June 5, 2019
10:30 AM – 6:00 PM
June 6, 2019
11:00 AM – 2:00 PM
For over 40 years, Anomet Products has focused exclusively on manufacturing innovative clad-metal wire composite solutions that deliver optimized performance for the most demanding applications. Our goal has always been to provide superior material quality, product value and customer satisfaction through service and support that far exceed expectations. We’re proud that this unwavering commitment has fostered strong, collaborative partnerships with leading OEMs across an extremely diverse range of business sectors, including aerospace & defense, automotive, battery & fuel cell technology, energy production (oil & gas), appliances, corrosion protection, industrial, electronic, superconductors, medical devices and electrochemical.
Arena Solutions helps innovative medical device companies design, produce, and deliver great products fast, while complying with ever-evolving regulations. Arena’s product-centric QMS solution provides a single place to manage quality, training, and new product development processes in context with the entire product record. Arena improves compliance, traceability, and communication between dispersed quality, product, and supply chain teams. With Arena’s cloud solution, teams collaborate anytime and anywhere to speed product realization processes while addressing today’s complex regulatory compliance requirements. For more information, visit:
Asahi Intecc USA Inc. is an ISO 9001/13485 manufacturer of wire-based medical components, including ACTONE, multi-layer 1-1 torque cable tubes, motor-driven drive cables, and flat wire torque coils. Other products include laser-cut hypotubes, coils, strands, and cables; guidewires; braid-reinforced catheter tubing of variable durometer; multi-lumen tubing, balloon tubing and ultra-thin PTFE liner. Along with applying our compounding capabilities with our metal products with jackets and liners.
Biomedical Polymers, Inc. (BMP), a quality manufacturer of plastic consumables for research and medical diagnostics laboratories, announced today that it has received ISO® 13485:2003 certification for its Quality Management System for the manufacture of Medical Devices. In order to meet these requirements for certification, BMP upgraded its quality management system to assist in achieving increased efficiencies, higher performance, and reduced operational costs.
Boston UX designs compelling touchscreen interfaces for high-impact embedded and connected medical devices. We pair intuitive interface design with expert engineering to create devices both beautiful and buildable.
Helps you meet stringent FDA regulatory requirements
Defines the product features that will appeal to your customers
Applies Design Thinking best practices to create powerful designs
Creates UIs with engaging visual imagery and clever animations
Validates designs with real-world users to gain the insight needed to develop products of superior quality
Boston UX is part of the Integrated Computer Solutions family, a product-driven software company offering development, project management and consulting services.
Cadence is a full-service contract manufacturing partner providing complete services that range from initial design through manufacturing and full supply chain management of medical devices worldwide. Cadence specializes in manufacturing specialty metal components and complex sub-assemblies, as well as assembly, testing/inspection, packaging and labeling, and sterilization management of finished medical devices. Stop by our booth #332 at DeviceTalks Boston to learn more!
From Prototype to Production CGI Motion enables design excellence across a wide range of industrial applications. We thrive on customer driven innovation in precision gearbox, precision machined components and electro-mechanical assembly solutions ranging from aerospace systems to semiconductor applications. We are your design and manufacturing partner helping to differentiate your product, machine or innovation. Our team of problem solving engineers and product managers can bring your application to market on time and under budget. Whether it’s an improvement on a current design or groundbreaking new designs, CGI has the know-how and team to enable design excellence.
ClickFold is the preferred partner for companies that regularly require custom plastic parts and enclosures in smaller volumes. Our systematic design approach and unique zero-tooling process allows just-in-time delivery of high-end fabricated plastic parts and we aim to be the market leader in this segment. Our focus is on fast and simple product development, prototyping, and cost effective production.
Da/Pro Rubber consists of 5 facilities for compression/injection molding – high-quality custom rubber, TPE, & plastic components molded to precision tolerances such as diaphragms, seals, connectors, molded shapes, rubber to metal parts for medical device, electronic & aerospace industries. Class 10,000 cleanroom – chemists & engineers assist in optimal moldability. firstname.lastname@example.org
With over 30 years of experience servicing the Medical Device, Manufacturing and Engineering communities, DAVIS is a consultative partner providing Staffing Solutions and Talent Advisory Services.
