What You Need To Bring an Innovative Healthcare Product To Market

Innovating in the field of medical devices can get extremely complicated and overwhelm even the most experienced engineers.

For startups all the necessary areas of expertise can prove be too much, but even for well-established medical companies it is not an easy task to keep up with the ever-changing field, increased complexity and regulations of medical devices.

Nyxoah – Surgical implant tool
Nyxoah – Surgical implant tool
Areas of expertise

The first thing you need is a multidisciplinary team that covers all the different areas of expertise. For startups, this is often impossible, and they need to look for external services to complement their skills. If you take this external route, look for teams that are flexible and can work well together with your team. Look for a team that has an extensive history in medical products and other fields. They can provide a wealth of expertise and experience in various areas that even some medical device manufacturers may lack internally. This will ensure you look at your project from different angles and transfer solutions from other fields.

Experienced design firms have tried and tested development methodologies that will guide you through the whole process. They know where the pitfalls are, and can work according to the required ISO standards.

MEDEC - Anaesthesia device
MEDEC – Anaesthesia device
Start from the user

Human factors, user-centric design, and usability engineering play an increasingly important role in the medical device industry.

Designing for healthcare must start from the user (patient, doctor, caregiver), not the technology. Particularly crucial is designing for human factors from patient acceptance, to increasing patient and user safety, to minimizing the risks of potential human errors.

Acquiring insights into user needs, fears, and use from patients and workers is essential for designing a successful medical device. Therefore, extensive user research and testing are an absolute must in the development process.

A couple sleeps peacefully. The man is wearing a medical patch device on his throat
Nyxoah – Obstructive Sleep Apnoea implant
Connected

Medical devices are not stand alone anymore. Many products are connected to platforms and exchange data with patients, doctors, and caregivers. This requires new insights and disciplines to design frustration-free user interfaces, secure data protection, and interconnected products.

Additionally, some healthcare is shifting away from hospitals and other medical environments to patients’ homes. Connected smart products collect medical data and make it available for patients, and doctors, in real time, to make the right decisions. This not only makes the development of products more complex, with smart censors and high connectivity, but also demands a complete rethinking of how healthcare services are delivered. These products become product-service systems that require a service design expertise to make them successful on the market.

TERUMO BCT – Laboratory tube sealing
TERUMO BCT – Laboratory tube sealing
Production

Finally, when you have your minimal viable product, proof of concept, and final prototype, you must be able to produce it in a consistent error-free way.

Thinking about this is not something you start with after the design is finished. Design for manufacturing should already be part of the design process from the very beginning. Production and product cost need to be taken into account at the very start of development.

Finding the right partner to produce your product is also essential, and if you start early enough, a good partner will help you in the last stage to go to production.

UNEEG Medical– For long-term monitoring EEG
UNEEG Medical– For long-term monitoring EEG
Go to market

Established healthcare companies have the necessary expertise to market their products in-house. For startups this can be a challenge. Even the best designed product can fail if it is not brought to market the right way. At the start of the development, product marketing and branding must already be part of the thinking process. This is the only way to make sure they will reinforce each other and avoid unpleasant surprises at launch.

How does Achilles face medical design?

At Achilles, we advance healthcare through people-centered design. We prototype early and often, to ensure we keep the people we design for at the heart of the process. By putting ideas in the hands of users from low-fidelity paper interfaces to 3D-printed prototypes and high-level immersion VR, we systematically identify improvements and preventively exclude risks without compromising our intuition.

We believe better health is achieved by engaging people at every stage of their health journey. Our cross functional team — consisting of biomedical engineers, designers, usability experts, and a doctor — work across disciplines to integrate people’s needs with responsible technology and sustainable business models. We strive to establish innovative healthcare service solutions that drive business value by advancing the standard of healthcare.


Visit Achilles Design at MEDICA Düsseldorf from 16-19/11/2020.

Written by

Jurgen Oskamp
Jurgen Oskamp

Founding partner at Achilles Design

Pandemic Work Rhythms: Moonbird takes a look at the new “business as usual”

There’s no doubt that the novel coronavirus that causes Covid-19 has changed our lives. Of course, it has most heavily affected those directly infected, their families, and those caring for the sick. But the pandemic has affected – and will continue to affect – everyone and every facet of society, not least of which is our work rhythms.

