Life sciences Archives • Verhaert Masters in Innovation

The impact of decentralization on IVD engineering

Aimée Mugisha — Thu, 07 May 2026 14:34:37 +0000

In-vitro diagnostics (IVD) is moving past the era of ‘better specs’ and into the era of ‘systemic integration’. While decentralization and connectivity have been discussed for years, we have reached a fundamental inflection point: the convergence of stricter global regulations and the ‘retailization’ of healthcare. For R&D and leadership, this requires a total rethink of the product lifecycle, moving from designing isolated technologies to building scalable, connected ecosystems. Let’s explore the key trends driving this change, what they mean in practice and what we can learn from other industries.

Big-picture context

IVD success is no longer a purely biological challenge. While companies remain strongly rooted in scientific excellence, many are hitting a capability ceiling: their expertise in assay performance hasn’t yet been matched by the specialized systems engineering required for decentralized adoption. Diagnostics now need to function across fragmented healthcare settings, from central labs to point-of-care environments and even patient-facing use cases. That means usability, connectivity and workflow integration are just as critical as analytical accuracy. On top of that, regulatory expectations around traceability and real-world performance have intensified, while cost and operational pressures continue to grow. These combined pressures are redefining success in diagnostics, shifting the focus from isolated analytical performance to end-to-end ecosystem effectiveness in complex healthcare environments.

Trend 1: Decentralized testing needs robust usability

In vitro diagnostics have always been designed for trained lab techs working in controlled lab environments. That model doesn’t really work anymore. Testing is steadily shifting out of central labs and into clinics, hospital wards, pharmacies, and even patients’ homes. That means what used to be a very technical process now has to be simple, intuitive and robust in real-world conditions.

For IVD system design, this shift is profound: Usability now effectively defines the product. Devices must be small enough to fit into constrained clinical spaces, but also simple enough that there is only one way to run the test: the correct one. Every extra step increases the risk of error. At the same time, workflows need to be managed and streamlined end-to-end, including how patients register, how samples are collected, and where results are integrated.

Cartridge and consumable design are also changing, since tests are no longer performed in clean lab environments. Contamination risks must be engineered out at the design stage. All of this must be achieved while using lower-cost materials and supporting less specialized users, without compromising reliability or consistency.

Trend 2: Connected traceability changes system architecture

With stricter frameworks such as EUDAMED and tighter post-market surveillance rules, manufacturers are now expected to continuously generate, structure and report performance data across the entire product lifecycle. The old model of building a device and releasing it is giving way to one of ongoing accountability.

This shift matters more than ever because diagnostics are moving into higher-stakes clinical areas. Tests that once supported relatively simple decisions, such as pregnancy confirmation, are now being used in complex and sensitive domains like neurodegenerative diseases and long-term condition management. As clinical impact increases, so does the demand for traceable, reliable and auditable data.

Connectivity enables this transition, turning what was once sporadic data collection into a continuous flow of structured information. Yet, it also changes the fundamentals of system design. Devices must now be built as data-generating platforms from the outset, with storage, parameters and data streams considered at the architecture level, rather than added later.

The consequences for existing offline systems are significant. Companies must either re-engineer legacy products or phase them out, both of which can divert valuable engineering capacity from new innovation. This shift is particularly challenging for mid-sized and niche players, because larger companies are more likely to leverage existing software capabilities across business units. As a result, regulatory compliance demands strong in-house expertise to ensure systems are registered and data streams are correctly structured and maintained.

Trend 3: Scalability starts earlier, in cartridge and platform design

Scalability in IVD is often treated as a manufacturing or supply chain challenge, but in reality, it starts much earlier, in the architecture of cartridges, consumables and platforms. As diagnostics move closer to patients and away from centralized labs, manufacturers are being pushed toward smaller, simpler devices that can operate in clinics, pharmacies and other decentralized settings. Paradoxically, this miniaturization often increases technical complexity inside the system.

In the past, devices were developed primarily for trained laboratory professionals, which reduced the pressure around usability, volume scaling and cost sensitivity. Today, that is no longer the case. Products must be designed from the outset for high-volume use and non-expert users, making early design decisions far more consequential. Usability considerations just can’t be postponed without risking expensive redesigns later in the cycle.