We understand the intricacies of companies where products can be lifesaving as well as regulated.
Our specialized team can find you the talent you need to comply with federal standards and deliver your product to the market on time and on budget.
For over 40 years, Design Standards Corporation has been manufacturing precision medical devices for many of the biggest health care suppliers. We specialize in design and manufacture of disposable and reusable medical devices and instrumentation.
For more than 80 years, Draper has delivered new capabilities to support U.S. national security. In often challenging environments, when lives are on the line, your technologies have to work. Many of the tools and capabilities delivered for our national security customers may be applied to solve challenges in the commercial sector.
Draper’s Biomedical Solutions encompass neurotechnology, medical devices, rapid diagnostics, organ-on-chip systems, and cell therapy bioprocessing devices. By leveraging multidisciplinary expertise in microfluidics, microfabrication, image analysis, and other areas, we design, build and test working prototypes that make innovation real.
With extensive knowledge of the commercialization process, regulatory requirements and scientific trends in the Industry, Eurofins Medical Device Testing offers regulatory compliance expertise and experienced GMP/GLP/ISO 17025 testing to ensure rapid turnaround times with the highest level of service and most advanced technologies for your analytical chemical, microbiological, biocompatibility, electrical, mechanical and package testing needs.
Our scientists and engineers have been assisting companies, large and small, with developmental testing for more than 25 years; and our global network of 16 laboratories in North America, Europe and Asia Pacific provide extensive capacity and the highest level of instrument technology with a full scope of testing services.
FPL is an engineering company that prides itself on accomplishing extremely difficult programs in the custom mold design & build, injection, insert & micro-molding medical space. We also offer a wide range of complementary services around our molding; from sub-component sourcing to added value secondary operations (ie pad printing) to vendor managed inventory programs. We are a premier supplier offering top notch quality from prototypes(3D Printing) to full production services with our valued employees, operating in a world class ISO 13485:2018 facility.
Freudenberg Medical is a global partner for the design, development and manufacture of medical devices and components. With 11 manufacturing operations and 1,500 associates worldwide, Freudenberg offers a range of manufacturing capabilities from high precision silicone and thermoplastic components and tubing to coatings, finished devices and subassemblies for catheters and minimally invasive devices.
Our success is driven by an interdisciplinary development process that combines extensive and diverse engineering experience with manufacturable and creative industrial design solutions. We are the leaders in product design and engineering in the greater Boston area. Our logo reflects the culmination of a long research effort designed to distill the core values of our company. The gear exemplifies the technical precision of our engineers while the lower ring symbolizes the vision and innovation of our industrial designers. The center ring bonds the two disciplines together and represents our unique product development process. This proven recipe continues to give our clients the highest standard in on time and on budget product development.
Green Hills Software is the largest independent embedded software provider. With the most safety and security certifications and the best track record for solving embedded problems, Green Hills Software has been leading the embedded world since 1982.
At HealthLink, our mission is to be the number one choice for life science manufacturing companies looking to outsource their logistics and back office services. We achieve this by reducing costs throughout the supply chain and consistently delivering the highest standards in service, quality and efficiency. We are experts in the medical device, diagnostic, human tissue and pharma industry, supporting our clients’ growth in an ever-changing market. Whether you are growing rapidly, changing facilities or switching distribution channels, we seamlessly support your operations throughout the process, in your timeframe.
Integron is an Internet of Things (IoT) Managed Services company that serves the connected health, transportation, and cold chain industries. We manage the complexities of enterprise IoT solutions by offering a comprehensive set of services, technology, and strong vendor relationships across the entire IoT landscape. Our managed services include wireless connectivity, software defined networks (SDN), security, provisioning, device management, and support.
Kacvinsky Daisak Bluni (KDB) is a national intellectual property boutique law firm. Our attorneys are highly qualified scientists and engineers with most possessing advanced technical degrees and real-life technical work experience. Over a third of our lawyers have worked as Patent Office examiners or in-house counsel, including as vice presidents and chief IP counsel of Fortune 100 medical device companies.
