As more connected medical devices come to market, data and device security is of paramount concern. It is crucial to safeguard and protect customer’s data, security and the functionality of the device by designing with cyber security in mind. This presentation will discuss the cyber security challenges that connected medical devices face, including the new regulatory requirements published by the FDA and Health Canada.
Intertek's "Connected World" solutions help medical device manufacturers address new risks and potential vulnerabilities in their IoT-connected equipment. From cyber security to interoperability, usability and performance, Intertek can help identify and minimize risk to your products, your brand and your customers.
On the one hand we are constantly asked to innovate and evolve but the restraint often comes with regulatory requirements and the combination of new materials and technologies. Silicones have a long and prosperous history in medical due in part to leading bio-compatibility as well as delivering to critical specifications over a wide performance range; from elastomers and adhesives, to liquids and gels to foams.
The talk will give an overview of the silicones that are utilised in the healthcare industry and the benefits, this will include looking at various USP requirements and how silicones can cover a wide range of requirements from extreme temperatures, lubrication, chemical resistance and extractables to meet the most demanding specifications.
For those looking to the future, the latest developments and buzz areas will be covered, identifying how performance can be modified to meet niche specifications demanding conductivity, insulation, adhesion, as well as the plethora of options for processing including how 3D printing is being utilised and some of the common issues occurring in production.
Connected healthcare has benefitted many of us in numerous ways, from remote monitoring to care and support through artificial intelligence. The desire and need for a ubiquitous system that covers all aspects of our health and wellbeing is stronger than ever. Ubiquity however poses significant challenges, in particular at the device, infrastructure, security and data management levels. This talk outlines the major components of a connected healthcare platform, its recent advances and the direction of travel towards a ubiquitous healthcare system.
Smallfry are one of the leading UK Industrial Design and Innovation consultancies. Steve May-Russell Smallfry Managing Director and the elected Chairman of the British Industrial Design Association will host this session on the importance of a sound decision making process, Steve will demonstrate some of the consequences if this is not considered at the very beginning of the development process and will discuss some of the areas that need to understood, there will be case studies detailing how these practices have been implemented to commercialise some of the most innovative Medical Devices.
Digital Light Synthesis™ technology is the breakthrough technology from Carbon Inc that uses digital light projection, oxygen permeable optics, and programmable liquid resins to produce product and equipment parts with excellent mechanical properties, resolution, and surface finish.
Digital Light Synthesis™ has recently taken the spotlight in the dental sector, with Carbon’s specially formulated DPR10 dental resin 3D printing highly accurate dental models approximately 10 times faster than other 3D print or additive manufacturing methods.
Now this revolutionary technology is ready to move into the mainstream medical equipment arena. To support its market development programme, Carbon Inc has produced MP100. This two-component, medical-grade resin that produces isotropic parts with fine features has been specifically designed to enable medical product manufacturers to accelerate product development cycles and improve product quality. Applications include:
• Single use surgical instruments and guides
• Components of medical equipment system, such as covers, guards and adapters
• Drug delivery systems such as inhalers, pill bottles and single-use bio-processing devices
Paragon AM Technologies, a Paragon Rapid Technologies company, offers Digital Light Synthesis™ as a highly efficient, cost-effective medical innovation and production process.
ITERATE is an engineering design consultancy focused on the development of new products. In 2017, the company secured a £1m InnovateUK grant to develop a new 3D printing technology that combined the deposition of polymer and conductive ink within the same build. 3D printing is now considered a viable option of manufacturing products in medium sized quantities; the introduction of conductive tracks potentially replaces the need for copper wires, enabling functional electro-mechanical products to be produced within a rapid time-frame. One area that this has been successfully realised is in the design of sensor-controlled prosthetics, which are more cost effective, light weight and adaptable than traditional alternatives.
At least one third and potentially up to two thirds of all reported adverse incidents with medical devices (including stand-alone software devices) can be linked to use and usability errors. Device regulators are increasingly requiring new devices to demonstrate usability along with existing safety and efficacy requirements. International standards have been developed (ISO/IEC 62366) to support the testing of device usability with the ultimate goal of generating a summative report to be included in the technical file.
This presentation will explore the challenges set by implementing testing to ISO/IEC 62366 with real users in a realistic environment but not on real patients and then look at the implementation of “real world” usability studies could play in the accelerated uptake of new technology into the NHS and other healthcare systems.
International law firm Bird & Bird LLP is renowned for its Life Sciences and Intellectual Property expertise. It has led the way in protecting the ideas and technology that have made some of the world’s greatest companies successful. Attend a session hosted by leading experts from the team who will guide you through key topics crucial to the Med-Tech world, including:
• IP Protection – Tailoring IP protection strategy for Med-Tech products.
• Regulation – Key points for keeping up with the changing regulatory and technological environment.
• Digital Med-Tech – Special considerations for the new generation of connected Med-Tech.
The evolving improvements in the processes, materials, partnerships, and resources available for medical device R&D are promising--but can be hard to align with the the fundamental mechanical design processes. The speaker will review current and emerging capabilities available from key sources. These offerings will be focused on speeding the process of development for designs ranging from the most traditional to the most cutting edge, providing the 7 key things to know about this critical topic. Highly recommended for early-stage companies and entrepreneurs.
Andy Tibbs will show milestones along the Boddingtons journey in becoming a trusted and expert international supplier of medical mouldings and services.
His presentation will include:
Visual and video material – including the project management and creation of the company’s purpose built £4.6m facility incorporating a dedicated Class 7 cleanroom for the production of Class 1 and 2 medical devices.
101 Class 7 Cleanroom moulding – showing the investments (time, resources, personnel) required - a typical spread of work done – and some special added-value services.
‘The extra mile’ – how the company manages to service the multifarious needs of the med-tech sector, with a special emphasis on its assembly work and related services such as printing, packaging and despatch.
Administration, standards and paperwork. How Boddingtons takes on the management of all regulatory, standards and ‘red tape’ work for clients, together with all technical evolvement of designs and prototypes. How both processes combine in the company’s gated product introduction methods; reducing client risk and maximising opportunity.
Marketing med-tech. How Boddingtons has supported its med-tech manufacturing strategy with related and focussed marketing activities in terms of company communications and exhibition and seminar work.
In the case of stents, package integrity testing is of crucial importance. It assures the package barriers are intact and will protect the product from environmental contamination for its shelf life. Taking the right approach to establish package quality testing protocols and implementing the proper test method is no longer an option but is necessary to reduce patient or consumer risk by delivering high-quality, defect-free packaging.
Regulatory oversight by the FDA has increased with the emergence of combination drug devices. Regulatory expectations within the medical device industry are tied to the advances and requirements realised within the pharmaceutical industry.
The USP 1207 was rewritten to re-establish requirements and expectations with regard to testing sterile barrier packaging. The FDA uses the USP 1207 as a guide to relevant methodologies that can be deployed for package integrity testing. The FDA uses the same bar of risk based assessment and suggested methodologies listed in the USP 1207 in regulating combination products.
The discussion will encompass package integrity testing, USP 1207, and regulatory shifts to come.
A great place to engage with innovators and stakeholders across the innovation landscape.
A well organised exhibition that generated plenty of foot fall. We would happily support Med-Tech Innovation Expo again, and look forward to the relocation to the NEC.
We met several companies who gave us interesting and knowledgeable information which will assist us in our future product and manufacturing decisions.
Great show for presenting our company to the medical device marketplace we had plenty of interesting conversations which am i sure will convert into business opportunities.