Cost of goods has also become a defining constraint. Unlike central labs, which can absorb higher per-test costs, general practitioners and point-of-care settings operate under tighter budgets. This forces manufacturers to make manufacturability and cost trade-offs much earlier in development. At the same time, they need to shift toward system-level thinking and modular platform designs capable of running multiple tests on a single system, rather than single-disease instruments. Many R&D teams are still adapting to this way of working.

What you can learn from other industries

Luckily, IVD’s current transformation is not happening in isolation. FMCG and aerospace, in particular, offer clear lessons in how to design for miniaturization, modularity, and tight system integration without losing control over cost and complexity. In FMCG, high-volume product development has long depended on breaking systems into modular, interchangeable parts that can be rapidly iterated and optimized. Aerospace and space applications, on the other hand, have pushed miniaturization and reliability under extreme constraints, where every gram, component choice, and interface matters.

In practice, this translates into a more structured cost-down approach early in development, screening architectures faster and eliminating non-viable options before heavy R&D investment. In some of our projects, such as for Hippo Diagnostics and Fujirebio, applying this discipline helped reduce bill of materials costs by up to 50%, mainly by simplifying subsystem choices and improving component alignment.

Another transferable capability is holistic gap assessment: mapping the current system state, identifying regulatory and technical gaps, and translating them into a clear product roadmap. While we don’t replace regulatory expertise, this approach helps you turn complex requirements into actionable engineering decisions.

Finally, FMCG and industrial sectors also provide mature models for cybersecurity and system robustness, including proven approaches to risk management, layered security architecture, and continuous monitoring. These practices are increasingly relevant as IVD platforms become more connected, data-driven, and exposed to external systems and networks.

What you can learn from other industries

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Bold trends in drug delivery: the path to value-based healthcare

Lieven Claeys — Thu, 07 Nov 2024 14:38:18 +0000

In today’s rapidly evolving world of drug delivery, companies have to increasingly balance new demands in cost efficiency, sustainability, data and stringent regulations. At first glance, this might sound like a tall order, but when these demands are aligned right, they create powerful opportunities for breakthrough solutions. Let’s explore how they intersect and which strategies tackle these challenges head-on to keep pushing the industry toward exciting product innovations.

Innovation unlocked through regulatory challenges

Navigating the complex regulatory landscape is challenging, however, it also opens doors for innovation. As recent regulations put greater emphasis on personalization and safety in drug delivery systems, companies are tasked with being both compliant and forward-thinking.

By considering compliance early in the development process, companies can avoid costly redesigns and speed up time-to-market. Additionally, the shift toward value-based procurement, which focuses on outcomes and total value, aligns well with these regulatory goals, promoting innovations that are both effective and efficient.

This synergy between regulation and innovation means that companies who skillfully manage these requirements will not only meet compliance but also set new standards for quality and performance in the industry.

Transforming costs through sustainable innovation

As the drug delivery market evolves, the pressure to cut costs is stronger than ever. Traditionally, sustainability efforts were seen as just another expense, luckily this view is shifting. When integrated thoughtfully, sustainability can actually drive cost savings.

One approach gaining traction, especially in Europe’s Nordic countries, is value-based procurement (VBP). VBP focuses not just on initial costs, but on the total value that a product delivers throughout its lifecycle, including its environmental impact. This model promotes sustainable practices that reduce material use and simplify production, ultimately lowering costs while benefiting the environment.

Streamlining device design also cuts manufacturing costs and reduces waste, supporting both cost efficiency and sustainability. This dual advantage repositions sustainability from a cost add-on to an essential part of a smart, modern drug delivery strategy.

Data-driven innovation to enhance value

Integrating data into drug delivery systems is a game-changer for both treatment outcomes and operational efficiency. Connected devices that capture real-time data enable personalized treatment plans, ensuring patients get the right dose at the right time, reducing waste and boosting effectiveness.

Beyond streamlining operations, data integration supports the shift toward value-based healthcare. In this model, the ability to track and prove treatment effectiveness is essential. Data-driven insights allow healthcare providers to adjust treatment protocols on the spot, improving patient outcomes and aligning with the principles of VBP.

Incorporating data into drug delivery isn’t just a tech upgrade, it’s a strategic enhancement that strengthens the value of these systems in the healthcare landscape.