In 1953, we were founded as a precision parts supplier for wrist–watch manufacturing in Japan. By the mid-1980s, we expanded our business field as an automobiles parts supplier. Utilizing our proprietary processing technologies, we have effectively captured over 30 % of the global market for electronic–controlled fuel injectors. In 2002, we established a new manufacturing facility in Thailand as the first step in our ongoing globalization strategy.
To achieve even higher levels of precision processing, we have developed a novel material: nanoSUS, ultra fine grained stainless steel. In collaboration with Prof. Thomas J. Webster at Northeastern University, we are beginning to engage with academic and industrial partners within US in order to determine how our materials and specialized manufacturing capabilities can most effectively support the medical devices and instrumentation fields.
Laser Light Technologies is focused on improving the lives of both clients and community with advanced laser micromachining technology. We’re a trusted resource for life sciences, medical device and microelectronics companies, bringing decades of experience to precision laser services and systems.
We use our precision laser systems to manufacture microscopic part features, down to 3 microns in size. We specialize in cutting, drilling, ablation and coating removal, product research and development, and design for manufacturability. We also assist clients moving to in-house manufacturing in developing custom laser systems.
Market leaders are continuously challenged by the search for new product opportunities and the logistics of rapid development to bring innovations to market. With over 25 years of product innovation experience, we are experts at evaluating technologies, identifying opportunities, managing development, and rapidly transitioning to effective production solutions. We meet user needs, solve complex ergonomic and engineering issues, and communicate brand sophistication to targeted markets.
MedAcuity is an ISO 13485-certified custom software engineering firm focused solely on supporting the MedTech industry. Its team of over 100 full-time, senior, Massachusetts-based engineering specialists works with clients on both strategic and tactical levels to clear the most challenging hurdles and accelerate the right products to market. Through its pragmatic “special forces” approach, MedAcuity offers clients unique, practical insight, and predictable, successful business outcomes.
Created in 1979 by the healthcare technology industry, Medmarc’s purpose is to be the superior provider of liability insurance and related risk management solutions and to support the development, testing and delivery of medical products that save lives and improve the quality of life. Through collaboration with our parent company, ProAssurance, and our clinical trial industry experts, we provide a single source of innovative healthcare liability insurance solutions to the life sciences companies we serve. From ideas and prototypes to the reality of commercialization and success – We can Meet Your Changing Needs. Call me, George Ayd (800) 356-6886, to discuss the cost of insurance coverage, what coverages are needed and when, for your business plan.
Every day, MPR’s motivated and talented engineering professionals make a difference in locations around the world. We’re working to solve energy shortages by helping to develop the next generation of technologies and improving the operations of existing power plants, and we’re applying advanced technologies to ensure cleaner air and water. MPR is developing innovative medical devices and biotechnology products that offer solutions to world health problems, and we’re on the frontier of smart technologies, developing innovative improvements to make critical systems more secure.
We design and manufacture high-performance, custom medical cable specializing in product development, concurrent engineering, design for manufacturability and quick-turn prototyping. We currently supply OEMs for pulse oximetry, fetal monitoring, nerve stimulation devices, defibrillators and cardiac rhythm applications, surgical and dental imaging, hearing devices, footswitch cables and robotic prosthetic applications.
Our team of expert design engineers works with customer supplied requirements or specifications to design cables that perform in the most demanding applications—micro-miniaturization, high flex life, autoclavable, low noise, low-elongation, high tensile strength, ultra-flexibility or hybrid cables.
We’ve got you covered! North Grove Enterprise is a Solutions Partner, assisting companies with filling service/product needs. Our list of partner vendors can help with a wide range of solutions options including:
*Product design of implants and instrumentation
*Regulatory and FDA guidance
*Quality systems support
*Intellectual Property guidance
*Full marketing and SEO services
*Contract Manufacturing of prototypes and full production
*Silicone grip rubber handles and screwdrivers
*High quality hand-crafted German instrumentation
*Single-Use products for surgery
*Implant and instrument sterilizing cases and trays
*Full procedure instrument trays for both cervical and lumbar retractor and curette sets
Use your time to what brings you value for your business. Let us do the rest. Our business is growing Your business!
