Listen to Aligned's CEO Anders Emmerich on "Mindset Impossible?"

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On Thursday this week (Thu 11th, 1:30 PM - 2:30 PM), our CEO Anders Emmerich, talks at the "Mindset Impossible?" online event about the history, trends, and patterns in the digital transformation currently sweeping the medical device industry.

You can join this zoom - event. Register and get log-in details here.

The event is hosted by Digital Chameleon, a consultancy for digital transformation in the healthcare and life science sector.

 

Free Online Medical Device Development Seminar - Sharpen your Skills 2021

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April 13th, 2021 | 09:00 - 12:15 | Free Online Medical Device Development Seminar


Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2021.

We have called on a group of experienced industry experts to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

Register on Linked In: https://www.linkedin.com/events/freeonlinemedicaldevicedevelopm6773634480822353921 

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.

 


Key Learning Objectives

The secret life of Medical Device Development

Let me take you on a holistic walk through the act of developing a medical device, joining dots rather than picking on a discrete activity.
There is a lot of common sense that underpins the regulation but it seems lost in both presentation and interpretation.
Taking a step back and asking: “Why are we doing this?” can help you to see the woods beyond the regulatory trees.

Presented by: Mike Heald, CEO, Commala

Demystifying software risk management

Medical device software risk management is often perceived as complicated to understand and work with – it is not!
In this seminar, you will not only get the foundational understandings, but you will also understand how to practice medical device software risk management!

Presented by: Christian Kaestner, co-author of IEC 62304 and IEC 82304-1, trainer at Medical Device HQ 

Human-centered development as a driver of medical product innovation

If you want to create medical devices that people love, then usability, user experience (UX), and ergonomics is the road forward.
We will describe how you can establish a human-centered development process and how using prototypes with real users during the early stages can provide new and powerful insights.
We will explore the usability and human factors engineering regulatory underpinnings and their relation to ISO 13485.
We will dissect which types of use-related risks exist and how they can be analysed according to ISO 14971 during your product development.

Presented by: Dr.-Ing. Benedikt Janny, CEO, USE-Ing. GmbH

EUDAMED - how bad can it be?

If you thought you had covered Eudamed by implementing UDI's, then think again!
In this talk, we will address the deliverables required by medical device manufacturers, how to use medical device codes, how to communicate with the Eudamed servers.
We'll describe how to deal with legacy devices and how you can best organize your work to efficiently meet the Eudamed challenges ahead.

Eudamed is coming for you. We will help you prepare.

Presented by: Richard Houlihan, CEO, Eudamed Ltd, former technical manager for Eudamed 2 and MDR EUDAMED July 2017 - April 2019 

Finding, eliminating, and avoiding errors in Design Control Documentation - before audits and submissions

Having spent years developing and documenting a medical device just to get it rejected by a Notified Body or the FDA is a costly and disheartening experience.
Are there other ways than lengthy reviews to find and eliminate inconsistencies in your Technical Documentation?
Learn from this session about strategies, techniques, and methods for finding, eliminating, and avoiding errors in your Technical File.

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG


Time and Place

  • Date: Tuesday, April 13th
  • Time: 09:00 - 12:15
  • Live Streamed from the Aligned HQ. Sign up to get your access link!

Presentations are held in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.

Registration

Register to get your online access. We are looking forward to seeing you in this virtual seminar!

 


 

About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.

 HTCS

Aligned at MedConf 2020 21-23 October

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In just a few weeks you can meet us at MedConf2020 in Munich!
If you do not want to travel that far, you can benefit from this year's Hybrid event! All participants can follow the lectures and keynotes remotely just as well as on-site!


On Thursday, October 23. 13:30 - 14:15, our Design Control Management Expert Karl Larsson will present "The hidden treasure in your Technical Documentation".

Read more about the full agenda here.

We look forward to your participation! Sign up today!

Videos and presentations from Sharpen Your Skills 2020

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We are very thankful for the engaging participation of all medical device colleagues in this year's Sharpen Your Skills event.

Videos and Slides

Perspective of Post-Market Surveillance under MDR

 

Download slides here.

Presented by: Linda Ahnen, PhD, Project Associate, Medidee

When to test what and why. A true story from a developer’s perspective. 

 

 

Download slides here.

Presented by: Dr. Thomas Degen, Dozent, Institut für Medizintechnik, Hochschule Luzern

Software Development According to IEC 62304 - A Real-World Perspective

 

Download slides here.

