Medical Devices have the potential to revolutionise medical treatments, diagnostics, patient engagement and quality of life. Yet, innovation comes with ever increasing regulatory scrutiny and security challenges. The 10th Annual Software Design for Medical Devices Global Forum is the ONLY conference that is dedicated to ensuring your teams can achieve regulatory compliance and protect your devices from increasing cyber threats, whilst still embracing the cutting edge designs to get to market faster and stand out from your competitors.
Ensure you can meet future medical needs by adopting innovative software design methodologies. Ensure your cybersecurity is airtight to protect your devices and evaluate how you can safely implement AI without compromising on security. Enhance your product quality and gather intelligence on tech companies' perspective on SDMD. Take away key strategies to industrialise your software development to take your device to market quicker and more efficiently.
The ability to network with peers and also soundboard industry relevant issues was priceless". Interesting to see how other companies work and handled challenges. Very good overall! Services offered include opportunity definition, brand strategy, development planning, user research and human factors testing.
At its core, there is extensive expertise in user experience design designing humanized usable systems , industrial design and User Interface products that are functional, beautiful and intuitive , new product prototyping, and the design of instructional materials. This coupled with extensive in-house specialties in mechanical engineering, embedded software systems, and electrical engineering allows HSD to offer robust services for a diverse range of medical device companies.
The firms collaborative approach is evident in its over 40 year history of successful medical device development.
As an ISO certified design firm, HS Design serves large fortune corporations as well as novel start-up medical and scientific companies. The Jabil group of companies represents a worldwide organization of innovation, engineering and design firms, collaborating to deliver value across the life cycle of every product touched by Jabil. The group includes Nypro Healthcare, a firm whose track record in innovation has taken numerous products from the concept stage through to full-scale production.
Radius Innovation and Development, another Jabil company, provides regulatory and compliance services along with conceptual engineering and mechanical design services for medical device companies.
Flex is one of the largest product design and development companies in the world. The firm boasts approximately , employees in different locations across 30 countries, collaborating to deliver innovative and effective product designs, quality engineering, outsourced manufacturing services, logistics, and supply chain management services for client companies in all markets. Established in , Plexus is a truly global company of nearly 18, employees providing product design, outsourced manufacturing, supply chain management and after-market product support services for clients in a variety of markets.
Plexus applies its special capabilities in electronics to design and engineer high-quality and commercially successful medical devices for its customers.
Plexus is an experienced developer of medical devices with applications in diagnostic imaging, drug delivery, electronic surgical devices, hospital and in-home monitoring, food safety, laboratory automation and therapeutic devices.
The firm was recognized by General Electric as their supplier of the year for , and by Qiagen as their supplier of the year.
Design and Industry is a certified industrial design and product development consultancy with a year track record of delivering commercial success and quality products for their clients. The firm employs a staff of over 50 industrial and mechanical engineers in Sydney and Melbourne, Australia, and has won over awards for excellence in design and engineering.
Cambridge Design Partnership is a full-service product innovation and realisation firm that provides end-to-end services, including research for innovation, product design, brand innovation and packaging, technology development including wireless and connected devices , electronics and mechanical engineering and manufacturing. Cambridge Design Partnership offers decades of experience in innovation, with product releases that include drug delivery systems, diagnostic devices and surgical equipment.
The firm promises time and cost savings for medical device companies who integrate Cambridge as an external partner into their own QMS. Kapstone Medical promises its customers a professional, thorough, responsive and pragmatic service, personalized solutions, rapid execution and a relentless commitment to quality. The firm offers full-service end-to-end product realisation for customers ranging from established medical device companies to first-time medical device entrepreneurs and inventors.
Kapstone helps medical device companies develop products with services that include early-stage conceptualization, project management and engineering. The firm leverages 3D printing capabilities to assist with prototyping and can provide support for regulatory planning, k submissions, CE mark attainment and quality system development and maintenance.
StarFish Medical is a medical device contract manufacturing company with a track record of creating breakthrough products in a variety of specialty areas. StarFish Medical uses its technical capabilities and precisely refined processes in product definition, technology development, product development and quality management to take medical devices from the ideation stage through product design and definition and into a first prototype.
StarFish Medical also provides regulatory support and full-product manufacturing services, making them a robust end-to-end partner for medical device development services. Celestica offers creative manufacturing and supply chain solutions that cater to the specific needs of the medical device development industry. Celestica began in with two facilities and employees and has since expanded its operation to over 35 sites, employing 28, The firm offers end-to-end product design and development services, including product ideation, prototype engineering, manufacturing and select after-market services.
Orchid Orthopedic Solutions is a world-leading provider of outsourced design and manufacturing services for orthopedic medical devices. The firm specializes in orthopedic implants, instruments and technologies that facilitate joint reconstruction, spine health, sports medicine applications, post-trauma recovery and dental applications.
The firm has completed manufacturing projects for knee, femoral and tibial components, acetabular cups, hip femoral stems, hip resurfacing, joint implants and cast instrumentation. The firm has designed and engineered products such as the Dexcom G6 continuous glucose monitor to give patients with diabetes a painless way to apply a sensor to their bodies, the massive SC proton therapy system to treat cancer patients with life-saving radiation, and the EXOGEN, the only FDA-approved bone healing device, to expedite recovery using ultrasound radiation.