Polaris Contract Manufacturing, Inc., a wholly-owned subsidiary of Lockheed Martin, has been a provider of contract manufacturing for more than 25 years, servicing high technology customers across a diverse set of industries. We serve customers who have higher mix, medium volume requirements for mission critical printed circuit board (PCB) assemblies and full box build assembly. Our full-service manufacturing and component engineering, end-to-end customer order fulfillments, and trusted sourcing affiliation enables quick delivery and ensures reliable parts. ISO13485:2016 Certified
Since 1989 ProMed has been a leading force in the art and science of medical molding to address an industry need for cleanroom molding of silicone components and assemblies. With our primary focus to manufacture components, which have medical applications which are short-term and long-term implantable, that are intricately designed silicone and plastic components. Our innovative processes include molding of components and automated assembly, including assembly of complete devices. Over the years, we have evolved into a full-service provider of molded parts and assembled products, including molded silicone components, bio-material grade plastic components, combination components (incorporating pharmaceuticals) and value added assemblies.
Promenade provides a full suite of software engineering services for medical devices and instruments. From firmware, device applications, cybersecurity, mobile apps and cloud, we have the expertise to efficiently help take our clients to market with exceptional quality. Our extensive code frameworks and tools facilitate and accelerate the development of your product while offering your engineering teams full control, visibility and accessibility to the instrument internals for development, test, and service.
At Propel, we’re building modern cloud Product Lifecycle Management, Product Information Management and Quality Management software to help propel your digital transformation. Whether you’re at an established company dealing with potentially more nimble competitors, or you’re ramping a young startup and scaling your business, Propel’s cloud software can help.
Founded in 1999, the Regulatory and Clinical Research Institute, is a leading strategic regulatory affairs and clinical research consulting firm providing full contract research organization services for medical devices and in vitro diagnostics. The company has built a reputation for designing and implementing innovative regulatory strategies and managing complex clinical trials through application of an integrated, regulatory-centric approach that optimizes compliance, cost and timelines for clients at every stage of medical device development. Our rich breadth of experience spans early regulatory strategy development through post market clinical studies. RCRI’s services include regulatory and clinical strategy, reimbursement, health economics, clinical study design, study operations, biostatistics, data management, regulatory affairs including FDA/regulatory body negotiation and quality systems support and compliance.
RCRI is a medical device and diagnostics focused consulting firm. Each project is uniquely designed to address both the business and product goals within the constraints of a regulatory driven system. Our integrated approach takes into consideration all of the stakeholders across the medical products development process from regulatory bodies to payers and providers.
Slingshot Product Development Group is an award-winning firm delivering product innovation, new product development, and manufacturing services for it’s national clientele. It is driven to create innovative products to enable clients to dominate their markets. It leverages a unique team with core competences in: Science & Technology, Industrial Design, Engineering, IP Strategy, Risk Analysis/Management, Voice of Customer, and Manufacturing Support.
Slingshot’s mission is to help you “Innovate, Transform, and Lead”. Challenge us today!
SMC Ltd. provides contract manufacturing of single-use devices for the healthcare, pharmaceutical, and diagnostics industries. Dedicated to medical manufacturing, SMC provides full product services from initial concept through final packaged device, including program management, design and development, product manufacturing, clinical manufacturing, electronics integration, and global supply chain management. For more information visit:
For over 25 years, clients have come to Sunrise Labs for complete product development and engineering services, leveraging our ISO 13485:2016 certified process. Specializing in Medical Device and Life Science instrumentation development, we are known for solving tough engineering problems and turning novel ideas into commercially viable products. Our client success stories reflect our strength in software, electronics, systems, mechanical and optical engineering practices.
Our project portfolio includes patient monitoring solutions, neuro, surgical robotics, imaging, cardiac, therapeutic, dermatology, IVD, and connected systems. Located one hour north of Boston, we are proud to employ over 75 dedicated employees in a high-performance culture based on engineering excellence, mutual respect, ethics and integrity.