Presented by: Matthias Steck, Senior Consultant SW Development & Cyber Security, ISS AG

Hit by a laser – Risk Assessments Management at Ziemer Ophthalmic Systems AG

 

Download slides here.

Presented by: Reto Sigrist, Project Manager, Ziemer Ophthalmic Systems AG

Are we there yet? Using KPIs to track Technical File progression

 

Download slides here.

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG

Aligned Elements as Hosted Solution

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As of April 2020, we offer Aligned Elements as a Hosted solution as a complement to our existing deployment options. It is thus now possible to deploy the Aligned Elements server On-Premise, in your own Cloud, or have it hosted by us. 

The Hosted Solution will be a welcome option for our medical device manufacturing clients that do not have or are not in a position to engage, IT infrastructure and/or IT personnel.

We host your Aligned Elements database server, web application, and system integrations in the cloud on the reliable Microsoft Azure platform, applying your unique configuration of Aligned Elements, designed to match your QMS, development process, and document templates. 

Use your standard browser to access the Aligned Elements web client and allow your team to break free from technical considerations and focus on their medical device development. Automatic maintenance and monitoring are continuously performed by our experts.

As new versions of Aligned Elements are released, each client decides on when the new versions shall be deployed. A client's solution will only be updated upon explicit request in order to deliberately move from one validated application state to another. 

Register for "Sharpen Your Skills 2020" - Free Virtual Medical Device Development Seminar

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April 28th, 2020 | 09:00 - 12:15 | Free Virtual Seminar


Aligned Seminar

Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2020.

We have called on a group of experienced industry experts to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.

REGISTER NOW!


Key Learning Objectives

Perspective of Post-Market Surveillance under MDR

The Medical Device manufacturer’s effort put into Post Market Surveillance (PMS) is increasing drastically under the MDR regime.
The task in front of us appears daunting at best and overwhelming at worst.
Learn from our invited experts on how to collect enough PMS data to stay compliant and efficient at the same time.

Presented by: Linda Ahnen, PhD, Project Associate, Medidee

When to test what and why. A true story from a developer’s perspective. 

V&V activities are always planned last, that is why they have no right to fail, but from failure, we learn, how can we use testing to our advantage?
Based on the example of an implantable pump, we discuss what kind of verification can and should be done at which stage of development and how it should be documented.

Presented by: Dr. Thomas Degen, Dozent, Institut für Medizintechnik, Hochschule Luzern

Software Development According to IEC 62304 - A Real-World Perspective

It is said that 'No battle plan survives the contact with the enemy'. What is the best way to plan and implement IEC 62304 in an efficient and compliant manner?
Learn from the successes and failures of leading medical device manufacturers in Switzerland.

Presented by: Matthias Steck, Senior Consultant SW Development & Cyber Security, ISS AG

Hit by a laser – Risk Assessments Management at Ziemer Ophthalmic Systems AG

’Did you assess the risks correctly?’ When your device is a laser for eye surgery, this is a very valid question.
Find out more on how Ziemer Systems structures the risk management file; and integrates device data, post-market surveillance information, clinical data, and much more in a comprehensive risk assessment approach for a complex medical device.

Presented by: Reto Sigrist, Project Manager, Ziemer Ophthalmic Systems AG

Are we there yet? Using KPIs to track Technical File progression

Key Performance Indicators are widely used by organizations to evaluate their success at reaching critical targets. In the context of Medical Device Technical File documentation, what are examples of good and bad KPIs.
Learn from this session how Requirement Management, Risk Management, Test Management, and Document Management can be monitored using KPIs.

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG


Time and Place

  • Date: Tuesday, April 28th
  • Time: 09:00 - 12:15
  • Live Streamed from the Aligned HQ. Sign up to get your access link!

Presentations are held in German. Slides are written in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.

Registration

Register to get your online access. We are looking forward to seeing you in this virtual seminar!

REGISTER NOW!


 

About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.

 HTCS

Accelerating the Conformity Assessment process

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Ripple effects of all sorts is felt on many levels throughout the industry due to the strained European MDR situation.

The bottom line is simply more work for everybody. As medical device players scramble to get compliant in time, the convoluted situation has ignited creativeness among digital solution providers. New propositions emerge on how to carry out the increased workload in the most efficient manner possible. We certainly try to be one of these providers but there are plenty of other exciting companies with fantastic ideas.

