itself in the business when the company developed its earliest works for WEGA, a German consumer electronics manufacturer that was later bought by Sony. It maintained partnerships with Sony and was involved in the development of a few renditions of the Walkman. Some of its more prominent design works include the case of the portable Apple IIc and several Macintosh models, the NeXT Computer, and Sun Microsystems’ SPARCstations.

In the ice category, Frog Design is known for such innovative products as the UV-C Enhanced Respiratory Protection for XCMR, the aScope Duodeno single-use sterile endoscopy device for Ambu, the Aixplorer Mach 30 Ultrasound platform for SuperSonic, a fully automated retinal imaging device for identifeye HEALTH, the Lumen CO2 tracker, and the MeMed Key portable multiplexed protein measurements device. In 2021, Frog Design became part of Capgemini Invent. Frog Design is headquartered in San Francisco, California.

Website: Frog.co

14. IDEO

A global industrial design company, IDEO offers first-class product development services covering a broad range of industries and sectors, including but not limited to consumer goods design services and retail, climate, manufacturing, media and entertainment, mobility, technology, and health. The company has been around for more than 40 years, creating innovative products and providing creative capabilities for clients worldwide. In the health (medical device category), most of the products in IDEO’s portfolio are developed in collaboration with Eli Lilly and Company, a multinational pharmaceutical company operating out of Indianapolis, Indiana. Examples of such products include the HumaPen SAVVIO insulin injection pens, the refillable kid-friendly HGH injector, and a reconstitution device to mix Lilly’s liquid-and-powder HGH. IDEO is based in San Francisco, California.

Website: Ideo.com

15. Ammunition Design Group

Winner of the Cooper Hewitt National Design Award for Product Design (2016), the Ammunition Design Group is best known for its involvement in the development of such popular consumer electronics as Beats by Dr. Dre, the Polaroid Cube, the Square Stand, Adobe Ink and Slide (internet-enabled stylus compatible with iPad), Lyft Glowstache, the UNICEF’s Kid Power Band, and the packaging for NOOK e-book readers, to name a few. Ammunition has also created medical devices before, for example, the Larklife fitness tracker developed for Lark and an invisible hearing device for Fargo. The company is based in San Francisco, California, and Brooklyn, NYC.

Website: Ammunitiongroup.com

16. Smart Design

Another industrial design company in Brooklyn, New York City, Smart Design specializes in five industries, including technology, healthcare, consumer goods, financial services, sports and fitness, and mobility. In the healthcare category, the company works in several sub-sectors such as fitness, medical devices, consumer health and retail, nutrition, patient education, and mental health. Among the highlighted medical devices in the company’s portfolio are the AutoClicks disposable autoinjector pen developed for UCB, an acne-healing face mask for La Lumiere, and the Gx Sweat Patch for Gatorade. Smart Design’s product designers are popular for their tendency to produce prototypes quickly and iterate on them in rapid succession throughout the development process.

Website: Smartdesignworldwide.com

17. Beyond Design

Since 1994, Beyond Design has been providing industrial design consultancy and engineering services for NPD (new Product Development) projects. It specializes in consumer electronics, commercial equipment, and, of course, medical devices. Some of the company’s best medical devices so far include the point and measure thermometers developed for 180 Innovations & CVS Health, the WP-600 Oral Hygiene Orator created for Waterpik, the AirGuard XP advanced aerosol guard for AirGuard Health, and the GUM Proxabrush Go-Betweens interdental brushes for SUNSTAR. Beyond Design is headquartered in Chicago, Illinois.

Website: Beyonddesign.com

18. Studio Red

Situated in Palo Alto, California, Studio Red boasts an advanced prototyping facility capable of producing photorealistic models and high-tolerance parts for just about any physical product engineering project. The company is backed by a team of mechanical engineers with extensive experience in end-to-end product development of various complexity levels, from simple consumables to high-tech equipment. Thanks to the in-house expertise and prototyping capabilities, Studio Red has what it takes to implement the DFM approach from the get-go while ensuring tooling cost efficiency and safety compliance. A few examples of medical devices in the company’s portfolio include the LAP-BAND System developed for Allergan, the LifeChoice portable oxygen concentrator for Inova Labs, the Aluma skin renewal system for Lumenis, and the Heartstring III Proximal Seal System built for Getinge.

Website: Studiored.com

19. NewDealDesign

At the helm of NewDealDesign is Gadi Amit, who earned the National Design Award in 2013 for his commitment to building creative designs in everyday tech objects. The company has been around for more than 25 years, providing new product development services to consumer electronics, health and wellness, commercial equipment, robotics, and automation industries. NewDealDesign is probably best known for its long-running collaboration with Fitbit, which resulted in well-received products such as the Fitbit Zip and the sporty Fitbit Charge. It also played a pivotal role in the development of Avive’s connected AED (Automated External Defibrillator).

Website: Newdealdesign.com

20. Fuseproject

Founded in 1999, Fuseproject has developed hundreds of new products for Fortune 100 brands and launched at least 90 early-stage ventures as well. The company is known for its many unique approaches to product design, often resulting in innovative solutions created on behalf of disruptive startups and established companies alike. In the medical device category, some of its best works include the Juno high-throughput DNA testing platform developed for Fluidigm, the mobility-enhancing robotics suit built for Seismic, and the Neural Sleeve bionic clothing for CIONIC. Fuseproject, in collaboration with CIONIC, also developed a modular, pneumatically driven ventilator during the COVID-19 pandemic. The company is based in San Francisco, California.