Synopsys helps development teams build secure, high-quality software, minimizing risks while maximizing speed and productivity. Synopsys, a recognized leader in application security, provides static analysis, software composition analysis, and dynamic analysis solutions that enable teams to quickly find and fix vulnerabilities and defects in proprietary code, open source components, and application behavior. With a combination of industry-leading tools, services, and expertise, only Synopsys helps organizations optimize security and quality in DevSecOps and throughout the software development life cycle.
For more information, go to synopsys.com/software
Known as the company that brings medical devices to life, Tegra Medical is focused exclusively on the medical device industry, providing end-to-end solutions from prototyping to full production, and from complex components to finished medical devices. Offering a wide range of manufacturing technologies, the company creates devices used in cutting-edge procedures for leading surgical, interventional and orthopaedic companies. Tegra Medical has four locations in the U.S. and Costa Rica and is ISO 13485 and FDA registered and QSR compliant. Tegra Medical is a member of SFS.
Toxikon is a preclinical contract research organization. We contract and partner with biotech, pharmaceutical and medical device industries to deliver exceptional product development services from concept to final product.
Triple Ring is an imaginative research and development firm that, together with our clients, solves critical, often complex technical challenges. We work across the development process in regulated markets including medical devices, in vitro diagnostics & life science tools, imaging, and industrial applications.
Founded in 2005, our team now includes over 100 experienced scientists, engineers, and market experts. We have worked with over 200 clients ranging from entrepreneurs to large OEM’s both inside and outside the US and completed over 500 projects spanning technology assessments and brainstorming to complete product development.
Vaupell designs, engineers, and produces custom, high performance engineered plastic and composite components and assemblies for demanding applications. We are the global market leader in plastics components and assemblies for aircraft interiors while also serving the broader aerospace, defense, medical, and commercial markets. Vaupell provides engineered solutions to top tier OEM’s, market-leading growth companies, and promising start-ups. Collaboration with our customers in all phases of a the product life cycle results in the highest value solutions that reduce time to market, manage risk and control costs.
At Viant we are more than end-to-end manufacturing partners. We are bringing Lean to life across the product lifecycle, in concert with our considerable resources, to deliver optimal cost of ownership with uncompromised quality and reliability. And more than simply big-company resources, we also deliver small-company attention. Our leadership is imbuing a culture of relentlessly upholding our customers’ reputation for delivering high-quality, high-value devices – a culture of excellence. We have 24 locations worldwide and are well-positioned to serve our OEM partners. For more information, visit:
Vistex solutions provide Life Science companies with a full suite of program management capabilities for pricing, contracts, membership, chargebacks, rebates, partner fees, commissions, royalties, and government programs. These programs can impact margin in ways not easily observed without comprehensive analytics. Vistex solutions help Life Science enterprises to efficiently manage these programs and automate compliance as an integral part of the revenue management process. With Vistex software and service offerings, businesses are empowered with unprecedented visibility into program performance that helps drive revenue, control cost, minimize leakage, and streamline processes.
PracticePoint is a membership-based research, development, and commercialization alliance founded to advance healthcare technologies. The focus is on smart and secure medical devices that interact with the physical world to improve the promise of patient-centric care.
Ximedica is a full-service ISO 13485-certified and FDA-registered medical device and diagnostics product development firm. For 30 years Ximedica has provided a unique growth platform enabling organizations to successfully deploy medical technology products into the market. Its headquarters are in Providence, R.I., with offices in Hong Kong, Minneapolis, San Francisco and Silicon Valley. In November of 2014, SV LifeSciences, a Boston-based private equity firm, acquired a majority stake in Ximedica, enabling the company to execute its growth strategy.
Xometry is the largest online marketplace for custom manufacturing, connecting companies with manufacturing solutions through proprietary AI algorithms. Xometry provides on-demand manufacturing and industrial supply materials to a diverse customer base, ranging from startups to Fortune 100 companies. Xometry offers CNC Machining, 3D Printing, Sheet Metal, Injection Molding and more.