One such solution provider is MedtechVault in Switzerland, a company that launched its digitization product in 2019 to target some of the complexities that emerge out of MDR. We had the opportunity to meet with Mr. Arik Zucker, co-founder of MedtechVault, and got the chance to ask him more about MedtechVault.

Register for "Sharpen Your Skills 2019" - Medical Device Development in the MDR Era

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Sharpen your Skills 2019

May 21st, 2019 | HWZ University, 3 minutes from Zürich Main Station


armchairs blur business 296883 3

Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2019.

We have called upon a group of experienced industry experts to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.

REGISTER NOW!


Key Learning Objectives

The way to MDR: real-world experience

The MDR transition window is closing. Manufacturers, Notified Bodies, and Distributors are working vehemently to reach the opposite shore in one piece.
An excerpt of the experience of adapting to these new requirements, including hints and best practice are presented in this session.

Presented by: Hansjörg Riedwyl, CEO, ISS AG

Hidden cost drivers in clinical investigations - the importance of strategy

Market access and approval are more dependent than ever on clinical data. Getting your clinical trial design right, in time and within budget, is one of the most important steps.
This session focuses on the importance of collaboration with regulatory and clinical operations experts to minimize the risk for delays as well as costs.

Presented by: Carin Nilsson, Partner, Confinis CPM

Computer System Validation CSV – between ZERO and HERO

How to best handle the conflicting expectations from Management, IT, Quality Department, and (last but not least) the Auditor?
Gerhard Dariz provides deep, real-world insights from corporate practice and shows possible strategies to survive this area of tension.

Presented by: Gerhard Dariz, CEO, Inmedis GmbH

Clinical Evaluation and Post Market Clinical Follow-Up under MDR

MDR introduces important changes in expectations on how to demonstrate device safety and performance prior to market access.
This session provides an overview and hands-on examples of the Clinical Evaluation and Post-Market Clinical Follow-Up processes under the MDR.

Presented by: Dr. Autumn Lang, CEO, Confinis CPM

Automated Design Control Documentation

Machine Learning. Digitalization. The future holds a promise of machines performing more and more of our daily tasks. However, many of us are still putting Design Control Documentation together character by character. Can the Design Control Documentation be automated? What would that look like? What are the limitations?

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG


Time and Place

  • Date: Tuesday, May 21st
  • Time: 08:15 - 13:30
  • Place: HWZ University, Zürich

Presentations are held in German. Slides are written in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.

Registration

We are looking forward to seeing you at this seminar!

Registration Fee: 125 CHF

30% early bird discount for registration before May 1st.

REGISTER NOW!


Location

Address: HWZ Hochschule für Wirtschaft Zürich, Lagerstrasse 5, Zürich

HWSMap

 

About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.

 HTCS

Register for "Sharpen Your Skills 2018" - Efficient Medical Device Development

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Sharpen your Skills 2018

May 17th, 2018 | HWZ University, 3 minutes from Zürich Main Station

Skills

Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2018.

We have called on a group of experienced industry experts to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.


Key Learning Objectives

Medical Device IT Security

Live hacking session, an introduction to the regulatory requirements and hands-on tips for developers of medical devices - by Prof. Dr. Christian Johner, CEO, Johner Institute

Implementing GDPR at Polar

Learn more about how Polar implemented one of the most important regulatory changes in 2018. If you haven't started yet, get the do's and don'ts from Niclas Granqvist, Director Apps & Electronics, Polar Electro Oy

Common Usability Engineering Pitfalls

What could possibly go wrong? Expected and unexpected outcomes from the usability engineering process based on real-life examples - by Andrea Schütz-Frikart, Human Factor Specialist, Frikart Engineering GmbH

Post-market surveillance, Transition from MDD to MDR

The lean and mean approach to performing MDR post-market surveillance using a realistic framework - by Stephanie Grassmann, MedTechXperts GmbH

Modular Design Control Documentation

Can Design Control Documentation be modularized and re-used in several Medical Devices? Discover the Pros and Cons - by Karl Larsson, Design Control Documentation Expert, Aligned AG

 


Time and Place

  • Date: Thursday, May 17th
  • Time: 08:15 - 13:00
  • Place: HWZ University, Zürich

Presentations are held in German. Slides are written in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.

Registration

We are looking forward to seeing you at this seminar!

Registration Fee: 125 CHF

30% early bird discount for registration before May 1st.