Website: Fuseproject.com

21. Bleck Design Group

An end-to-end industrial design company, Bleck Design Group’s product developers specialize in the development of medical devices, consumer goods, office products, and industrial equipment. The range of services in the medical device category covers capital medical instruments, surgical tools, clinical test platforms, and consumer health products. Its portfolio includes such products as the PicoSure laser skin revitalization device developed for Cynosure, an app-controlled smart thermometer created for Kinsa Health, the PillStation for SentiCare, the Endo360° suturing device for EndoEvolution, and the Xhale medication adherence system for Xhale. Bleck Design Group is based in North Chelmsford, Massachusetts.

Website: Bleckdesigngroup.com

22. Speck Design

Yet another turnkey product development service, Speck Design transforms an idea into a fully functional product and provides manufacturing support for clients. The service covers major business sectors including consumer goods, retail, industrial, transportation, telecommunication, wearable, robotics, and medical devices. Speck Design has been around for more than 25 years, creating innovative medical devices such as the Intellisense Medical Drill and the Rainin Medical Pipettes. In collaboration with Providence Medical Technology, the company developed the DTRAX minimally invasive surgical tools for cervical spinal surgeries. Speck Design maintains three locations in the United States, including San Jose and San Francisco (California), and NYC.

Website: Speckdesign.com

23. MAKO Design

In the United States, you can find MAKO Design in Austin, Texas, and Oakland, California. The company is now part of the TriMech Group. They are industrial engineering specialists with the resources and expertise to help you develop products of just about any category in existence, from toys and office supplies to garden tools and medical devices. MAKO Design is known for its inventor-friendly services, in which the company sets up a client-specific approach and provides the necessary resources to transform ideas into tangible products. Its works in the medical device category include the crossbody training machine developed for Pro X and the MedTech Mobility Headrest for Adaptive Switch Labs & Invacare.

Website: Makodesign.com

24. Porticos, Inc.

A turnkey industrial design company with post-production support, Porticos promises to stay engaged with your venture for as long as you need, even after market launch. The post-production support covers such services as component obsolescence, feature enhancements, and sustainable engineering throughout the entire life of the product. Porticos has handled more than 200 projects over the course of 20 years. Medical devices in its portfolio include the TelePatch cardiac monitoring device developed for Medicomp, the Optical Coherence Tomography (OCT) systems for Bioptigen, the adaptable medication-dispensing device for Livi, the Portray dental imaging system for Surround Medical, and the Cap Tube and Medication Dock for Sensal Health. Porticos is headquartered in Morrisville, North Carolina.

Website: Porticos.net

25. Brash Inc.

In the US, the Brash product development company is situated in Carlsbad, California. It also maintains a location in Ottawa, Canada. Their new product development team specializes in the development of consumer products, IoT, and medical and dental devices. For more than a decade now, the company has served startups, entrepreneurs, and well-known companies, transforming mere concepts and ideas into market-ready products. Its portfolio highlights various medical devices such as the touch-control patient lift developed for Handicare International, the Metered Dose Inhalers (MDIs) for Breathesuite, the SoloWalk movement recovery robotics for GaitTronics, and the robotic enclosure for the Kinarm Brain Injury Recovery device.

Website: Brashinc.com

More US-based medical device development companies to consider

26. MCRA

One of the leading regulatory advisors for medical device industries in the United States, MCRA claims to have cultivated strategic relationships with government agencies and invaluable insights to help you go through the regulatory application clearance. The company understands all too well the typical lifecycle of medical devices, making it uniquely qualified to be a reliable partner all the way from conception to commercialization. MCRA is based in Washington, DC.

Website: Mcra.com

27. EMERGO by UL

In 1997, Emergo first came into existence primarily to assist IVD (In Vitro Diagnostics) and medical device manufacturers with regulatory affairs. It has since grown into a full-scale product development company designing hardware medical devices, software interfaces, and instructional materials. Emergo is situated in Concord, Massachusetts, and Austin, Texas.

Website: Emergobyul.com

28. Flex

An end-to-end 3D product modeling company that’s willing to partner with you at any point of the product development stage. With more than 35 years of experience creating medical equipment and drug delivery systems for clients worldwide, Flex has what it takes to build any medical device and meet even the most stringent regulatory standards in the US. The company is based in Austin, Texas.

Website: Flex.com

29. HS Design

An ISO 13485 certified company and a Qmed qualified supplier, HS Design takes pride in its “common sense” approach to medical device development practices. This means the designers and engineers strive to build a product that’s both aesthetically pleasing and fully functional. The company says the approach makes it easier to uncover a lot of ergonomic concerns during the prototyping stage. HS Design is based in Morristown, New Jersey.

Website: Hs-design.com

30. Glassboard

Backed by an in-house team of specialists and generalists, Glassboard isn’t fixated on any specific approach to medical device development. Instead, everything is done in accordance with what’s best for the clients’ needs and business strategies, all the way from concept stage to market launch. Glassboard is headquartered in Indianapolis, Indiana.

Website: Glassboard.com

31. Plexus

Primary services from Plexus include new invention development services, manufacturing, and supply chain solutions. Within the healthcare sector, it focuses on developing FDA Class II and III devices, including therapeutic technologies for point-of-use applications and at-home monitors. Plexus is known for the DFX (Design for Excellence) approach, where product development is optimized for manufacturing, testing, and cost efficiency. The company is based in Neenah, Wisconsin.

Website: Plexus.com

32. Kapstone Medical

Since 2007, Kapstone Medical has developed and launched more than 150 products and filed over 75 regulatory submissions. It serves clients of all sizes, including individual inventors and large medical device OEMs. Kapstone Medical is an ISO 13485-certified and FDA-registered company, situated in Charlotte, North Carolina.

Website: Kapstonemedical.com

33. Biomerics

Every medical device development handled by Biomerics follows the established ISO requirements and standard operating procedures, including the validation protocols. Biomerics is a proponent of a proactive DFM service approach to bring clarity to product specification, confirm quality, and provide cost-effective pricing options. The company is located in Salt Lake City, Utah.

