MEDTEC Ireland, Ireland’s premier trade fair for the medical device manufacturing industry, will feature, in addition to scores of companies exhibiting sector-specific products and services, an extensive two-day conference programme and four workshop-style tracks. “Whether you’re focused on product development, regulation, quality and risk control, or manufacturing, the sessions will provide an ideal platform to learn more about and master the challenges in developing and bringing to market a medical device,” says Dina Marden, Conference Manager Europe, UBM Canon. “If you are in R&D, product development, general and corporate management, manufacturing, or regulation and quality, you should definitely make it a point to attend,” she adds.
Designing medical devices for humans
The two-day MEDTEC Ireland conference will cover such far ranging topics as regulation, orthopaedic and medical device design, product development for medical device start-ups and risk management in accordance with EN ISO 14971:2009.
In a presentation titled “Designing Medical Devices for Humans” on the first day of the conference, Steve May-Russell, Managing Director of industrial design firm Smallfry, will look at why medical devices that have been designed around user needs will achieve better compliance.
“Noncompliance is a major obstacle to the effective delivery of healthcare,” says May-Russell. “More people [than ever] regularly rely on prescribed medication but many are failing to take it as directed.” He says that failure to follow treatment as directed leads to a significant drain on healthcare resources. For instance, noncompliance of diabetes treatment could result in a patient being hospitalised for nerve damage or kidney failure. “It seems obvious that if a device is easy to use it will have a huge impact on patient acceptance, dosage compliance and, ultimately, health outcomes,” he notes. “This means that patient experience should be a primary focus in the development of devices. As with consumer products, we don’t just buy things for what they are, we buy them for what they do for us on an emotional level.”
There are a number of medical devices currently in development at Smallfry, including a product for people living with Parkinson’s disease. “Designed with the user in mind, this drug-delivery system helps destigmatise the disease as it looks more like a consumer product than a medical device,” May-Russell explains. “If device manufacturers want to enhance the compliance of their devices, they need to start the design process by looking at the user—the patient. Essentially, if the device enhances the user experience, fits better into the patient’s life and has less of a stigma attached to it, there is a greater chance it will be used. The end result will mean happy customers, and a manufacturer who has gained a competitive edge in the marketplace,” stresses May-Russell.
Nicholas Duggan, Innovation Expert at Viadynamic, who will be chairing the conference on day two, will start the day with his presentation, “Accelerating and De-Risking a Medical Device Start-Up Business.” Duggan will provide an overview of how to define the product and develop a plan. “I will cover how to define the “problem worth solving,” build the right team, target meaningful milestones and drive to delivery,” he says. “Perhaps most important of all, I will explain how to package and communicate the output to maximise value realisation. The presentation will enable medical device companies to appraise how fit for purpose their innovation processes and tools are,” he notes. “It will help innovation teams—whether in a start-up or corporate environment—to work more efficiently and effectively to make their innovation happen,” adds Duggan.
In addition to the conference, two full days of in-depth workshops featuring four different tracks will educate attendees on important topics such as medical device regulations and reforms in the United States and Europe; building effective design, validation, and product approval processes; and risk management for medical devices.
The first track on day one will provide an in-depth analysis of both the 510(k) and CE marking processes from a variety of perspectives, focusing on reforms likely to occur in the coming year in the United States and Europe. Miriam C. Provost, PhD, a senior consultant specialising in medical devices with Biologics Consulting Group Inc., and Mika Reinikainen, who has recently set up his own medical device consulting company, Abnovo Ltd., will chair this session.
Provost will open the track with her presentation, titled “Anticipated Changes to the 510(k) Process.” Proposed changes and their potential impact on medical device development, including the determination of substantial equivalence and preclinical testing requirements, will be reviewed. “Many changes are expected for FDA’s 510(k) programme in the coming years,” Provost says. She notes that the agency has done its own internal assessment and announced an action plan for implementing modifications to the programme. The Institute of Medicine has issued its own report calling for US FDA to abandon the 510(k) programme entirely, she adds. “In this environment, it is likely that there will be an increase in the requirements for preclinical and clinical testing of new devices as well as more scrutiny by FDA of innovative devices,” Provost explains. “It is more important than ever for medical device developers to stay informed of evolving regulatory requirements.”
The second workshop track will provide design, manufacturing, process development and regulatory/quality systems professionals with the knowledge needed to comply with design and process validation requirements while offering information on how to implement an effective validation programme.
The third workshop, which starts on day two, will be devoted to understanding the total product life cycle. This workshop will take participants through the US FDA approval process, touching on IP considerations during product development, do’s and don’ts during the preclinical evaluation process, and regulatory and clinical considerations.
The fourth and final track will cover risk management concepts and terminology and provide an understanding of regulatory considerations.