Tag Archives: device development

Navigating the transition

The countdown clock to the application of new EU Medical Device Regulation (MDR) started its three year life in May 2017.

Understanding the changes, let alone navigating them successfully to prepare for compliance in May 2020 is no small task.

Thankfully, the UK regulatory agency (MHRA) has produced a guide to help you get to grips with what has changed and what you may need to do to get ready for a smooth transition in 2020.  After a detailed review of the MDR, we published the 15 things you need to know.

Unlike many other regulatory changes in the EU and US, there will be no “grandfathering” of existing medical devices under the MDR, so we strongly recommend starting your preparations sooner rather than later.  If you’re developing or marketing a Class 1 medical device, you should read about what’s happened with the self certification route too.

And with the ever decreasing pool of Notified Bodies available to work with for the higher risk devices, you’ll probably need some guidance and help before you reach out to one of the few remaining bodies to assess your product against the MDR and (re)certify your CE marking.

We’re always here to provide reassurance, guidance and a helping hand, to ensure you don’t do too much, or too little. We ensure you only do what you need to.

Get in touch today, make the most of the time you have left on that clock.

Additional Resources:

Read more on this topic with these related posts:

Getting to grips with managing a medical technology project

With increasing pressures on healthcare businesses to get to market quicker, with lower development costs, managing your projects effectively has never been more important.

However, regulatory expectations folots of signpostsr medical technology development are continuously evolving.

There’s a natural tension between these two aims that is further complicated by the interactions and interdependencies of the major strands of product development.

Following a project management process that is focused on doing the right things, at the right times, ensures the balance is maintained, shortens your time to market and reduces development costs.

Perhaps you want to understand the crucial steps that need to be taken to ensure successful project completion? Then clear your diary for Tuesday 27th September 2016. We have collaborated with Medilink South West in delivering a one day seminar to outline the common pitfalls and how to avoid them, as well as providing implementable strategies to apply to existing and new projects.

“Great insight into the detail involved and how I can get started”

img_20150917_123707740-croppedThe day is will cover topics like:

  • Why projects fail
  • Why project management makes business sense
  • Project leadership and project management
  • Navigating the complexities of medical device development
  • Key strands of medical technology development:
    • Defining your project
    • Development
    • Industrialisation
    • Product Launch
  • Working with project management methodologies

“Very good, in depth project management tools”

extremely useful, very interesting and well structured.  My interest was held all day which given that it was an all day session is extremely difficult to do.”

At the end of our time together, you will have

  • Gained a thorough understanding of the latest principles of project management
  • Learned how to plan effectively, identifying and mitigating significant risks to your product’s development
  • Created a toolkit for adopting and implementing practical steps and measures at each stage of the process

“Workshops were very energetic and welcomed”

“I know now what we should be doing, and who to call for expert help”

Get started with resolving your project issues by clicking here to book your seat right now.

Take these 3 steps to smooth your medical device development path

Whether you’re developing a medical device, medical technology or combination product, there are three ways you can smooth your path towards a successful conclusion.

1. Define, upfront, the journey you will take from the very start, right the way through the 4 stages every project transits, to getting your product on the market.

2. Set out the big steps for each of the 9 key disciplines involved in development projects.

3. Identify the points along each track, where the disciplines must interact, and ensure these happen.

Scroll down to read more about each of these.

Then keep on scrolling to see how they can be put together on one page.

Every project moves through 4 stages; define; develop; industrialise; launch. Resist temptation to rush through the first stage. Instead, reap the rewards of time spent here. Ensure that you have a clear view of what is needed to navigate the choppy seas of development to reach your product launch.

The vast majority of projects to develop a medical technology involve 9 key disciplines, each with their own must haves, intricacies and dependencies. Regulations and international standards dictate some of the things that must be done in each of these arenas, but there will be others you’ll need. Be clear about what must happen for each discipline, during every project stage. That way you will be able to review your project at appropriate times, with one eye on the detail and the other on the big picture.

How often do projects resemble a collection of silos, without interconnecting tunnels? Establish the points at which these tracks must connect/  The times at which their coming together is essential, for a sound understanding of what’s been done and where you’re going next. Design Reviews are a case in point. These only cease being a millstone around your neck and become really valuable when all disciplines are involved and the review reaches decisions based on hard data and results from each and every one of track.