Connecting trends for drug delivery success

In the complex world of drug delivery, cost pressures, sustainability goals, data integration, and innovation all come into play, bringing both challenges and opportunities. Viewing these trends as interconnected rather than separate allows stakeholders to design drug delivery solutions that are cost-effective, sustainable, innovative, and aligned with the healthcare market’s evolving needs.

This holistic approach, guided by value-based procurement and a strong grasp of regulatory requirements, positions companies to lead the next generation of drug delivery products, meeting the needs of both patients and healthcare providers.

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Closing the loop: sustainability in drug delivery ecosystems

Lieven Claeys — Thu, 28 Mar 2024 12:55:24 +0000

Amidst the myriad challenges posed by soaring costs, environmental impacts, and patient adherence issues, the landscape of drug delivery has been fundamentally shifted in the aftermath of COVID-19. This period has witnessed a remarkable surge in the adoption of smart drug delivery platforms, seamlessly integrating connectivity and wearable technologies. An evolution that presents fresh opportunities for transformation within the field. Are you cruising down the MedTech innovation highway, tackling these challenges? This blog serves as your guiding compass in navigating the dynamic journey toward sustainable solutions in drug delivery innovation.

Revolutionizing patient care: the evolution of smart drug delivery systems

Step into the realm of innovation! Just over 5 years ago, a groundbreaking milestone unfolded with the launch of the first FDA-approved connected smart inhaler. This marked a new era in healthcare technology, where the convergence of low-power electronics, advanced sensors, and connectivity is reshaping patients’ experience. Imagine the possibilities: these cutting-edge technologies are more than gadgets, they’re revolutionizing the patient’s well-being and how they interact with their treatment care.

Advanced sensors delicately measure physical parameters like activity with accelerometers, body temperature, and even physiological markers with biosensors. Ultimately paving the way for enhanced patient safety, outcomes, and personalization. With every breath, patients are empowered to take control of their well-being like never before. And it doesn’t stop there. These innovations aren’t just about convenience, they’re about safety too. By leveraging smart technology, we’re addressing key issues like unauthorized medication use and ensuring therapy adherence. Take, for instance, Ability MyCite – a groundbreaking solution that monitors depression treatment using a smart pill and wearable platform.

Amidst these advancements, a pressing question lingers: how can we harness the power of these technologies while minimizing their environmental impact? Join us on this journey as we explore how to create solutions that not only enhance patient care but also tread lightly on our planet’s resources.

Designing for sustainability

Addressing the ecological impact of drug delivery systems, particularly those incorporating electronics, is paramount in our field. Abandoning smart solutions, proven to fulfill critical needs and deliver unmet outcomes, is not a viable path forward. How then do we navigate this challenge?

The key lies in recognizing that device sustainability hinges on its integration within a broader ecosystem. Our approach must embrace this interconnectedness, embedding traceability from production to end-user (B2B2C) and eventually back (B2B2C(2B). This not only facilitates recycling or proper disposal but also directly benefits patients. For example, integrating sensors to ensure drug integrity along cold supply chains enhances patient safety. Yet, such advancements demand meticulous attention to data privacy, prompting the exploration of technologies like blockchain (see Verhaert Digital). By combining intelligent devices with robust recycling strategies, we chart a course toward sustainability in drug delivery, forging new value chains, and enhancing profitability. Inspirations from initiatives like Litterbits or Nanopores recycling scheme guide our endeavors.

While enabling recycling is crucial, we must also prioritize the recyclability of our products. Minimizing the use of materials challenging to recycle, such as pure polymers and metals in single-use components, is imperative. Strategically defining the split line between smart, critical, and non-critical components can significantly reduce the environmental footprint. Embracing recycled materials, exemplified by the integration of pulp injection molding in auto-injections, underscores our commitment to sustainability. Streamlining component count, as exemplified by Haselmeier’s award-winning Picojet auto-injector with just 8 components, further exemplifies our dedication to eco-conscious design.

Sustainability in drug delivery: imperative progress

In conclusion, the journey toward a sustainable drug delivery ecosystem presents both formidable challenges and indispensable imperatives. Our exploration through this blog underscores how the infusion of intelligent technologies into drug delivery systems has revolutionized patient care, offering unparalleled levels of safety, customization, and adherence. Nevertheless, we cannot afford to ignore the environmental impacts of these cutting-edge systems.