Website: Biomerics.com

34. Omnica

Over the last 36 years, Omnica has worked on an average of 80 projects annually. It serves startups, medium-sized companies, and big corporations from all around the world. Omnica’s main office is in Irvine, California, but it has a separate engineering and industrial design facility situated in Los Angeles.

Website: Omnica.com

35. D&K Engineering

The Total Commercialization Solutions by D&K Engineering provides support through the entire product lifecycle, from concept creation and system architecture to rapid prototyping services and post-launch. Apart from specializing in medical device development, it also serves the military and defense as well as the life science industries. D&K Engineering is based in San Diego, California.

Website: Dkengineering.com

Outside US

If you plan to sell medical devices in Europe or outside the United States in general, it might be a good idea to partner with offshore companies based in the target market location. Some of the best firms are as follows.

36. PQ Design Group

Throughout 15 years of history, PQ Design Group has managed to handle more than 250 product development projects; every single one of them was an end-to-end effort, transforming an idea into a functioning design. The company specializes in medical devices, design services for wearable products, and toy design. For the medical device specialization, PQ narrows it down a little bit further to focus on consumer health, neonatal care, and hospital-based applications. Some of its best works so far include the smart drone or capsule intended as a medical product (medicines, organs, blood, etc.) delivery vehicle developed for ABZero, a distribution arm to be used in operating rooms for LM Medical, and the DOC.D saliva-monitoring toothbrush for AICube. PQ Design Group is located in Pisa, Italy.

Website: Pqdesign.com

37. CLEIO

Established in 2005, CLEIO has now completed more than 2,500 medical device and high-tech product development projects; most of them were end-to-end services. In the medical technology and healthcare category, the company focuses on developing wearable devices, RPM (remote patient monitoring) tools, surgical instruments, catheters, drug delivery systems, and medical imaging equipment. CLEIO also offers manufacturing support that covers supplier sourcing, manufacturability verification, lab testing, and cost estimation. Some of its best works include the osmolarity test device for dry eyes developed for I-MED Pharma, the tinnitus assessment device for Menodys, the veterinary anesthesia ventilator for Dispomed, and the FreeO2 medical oxygen therapy device for OxyNov. CLEIO is based in Quebec, Canada.

Website: Cleio.com

38. WILDDESIGN

One of the best things about WILDDESIGN is the all-encompassing regulatory compliance medical device development services, whether you plan to market the product in the United States, Europe, or China. The company makes sure to integrate product requirements set by regulatory bodies such as the FDA, MDR, and NMPA into its development services from the outset to improve the chances of approval. WILDDESIGN’s range of services includes industrial design, rapid prototyping, DFM (Design for Manufacturing) services, ergonomics study, 3D visualization, packaging, labeling, and IFU design.

Some of the highlighted projects in the company’s portfolio include the Polaris operating light for Dräger, the PraluBase medication pens for SANOFI, the Magnos digital dermoscopy system for Magnosco, the Basic Orthopedic Instrument Set for Aesculap, the ELISA clinical intensive care ventilation systems for SALIVA (now Löwenstein Medical), and the laparoscopic instruments for Erbe. WILDDESIGN is based in Gelsenkirchen, Germany.

Website: Wilddesign.com

39. Design 1st

One of the best things about Design 1st is the ability to transform or translate technical sophistication into user-friendly products. Simplification doesn’t mean reducing features; instead, the company identifies the product’s core functions and presents them in an approachable way so that users quickly recognize and master them without the need for extensive training. The approach proves to be useful, especially in the development of medical devices. The company’s portfolio includes the Universal High-Speed Dental Drill System developed for ProDrive, the pain and addiction therapy using neuromodulation for Nuraleve, the pharmaceutical tank cleaning device for Swabbot, and the therapeutic tool for myofascial release and trigger massage for SoloRolo. Design 1st is based in Ottawa, Canada.

Website: Design1st.com

40. Haughton Design

Initially specializing in automotive design & engineering services and the aerospace sector when it was founded 25 years ago, Haughton Design gradually shifted focus to medical device development along the way. The UK’s Companies House listing describes the company’s nature of business as “specialized design activities” and “manufacture of medical and dental instruments and supplies.” It’s an ISO:9001 and 13485 certified company, with a flexible quality management system to make sure that all the product development projects under its roof are compliant with the EU MDR and the US FDA. Highlighted products in its portfolio include the Stomacher 400 laboratory paddle blender developed for Seward, a blood sampling device for Sirus Diagnostics, and various pharmaceutical testing instruments for Copley Scientific.

Website: Haughtondesign.co.uk

More design firms to consider

41. TTP

The medical device development services from TTP cover biosensors, neurotechnology, drug delivery systems, surgical instruments, ophthalmology, and optometry. Despite being situated in Cambridge, England, the company also offers services to US-based clients and builds products to meet FDA regulations. TTP is an ISO 13485-certified company.

Website: Ttp.com

42. D+I

The product development services from D+I include industrial design, mechanical engineering, hardware electronics, and software. Part of Capgemini, the company has been developing a range of complex medical devices for nearly four decades now. It has worked with such big-name clients as Siemens Healthcare, Chattanooga, and Trajan Scientific & Medical. The company is based in Melbourne, Sydney, and Newcastle (Australia).

Website: Design-industry.com.au

43. Celestica

Besides developing medical devices, Celestica also specializes in the aerospace, defense, smart energy, and communications industries. The company focuses on rapid prototyping and supply chain management for its NPD services. The supply chain management solution would involve local and global sources to help optimize product design so that it meets the regulatory requirements. Celestica is headquartered in Toronto, Canada.

