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Cybersecurity issues resulted in 465 000 St Jude pacemakers being subjected to an FDA recall due to fears of exploiting existing cybersecurity vulnerabilities in the device. A security hole exposes the device to hacking risks, potentially resulting in running the batteries down or even alter the patient’s heartbeat.

Although the risk is extremely low, the cost for St Jude / Abbott is significant. For a smaller firm, these ramifications can be detrimental. The long lifetime of medical devices and an ever-evolving cybersecurity arena makes devices vulnerable to cyber risks. Handling them effectively will be a significant challenge for the industry in the years to come.

We are addressing Cybersecurity Issues in the Supply Chain during a Keynote at the Swiss Medtech Expo in Luzern, 19-20 September.

Join us for this keynote or come and meet us at the Expo at Booth B2045, Halle 02.

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Aligned will present at the Swiss Medtech Expo in Lucern from 19-20 September!

Come and meet us at the Expo at Booth B2045, Halle 02 and discover the possibilities you have to reduce time and money spent on Design Control Documentation.

Let us explain to you the idea behind the Aligned Elements and how other medical device manufacturers have saved up to 60% of their documentation maintenance effort. 

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Our friends at Qadvis have grown steadily over the last couple of years and this is no wonder.

These guys are co-authors of many of the standards you use today. If you have questions about ISO 13485, IEC 62304, IEC 80001-1, or IEC 60601-1, who would be better to ask than the person who actually penned it? 

I can highly recommend their services and advice. Just recently the Qadvis Team put together a ton of Quality and Regulatory material for download on their website. For free!

Go take a look!

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We are participating in the Med Conf 2016 25-28 October with our lecture "Death by Documentation - how to identify documentation inefficiencies in your medical device development process"

If you are interested in how to assess the documentation process in order to find process inefficiencies in your own company, then this one is for you!

The lecture is held by our CEO Anders Emmerich on 27. October at 14:10.

Find the complete agenda here.

If you want to meet us during the conference, please Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein. and we'll set up an appointment!

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On 25 May 2016, the same day as the EU agreed new rules on medical devices and in vitro diagnostic medical devices, the seminar "Medical Device Development - Sharpen your Skills!" was held at the sold-out event venue Marriott Courtyard in Zürich.

The theme of the seminar "Medical Device Development in a dynamic regulatory landscape" was scrutinized in depth by Mario Gennari, Gemar SRL, former TüV auditor and special-guest brought in by the Prismond Group, who stressed the importance of undertaking a combined, timely gap analysis of the new EU regulations as well as the updated ISO 13485:2016 in order to understand, plan and execute the necessary step to comply to the new regulatory requirements. The talk was followed by a lively discussion on how to best solve practical issues entailing these regulatory changes.

Mr. Christian Steiner, from Thoratec Switzerland GmbH shared insights and lessons learned from a recent risk management audit, how to deal with potential findings, and elaborated on best practices when undertaking risk management improvements while optimizing limited resources.

Finally, the Aligned Team presented an analysis on medical device documentation aspects, the drivers behind excessive documentation work and possible solutions around it, concluding that large potential improvements can be made through tight collaboration and feedback between the party that design processes and templates and the party being required to use and fill these artefacts with content.

If you are interested in the presentations, please Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein..

We are looking forward to see you at the next seminar!

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"Dexcom has announced a massive and serious continuous glucose monitors recall, involving more than 260,000 devices with alarms that may fail to sound."

Not hearing the alarm of a medical device is not a good thing. When should the manufacturer have picked up on this? During the usability validation at the latest.

Underestimating usability engineering and proper usability validation can have serious consequences (obviously). Still, usability engineering is still in many places regarded as an outsider practice by many "regular" engineers, considering it being a discipline about "taste". I assure you that this is not the case.

There is tremendous potential in applying usability engineering during product development. Standards covering usability and human factors design such as the IEC 62366-1:2015 address the potential risks of poor usability design. However, being compliant with these standards will not only make the medical device safer. They also make the product easier to use and thereby creates more value for the users and patients. 

To make the documentation of the usability engineering tasks faster and easier, we have added a preconfigured IEC 62366-1:2015 setup to Aligned Elements.

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Register to the seminar "Sharpen your Skills! - Medical Device Development 2016 in a dynamic regulatory context"

Take this opportunity and find out how to rapidly deliver innovative medical devices as the regulatory landscape is changing.

Key learning objectives:

• New EU MD Regulation & ISO 13485:2016 - Assess and adapt, change and comply
• Design Control Best Practices - common mistakes and lessons learned from real project cases
• Death by documentation - innovate or administrate? Uncover documentation inefficiencies in your DHF process
• Risk Management when the heart stops - An ISO 14971 Case Study from a Class IIb product

Register now to reserve your seat!

Our event is aimed at medical device development professionals, project managers, QARA professionals, software managers and architects, designers and developers, and other personnel engaged in medical device development. We are at this seminar dealing with the fundamental question of medical device development: how to rapidly develop and deliver innovative medical devices while ensuring compliance.

Take the opportunity to sharpen your medical device development skills and update your knowledge at our half-day seminar on the existing and upcoming challenges in today's dynamic regulatory environment.

