How will Brexit affect Europe’s medical device industry?

After the United Kingdom’s vote to leave the European Union, uncertainty has become the norm. Erik Vollebregt, a founding partner of life sciences law firm Axon (Amsterdam), writes on his medicaldeviceslegal website that medical device companies are asking him “what this means for CE marks for medical devices and for the process of the [new medical device and in vitro diagnostics regulations] as well as medical device law and policy in the EU, in general.”

Source: plasticstoday

It’s unlikely that the so-called Brexit will have any impact on the new medical device and in vitro diagnostics regulations (expected to be adopted by the European Council and Parliament this year). “The EU will certainly not suspend the project because of the Brexit because the texts were established following the normal legislative procedure. The texts will enter into force in the EU as planned and may also take effect even in the UK, up until the date on when the UK formally disengages from EU law,” writes Vollebregt.

The United Kingdom still has to trigger Article 50 of the Lisbon Treaty, formally starting the process of withdrawal from the European Union. Until that happens, nothing changes. Even when the UK government pulls the trigger, “the law calls for a two-year process, and the adoption of the new medical device and IVD regulations will be well underway at that point.”

The main question across the globe is what type of relationship the United Kingdom will have with the European Union after it pulls out: one possible outcome is the signing of a mutual recognition agreement along the lines of the treaty that Switzerland has with the EU. “That agreement allows Switzerland to have notified bodies and provides for mutual recognition of the CE mark,” notes Vollebregt.

For the time being, until the final breakup, “British legislation remains fully aligned with European rules and CE marked products can move freely across the Channel.”

No one really knows where this uncertainty is heading – causing a lot of headaches throughout the global manufacturing, business and financial communities.

5 ways to avoid Murphy's Law in medical devices

Murphy’s Law influence in the design of a medical product can cause harm, irreparable damage, and even death. After all, according to the theory, “if someone can use a product the wrong way, then they will”. The goal of medical device engineers is to design products that are intuitive, easy-to-use, and simple.

Source: Qmed

The challenge is to project devices that never allow Murphy’s Law to work. Medical technology needs to be developed based on how the patient thinks, feels and behaves. It needs to fit perfectly and perform flawlessly.

Bryce Rutter, founder and CEO of Metaphase Design Group, provides a cheat sheet for the top five critical success factors in eliminating human error:

“1. Keep it Simple­

Less is more. Don’t get cute or clever.

2. Create a Visual Hierarchy

Everything is connected someway. Group controls and displays need to be based on function, importance, and frequency of use.   Establish visual importance through size, position, color, contrast, and shape.

3. Strive for Order

Our brains like order, not chaos.  Aligning and grouping fields, functions, and buttons and dividing content into digestible and meaningful chunks will create order and simplify a graphical user interface.

4. Design for Consistency

We like patterns. Good graphical user interfaces use consistent behavior throughout the application.

5. Embrace Conventions

Experience is empowering. Building upon a user's prior knowledge and experience expedites learning and efficacy.”

Why we need an Elon Musk in healthcare

   2016 is not even over yet but it has already been a fantastic year for billionaire businessman Elon Musk: Tesla Motors revealed its Model 3 car in March and in April SpaceX was finally able to land the reusable Falcon 9 rocket on a platform at sea. Musk has brought his ambition, innovative ideas and hard work to everything he touches: besides the electric vehicle company and the private spaceflight firm, Elon Musk also cofounded Paypal and has plans to colonize Mars by 2014. However, healthcare is probably the sector in which his golden touch is needed the most, with the aging population and medical costs going out of control.

   One important reason why Elon Musk has been able to drive breakthrough changes in the areas he’s been working with is that he’s not afraid to aim high and it’s time for that kind of big thinking in healthcare. “Instead of treating cancer, we need people set on eradicating it”, states Jamie Hartford - MD+DI's editor-in-chief. How inconceivable is it really to think we can’t wipe out this disease by the time we see the first generation of men on Mars?

