How medical device and service designers balance form and function with regulatory compliance

Like any creative work, designers of medical products and services must consider a range of factors as they conceptualise the form and function of a physical, digital, or service product. Unlike most design work, the end-product in the medical space is meant to change – and even save – users’ lives, while its failures can lead to adverse – sometimes lethal – outcomes.

This responsibility makes medical design an equally challenging and rewarding field. Recently, the Design Museum Everywhere podcast explored opportunities for designers in healthcare and featured Scott Stropkay as guest co-host. He was joined by Head of Design at Connected Care – Philips, Richard Eisermann. Together, they discussed the processes involved in bringing new medical technologies and practices to market.

Medical product design starts with the user

The first stage of design, no matter the industry, is understanding user needs and stakeholder requests. In healthcare, the user may be a medical professional using equipment to diagnose a patient, a person managing their condition at home, a telehealth provider, and other care-delivery stakeholder. No matter who will be using the tools, designers need to consider overall function, comfort, and ease of use.

“When we're designing home health products, the way a visiting nurse sets ups a patient with a new device or appliance is as much of the design effort as the device itself,” Scott explained.

He described the importance of intuitive design that requires less training for at-home applications. User manuals are rarely referenced, so designers must find ways for users to learn and remember how devices work. In addition to the product itself, instructions should be easy to understand and concise enough to be a quick reference when needed.

The user focus in design is fundamental to Philips’ ability to deliver connected healthcare ecosystems that perform optimally in the healthcare market.

Design, at a high level, rests on creating memorable stories. “[Design is about] being able to boil these stories down into emotionally engaging narratives that allow people to understand very complex things,” said Richard. “We're using a lot of storytelling to help physicians communicate with families.”

At Philips, the calibre of medical care is often assessed through the “Quadruple Aim.” An international framework, the “Quadruple Aim” is used across the healthcare industry to outline four key goals for optimal healthcare delivery: better health outcomes, reduced costs, improved patient experience, and improved clinician experience.

“50 percent of the ‘Quadruple Aim’ is all about experience,” Richard points out. This focus on patient and clinician experience – or stories – in the healthcare industry directly parallels the central aim of designers. “That’s the mission, right? Deliver a better experience for everybody involved.”

When designing for highly-trained users, like surgeons and other medical professionals, Scott described the importance of human factors and ergonomics to usability and product success. He described a surgical robot that we designed; in addition to the robot itself, the team created quick mock-ups of operating scenarios to understand how people would engage with the technology and ensure it addressed real-world challenges.

“We were designing [a conceptual] environment that the surgeon would be working in as we were designing the physical hardware they were interacting with so – during long surgeries that take hours – [the hardware] could still be ergonomically comfortable, adjustable to different-sized people, and do different things over different periods of time,” he said.

Meeting regulatory standards in the US and abroad

As user needs are being framed, the team must also determine how regulatory standards must be met. Considerations include which countries the product will be distributed to, and what the local regulations are for those products.

“We have to meet safety and quality standards that the FDA in the US requires,” Scott said. “And if you're creating a device that's meant to be sold elsewhere in the world, there are different sets of standards you have to design to. You have to understand those requirements and test your designs repeatedly to prove that they are safe and effective before you get the stamp of approval.”

The diverse team of experts working on a medical design project helped with regulatory agency filings, as well as performed studies to submit to the FDA and other regulatory bodies. PA’s international presence assures that subject matter experts are familiar with regional standards and can help clients enter new markets confidently. While the process of getting products to market typically takes longer in the medical space than others, it is rewarding for those involved in creating life-saving devices.

“We've done a research-based project for a product that we have coming out soon – it’s in clinical testing right now, so soon in medical development terms, or in other words years – for a Neo neonatal intensive care unit,” Richard explained. “We interviewed a lot of families, clinicians and NICU nurses. It's amazing to hear these stories and to experience through them what it's like to be faced with that condition, and know the difference that we can make as a company. It's incredibly, incredibly fulfilling.”

Why a platform approach wins

There are many facets to end-to-end healthcare design and delivery. From initial concept to prototyping, testing and approvals, to manufacturing and distribution. Each of these steps is critical in any development effort, but in the healthcare space especially, there’s no room for error.

A truly end-to-end thinking approach brings together a diverse team of experts who are each experienced in a particular niche. Working together, those teams create discrete and system solutions to address project goals.

“The teams can be pretty diverse, but [each individual is] similar in that everyone is an amazing critical thinker,” Scott said. “We can play each other's roles to some degree, but each of us is expert in an area, and we'll take responsibility for that area as we engage our colleagues and clients.”

At Philips, the successful delivery of healthcare solutions also requires that designers work closely with different business functions across the organisation.

“The leaders of strategy, clinical, innovation, marketing, and design all sit together [to] evaluate the various proposals from the businesses that we'd like to take to market,” Richard explained. Across these departments, each team member is aligned to the same primary focus: balancing what customers want with what patients need.

Having a wide range of professionals working together on a project keeps everyone accountable and ensures there’s a strong flow of ideas throughout the process. In the end, the result is something designed specifically to make lives better.

“Everybody wants to design products that are meaningful to others in the healthcare space,” Scott said. “Everybody in our organisation wants to help their families, their friends, and their communities live better lives.”