Register now to reserve your seat!

When: Wednesday, May 25th, 08:30 - 13:00

Where: Hotel Marriott Courtyard Oerlikon, Zurich (directions)

Price: 125 CHF  (Note! 30% early bird discount for registrations before May 1st)

Presented by: 

• Mario Gennari, Regulatory Affairs and Design Control Expert, Prismond Group AG, former Lead Auditor at TÜV SÜD
• Christian Steiner, Quality Assurance Manager, Thoratec Switzerland GmbH
• Anders Emmerich, CEO, Aligned AG

Hosted by: Prismond Group AG / Aligned AG

For any questions, please feel free to Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein.. 

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Within the last 24 months, mobile health technologies (eHealth apps) have radically changed the way we think about health and medical devices. The combination of smart apps and wearable sensors has brought monitoring and diagnostic power into the hands of the patient, increasing value and utility, often to a very competitive price. There is a surge for patient-centric offerings across the industry, truly leveraged by the new mobile health technologies. 

Ava Women is one of the companies that has moved quickly in the right direction and with the product “Ava”,an advanced fertility tracking bracelet, they assist women and couples in narrowing down the right timing of a successful conception.

We were lucky to get a word with Mr. Philip Tholen, Co-founder and VP of Operations of Ava Women, and took the chance to ask some questions about the opportunities and challenges that face a "wearables"-company.

Mr. Tholen, we have seen a host of consumer electronics companies, including Apple, Microsoft, and Google, with little or no experience in medical device development, trying to penetrate the market with wearable technologies, banking on their expertise in consumer products. 

There are also more traditional companies such as Medtronic, with substantial experience in medical device development that are now jumping the bandwagon, attempting to entering this new playing field.

Looking at the two extreme ends of this spectrum, where would you say the Ava story fits in?

I would say we are positioned right between these two extremes. On one hand, we have a Class I regulated medical device with all its pros and cons. This demands for compliance with GMP, FDA Class I, taking IEC 62304 into consideration, etc. On the other hand, we focus on selling directly to the end-user. In that sense, we have to market our medical device as if it was a consumer product. Striking this balance is not always easy.

With numerous players grabbing for their share, I assume that speed is of the essence in the mobile health market and time-to-market is critical. What measures has Ava taken to make sure that the development proceeds as fast as possible?

Exactly. Our market operates as fast-paced and as short-cycled as a classical consumer market. But in the background, we still have to assure compliance and organize our company in the classical medical device way. Guess how long the lights are on in the Ava-atelier each night!

In order to be fast, we massively parallelized all process steps right from the start. For example, we started hardware development even before we had the clinical study results which delivered the data we need and which confirmed that the sensor concept we chose works. We made so many educated guesses! But luckily, it always worked out and we never had to go back to the drawing board due to inaccurate assumptions.

Furthermore, we purposely selected “off-the-shelf” hardware technologies and components. We neither had our suppliers develop or modify components specifically for our purpose nor did we trust in suppliers’ statements such as “we will have this new product ready when you are going into production”. Only what’s already been commercially available in the mass market made it to our product concept shortlist. We could effectively eliminate the risk of supply-related delays using this approach.

Developing a working medical device is a formidable task per se. Doing it in the strictly regulated environment of medical devices is usually not making it easier. How has Ava, as a start-up company, managed to tackle the regulatory challenges of the medical device market?

Since the beginning we kept an eye on regulatory aspects of product development: for example, we have always made sure that candidates have experience in this field when we selected key team members. Furthermore, during the hardware supplier selection process we only considered ISO 13485 certified companies. On top of that, we have hired a highly experienced professional who is busy refining our QMS and accelerate us through an ISO 13485 certification in due time before market launch. All of these steps might be expensive and seem much work for a startup, but they are part of our strategy to become a cutting-edge digital health company providing state-of-the-art technologies for the end-user as well as for medical professionals.

There has been much debate lately about cybersecurity and data integrity when it comes to mobile health applications. Even FDA has concerns about how patient data is stored, transferred, and accessed. How has Ava addressed these questions?

We are taking the FDA guidance on cybersecurity very seriously. Confidentiality and data integrity is paramount for us, as is the trust our customers have in our product. All data in our application is stored, handle, and transmitted with utmost vigilance. Our security concept is being challenged and improved periodically, and it will also be audited by independent third parties. However, making sure that security measures do not impair the usability of our device shall not be neglected. Luckily, I am confident to say that we have the right team in place to cope with these challenges.

Finally, based on your experience with Ava, do you have any advice to other start-ups currently thinking about embarking on a similar journey?

Do not underestimate the commercialization process of a medical device! Having a working prototype is a good start, but there are many other pieces that have to be put in place before you can place the product on the market. Having the right team and the right partners will certainly make that part of the journey less rough.

AVA Women uses Aligned Elements to manage their medical device development documentation. 

Learn more about how Aligned Elements can help with achieving regulatory compliance for your app

Request a live demo and let us show you how Aligned Elements can manage your documentation for your app

Looking forward to seeing the new Start-up Academy at Medtec Europe Stuttgart 2016!

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