Website: Celestica.com

44. Marturion

The main capabilities of Marturion are electronic device design and firmware for medical devices, but it also develops in-vitro diagnostic (IVD) readers. The services include on-site support at external test laboratories and device submission for regulatory compliance, such as the 510(k) to the FDA, and technical files for CE approval. Marturion is based in Lisburn, Northern Ireland.

Website: Marturion.co.uk

45. Nordson Medical

One of the biggest selling points of Nordson Medical is the PDP (Product Development Process) Service, which aims to develop medical devices in alignment with ISO and FDA regulations, standardized practices, and concurrent engineering. PDP also implements a flexible business model to cater to different project scopes. Nordon Medical is located in Boyle, Ireland.

Website: Nordsonmedical.com

46. Cortex Design

Working with Cortex Design means you’ll be connected to a vast network of product development partners for die casting, injection molding experts, metal forming, and PCBA to make sure that the final product comes out exactly as intended. You also receive assistance from a team of NPD advisors who operate under ISO 9001:2015 and ISO 13485:2016 standards. Cortex Design is headquartered in Toronto, Canada.

Website: Cortex-design.com

47. Fearsome

The full in-house team of product design & development expert designers and engineers at Fearsome all specialize in the development of high-risk medical devices, or the equivalent of FDA Class III. The company has been making ocular equipment, surgical instruments, drug delivery systems, neurosurgical tools, and diagnostic devices since 2002. Fearsome is based in Glasgow, Scotland.

Website: Fearsome.co.uk

48. Creation Technologies

An NPD company, Creation Technologies works in the aerospace, defense, and healthcare industries. The company boasts advanced manufacturing systems for the development of Class I, II, and III medical devices and pharmaceutical OEMs. Every product development process is done with the proprietary LEAP (Launch with Excellence to Advanced Production) approach. Creation Technologies is situated in Burnaby, Canada.

Website: Creationtech.com

49. Tiller Design

The core product prototype team at Tiller Design is composed mainly of program managers with expertise in production, industrial design, regulatory compliance, and commercialization. In the development of medical devices, the company works with its CRO (Clinical Research Organization) partner, Mobius Medical. Tiller Design is based in Rozelle, New South Wales, Australia.

Website: Tillerdesign.com

50. Planet Innovation

A healthcare product specialist, Planet Innovation focuses its development services on medical devices such as wearables, consumables, and high-tech laboratory equipment. It’s a full-spectrum industrial design company with engineering and manufacturing capabilities to transform your concepts into commercialized products. Planet Innovation is headquartered in Melbourne, Australia, but it also maintains a US location in Irvine, California.

Website: Planetinnovation.com

51. Freudenberg Medical

The journey of Freudenberg Medical began in 2004 when it acquired Jenline Industries in Massachusetts. Since then, it has grown into a specialized medical and pharma development company boasting more than 800,000 square feet of manufacturing facility and 12 production sites worldwide. Freudenberg Medical is headquartered in Kaiserslautern, Germany.

Website: Freudenbergmedical.com

How Cad Crowd can help

Developing a new medical device and actually bringing it to market are rarely straightforward processes. A small oversight can lead to excessive delays and costly modifications. In most cases, you must work with a development and prototyping partner to help you navigate the technical, clinical, and regulatory challenges along the way.

An end-to-end industrial design company can be a good choice, but engineering-specialized freelancing platforms like Cad Crowd might be even better, as they allow you to assemble your own team of professionals while maintaining affordability. Cad Crowd also provides a comprehensive IP protection service through NDA, patent search, and filing, and product licensing. Contact us for a free quote.

MacKenzie Brown is the founder and CEO of Cad Crowd. With over 18 years of experience in launching and scaling platforms specializing in CAD services, product design, manufacturing, hardware, and software development, MacKenzie is a recognized authority in the engineering industry. Under his leadership, Cad Crowd serves esteemed clients like NASA, JPL, the U.S. Navy, and Fortune 500 companies, empowering innovators with access to high-quality design and engineering talent.

Connect with me: LinkedIn ✦ X ✦ Cad Crowd

Advancements in 3D Visualization Services for Medical Device Prototyping Companies

Posted on April 2, 2025 by faz_business

3D visualization has been a real game changer in the manufacturing industry since the 1970s. However, during the 1990s, the technology transformed into a mainstream application in hardware design, architectural planning, and animated videos. Over the years of development, technology has become so progressive that it leads to a point where it can recreate hyper-realistic visualization of the human body, providing an insight into our anatomy more accurately than the old-fashioned 2D imaging ever achieved.

Cad Crowd has seen the development of 3D visualization in the field of medicine as an industry leader in providing design and engineering services to engineering and product design companies. The combination of both 3D scanning services and 3D printing shows a factual and reliable foundation for building a precise medical device prototyping method to ensure compatibility with the patients and improve health benefits.

🚀 Table of contents

What is 3D Medical Imaging?

While doctors, surgeons, and other medical specialists already have a working knowledge and understanding of the general principle of human anatomy, each patient is unique and may present a distinct set of challenges. 3D visualizations allow for a more personalized and holistic approach to treatment, which may significantly affect the outcome.

In contrast to traditional 2D imaging, 3D visualizations allow medical professionals to observe the anatomical structure of an organ from various angles, offering clear perspectives into the spatial relationship and how everything is connected together. Medical imaging has seen quite some transformative advancements since the early days of mammography devices and CT scanners in terms of resolution, detail, and information conveyed in the visualization.

