Med-Di-Dia's Presentation On Helix!
Med-Di-Dia has always committed to empowering medical device manufacturers with appropriate product development strategies. Following our parent company's principles (Global Regulatory Services - GRS), we took a step forward with our industry partners.
This year, ON Helix showcased a series of Innovation Workshops from the 7th to the 9th of July. Several companies and experts took part and shared their knowledge and experiences.
Med-Di-Dia’s Innovation Workshop provided insights into 'How Regulatory Compliance in Medtech is a Tool for Success.' As mentioned in the ON Helix programme, this session shared real-life experiences and hints, and tips from people who have 'been there, done it and (almost) got the T-Shirt!’
Dr Oliver Bonner, Medical Devices Researcher – University of Cambridge, spoke about a medical device he has been researching and innovating. This medical device builds a bridge between vital sign sensors and patient monitors in intensive care. The device focuses on reducing the usage of wires and increasing the physical touch between babies and parents.
His contribution to the session highlighted a major landscape shift as until now, the medical device was being tested in an academic setting, but now, things are changing because the product is moving along the road to commercialisation.
Later, Greer Deal – Director – Med-Di-Dia took the baton!
She mentioned the lack of awareness for regulatory compliance and how many manufacturers stay busy with the innovation process and either overlook or avoid mandatory regulatory requirements. The regulatory process begins with defining and classifying the innovation into the correct classification.
Since innovations can be borderline medical devices, it is important to set the basis right and focus on correct classification. Through regulatory expertise and strategic planning, manufacturers can pave a pathway leading to a relatively smooth and successful commercialisation of their product.
Elizabeth Ralph (Liz) – Chief Operating Officer – Afortiori Development focused on the requirement for clinical investigations. Over the years, the requirement for clinical investigations has increased and even more so with the new EU medical device and IVD regulations. Liz explained the increased need for clinical investigations for medical devices because, just like any pharmaceutical pills/tablets, many devices are now far more invasive and therefore, are riskier to use. It’s essential, therefore, for clinical investigations to be an integral part of any plan to develop and market a medical device.
A good clinical investigation starts with spending time in properly planning and designing the investigation. It should be scientifically robust and performed with the appropriate people and in suitable locations.
Greg Thay – Managing Director – Thay Medical took the lead and spoke about the importance and requirement of Human Factor Testing. During his presentation, Greg emphasised the meaning, definition and the need for human factor testing. He says that human factor testing is evolving every day. It is vital to perform this engineering process as it defines the usability of the medical device.
In his presentation, Greg provided some essential and basic tips for the right human factor testing process. You can watch the video by simply clicking the YouTube text at the end of this news feature.
The innovation process takes a lot of time and resources of the manufacturer, and even after combining with regulatory compliance, manufacturers still find it challenging to enter their target market.
Brenda Dooley – Chief Executive – Axis Consulting explained how manufacturers often develop their products obtaining all the necessary certifications but then face significant challenges trying to access their chosen market.
Unlike a step-by-step process, market access is more like a strategic plan with multiple courses and options for the manufacturer to select. Brenda mentioned a simple formula of the “3 Ps”: Patients, Providers and Players, to understand more about the market ecosystem and responsibilities of all players.
This entire presentation was moderated and conducted by our communications officer Jay Shah.
The entire session can be accessed by clicking here: YouTube
Med-Di-Dia continues to raise awareness for ‘all things’ MedTech and provide our clients with solutions.
Feel free to connect with our experts.
Call: +353 (0)91-704804