Accumold® is a high-tech manufacturer of precision micro molded plastic components with part geometries from 5cm to less than 1mm in size. Processes include: insert molding, clean room molding and 2-shot molding. Materials include: PEEK, Ultem, LCP, and most engineered thermoplastics. Markets include: Micro Electronics, Medical, Micro Optics, Sensors and other emerging technologies.
The MedTech Conference is your opportunity to connect with thousands of medical technology professionals in one place, at one time. Join us in Philadelphia for business development, innovative technology, and networking with 3,000+ policymakers, business executives and industry leaders.
Alira Health simplifies the complicated journey that is the healthcare and life science product and corporate lifecycle. With us, you get a full spectrum of advisory support to help you overcome your strategy, execution, and innovation challenges from one dedicated partner committed to your best outcomes. We respect the journey that life science and healthcare innovators and market leaders must take. We’re committed to helping our clients arrive at their destination with confidence and a competitive advantage.
We’re on a mission to grow healthcare and life science innovation companies. Alira Health partners with clients to identify the best roadmap for advancement and goal realization. We provide the right financial, scientific, clinical, and marketing tools to empower their ideas, implement their strategies and succeed at every turn.
ALKU is a highly-specialized consulting firm that provides FDA Compliance and Remediation staff augmentation services exclusively within the Medical Device and Diagnostics industry. ALKU’s core competencies include Quality, Validation, Regulatory Compliance, and Project Management consulting services.
Our expertise in medical products and healthcare comes from nearly thirty years of serving the world’s best-known companies, as well as emerging ventures, in medical devices, diagnostics, life sciences, pharmaceuticals and healthcare delivery. Our team has advised innovators in nearly every clinical specialty. Clients trust us to execute high-quality market research for healthcare markets that informs global product strategy, design and marketing decisions. We deliver actionable insights to help you better understand clinicians, administrators, payors and patients, leading to improved patient outcomes, more satisfied providers, and better financial returns. Rely on our experts to create innovative medical products and distinctive patient and clinician experiences.
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.
B. Braun’s OEM Division delivers complete contract manufacturing capabilities focusing on fluid administration and admixture products, kits, valves, catheters and interventional accessories. In-house services include product development, laboratory, design, prototyping, tooling, molding, validation, manufacturing, packaging, sterilization, quality control, private labeling, regulatory guidance and supply chain management services.
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.
A $6B global provider of product lifecycle solutions, Celestica drives enhanced quality and competitiveness for some of the world’s leading healthcare companies. We specialize in solutions for high-reliability applications from design and manufacturing through to delivery and after-market support. With focused expertise in complex electro-mechanical systems and ultra-high volume automated finished goods manufacturing for single use devices, Celestica helps our customers accelerate market entry, reduce total cost and advance healthcare technology to improve patient care. We also specialize in advanced solutions for surgical instruments, in-vitro diagnostics, and imaging and patient monitoring. Through our certified Healthtech Centers of Excellence network and enterprise-wide global quality system, we ensure flawless execution in compliance with the most rigorous quality standards.
We strive to help accelerate and simplify the product development and FDA approval process. We offer custom compounding to achieve a wide range of colors utilizing pigments listed under the FDA 21 CFR 73 Subpart D colorants exempt from certification in medical devices.
The Trade Commissioner Service (TCS), part of the Government of Canada, is a network in 161 offices around the world and across Canada. Trade Commissioners provide Canadian business and innovation clients with practical advice, on-the-ground intelligence, and connections to help them achieve their global goals. Our team of nine Trade Commissioners in Consulate General of Boston work along sector lines and manages the CTA. Our priorities align with what New England has to offer and where Canada has strengths: life sciences, IT (AI, clean tech, digital health), agriculture (including food tech), consumer and retail, aerospace and defence, robotics and ocean technologies.Trade Commissioners work with businesses in New England by making connections to Canada, driving value and innovation to the region.
CPSL Language Services, is one of the longest-established LSP in the translation and localization industry, having served clients for over 50 years in a range of industries including: life sciences, energy, machinery and tools, transport, software, telecommunications, financial, legal, electronics and government. We are among a select number of language service suppliers that are triple quality certified, including ISO 9001, ISO 17100 and ISO 13485 for medical devices.
