iDE8: A Helping Hand in the Convoluted World of Medical Device Regulations
David Howarth, Founder
In the summer of 2015, David Howarth withdrew as the R&D manager from the medical device corporate and startup landscape that he was a part of for 13 years. With such experience in the development of medical devices, it was safe to say that Howarth knew the ins and outs of his domain. While this experience proved to be overtly beneficial in helping the business edge further, it also allowed him to reflect on the shortcomings that his team witnessed while working in both corporate and startup R&D environments. The most glaring one was the shortage of skill to manage medical devices, from their concept design to their validation and CE marking. The second was the ludicrous operational expense involved in developing and training an in-house team. Even if consulting agencies could cover the charting of concepts involved in creating these devices, they found themselves entangled in the multiple ISO and other regulatory standards that demanded high quality in medical devices. Howarth decided to not only help struggling medical device manufacturers surmount these hurdles, but also educate them on the processes involved to carry out their own R&D. And thus, iDE8 was born.
iDE8 tackles their clients’ issues on two fronts—as an outsourced quality department and as a manager to design and develop R&D functions. When manufacturing medical devices, the company adheres to quality and regulatory requirements not just as add-ons, but as an integral part of its R&D. “We’ve built the company around services that monitor quality but also provide R&D to be on par with every new medical device regulation in the industry,” says Howarth. The experienced team at the company works as a reliable external partner or as an addition to the client’s team, to reduce their operating expense and trim down on the overheads associated with hiring and training a new workforce.
We’ve built the company around services that monitor quality but also provide R&D to be on par with every new medical device regulation in the industry
“iDE8 is built to take quality risks and alignment to all international standards at its core,” continues Howarth.
Soon after the company’s inception, Howarth received significant investments to scale the business into a large organisation. Giving in to better judgment, he decided to stick with the current business model and ensured that all internal processes were in line with the customers’ needs. Even four years after the company’s inception, the iDE8 team have never ceased in their efforts to refine their R&D processes and surpass the quality demanded by ISO standards. The company’s niche specialisation in design verification and design validation within R&D proves invaluable to the medical device industry where, traditionally, companies only build the product, but skip out on the checks and validations needed, due to the lack of an efficient quality assessment system.
One such scenario was highlighted when engaging was a client that required iDE8’s expertise in providing design validations for 40 different instruments. With newly revised Medical Device regulations (MDR) on the horizon, the client needed a continuous improvement revision to their entire design portfolio. iDE8 provided the necessary quality checks and design validation services within just six months. Now, iDE8 has partnered with the client as a quality consultant that checks for regulatory compliance on an international level, provides continuous improvements for the client’s operations, and keeps track of current manufacturing methods to sustain and improve production.
In light of the Covid-19 outbreak, iDE8 has rolled out a range of quality management packages to provide remote quality management to companies around the globe. The range of quality management solutions are tailor-made to meet the specific needs of clients. Their R&D and Quality solutions built under a B2B model, helps alleviate the pressure of recruitment and staff onboarding by outsourcing its seasoned team for the clients’ disposal.
Description iDE8 is a medical device development company that provides technical engineering and quality services and specialises in point of care diagnostic technology. iDE8 develops and manages their clients’ medical products to meet the needs of the patient and the business. From development to quality management and operations, iDE8 has cost-benefit solutions on offer. iDE8’s services and solutions stretch from concept development to CE submission to working with senior stakeholders and internal project teams to deliver a solution that meets the customer’s need
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