 

 


Location

Address: HWZ Hochschule für Wirtschaft Zürich, Lagerstrasse 5, Zürich

 

HWSMap

 


About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

What I learned at the Aligned Elements User Conference 2017

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Last week we met up with some of the Swiss Aligned Elements users at the Aligned Elements User Conference 2017. It was a very rewarding occasion for me and our team. For ten years, we have grown together with our customers and many of the best improvements we have done to Aligned Elements, are ideas from our customers.

It is not always about new features

It is easy to get locked into the thought process of adding new features as an ISV. However, this user gathering underlined how much "unlocked potential" lies in slightly tweaking existing features, features that might not look very impressive on the surface but still has an enormous impact on usability due to their frequent use. For us, it was a real eye-opener to hear about the large impact of two small features called "Reset Format" and "Paste as Plain Text". The participants had some good suggestions for improvements that we certainly will implement for the next service pack.

Different Users have different needs

As the discussion went on, it became clear that the needs of the groups "Frequent Users", "Infrequent Users" and "Administrators" are quite different. Whereas the Administrator representatives requested better support for User Management and changes made over large Project sets, the Infrequent Users were in greater need of clearer work instructions and an interface adapted to their specific tasks. One user compared Aligned Elements with Photoshop, "if you are a power user, Aligned Elements is extremely powerful, but if you only log in every six months to tick of tasks assigned to you, the interface is intimidating and do not do much to guide this user." We have great ideas in this area that we hope to be able to include in our next version.

Follow that document

Several users pointed out that Document Management, Review, Release, and Sign-off actions have the potential for improvements, both in scope and implementation details. This is something we are aware of and the user feedback delivered during the conference was very helpful on these points.

We are grateful to the participants for having joined this year's User Conference and will do our best to incorporate the improvements and suggestions in future Aligned Elements releases.

Cybersecurity, pacemakers and recalls

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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.

pacemaker

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 key note or come and meet us at the Expo at Booth B2045, Halle 02.

Aligned at Swiss Medtech Expo, Lucern 19-20 September

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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. 

cms mf download 2 datei

To get your free ticket, click here: Free Entry Ticket Swiss Med Tech Expo

Find more information about the Expo here.

 

 

Questions about MedTech standards? Get the answers straight from the source!

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

qadvislogo

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!

 

Meet us at Med Conf 2016 in München 25-28 October

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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 This email address is being protected from spambots. You need JavaScript enabled to view it. and we'll set up an appointment!

B MEDCONF 16 500x500

Announcing the 2016 Medical Device Documentation Survey!

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The 2016 "Documentation Trends and Insights in Medical Device Documentation" survey is live!

Are you alone in experiencing challenges when it comes to Medical Device Documentation? Or is what you feel shared by the industry?

Man with papers

We invite you as a Medical Device professional to share your thoughts on the state of documentation practices by participating in this survey.

The survey will assess how Medical Device organisations manage regulatory driven documentation challenges during the R&D phase.

Take the 2016 Medical Device Documentation Survey now!

EU agreement on new medical device rules as Switzerland "Sharpens the Skills!"

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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.

sharpen

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 This email address is being protected from spambots. You need JavaScript enabled to view it..

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

Take Usability Engineering seriously!

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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.

usability

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.

Sharpen your Medical Device Development Skills!

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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.

sharpen your skills!

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

Mobile Medical Application Development in 2016 – an insider’s perspective

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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.

Ava woman wearing bracelet

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 penetrating 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 Avatelier 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.

Ava Chart Hormones Phases new

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

Aligned Website jetzt auf deutsch

Wir freuen uns Ihnen mitteilen zu können, dass unsere Webseite ab sofort auch in Deutsch verfügbar ist. Auf diese Weise können wir unsere Kunden im deutschsprachigen Raum noch besser informieren und unterstützen.

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Sie können die Sprache oben rechts auf einer Seite wählen.

Falls Sie die Aligned Webseite auf einem mobilen Geräte anschauen, so findet sich die Sprachwahl oben im Menü:

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Meet us at [INSIGHT] Tools, Support and Capital for Innovators in Biel

We are excited to participate in the [INSIGHT] Tools, Support, and Capital for Innovators event at INNOCAMPUS in Biel on November 30th! So far more than 60 organizations have confirmed participation at the event.

innocampus

The event is a matchmaking event for startups, small and medium-sized enterprises (SME), service providers, investors as well as academic and global players from the Medtech sector. The agenda includes pitches by startups/industrial innovators and solution providers as well as tabletop exhibition stands and a 1:1-partnering service.