Now, with the help of 3D modeling design experts and 3D technology, healthcare professionals are able to see the “scanned” organ almost in its entirety for an all-around observation of the body part in question while reducing the amount of radiation exposure for patients.

prosthetic design and development services

3D Imaging offers more Slice Counts

Over the last 20 years, procedures or treatments involving 3D medical imaging have increased from only about two cases per day to more than 130 cases daily on average in hospitals in the United States. Before 3D technology made its way into medical applications, conventional scanners were largely considered state-of-the-art devices simply because they allowed doctors to see through internal organs without cutting the skin open.

For instance, X-ray machines are great at what they do, but there have been very few advancements in their capabilities since the day they were invented, at least until 3D visualization software and 3D designers came onto the scene. Today, it’s possible to do an X-ray scanning with an array of emitters placed around the target object to create three-dimensional imaging assembled by software. In the old days, MRI and X-ray devices could only produce anywhere between 4 and 16 slices in a single sweep.

Low slice count generated images in low resolution that also included a lot of noise. With 3D visualization software, the scanner technology took a massive performance leap forward in terms of performance and capabilities to create larger data sets that allow for higher resolution and, therefore, details. In fact, one of the biggest improvements in 3D medical imaging is mostly about the increased slice count.

The technology company NVIDIA has been working in collaboration with medical equipment manufacturers and radiologists for more than 10 years to improve the design of medical imaging computer infrastructure used today, such as X-rays and MRI devices. And they’ve come up with a promising result, too: radiologists can now take images with thousands of slices to produce much clearer 3D visualizations than ever before. With higher resolution, the imaging can more precisely represent the anatomy.

3D Imaging in Medical Device Animation

Considering medical device design and manufacturing, 3D visualization technology also comes with animation capabilities, which allow manufacturers to generate realistic presentations that demonstrate the inner workings of the products in question and not only still/static images of medical devices. Animated visualization brings the imagery to life as it represents the devices’ functionality, as if the audience can see the underlying mechanism and technology.

The animation can simulate how the device works in hypothetical scenarios to illustrate ease of operation, maintenance, patient comfort, cleaning, and maintenance, to name a few. Due to the advancement of technology nowadays, It’s becoming true that you don’t need X-ray and MRI scanners to produce any medical device.

Still, the images generated from those scanners create the basis for device development in the first place. For example, when a manufacturer is designing a gas mask respirator, it might be helpful to use a 3D visualization of the typical users’ facial structures to help determine the best materials, shapes, and types of straps.

Since the device is meant to be mass-produced and the manufacturer cannot possibly scan every single person’s facial anatomy, the design team needs to make compromises for the sake of user-friendliness and flexibility. With the help of 3D visualization professionals, those compromises are based on well-informed decisions instead of mere guesswork. The same thing can be said for a myriad of other medical devices, including implants, prostheses, breast pumps, dentures, crutches, wheelchairs, stethoscopes, hospital beds, thermometers, oxygen canister masks, and so on.

Why You Need 3D Visualization in Medical Device Prototyping

For patients and users, 3D visualization and animation help them understand complex medical concepts, intricate procedures, and basically what the device does within the context of treatments and recovery. Not only does the animated simulation enhance learning on the patients’ part, but it also aids healthcare professionals in deciding whether or not the treatment is well-optimized for the condition. From the perspective of medical device manufacturers, 3D visualization is all about virtual prototyping.

And like all virtual prototyping, the main purpose is to build a “complete” design of any product on a computer screen using specialized software, eliminating the need for repetitive trial-and-error processes during the early phase of development. In conjunction with animation and simulation, engineers have better chances of perfecting the design in a cost-efficient manner with a digital prototype.

The entire design is built from scratch as a digital file, and all changes can be quickly implemented without having to physically rebuild the prototype each time. More and more manufacturing firms (not just in the medical device industry) are moving away from the traditional method to 3D visualization implementation in their design approach, and for good reasons:

Detail and Precision of 3D Imaging Visualization

Medical device visualization requires a high level of accuracy and often demands a complex depiction of not only the device but also the part of the body that is fitted with the product. While traditional illustrations can be pretty elaborate, they cannot create a depiction of lifelike quality.

3D software renders the image with spatial relationships in mind to showcase fine details – previously challenging, if not impossible, to capture with conventional imaging techniques – even in complex devices. Due to the fact that the modeling is drawn in a digital format on a computer screen, the designers can manipulate the prototype with precision.

Dynamic Presentations

Since Static 2D visualizations have limitations in their ability to illustrate the mechanical processes of a device, 3D prototyping software offers a far more advanced dynamic feature that allows the prototype design experts/illustrators to simulate how the device does what it’s supposed to do and the way it affects the users. This kind of illustration works best for mechanical devices, such as wheelchairs, knee braces, crotches, prostheses, etc.

If the device is electronics, the simulation tends to focus on its mechanical components. For example, a 3D visualization of a forehead thermometer will not likely illustrate how the sensors pick up the temperature and how the firmware transforms those signals into digital read-out. Instead, the visualization may showcase an exploded view of the entire device, the ergonomic handle and control, digital user interface, battery door, button placement, and probably a short guide on how to use it.

Biochemical Analysis

For devices designed by prosthetic design experts that are meant to make continuous contact with the human body (such as prostheses and implants), it’s important to make sure that the overall geometry is specifically designed for the user. 3D visualization can generate simulations under various scenarios to observe how well the device improves the patient’s conditions and affects living tissues/organs in the long run.

Of course, the simulation requires a 3D model of the patient’s body part as well, which can be done with a 3D scanning method. Advanced visualization software offers a wide range of options to set the simulation parameters like bone density, joint rotation, typical physical activities, and patient’s weight, among others. The purpose is to make sure that the device is both functional and safe to use.

Choice of Materials

Ensuring the right choice of material is an important decision that affects performance prediction and ensures durability, for instance, in biochemical analysis. One example of a medical device is knee braces, which are prone to cause concerns such as allergic reactions, flexibility, and comfort. Using rapid prototyping services for this medical device with 3D visualization makes it easy to configure the types of materials and density to ensure maximum performance.

