Tag: Quality & Regulatory Affairs

Handling personal information, a salutary tale from the IOT

March 17th 2017

James Baker 

Connectivity is a reality, it’s part of our daily lives, and the ‘quantified self’ is a recognised phenomenon be it through wearable health and activity trackers or your smart phone.  The personal information created must be taken seriously, and developers must not only deliver a great user experience but also consider the end user’s privacy as well.

Failure to take a considered approach can have dramatic consequences – witness the recent news story regarding We-Vibe1. The Canadian manufacturer launched a revolutionary adult toy incorporating Bluetooth connectivity that enabled users to control the device remotely with their phone. This was their USP, as it ‘allows couples to keep their flame ignited – together or apart’, but it appears the manufacturer also collected data on user’s habits. A security breach resulted in a class action in the Illinois federal court that ordered the company to pay a total of C$4m to customers whose data was compromised. It seems the poor security within their system allowed third parties access to personal information or even to control the devices themselves.

This story illustrates how privacy and security must be incorporated into the product development process from the outset to avoid costly and embarrassing (in more ways than one) ramifications once a product gets to market.

This is where medical device thinking is in advance of consumer products. Health information is considered private and privileged so it is closely regulated and only the unwary will develop systems and services without considering these regulations as they have real teeth. The Health Insurance Portability and Accountability Act (HIPAA) in the US governs how medical information is transferred, maintained, secured and utilised and the regulator can issue company fines plus company officers can face jail for up to 10 years. In the EU, its ISO27001 and the forthcoming European “General Data Protection Regulation” that mandate how personal electronic data is to be managed.  It allows the regulator to impose a maximum fine of 4% of the total worldwide annual turnover of the preceding financial year for an offence.

While these penalties are a backstop, as I have mentioned in other articles, regulations and standards are not just inconvenient hurdles but useful sources of information to guide product development. They can be examined and distilled early in the planning process for any connected system across which information is transferred. Complying with the standards is achieved by implementing an effective strategy that ensures the system is designed and tested well.

With the correct handling of personal information the benefits of connected products can be fully realised. Consider for example:

  • In the medical arena: Monitoring delivery of a therapy over time and correlating this against outcomes enables more effective interventions. Some are even closing the loop and linking delivery to patient monitoring, in effect updating a prescription in real time, automatically.
  • In user studies: The ability to instrument products and investigate how users actually use them as part of their daily lives combined with the ability to monitor outcomes over extended periods will allow manufacturers to develop devices devices that meet user needs more effectively.
  • In social media: While some information must always be confidential, in the age of social media many consumers are happy to share much more than you might expect. In sports this enables virtual competitions amongst groups or peers. Possibly a dubious feature for adult toys…

Seriously, each one of these examples can provide demonstrable benefits to both users and businesses but also the opportunity to violate privacy if the data generated is not handled correctly.  The moment data can be tied to an individual, it becomes ‘privileged’ or ‘private’ and must be protected.  Anonymisation of data may seem like a simple solution to these concerns – but of itself will not satisfy the regulations on two counts:

  1. Big data techniques are evolving apace with the ability to generate data. Whilst single data elements may be anonymised, analysis and correlation of multiple data streams and sources can be used to identify and ‘re-attach’ anonymised data to individuals.
  2. Much benefit is lost when the data is no longer tied to an individual because in general, examining usage patterns and interactions can lead to better understanding of user needs and better products.

Ultimately, we believe it is best to embrace the need to handle privileged information in a considered, measured and compliant fashion. This realises the commercial benefits of connected systems, serves as a barrier to entry to those unwilling or unable to take that step in a responsible fashion, and ensures the consumer stays in control whether in the bedroom or not!

  1. We-Vibe vibrator tracking users sexual habits
Ryan N triathlon pic

Meet Ryan: Our senior Quality Specialist

February 22nd 2017

Meet the team at Cambridge Design Partnership – a brief profile of the experts, engineers and interesting people that work here. This month we’re talking to Ryan Noble, a senior quality specialist.

What was your background prior to joining CDP?
I spent 16 years at a large international pharma company, working in various different departments — from drug product development through to combination device development.

What drew you to CDP?
I was looking for an organisation that would give me an opportunity to explore a wider range of projects across the medical industry and use my experience to have an impact on their success. I was also looking for the opportunity to work in other industries. CDP works across a number of industry markets at all stages of the innovation process — from front-end research through to transfer to manufacturing. It seemed an excellent place to get involved with.

What’s your formal education and training background?
I have a degree in Applied Chemistry, I’m an APMP-certified project manager, auditor trained and GMP (Good Manufacturing Practice) experienced. To enable the development of drugs and devices into combination products, I developed and implemented a quality management system compliant with ISO 13485 for medical devices for a pharmaceutical organisation. I’ve also written several regulatory documents for product submission.