If you are planning to be there, please drop by our stand - we look forward to seeing you!

Swedish Medical Product Agency threatens to remove mobile health app from the market

In an interview in the magazine Computer Sweden, Mats Artursson, investigator at the Swedish Medical Product Agency (MPA) claims that “This is a question about demarcation where a mobile health app becomes a medical device.” As an example, Mats Artursson mentions an app that checks skin cancer (malignant melanoma), a diagnosis for which a CE mark is required. “The app maker attempts to denounce responsibility by telling the user to contact a medical doctor in order to be sure. This is not OK according to the regulations.”

mobile health apps

“These app developers do not know the regulations,” says Mats Artursson. In order to send a clear signal to the health app market, the MPA is seriously considering forcing the removal of an app from the market. “They are not following the regulations and we hope this will be a wake-up call for other health app manufacturers. They must understand that this is serious.”

Anders Emmerich, CEO at Aligned AG: "There has been some uncertainty among manufacturers regarding the regulatory status of many mobile health apps. This statement from the Swedish MPA will certainly level the playing field. Patient safety needs to be put in focus."

The number of available health apps, sometimes in combination with wearables, have literally exploded the last 12 months and there has been a lot of discussions about to which extent these apps need to follow regulations. The Swedish MPA now sends a clear signal to the market.

“We ask everyone who sees a product that might be dangerous to let us know.” finishes Mats Artursson.

Death by documentation? - meet us in Lund on Tuesday September 29th

Join us at Ideon Science Park in Lund, Sweden, on September 29th for the morning seminar "Your Medical Device Development - death by documentation?" 

“Writing documents and putting them into binders does not sound like rocket science.”

Nevertheless, many of us have experienced how documentation and traceability according to ISO 13485 and FDA QSR 820 turns into both complex and cumbersome activity. Surprisingly enough, as long as regulatory demands are met, the documentation process itself is seldom scrutinized for efficiency improvements.

This seminar highlights how great savings can be made in this area. We uncover bad documentation practices, their consequences, and potential remedies with the intent to make the medical device documentation process more efficient.

This event is a cooperation with Qadvis. Event details can be found here.

Looking forward to seeing you there!

Efficient medical device documentation

"Where did all the hours go?"

It is a well established fact that a large part of the medical device development effort is made up of producing documentation. The 30+ participants of the Aligned morning seminar "Death by documentation" in Kista, Stockholm, were all too familiar with this situation.

Regulations such as ISO 13485 or FDA QSR 820 require us to produce documented evidence that our product is safe.

Sometimes, however, there is an overwhelming feeling that documentation work undertaken does not necessarily fulfill this requirement. 

DeathByDocumentation

At this seminar, we explored the drivers of excessive documentation in the search for plausible causes for the documentation requirements to get out of hand and the recognizable effects that let us identify these drivers.

Although the solution to the documentation problem of a particular company is likely to be found in the specific circumstances of that company, asking explorative questions about documentation aspects can unveil overlooked root causes for excessive work.

Examples of such questions are:

  • "Why are certain documents modified more often than others?"
  • "Why do certain documents involve more people than others?"
  • "Why do certain documents take longer to complete than others?"
  • "Why do certain documents exist in more instances than others?"

In many cases there exist perfectly reasonable answers to these questions. In other cases, these differences might not be called for.

Identifying documentation drivers and eliminating unnecessary work can help us to reallocate valuable resources from documentation to innovation.

This event is a cooperation with Qadvis.

The seminar presentation can be found here.

Death by documentation? - meet us in Stockholm on May 12th

Join us at Kista Entré Konferens in Stockholm, Sweden, on May 12th for the morning seminar "Your Medical Device Development - death by documentation?" 

“Writing documents and putting them into binders does not sound like rocket science.”

Nevertheless, many of us have experienced how documentation and traceability according to ISO 13485 and FDA QSR 820 turns into both a complex and cumbersome activity. Surprisingly enough, as long as regulatory demands are met, the documentation process itself is seldom scrutinized for efficiency improvements.

This seminar highlights how great savings can be made in this area. We uncover bad documentation practices, their consequences, and potential remedies with the intent to make the medical device documentation process more efficient.