Delve has achieved ISO certification and is committed to working in accordance with all FDA regulatory requirements. It follows a streamlined design transfer process, ensuring that a successfully engineered device can be profitably and smoothly manufactured once the design has been finalized.
Team consulting are experts in the design and development of medical devices. Serving medical device companies such as Haselmeier, Meridian Medical Technologies and Sensile Medical, Team Consulting offers expertise in product and user experience design, engineering, human factors analysis and testing, science and project management. Recent product successes for Team Consulting include a collaboration with Organox to innovate a new system for keeping transplant livers alive, a bluetooth-enabled sleep apnea mask and monitor, and a range of innovative drug delivery systems.
Planet innovation is a product design and contract manufacturing firm that specializes in designing medical devices for compliance with European and American standards and regulations. When it comes to product design execution, Planet Innovation specializes in regulated biomedical products and connected devices. Its capabilities include industrial design, systems and software engineering, optics, project management and manufacturing.
Donatelle is a medical device design and development, and contract manufacturing firm that boasts a year history of helping innovative companies create and commercialise new products in the medical device market. Services available with Donatelle include product development, prototyping, injection molding, liquid silicone molding, precision machining, packaging, process validation and more.
Engineers at the firm have worked on pacemakers and implantable heart monitoring systems, ventricular assist devices, microfluidic diagnostic instruments, medication pumps and other drug delivery products, orthopedic and surgical technologies and more.
Years of experience along with versatile expertise and capabilities make Donatelle a valuable product design partner for medical device companies. Bressler Group has developed hundreds of medical device products in collaboration with its clients, including therapeutic and life support equipment, patient monitoring devices, laboratory and diagnostic equipment, consumer devices, infusion pumps, injection devices and more.
Biomerics is a versatile product design and development partner in the medical devices space with capabilities in product design, engineering, and manufacturing. The firm manufacturers many proprietary products in-house, including a range of medical polymers, coatings, advanced catheter capabilities, extrusion technologies and device assembly solutions that are sold to medical device companies or OEM providers.
The engineering team at Biomerics implements a multi-step stage-gate design process, ensuring that all design, manufacturing and regulatory requirements for each new medical device are satisfied.
The team provides world-class testing labs, process development and product validation services that help medical device partners around the world build safer and more effective products while reducing their time-to-market.
Integrated Computer Solutions is a medical device design company that is building the next generation of connected, wearable and IoT-enabled medical devices with a focus on software development. ICS has delivered custom hardware and real-time operating systems for a variety of medical device applications, including drug infusion pumps, respiratory devices and medical imaging.
Freudenberg medical is a global product design and development firm with offices in California, Massachusetts, Minnesota, Indiana, Costa Rica, Ireland, China and Germany. With each production location having achieved compliance with the ISO medical device quality standard, Freudenberg has demonstrated a world-wide commitment to delivering quality products for its customers.
Freudenberg provides upwards of 80 million custom molded components per year to manufacturers of in vitro diagnostic devices. Synectic is a medical device product design and development company with locations across the Eastern United States, including Boston, Philadelphia, New York and New Jersey. The firm works with medical device inventors and start-up companies, providing mission-critical product development services that include user needs establishment, device specifications generation, intellectual property review, legal and regulatory compliance, clinician feedback studies, and clinical trials.
The skilled and experienced team at Synectic also offers a machining and prototyping service and can ramp up your product into full-scale production with the facilities of its parent company, Mack Molding.
The end-to-end product design and manufacturing capabilities of Synectic mean that your project can be handled in-house from conception and ideation through to market release. Novo engineering implements a quality management system with a five-phase product development process that extends from the initial product concept development through to manufacturing transfer, facilitating rapid development of Class I, II and III FDA-regulated devices.
In addition to their expertise in medical device compliance, Novo has developed specialized capabilities in the development of certain types of devices, including autoinjectors and pen injectors, insulin pumps, wearable drug delivery devices and RFID tagging and detection IoT-enabled devices. Sunrise Labs employs a team of over 65 engineers delivering full product development and engineering services to medical device companies in the United States.
With in-house quality processes that comply with the stringent requirements of ISO , Sunrise Labs applies its expertise to projects and companies of all sizes and promises to deliver cost-effective design solutions with a focus on time-to-profit. According to that article, it is the use intended by the manufacturer that is definitive for classification as a medical device.
Using that yardstick, the software pursues a specifically medical purpose in assisting in the prescription of medicines.
The ECJ, however, also made it clear that this does not apply to just any software intended for deployment in the health sector. The software must also have a medical functionality that goes beyond the intended use. In other words, it must utilise data for a medical purpose. That is the case if data are recorded or modified, or if calculations, quantifications and comparisons are made.
The ECJ draws the line between this medical functionality and that of mere storage software. If a software only archives, gathers or transmits data, it is a mere database. If it does not have any impact on the data or interpret them, it has no medical bearing. In these cases it is not a medical device within the meaning of the directive.
The ECJ notes that in the classification of software as a medical device the EU legislators aimed to concentrate on the intended use of the software.
This makes it easier for manufacturers to assess whether or not their software is to be categorised as a medical device.
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