What are you working on at the moment?
Since the combination product ruling by the FDA (Food and Drug Administration), I’m doing a lot of remediation work, trying to bring existing/developing combination products up to standard for the requirements. Before the final rule was published by the FDA in 2013, there was no clear guidance on how to integrate medical and drug products quality systems e.g. historically an injection system would have been considered as a container closure system under GMP, with no appreciation for medical device quality system regulation. The recent FDA final guidance on Current Good Manufacturing Practice Requirements for Combination Products clarifies this even further.

What does a ‘senior quality specialist’ do?
I make sure that in relation to quality management systems and regulations, medical device and combination product systems are developed and underwritten appropriately. This ensures projects are designed to have the right documentation, testing and risk management, and comply with quality and regulatory guidelines.

How does what you do fit in with the process of developing new products and services at CDP?
I provide the foundation (especially when we’re working for the medical world) that supports all of the other technical ideas. Put another way, a solid regulatory and quality framework underneath a new technical innovation is integral. All the technical wizardry in the world won’t count for anything if the new product or device can’t make it to market due to it not meeting the required quality, materials or other standards. Quality and regulatory considerations play a role, therefore so do I, at all stages of innovation development at CDP. This is right from initial Phase 0, through to finalising products for manufacture, and post-launch into the marketplace, via post-market surveillance systems.

Do you recall what inspired you to take this career path?
It happened in an organic way. Coming from a scientific product development background (where quality is innate in the development process) the evolution into the combination product world was fairly seamless. I’ve been able to bring through those skills I used back when I was a bench analytical chemist through to what I do now. Now as I was then, I’m guided by ‘good scientific practice’. Most of the time I find that what I consider to be the ‘right’ way to achieve something, from a quality perspective, is supported by regulatory requirements.

In the medical device development/quality space are there any recent discoveries or future trends you’re watching for?
The upcoming changes to Medical Device Regulations (MDR) in Europe will have a large impact on scrutiny of medical devices and drug delivery.

What do you get up to in your spare time?
Most of my spare time is taken up entertaining my two young sons and I’m about to become a Scout leader. In the time remaining, I’m a wannabe triathlete. My pinnacle achievement so far has been the Alpe d’Huez triathlon in France. I’m also trying to learn the acoustic guitar.

AAMI human factors for medical devices course returns to Europe

October 16th 2014

Innovative technology and design consultancy Cambridge Design Partnership today announced that due to the huge success of Europe’s first AAMI Human Factors for Medical Devices course they will be sponsoring more courses in 2015.

Cambridge Design Partnership worked with the US based Association for the Advancement of Medical Instrumentation (AAMI) and Pure Insight to bring the course to Europe for the first time in April 2014 and the course was hugely oversubscribed. In response to demand from medical device development companies, which deem the course content as a ‘must have’ piece of knowledge for their medical device development teams, a course has been scheduled for January 2015.

Cambridge Design Partnership have recognised the importance of Usability Engineering in medical device development programmes for many years and are keen to share this enthusiasm with the wider development community by teaming up with AAMI and Pure Insight to bring this definitive course to Europe.

This course delivers practical Usability Engineering techniques that can be implemented in any medical device development programme and gives insights into creating usability submissions for both the USA and the EU regulatory regimes.  With new guidelines proposed in the US, medical device companies worldwide need to be vigilant in understanding how to navigate these changing regulatory landscapes. The AAMI course not only addresses Usability Engineering itself, it also looks at the growing harmonisation between global standards, streamlining device submissions.

The course leaders are the highly regarded Dr. Ed Israelski who is the convener of international HF medical standards with IEC and ISO and Dr. Robert North, who is a co-author of the FDA human factors standards. This course is exclusively the only event held in Europe where companies can talk directly to an FDA representative who hosts a question and answer session and gives delegates the benefit of the latest insight into streamlining submissions as well as common submission errors and deficiencies.

“At CDP our experience developing novel medical devices shows us that effective Usability Engineering is crucial to commercial success, not only to meet regulatory requirements but to enable new products to succeed in a competitive marketplace. When developing fast moving consumer products companies naturally place the user at the centre of the design process,  but when it comes to safety critical medical devices sometimes the complex technical and clinical requirements overshadow basic patient needs. This course explains the processes you can use to ensure your devices are easy and safe for patients to use.  Medical device manufacturing companies must demonstrate this to the regulators and this course explains how this is achieved.” Comments Mike Cane, Founder, Cambridge Design Partnership.

Cambridge Design Partnership is a leading technology and product design partner focused on helping its client’s businesses grow. Some of the world’s largest companies trust CDP to develop their most important innovations.

Cambridge Design Partnership specialises in the healthcare, consumer, energy and industrial equipment markets and its multidisciplinary staff have the expert knowledge to identify opportunities and solve the challenges its clients face.

www.cambridge-design.co.uk/
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Contact Abbie Meliniotis or Laura Cavaliere at CDP for more information:
lc1@cambridge-design.co.uk / avm@cambridge-design.co.uk /+44 (0) 1223 264428

Media contacts: Andrea Berghäll, EML Wildfire Technology PR
cdp@emlwildfire.com / +44 (0) 208 408 8000