   Another great thing about Musk is his realization that he cannot achieve everything by himself: SpaceX’s open-sourced design and Tesla’s open patents are an example of this – as Musk explained in 2014, “sharing intellectual property benefits not just his companies but the entire world”. Our industry players need to start thinking outside of their own organizations if we want to solve many of the healthcare problems we face today.

   Elon Musk’s ability to fascinate has truly inspired his followers to go on to launch their own groundbreaking companies – here’s to at least one of them come to disrupt healthcare…

FDA’s initial thoughts on 3D printed medical devices

The U.S. Food and Drug Administration (FDA) has recently released a draft guidance for the 3-D printed medical devices sector. The agency took into consideration inputs from device manufacturers, 3-D printing companies, and academics who testified at a 2014 hearing. According to QMED, the document covers device design, manufacturing, and design testing and for the purposes of the draft, FDA identified four main types of 3-D printing—powder fusion, stereolithography, fused filament fabrication, and liquid-based extrusion.

Source: QMED

3D printed medical device producers would have to “clearly identify every step in the 3-D printing process, and might need to submit a ‘high-level summary of each critical manufacturing process step,’” the guidance says. They would also have to record each step’s risk, and describe how they would lessen those risks. “The type of testing data needed would depend upon whether the device is an implant, load-bearing, and available in standard sizes or custom-made for each patient, or as FDA put it ‘patient-matched.’”

The implications for 3-D printed devices are enormous – therefore the draft guidance is the agency’s initial thoughts on the technical considerations surrounding the design, manufacture and testing of 3-D medical devices, which have few precedents. “While this draft guidance includes manufacturing considerations, it is not intended to comprehensively address all considerations or regulatory requirements to establish a quality system for the manufacturing of your device,” the agency said.

The draft guidance “provides a solid basis for medtech innovators to understand what is needed to prove safety, efficacy, and consistency to growing on-demand components for the human body,” said Derek Mathers, an adjunct professor of 3-D printing at the University of Minnesota and business development manager at Worrell Design in Minneapolis.

     “Standard-sized 3-D printed devices are offered in discrete sizes, and include features that are too complex to be manufactured with traditional processes like machining and molding,” he explained. “Patient-matched 3-D printed devices are devices that are digitally scaled (manually or by using an algorithm) to match a patient’s specific anatomical features. The FDA identifies that these bespoke devices will require significantly more validation work across every step of the ‘scan-to-fit’ design process.”

Making medical devices that customers want

Major challenges influence how the medtech industry works in term of product management, market positioning, and early-stage design and development. From downward cost pressures, reimbursement and regulatory requirements, increased competition, and, internal pressure to generate sales. As easy as it sounds, a customer-centric approach is a difficult thing to accomplish – but it helps medtech companies to think differently, engage with customers differently, and design and market devices differently. Here’re some tips on how adopt this strategy:

Source: MDDI

* Start with the Right Mindset: being a medical device company means that you are in the business of restoring and improving health. “Recognizing that will help you stay focused on making devices customers want and will buy.”

* Get Customer Input the Right Way: don’t just ask what features customers want in your product – ask what outcomes they want from using your product. “It is not the responsibility of customers to figure out what features will provide the experience they desire or achieve the result they want. What customers can meaningfully talk about is what experience and outcomes they want.”

* Minimum Viability, Maximum Value: “Put in just enough features so you validate that what you’re making is viable. Viable means the lean product sufficiently meets a customer need and will sell”.  In the medical sector, this could be harder due to regulatory approvals, reimbursement issues, and clinical trials. However, this is an attempt to minimize both investment and risk to avoid going to market with an expensive, feature-rich product that bombs. Maximum value is all about how much value your product can provide to customers.

         Despite significant barriers to successfully launch a product, this is an industry that exists to save lives – so companies should stay focused on the value, not product features.