DAVIS Companies delivers staffing and workforce solutions to global Medical Device and Life Science companies. We leverage our 30+ years of industry experience and expertise to provide solutions for companies whose goal is to attract, engage and retain talent giving you a competitive advantage. We specialize in contract and direct hire professionals for all phased of the product development lifecycle including for Quality, Validation, and Project Management roles.
Design Concepts is a full-service product design and innovation consultancy with offices in Madison, Wisconsin, San Francisco and Boston. We design products, services and experiences that drive business success and improve people’s lives. Our process has been tested and refined through the completion of more than 2,700 projects for over 400 clients. Our research, design and engineering services deliver world-class strategies, physical products, digital products and services to clients in the healthcare, commercial and consumer industries.
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.
The critical advantage EAG brings to you is our exceptional range of multi-disciplinary scientific expertise. This enables companies like yours to utilize the power of EAG science across every stage of your product life cycle. This results in a seamless, holistic view of your entire initiative – bringing great efficiencies and product benefits that are far superior to a fragmented approach using different partners with disparate methods.
Enercon can help turn your ideas into profitable new products by offering comprehensive Product Development, Contract Manufacturing and value-added services. From state-of-the-art ISO-certified facilities in Maine, they can meet any or all of your contract manufacturing needs, from product design and engineering, through prototyping and volume manufacturing, to distribution, inventory management and service depot support.
EXB Solutions, Inc. (EXB) is an engineering services company focused on systems engineering and testing for safety and mission-critical software and systems. We are a Service-Disabled Veteran-Owned Small Business (SDVOSB) in the aerospace, defense, medical, critical infrastructure, and high-tech marketplace with over 14 years of performance history
Since 1999, Fang Consulting, Ltd. has provided specialized Regulatory Affairs consulting, Quality System consulting, Clinical consulting, as well as device fulfillment, primarily for the medical device industry. Our team is comprised of principal, senior and junior consultants who have a working knowledge of and expertise in the most current global regulations and certifications and work closely with global government agencies. Visit www.fangconsulting.com to learn more about our services.
At Fisher Unitech, we are changing the way companies innovate and create new products. We are one of the world’s largest technology provider of 3D design software tools and 3D printers. We are on the cutting edge of a changing and explosive technology. We make innovation possible and help to advance manufacturing with our solutions.
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.
Source Consulting LLC is a consulting group, started with data driven and managing data with data metrics for various organization. We are based in Massachusetts and helping our trusted clients since 2005. We provide our clients with Medical Device consulting, R&D / Product Design/ Manufacturing / Quality and Regulatory Compliances / Remediation. We leverage our knowledge of current GxP requirements to provide cost-effective solutions to life sciences organizations. Our Vision is to providing world class technology services economically and exceeding Customer expectation on Quality & Time. Our Technical expertise in Regulatory , Quality and Engineering allowed our customers to maintain current state of compliance while bringing continuous innovation in products to ease patients life. We help our customer to ensure their product are MDR compliance to sustain the product in the market.
Leading law firms and companies choose Global Prior Art to empower well-informed, successful decisions surrounding patent litigation, product clearance (FTO) and planning, licensing and acquisition due diligence, IP portfolio construction and business opportunity assessment. Global’s technical specialists provide proprietary visualization tools that allow our clients to leverage critical information typically buried in thousands of patent documents. Global Prior Arts enables its legal clients to offer sound opinions based on comprehensive and accurate searches.
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.
Health Advances is a strategy consulting firm that focuses exclusively on the healthcare industry. We are scientists, clinicians, and business professionals who share a passion for supporting commercialization and driving adoption of innovations that improve healthcare. The firm employs ~150 full-time professionals to help clients realize growth opportunities worldwide for healthcare technologies, products and services. Our consultants partner with senior executives and investors on their highest-stakes strategic decisions. We not only understand the complexities of each technology and disease state, but also appreciate the client’s context within the entire healthcare ecosystem.
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.
As a full-service medical imaging core lab, we provide comprehensive services in support of Phase I-IV Clinical Trials and Class I, II, III Medical Device Trials. Our team consists of more than 80 full-time, board-certified, fellowship trained radiologists and more than 250 consulting radiologists and key opinion leaders. We have sub-specialization in all therapeutic areas including Cardiovascular, Metabolic & Pulmonary, Gastrointestinal & Genitourinary, Medical Device, Musculoskeletal, Neuroradiology and Oncology. More specifically, we provide comprehensive medical imaging core lab services including overall leadership, project management, imaging charter development, image acquisition protocols, imaging site qualification training and management, patient scan transfer and quality control and radiology review. We serve as the “central reader” during clinical trials.