The effects of the 2020 global pandemic on work rhythms and societal norms was the subject of a recent piece written by Karen Borremans, resident clinical psychologist at Flemish startup Moonbird. Her essay, which you can read in Dutch here, asked the big questions facing employers and employees alike these days: “Are we going to go back to the ‘normal’ work rhythm? What lessons are we learning? What will be different?”

Changes from every direction

A major theme that Karen highlights is change. We all had to change our daily life and adjust our rhythms when the pandemic and the lock downs started. Now that lock downs are lifting (and in some places being reinstated), there’s whole new sets of changes.

She points out that just because we’re adjusting back to work doesn’t mean that it’s not an adjustment. What’s more, nothing is going back to exactly the way it was. So no matter what, we’re still having to figure out new ways of working. At the same time, we’re also still figuring out new ways of playing, moving, traveling, and everything else. As official measures are revised, what we can and cannot do changes. Nothing is secure or permanent. This is challenging at the best of times, let alone in a stressful situation that has serious implications for our health.

As we transition back to a less locked down work rhythm, individuals need to be mindful of their mental health. We need to introspect, take time to breathe, and allow our emotions room so that they don’t overwhelm us. Karen further points out that we need to pay attention to our physical well-being as much as our mental: relaxation and balance need to be combined with movement and healthy eating and sleeping habits.

She specifies, “Try not to be too hard on yourself . . . Define your limits and expectations, but be flexible and adjust your expectations over time. Take the time to consider what is feasible and what is not.”

Employers’ efforts to help re-establish post pandemic work rhythms

Companies, too, can play a role in easing the transition from lock down, even as they face financial difficulties in the face of the pandemic’s economic impact. “Especially at this moment employers have to find a balance between task orientation and people orientation,” Karen writes. “For organizations it will therefore be a question of finding a balance between their economic capital and the ‘mental capital’ of their employees.”

All the new ways of working that we’ve developed during the crisis do not necessarily have to be suddenly taken off the table. It’s not a black and white story. The crisis also created many opportunities: for example, in mobility or through more teleworking. Within organizations, there need to be discussions about which positive aspects of the crisis can be retained in order to increase productivity.

Karen Borremans, (Moonbird) Clinical Psychologist

Above all, it’s about paying attention to each other. Organizations need to create an environment at work that allows for Covid-19 adjustments aside from extra hand gel and spacing between desks. Senior colleagues should be cognizant of how much they ask of employees, and be watchful for signs of stress and anxiety. Flexibility will be the name of the game as we all try to re-establish work-life balances.

Tips & Tricks for employers and colleagues

Karen spells out some concrete actions we can be aware of in our working world, both as employers and coworkers, to help make the post lock down transition smoother:

  • “Regularly do individual face-to-face check-ins: ask before a meeting how someone is really doing, how that person feels with the current situation.” This might feel invasive, but knowing how a colleague is really feeling can help inform how we handle the work environment.
  • “Show understanding for someone’s feelings and look for appropriate measures: a better work-life balance, maybe more teleworking for more days, sliding hours, slowly rebuild the workload, balance productivity with capacity and adjust someone’s tasks, Or, if necessary, referral for appropriate (mental help) such as an internal confidential counselor, external prevention advisor or psychologist.”
  • “Be a role model for your employees: show how you can work on our mental well-being, spread actions and set up activities. Ask those responsible to explain how they actively do this, and teams will be more likely to try it out. Moreover, you create a culture where it is okay to feel less than great and you rid mental well-being of its taboo.”
  • “(Transparent) communication: it may be necessary to adjust the existing guidelines and procedures relating to sick leave, teleworking and welfare policy. A clear framework with a transparent communication plan helps for everyone. Plan individual one-on-one meetings between managers and employees, and facilitate networking between colleagues.”

About Moonbird

Flemish start-up Moonbird is focused on your breath. Well, they’re focused on helping you focus on your breath so that you can relax. Through a combination of biomedical sciences and clinical psychology, the team of four is working hard on digital technology-driven solutions to help us all calm down a little. You can check out their website and their forthcoming breathing exercise device here.

Moonbird logo
Visit Moonbird at their website and follow them via their social media channels