Designers are given plenty of simulation options to analyze material strength and properties under various real-life conditions. It’s all about iterative design through continuous tests to determine the best design for the purpose. Medical devices, in particular, present unique challenges because they’re required to deliver efficacy, meet strict regulatory standards, provide comfort, ensure safety, and sometimes look aesthetically pleasing, too.

Where Cad Crowd Comes In

Creating a medical device from scratch is a monumental undertaking, even for big companies. It’s inherently a collaborative effort between medical professionals, engineers, designers, and 3D artists to come up with a truly workable digital prototype.

Cad Crowd might not have healthcare experts to provide medical inputs, but we definitely can connect you with some of the most talented engineers, design professionals, and experienced 3D visualization artists to transform your design into a state-of-the-art virtual prototype as an industry leader in providing outsourced design services. Feel free to reach out to Cad Crowd for your free quote, and we’ll be glad to work with you right from the early concept stage all the way to the pre-production final prototype phase.

Connect with me: LinkedIn ✦ X ✦ Cad Crowd

CAD Files in Action: Industries and Companies Adopting Popular CAD File Formats

Posted on July 21, 2024 by faz_business

Today’s post explores CAD files and the companies and firms that adopt popular CAD file formats. Before the rise of CAD, paper and pencil were the only combination designers had access to. 3D designs and prototypes were all carried out manually. The result was the slow development of designs and the tedious prototype creation process. Without a doubt, the entire manual process required expensive trials and errors.

But with the introduction of CAD technologies, the entire design, development, and prototyping process has become easier, faster, and cheaper. As a result, it’s simple to address design concerns and can be done so throughout the design process itself. Instead of the usual drawing, CAD files have become the ultimate weapon for 3D designers to bring their CAD designs to life.

What are CAD files?

Computer-aided design or CAD files are the outputs of CAD software that contain information about the designed objects. These files might be made up of 3D or 2D data and are commonly used by designers, manufacturers, digital artists, engineers, and scientists. The format is the defining characteristic of CAD files. There are kernel, native, and neutral CAD file formats. Neutral file formats were elaborated as readable according to industry standards by most CAD modeling platforms.

These formats have publicly available specifications and are maintained by consortiums or companies. Meanwhile, major CAD vendors produce native formats. Third-party CAD tools conversion is necessary to import these files. Finally, kernel formats are derived from renowned geometric modeling kernels. CAD modeling kernels are components of modeling software. That defines how a shape is mathematically described by it. Kernel formats are recommended for software built on top of the kernel that corresponds to it. Here are some of the industries and companies adopting popular CAD file formats:

Interior design

CAD files allow 3D interior design firms to breathe life into their visions through detailed and intricate digital designs. It allows them to present designs to their clients, from every detail to the smallest ones. They can also showcase the final look of the project upon completion.

Architecture

Buildings are massive and costly projects. Flawless planning is critical when developing something as expensive and huge as a building. It is another case where CAD files come in handy. In addition to the actual layout and architecture of a structure, the CAD files can also be used to identify the correct specifications, such as weights, volumes, and measurements, even before the start of the actual construction.

2D drawings and floor plan services can be used in the field once the construction starts. Meanwhile, the 3D architectural visualizations are used to gauge the accuracy of 2D plans and help backers envision the completed project to increase the chances of them funding it. It is especially true for office buildings as well as other commercial structures. However, home designers and builders also increasingly use CAD files and 3D visualizations these days.

Landscaping

Landscaping companies also use CAD files to conceptualize their outdoor creations and identify the correct placement and location of different landscaping elements such as gardens, patios, fences, trees, and more. Companies can employ 3D landscape rendering designers to visualize their designs.

Automotive

Sophisticated CAD software and files are also used in different aspects and areas of automotive design. CAD companies for the automotive industry are used to produce 3D prototypes of new styles of car bodies and to design car parts such as engines, tires, upholstery, circuitry boards, and others. Data from CAD files can be fed into CNC machines that cut steel and robots that help construct vehicles on assembly lines.

Medical

CAD files are also used by prosthetic design and CAD services for medical applications for prosthetics construction or reconstruction of different body parts. Some of these are even printed out using specialized medical 3D printers. Traditionally, CAD has been used to help engineer designs and models for analysis, representation, and manufacturing. The advancements in biomedicine and information technology have paved the way for new CAD uses and applications with many essential and novel biomedical applications.

The CAD files are used for tissue engineering, where the CAD-based bio-tissue informatics model offers crucial data on tissue biophysical, biochemical, and biological properties for the design, fabrication, and modeling of complex substitutes for tissues.

Civil Engineering

Today’s urban planners also use CAD files to plan infrastructures in urban areas, including bridges, office complexes, industrial units, parks, and more. It is another aspect where 3D CAD is used most of the time. The urban planning process requires taxpayer dollars and funding. Many people find it hard to envision the appearance of a playground or park based on a 2D drawing alone. It’s even more difficult for them to visualize what a massive professional stadium will look like upon completion. This is where civil engineering professionals can help. If the planners hope for financial support and backing for a taxpayer referendum, CAD files are the best approach.

Fashion Design

Even though most of today’s reputable fashion designers choose to craft their designs for their unique creations by hand at first, fashion CAD files are often used in the latter phases of the design process. CAD files are also almost always used by industries specializing in ready-to-wear garments. The files are used to identify the most efficient fabric cuts and to change the pattern scale for various sizes.

With the help of virtual models, the files can also be used to present how the item fits and moves when worn. 3D cad fashion design professionals can make the necessary changes to the design afterward. During the manufacturing stage, the cloths can then be cut, typically in large layers, with the help of CNC machines to speed up the whole process.