This event is a cooperation with Qadvis. Event details can be found here.

Looking forward to seeing you there!

Full house at "IEC 62304 - how to make it work" seminar

There was standing room only when Mr. Robert Ginsberg, CEO of Qadvis and co-author of IEC 62304, and his team presented best practices and lessons learned at Marriott Courtyard Hotel in Zürich on March 31st.

Ginsberg's session addressed common questions arising from medical device manufacturers' attempt to implement the harmonized standard IEC 62304 "Medical Device Software".

"Even though many IEC 62304 issues are context dependent, there are a few persistent problems that I come across time and again.", says Mr. Ginsberg.

Not enough focus on Software Quality - manufacturers tend to stare themselves blind on the documentation required for IEC 62304 and subsequently lose focus on the intended goal of the standard, namely to increase software quality."

Lost traceability - we keep detecting gaps in the traceability during the audits we perform, particularly regarding how risk control measures are implemented as software requirements and how they are subsequently verified. Traceability is an immensely complex task to manage as the project evolves and I highly recommend using software support tools available to handle this activity."

No connection from the field to R&D - I can't stress this enough: post-market surveillance is one of the main focuses of the regulation. It is an incredibly important indicator on how the software is actually performing. Still, it is also one of the most neglected aspects of the software life cycle. Post-market data contains a virtual goldmine of opportunities for increased software quality and should be properly addressed."

Non-value added activities to fulfill IEC 62304 - The standard is not about producing alibi-documentation, it is about increasing software quality. In one "agile" firm I worked with, the detailed design was extracted from the existing code base after the coding was complete, using a software UML extractor. But documenting the detail design in such a matter provides no added value to the software quality whatsoever."

Too shallow risk management - Risk management is not an administrative activity to make Notified Bodies happy. It is the driver of improved software safety and quality. Therefore, to be able to improve safety, the depth of the analyses needs to increase. 

Mixup of concepts - the terms 'SW validation' (as defined e.g. by AAMI:TIR 36), 'product validation', and 'product verification' do not denote the same thing and these terms can therefore not be used interchangeably. IEC 62304 is not concerned with any types of validation activities. Do be clear vis-a-vis the auditors, formally define the terms as you intend to use them, and apply them consistently within the company and in your documentation.

Too strict interpretation of segregation - There is this note in IEC 62304 that indicates that the only possible segregation of items is to execute them on separate hardware. This is not entirely true. Soft segregation on a functional and/or logical level can be entirely appropriate depending on the risk the segregated items expose. The main point is that your segregation must be well-argued, proven to be effective, and documented.

Using system-level testing as a risk control measure - testing is by most notified bodies no longer accepted as a risk control measure. An RCM should result in a new SW requirement which in turn is verified.

No metrics supporting the process - having no metrics showing how well your software performs, might lead to unconstructive arguments with your auditor about the true level of safety your software retains. It is my advice to define and use performance metrics to support your case of having developed a high-quality software and in particular, make use of the available field data."

"This is by no means an exhaustive list but, as I mentioned, I see these issues a lot and I think the effort needed to address them is relatively cost-effective. Should you have any further questions, I'd be happy to address them afterward.", Mr. Ginsberg concludes.

The Aligned team presentation, with a focus on the documentation tasks required by IEC 62304, addressed the issue of conceptually connecting the software architecture and the risk management in the development documentation.

By using a concrete example, Aligned demonstrated how a Preliminary Hazard Analysis as a risk assessment could be used in their medical device ALM software "Aligned Elements" to not only fulfill the traceability requirements of IEC 62304 but also successfully connect the software architecture with existing risk assessments.

The seminar was concluded with a host of interesting and constructive discussions among the participants at the subsequent lunch buffet supplied by Marriott.

Medyria applies Aligend Elements to document TrackCath

Medyria is a Swiss Medtech startup that engineers technologies for endovascular catheter navigation and sensing.

Medyria’s core technology is a sensor-based system, called Flowcath, to measure blood flow and revolutionary technology for processing flow data and tracking catheters called Trackcath. The combination of these two technologies creates a set of tools that will redefine how physicians navigate and track catheters during minimally invasive surgical procedures. The technology in its first application provides contrast-dye-free precise catheter guidance for stent placement.

Medyria

Medyria has won a number of awards for its scientific development work. Medyria is using Aligned Elements for managing their medical device-related development documentation management.

Find out more about Medyria here.

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