We’ve experienced what works and what doesn’t, to be in a position to sketch what good looks like. Back in 2013 we crystallised all this into a route-map for medical technology development. Since then, it’s been used in Australia, Asia, Europe and North America. Users have fed back great experiences as a desktop aide mémoire, a teaching aid, through to a planning and design review tool!

Experience doesn’t stand still, and a lot has changed in three years. We’ve incorporated the changes into our evolved model. We call it medical technology development 5.0, though you’re welcome to suggest another name!

Click to open a pdf version you can download

Click to open a pdf version you can download

You may already see how this picture will be helpful, whether you’re working in medical devices, combination products, pharmaceuticals, aerospace, defence, electronics…

Send me your thoughts on how you can use the route map, because having a straightforward, independent view is always valuable.

9 questions to find out if your app is a medical device

It seems like every month another raft of “wellness” apps and “not-medical” apps are released into the wild. There’s clearly a lot of energy being expended to create apps that help people manage their lives, wellness and medical conditions. However, many developers that we speak with are really not sure how to tell if their wizzy new project needs to be worrying about complying with medical device regulations.

Navigating medical app development

FTC mobile app tool

Click to visit the tool

Help is at hand, if you’re developing an app that collects, manages or creates user data, diagnoses or treats diseases, for the US market. The US Federal Trade Commission (FTC) has launched an online tool to help you understand which (if any) of these laws and regulations you will need to comply with:

  • Health Insurance Portability and Accountability Act (HIPAA), enforced by the US Department of Health & Human Services
    Click here to show more
    The Office for Civil Rights (OCR) within the U.S. Department of Health & Human Services (HHS) enforces the HIPAA rules, which protect the privacy and security of certain health information and require certain entities to provide notifications of health information breaches.
  • Food, Drug & Cosmetic Act, enforced by the FDA
    Click here to show more
    The FDA enforces the FD&C Act, which regulates the safety and effectiveness of medical devices, including certain mobile medical apps. The FDA focuses its regulatory oversight on a small subset of health apps that pose a higher risk if they don’t work as intended.
  • Federal Trade Commission Act, enforced by the FTC
    Click here to show more
    The FTC enforces the FTC Act, which prohibits deceptive or unfair acts or practices in or affecting commerce, including those relating to privacy and data security, and those involving false or misleading claims about apps’ safety or performance.
  • Health Breach Notification Rule, enforced by the FTC
    Click here to show more
    The FTC’s Health Breach Notification Rule requires certain businesses to provide notifications following breaches of personal health record information.

Finding out if your app is a Medical app

The tool holds your hand through answering 9 questions, resulting in guidance about which (if any) of these laws apply to your product.

1. Do you create, receive, maintain, or transmit identifiable health information?

2. Are you a health care provider or health plan?

3. Do consumers need a prescription to access your app?

4. Are you developing this app on behalf of a HIPAA covered entity (such as a hospital, doctor’s office, health insurer, or health plan’s wellness program)?

5. Is your app intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease?

6. Does your app pose “minimal risk” to a user?

Click here to show more about 'minimal risk'

According to the FDA, “minimal risk” apps are those that are only intended for one or more of the following:

  • helping users self-manage their disease or condition without providing specific treatment suggestions;
  • providing users with simple tools to organize and track their health information;
  • providing easy access to information related to health conditions or treatments;
  • helping users document, show or communicate potential medical conditions to health care providers;
  • automating simple tasks for health care providers;
  • enabling users or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems; and
  • transferring, storing, converting format or displaying medical device data, as defined by the FDA’s Medical Device Data Systems regulations.

7. Is your app a “mobile medical app?”

Click here to show more about medical apps
A “mobile medical app” is one that is intended for any of the following:

  • use as an accessory to a regulated medical device (for example, an app that alters the function or settings of an infusion pump)
  • transforming a mobile platform into a regulated medical device (for example, an app that uses an attachment to the mobile platform to measure blood glucose levels)
  • performing sophisticated analysis or interpreting data from another medical device (for example, an app that uses consumer-specific parameters and creates a dosage plan for radiation therapy)

8. Are you a non-profit organization?

9. Do you offer health records directly to consumers (or do you interact with or offer services to someone who does)?

Developers unfamiliar with the requirements surrounding medical devices, such as the Quality System Regulation, FDA registration and approval process may find the tool useful in understanding whether the “thing” they’re creating qualifies as a medical device.


Evaluate your medical app development project

Talk with us about your medical app, because an independent view of your development project checks you’re on the right track.