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…

Medical Devices & Product Development: following every step

Harshal Shah, vice president of the Global Medical Technology Division at Cambridge Consultants, gave an interview for MD+DI online earlier this month on his insights on FDA approval processes and commercialization strategies for medical devices. As he works closely with medtech companies and innovators, Harshal advises that product developers must identify the category in which the product is going to fall into according to FDA’s guidelines and interact with the agency in the early stages of the development. The FDA has improved drastically and has a well-published process for requesting FDA’s feedback and meeting with some of the key people who are directly involved and relevant to the innovation. He also suggests that these startups and innovators should try to invest and plan out costs for hiring regulatory advisors, as it’s a complex process.

Regarding product development, Harshal explains that innovators should work with Quality by Design and the Design for Manufacturing principles: have specific experts who specialize in Quality by Design principles and QbD audits and Design for Manufacturing audits of design work. So, one can make changes early on and produce prototypes as well as the clinical trial devices in line with what will be able to produce for commercial scale in the future, after approval

“My deep expertise is more towards the late end of the development cycle when you’re preparing for your trials and approvals. Even before you think about producing your trial size batches for your new product, it’s really a must to get a good understanding of how you’re planning to get this product into the commercial market.”

3 Biggest Challenges to Healthcare Innovators

          Medtech companies are used to running into regulatory obstacles during their innovation processes. According to MDDI, these companies are divided into three type of business: large scale medical device innovators and manufacturers; new device innovators (ranging from the surgeon with a good idea to the existing medical device company with a product line of a few products); software technology innovators. It’s true that they all share common challenges, but their primary ones are different according to their role in this complex industry.

Source: MDDI

When talking with each segment; here are the three biggest challenges they all share:

1. Cost and complexity to improve and enhance innovation: large scale medical device innovators have a great overview of the marketplace and the regulatory system, but identifying the best R&D opportunities is not always easy. Big data analytics are expensive and complex to implement. “The more incremental the deployment of any new technology can be made, the more likely you are to achieve final success.”

2. Time and volume of follow-up and tracking data from FDA: it’s very time-consuming to go through FDA notices, recalls and regulatory changes. “Technology now allows you to both take optimal advantage of the level of effort required and increase the quality of the results for you by automating the access to the data.”  

3. “Getting blindsided by regulatory issues is probably the most common complaint from software innovators”. Having access to FDA guidance, regulations and industry best practices can help these innovators avoid this type of problem.

Medtech Industry needs to build credibility with Hospitals

McKinsey & Co. released a new report, called "Improving healthcare while curbing cost: Med-tech companies offer a solution", showing that the medtech industry has to, not only build awareness of its products and solutions, but also build credibility among hospitals.

MDDI

The McKinsey survey 157-hospital executives in the U.S. and Europe, fewer than half ranked the clinical and technical expertise of large equipment manufacturers as "excellent." The result was even worse for makers of devices and consummables. Only 19% of hospital executives responded that large medtech makers' understanding of the hospital business was "excellent."

"With few exceptions, med-tech companies do not offer to share risk with their hospital customers," the report charges. "They focus on marketing the technical features of their products and price accordingly. Yet providers say they are more willing to work with med-tech partners if they know they share the risks as well as the benefits of the arrangement."

       The report suggests that there is a $44 billion opportunity in the U.S. if medtech companies work with hospitals and provide "beyond the product" solutions.  It also points out that executing contractual agreements where medtech companies share risk would help to build credibility.