Dentistry

Did you get a tooth crown in the past decade? If yes, then chances are your dentist took advantage of technological advancements in CAD technologies. For 30 years, CAD files have been used in dentistry to digitize dental structures and oral cavities for virtual designs of complex and simple prosthetic units. However, the only difference is that this time, thanks to the rise of dental 3D printers and special dental materials, the structure is made right in the dentist’s office while you wait instead of being sent out to a laboratory first for construction. Dental CAD printing and design technologies can offer unmatched anatomical accuracy even while you wait.

Forensics

Just like how your well-loved CSI show uses CAD technologies to solve their cases, their counterparts in the real world do so as well. The role of 3D CAD design and 2D drafting services in forensic sciences is to help estimate a person’s age, analyze the injuries incurred, and identify the victim postmortem. Most of the time, postmortem identification involves comparing dental records in the form of models and radiographs of a person before death or ante mortem to that of postmortem or after death.

On the other hand, injury analysis may involve comparing bone contusions or fragments to the types of known injuries or weapons. Forensic sciences can also use CAD files to help in 3D reconstruction of the investigation of crime scenes.

Law

3D CAD reconstructions of crime scenes and accidents that resemble those used in forensics can be used even in courtrooms to assist the jurors in visualizing the events put on trial.

Mapping

As a form of CAD, computer-aided mapping is especially related to cartography and mapping. This is typically used by GIS mapping experts to generate utility, parcel, and street maps that can be used with GIS or on their own. Even though GIS and CAD are similar to each other, the two have some notable distinctions. Most importantly, CAD is designed to edit and create graphic entities. In general, CAD also has minimal database capacities, but this might not ring true in the case of 3D CAD.

On the other hand, GIS is the spatial database where graphics are used to display the analytical results, wherein graphic editing is the secondary ability. It is essential to note that several CAD programs come with GIS functionality as an add-on to their core functions in graphic editing.

Aerospace

The aerospace field is undoubtedly one of the most high-tech modern industries that use CAD files. The aerospace industry includes aircraft, missiles, satellites, and space vehicle manufacturers. Since these products come with colossal price tags, with a single aerospace item easily costing several million dollars, aerospace engineering services and CAD files play a crucial role in the design process.

Before the construction of the actual product, every single detail is planned and virtualized as thoroughly as possible with the help of sophisticated CAD design software. Advancements in computing technologies have undoubtedly paved the way for the continuous rise of CAD files in applications beyond the scope of conventional AEC design.

How Cad Crowd can help

Get in touch with Cad Crowd today and tap into the massive pool of CAD design professionals specializing in CAD files that can be used in various industries and by different companies. Contact us for a free quote.

Freelance CAD Prosthetic Designer: Cost, Rates, and Pricing for Individuals and Companies

Posted on June 21, 2024 by faz_business

Today’s post covers CAD prosthetic designer cost, rates, and pricing for companies and individuals. Before the invention and rapid adoption of 3D printing, the only way to produce prostheses was by conventional casting, injection molding services, or combining those two. Either method requires a lengthy manufacturing process from the initial evaluation of a patient, measurement, cast production, socketing test, fitting, and cosmetic restoration. A prosthesis must undergo several iterations (prototypes) before the final product is ready.

Since each patient needs a custom model (or socket for a prosthetic limb), a new device must be made from a different mold. It was not until the late 1980s that the medical world began recognizing the huge potential advantages of CAD/CAM methods to produce prosthetic devices. When 3D printing came along, it became possible to reduce the total turnaround time and labor cost to a great degree.

One of the most time-consuming tasks in the conventional manufacturing process of prosthetic limbs is the socket design. Each socket is unique and made specifically for the individual wearing the device. It is through the socket that the wearer’s body weight is transferred or distributed as naturally as possible to the ground to reduce discomfort. For upper-limb prosthesis, there needs to be knee an artificial knee joint to improve mobility. Here, the expertise of a freelance CAD prosthetic designer comes into play, crafting personalized designs for prosthetic solutions.

3D Printed Prosthesis

World Health Organization estimates that only around 5-10% of people (approximately 1 out of 10) who need prostheses have access to those devices. Much of the problems are due to high cost and availability. A functional and customized prosthesis can cost $120,000 or more. Many amputees cannot even afford the $2,500 traditional barebone options manufactured with conventional molding without any additional functionality. Prosthesis manufacturing optimization by 3D printing design companies can cut the cost to a considerable extent.

Financial constraints have always been the main problem that stands in the way of patients needing prostheses. In a world where only a tiny percentage of people who need prostheses have access to the devices, there needs to be a middle ground to ease accessibility without putting too much of a financial burden on the manufacturer or fabricator. And this is where 3D scanning services and printing come in.

medical-device-design-development-services

The cost of material to produce a prosthetic socket for adults amounts to only around $100, and the 3D printing process itself is $20; the cost only covers the manufacturing of the socket. It is worth noting that a transfemoral (above-knee) prosthesis also requires a knee joint and a structure called a pylon composed of lightweight metals or carbon fiber. Be that as it may, the total cost should not be anywhere near the $2,500 mark.

Let us say a shock-absorbing pylon and adapters are priced collectively at $200, a rotating knee joint with 100kg weight capacity at a conservative $300, and a simple artificial foot at a generous $200; the final product costs $820. With shipping and taxes, the maker can sell a complete device with a profit margin of $1000. Nearly all the design works are for the socket, while all other parts are ready-made. Of course, the prosthesis will not be as aesthetically pleasing or technologically advanced as its branded alternatives, but the functionality is all there.