Jordi Labs was founded in 1980 to provide the highest quality analytical services, polymer-based HPLC columns and packing media in the industry. Today, we are worldwide leaders in extractable & leachables testing, particulates & residue analysis, polymer analysis and more. Jordi Labs provides contract analytical services with a special emphasis on chemical identification and liquid chromatography products. As a family company, we take pride in the production of all of our products and analytical service offerings. Customers in nearly all industries are currently using our columns and packing media products worldwide. It is our goal to help our customers overcome their analytical challenges by providing excellent products and personal assistance from our highly trained staff.
Keystone Solutions Group is a West Michigan-based product development and medical device contract manufacturing company. Since 1997, the company has collaborated with customers around the world in the aerospace, automotive, and medical device industries to design, develop, test. and manufacture a wide range of products. Keystone’s operation is FDA registered and ISO13485:2016 certified and provides assembly, kitting, packaging, and sterilization management services for single-use disposable and reusable medical products.
Legit is the AI-powered system of record for medical device R&D. The platform uses machine learning and proprietary natural language processing technology to deconflict and coordinate R&D projects and spend across enterprises, identify potential device defects at the ideation stage, predict how closely aligned R&D projects are with customer requests, and provide unprecedented realtime transparency into R&D spend and efforts.
Legit was created in 2016 in MIT’s Computer Science and Artificial Intelligence Lab and partners with Fortune 1000 medical device companies as well as early stage companies working in medical technology.
The Massachusetts Medical Device Development Center (M2D2) is a lifeline for the state’s smaller medical device companies, offering inventors and executives easy, affordable, and coordinated access to world-class researchers and resources at the UMass Lowell and the UMass Medical School campuses of the University of Massachusetts.
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 80 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.
Medidata is leading the digital transformation of life sciences with the world’s most-used platform for clinical development, commercial and real-world data. Powered by artificial intelligence and delivered by #1 ranked industry experts, the Intelligent Platform for Life Sciences helps pharmaceutical, biotech, medical device companies and academic researchers accelerate value, minimize risk and optimize outcomes. Medidata serves more than 1,000 customers and partners worldwide and empowers more than 100,000 certified users every day to create hope for millions of patients. Discover the future of life sciences.
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.
Minnetronix is a medical technology and innovation company with deep expertise in electronic and electromechanical devices. Founded in 1996, the company creates new technologies and therapies that solve unmet clinical and business needs for patients and medical device companies. Minnetronix is FDA Registered and ISO 13485 Certified.
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.
NAGLREITER Medical Device Development Organization (MDDO) is a trusted partner for concept incubation, design, development and manufacturing engineering services within the Medtech industry. NAGLREITER prides itself on providing world-class services and employing a uniquely flexible business model to do so. NAGLREITER’s ‘The Right Path. With You’ business philosophy exemplifies the company’s commitment to partnering with clients in any way they require to yield the best possible outcomes. Based in the Ft. Lauderdale area in Miramar, Florida, NAGLREITER partners with medical device companies within the U.S. and abroad
NAMSA is a Medical Research Organization (MRO), accelerating medical device product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines – consulting, regulatory, preclinical, toxicology, microbiology, chemistry, clinical and quality – to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements anywhere in the world. NAMSA operates 13 offices throughout North America, Europe and Asia, and employs over 1,000 highly-experienced laboratory, clinical and consulting Associates.
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.
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.
Proven Process Medical Devices(PPMD) is a contract engineering and manufacturing company solely focused on the medical device and life sciences industries. PPMD development teams utilize a well developed process to manage the whole life cycle of a product for very large OEM’s and the many start-ups integrating exciting new technologies into cutting edge products. Our teams of mechanical, electrical, software and quality engineers design and build devices that assist clinicians to improve their patients healthcare outcomes. Our goal is to provide the expertise and capabilities that will drive our customers to success.
