The Covid-19 pandemic has presented a time-limited but immense window of opportunity for diagnostics companies. Changes in regulation and increased levels of investment are enabling radical innovations to have real impact, but only if they can be fast-tracked into new products which are cost effective and compelling to users. In…
James Baker, partner at Cambridge Design Partnership, considers the future for AI in the real world with help from a sideways look at its portrayal on the big screen.
It may seem like there is plenty of time before the new IVD (in vitro diagnostics) regulation (IVDR) [EU 2017/746] comes into effect. The deadline for transfer is 2 years later than that for medical devices [EU 2017/745], so May 2022 might seem distant. However, given the changes that are…
RAPS (Regulatory Affairs Professionals Society) publish a set of excellent “Fundamentals” books, each covering a different regulatory context: US, EU, Canadian and International (which covers other markets), (see here). These books detail the key aspects of the regulations for pharmaceuticals, medical devices and IVDs (In vitro diagnostics) with considerations about…
Women are still hugely under-represented in STEM (Science, Technology, Engineering and Mathematics) careers. Only 22% of the UK STEM workforce is made up of women according to a 2018 study. In Engineering specifically, the stats are worse: only 12% of all professional engineers are women. Here at Cambridge Design Partnership,…
The challenges of bridging the ‘design transfer chasm’ are well known in the medical device industry. If your approach to design and innovation has not fully anticipated the intricacies of volume production in a regulated environment, then difficulties will arise when it is sent to your manufacturing partner to be…
The Drug Delivery and Formulation Summit held in Berlin from March 12-14th offered a great opportunity to catch up on the current state of the industry. As a panellist in two sessions at the conference, here are the key regulatory insights I took away. The impact of changing regulations The…
Highlights from Martha's keynote talk centred on the belief that innovation happens where consumer insight, technology enablers and business opportunities coincide.
For the last decade I have been part of the medical devices industry, most recently as part of a design consultancy firm specialising in medical device innovation. In the last few years our world has been shaken with reports of the failure of medical device implants and the insinuation of…
This article was first published on Drug Development and Delivery.“Those who expect moments of change to be comfortable and free of conflict have not learned their history.” For many involved in the medical and pharmaceutical industries within the last few years, this quote – attributed to American historian Joan Wallach…
More than a year has passed since 25th May 2017 and the start of the three-year transition period from the Medical Devices Directive (93/42/EEC) and Directive 90/385/EEC on active implantable medical devices (AIMDD) to the Medical Devices Regulation (EU 2017/745).But what does this mean for businesses with products currently on…
Hardly a week goes by without the press or social media picking up on a story, often accompanied by dramatic video, of batteries overheating and even in some cases ‘exploding’ in a consumer product – raising serious concerns about product safety among both consumers and manufacturers. In reality, these incidents…