A smaller prosthesis, such as an ear replacement, should be even more affordable. Several years ago, researchers at the Queensland University of Technology proved they could manufacture an affordable soft tissue prosthesis using a low-cost desktop 3D scanner and printer. Silicone was the material of choice. All the consumables that went into the production process were worth no more than $3, and they paid $116 for two hours of labor. The researchers also built another version of the same prosthesis with a casting method using a 3D-printed ABS mold, which cost $155 for labor and consumables.

Either option was still more affordable than the traditional hand-crafted prostheses, ranging from $2,000 to $7,000 and taking at least 14 hours of labor. Everything sounds great, but there are a few potential drawbacks. 3D printing is not an instant process. While the scanning and designing processes are possibly done in just several hours, the printing alone may take 24 hours to complete. The prostheses are also limited in terms of material options. Chances are they are printed from PLA or ABS instead of powder metal, but it is necessary to sacrifice structural rigidity to save costs.

Another downside is that not every 3D printing company might be technically qualified to build prostheses for medical purposes. Unless the prostheses are meant to replace soft tissues or for cosmetic purposes like ears and noses, the most qualified people to make the devices are licensed prosthetists and orthotists. Obtaining the license is not easy because they must complete a master’s degree in the field and obtain the certifications to practice. They are professionals trained to design and fabricate prescribed prosthetic devices. Adjusting, repairing, and replacing prosthetic devices are also parts of their duties.

Design Cost

The BLS says that the average median pay for prosthetists and orthotists (2022, latest data available) is $77,000 a year or around $37 per hour. Prosthetists specialize in artificial limbs and other body parts, whereas orthotists work on supportive devices such as knee braces. The good thing is that prosthetists and orthotists are utilizing 3D scanning and printing technologies to do their jobs.

Although their clinics likely don’t have a complete 3D printing facility, they can collaborate with prosthetic design services and local manufacturers to simplify workflow and reduce turnaround time. For example, the production of an above-knee prosthesis typically goes through the following steps:

A prosthetist scans the patient’s residual limb at the clinic. 3D scanning is the most reliable technology to produce a 3D model of the mold (for the prosthetic socket). It will create a digital, accurate copy of the residual limb surface geometry and dimension for proper fitting. 3D scanning only takes a few minutes.

CAD software transforms the scanned image into a custom 3D model. It might involve cleaning up and post-processing before the file can be converted into printable format. The step takes about 2 hours.

The finished ready-to-print prosthesis model is sent to a 3D printing shop for manufacturing. The model should be ready in 2 – 5 business days after post-processing and cleaning up.

The manufactured prosthesis is ready to use and sent back to the clinic. The overall turnaround time is between 1 – 2 weeks.

The first and second steps make for the biggest design tasks, where a prosthetist or orthotist scans and creates the 3D model of the device to be manufactured. The hourly rate mentioned above only covers those services. If priced on a per-project basis and done by Autocad design professionals (instead of prosthetist/orthotist), the cost for 3D scanning and conversion into print-ready 3D images typically falls in the $120 – $150 range.

High-end 3D printing

Just because 3D-printed prostheses are more affordable than traditional injection-molded variants does not necessarily mean everything is cheap for everyone. Product options and prices are parts of a spectrum, so it is not entirely unlike other businesses. While it is possible to manufacture a functional above-knee prosthesis for under $1,000, the final product is likely a basic variant made of easily sourced material. It has the functionality of a prosthesis, and in many cases, nothing else is more important.

The business side of 3D printed prostheses runs from individual freelancers producing artificial limbs out of hard plastic to state-of-the-art facilities creating ISO-certified prosthetic devices. At the higher end of the spectrum, it is not uncommon to see above-knee carbon fiber or aerospace-grade aluminum prostheses. Companies operating at this level are essentially doing the same thing as their peers in the automotive industry. Some prostheses come with sensors to collect muscle data and adjust shock absorption accordingly.

They are almost robotic, with independent control for movement and grip. Starting prices are closer to $10,000 than to $1,000. For instance, Unlimited Tomorrow (one of the most well-known prosthesis manufacturers based in the U.S.) sells its prosthetic arm for nearly $8,000. Like most technologies, worldwide adoption is expected to impact prices. Lower manufacturing costs and readily available materials may permit the use of advanced prostheses in developing economies, where the devices are currently cost-prohibitive.

Development and Future

Manufacturing technologies for prosthetic devices have advanced significantly over the last 20 years. Much of the developments can be credited to CAD drafting services and 3D printing methods. It is not only about design visualization by a freelance CAD prosthetic designer on computers and additive manufacturing but also the engineering/invention of new materials to help with pressure dissipation and cushioning. Gel materials and carbon fiber composites, which have been used for decades in the automotive and shoe industries to produce parts, are also implemented into prosthetic manufacturing.

In modern above-knee prosthetic limbs, the pylon also has a shock absorption mechanism to improve the patient’s biomechanical performance. Certain materials are water/moisture resistant, making the prosthetics suitable for beach or shower use.One of the most exciting studies in the field is the implementation of brain-controlled prostheses. The idea is to connect prosthetic devices with electrode arrays placed in the patient’s brain, muscles, or nerves to control limb movement. It is intended to allow the patients to control their prostheses in a much more naturally comfortable fashion.

Researchers at the University of Chicago are taking a step further by using touch sensors and brain-controlled mechanisms in prosthetic arms. With a combination of sensory feedback and natural movement, prosthetic devices – in the future – may function to enhance human physical abilities.

How Cad Crowd can help

Cad Crowd makes it easier than ever to connect with designers to help you develop your prosthetic arm, foot, leg, eye, or joint. We help clients with design for 3D printing, injection molding, or any other manufacturing technology. We also offer contract manufacturing services to help you get your product made. Contact us for a free quote.