PTC helps companies around the world reinvent the way they design, manufacture, operate, and service things in and for a smart, connected world. In 1986 we revolutionized digital 3D design, and in 1998 were first to market with Internet-based product lifecycle management. Today, our leading industrial innovation platform and field-proven solutions enable you to unlock value at the convergence of the physical and digital worlds. With PTC, manufacturers and an ecosystem of partners and developers can capitalize on the promise of the Internet of Things and augmented reality technology today and drive the future of innovation.
Qosina is a worldwide supplier of thousands of stock OEM components including bioprocessing accessories, compression fittings, ENFit™ connectors, luers, clamps, clips, check valves, stopcocks, hemostasis valves, tuohy borst adapters, swabs, spikes, syringes and tubing to the medical and pharmaceutical industries. Qosina offers free samples, low minimums and just-in-time delivery. Purchasing from Qosina saves you time and money by eliminating tool costs and providing immediate delivery of in-stock solutions from our ISO 9001, ISO 13485 and ISO 14001 registered facility. Whether you need molded or extruded components, high value plastic or metal, sub-assemblies, tubing or packaging, we can modify any existing component or build new tooling to meet your exact specifications. Contact us or visit qosina.com to view our extensive line.
Qt Group is a global software company with a strong presence in more than 70 industries. QT is the platform of choice for medical devices, in-vehicle systems, industrial automation devices, and other business-critical application manufacturers. QT is used by major global companies and developers worldwide, and the technology enables its customers to deliver exceptional user experiences and advance their digital transformation initiatives.
RCRI is a leading provider of strategic consulting and integrated clinical trial services to the medical device, IVD, biologics, and combination product industries. For more than a decade, RCRI has been turning medical product concepts into successful, revenue-generating businesses for clients worldwide. More than 450 companies – from entrepreneurial start-ups to Fortune 100 market leaders – have experienced the value of RCRI’s expert insights.
Regulatory and Quality Solutions LLC (R&Q) is the industry leader in providing regulatory and quality consulting and engineering to medical device companies. From strategy to tactical implementation, R&Q partners with clients by providing balanced solutions and hands-on support that enhance the commercialization and post-market processes for medical devices.
Steri-Tek is the San Francisco Bay Area and Silicon Valley’s leader in E-beam sterilization and X-ray irradiation for complex products and sensitive materials. Steri-Tek offers irradiation sterilization services to the Medtech, Biotech and food/drug industries, academic institutions and technology businesses, for a variety of materials and combination devices including medical device, biologic, pharmaceutical, cross-linking/materials modification, and food/agricultural products.
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.
The UL Life & Health Sciences division is dedicated to healthcare industry innovation. We help clients with their biggest challenges in regulatory management, market access, and connected device risk i.e. safety, security, usability, and interoperability. We ensure that medical devices are safe to deploy and use in an increasingly patient-centric and connected environment. UL brings decades of the most advanced technical, regulatory and clinical expertise to solve the toughest challenges in the market with the goal of improving access to advanced safe healthcare around the world. Our technical experts and biomedical engineers each average of over 10 years’ experience and are active members of industry standards writing and technical committees. Throughout the UL family of companies, we offer services that life and health sciences companies need for business success and improving patient outcomes.
We innovate and manufacture miniaturized and high-precision complex products for our worldwide medical device partners. Our customers are leading suppliers of active implants, medical-grade wearables as well as medical and portable medical equipment. Our activities also cover advanced industrial assemblies, another field where our expertise and sense for innovation are appreciated the world over. For over thirty years, we have helped hundreds of companies develop and produce Class II & III medical devices as well as advanced miniaturized electronic assemblies. Headquartered in Switzerland, our company spreads over three continents with design, development, industrialization and manufacturing sites in Switzerland, the United States and Morocco and employs more than 350 employees worldwide.
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.
Velentium offers world class expertise in software, usability, cybersecurity, electrical, and mechanical development for medical devices. Our decades of experience, solid program management and systems engineering will ensure the success of your product.
WuXi AppTec partners with medical device manufacturers, guiding you through the often complicated regulatory process to successfully execute your project. We have supported hundreds of thousands of devices with the strategies and testing needed to gain global market access, avoid costly delays and support changing requirements throughout a product’s lifecycle. Whether your device requires minimal testing or a complex customized program, our team will outline and execute the optimal strategy necessary for regulatory compliance, leveraging decades of accumulated knowledge gained from hands on experience and serving on international standards committees.
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.