The key to sustainable advancement lies in conceptualizing each device as part of a larger ecosystem, where every facet, from inception to disposal, warrants meticulous consideration. By embracing integrated methodologies that prioritize traceability, recyclability, and the utilization of eco-conscious materials, we can alleviate the ecological footprint of these devices. Embracing advanced technologies like traceable sensors and blockchain for data management, alongside the exploration of pioneering materials such as pulp injection molding, heralds progress in the right direction.

Furthermore, the industry must persist in innovating to streamline the complexity and component count of drug delivery devices, as exemplified by the elegance of Haselmeier’s Picojet. Such innovations not only diminish the environmental impact, they also showcase the potential for refined, effective design in life sciences technology. Reach out to us to delve deeper into the artistry of integrating sustainable design into your drug delivery device.

Looking ahead, it becomes abundantly clear that sustainability in drug delivery transcends mere choice – it emerges as an imperative. Learning from other industries, perpetually innovating, and maintaining a holistic view of the drug delivery ecosystem, enables us to ensure that the advancements in patient care don’t come at the expense of our planet. The future of drug delivery isn’t just about being smarter and interconnected, it must also embrace eco-friendliness and be more sustainable.

In the next blog post, we’ll discuss the changing landscape of the drug discovery market – from discovery to administration! Stay tuned to learn how technology is changing the way businesses interact.

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From science fiction to reality: AI & robotics in healthcare

Niels Verleysen — Tue, 18 Apr 2023 10:19:27 +0000

If you’ve ever seen the movie Prometheus, you’ll probably remember the scene where Elizabeth just pushes some virtual buttons, lies down, and has her robotic pod perform surgery on her. What about the android personal butler, David, for the elderly character? Those devices don’t exist yet, but the medical industry is definitely making some great advances in that direction.

In this blog, we’ll do a little deep dive into the different types of robotic and artificial intelligence systems that are already being developed. Let’s start with the current state-of-the-art certified robotic systems present in surgery rooms!

How can robots contribute to better healthcare?

Competent medical staff is invaluable for the healthcare system, but specialists are incredibly rare. The expertise scarcity means that a large portion of resources (time, money, fuel) is being spent on transport instead of performing medical procedures (regardless of if the patient or the doctor needs to travel). This is where teleoperated robots can get handy, as only the information (the robot’s real-time motion control) has to travel instead of people physically.

Not to mention that training someone to become a surgeon takes many years and many more years are needed to become a specialist. A computer-based system can be ‘trained’ almost instantly by updating its software: not in the same meaning as training a machine learning model, which can be an extensive process, but with the meaning of deploying an existing model for example. Of course, first, we need the mechanical capabilities and the software stack. That’s something we’re already working on.

Moreover, what are robots best at? Repeating motions over and over again with superhuman precision. Repeating motions over and over again with superhuman precision? Yes, repeating motions over and over again with superhuman precision (author’s attempt at humor). Therefore, the execution mistakes due to ‘human error’ could be significantly reduced. This discussion can be layered and tackled in detail:

Robots as extensions: teleoperation with full human guidance and control.
Robots with limited critical autonomy: teleoperation with partial human guidance and control.
Robots with high critical autonomy: minimal human intervention during the medical procedure.
Robots with autonomy on non-critical tasks: guiding, servicing and rehabilitation.
Artificial intelligence enhanced healthcare: from perception and planning for robotics to volumetric registration for medical imaging and biosensors data analysis.

All these systems aim to:

increase global accessibility of specialized medical expertise
provide an early potential diagnostic
optimize time and performance of medical procedures
improve treatment/rehab consistency by making it fun

Da Vinci Surgical System

Robots as extensions

As mentioned in the introduction, we will discuss the state-of-the-art systems in terms of certified surgical robots. The most popular surgical robot is probably the ‘Da Vinci Surgical System’ (picture above). Although it represents a consistent technological advancement, the system isn’t conceptually complicated overall. In this setup, the robot is an augmentation of the medical practitioner via an optical system and a tactile interface. Basically a screen and a joystick controller (using simple words to describe a rather complex and sophisticated device).

Most of the surgical robots today fall in this class as they’re capable of giving superhuman perception and motion precision abilities to doctors. The teleoperation system acts as a scaling mechanism that can greatly improve the motion accuracy: “if the operator moves a joystick 10 cm, while the surgical robot moves an instrument only 1 cm, then the precision is 10 times increased. And it can be even much more. The optical system offers a focused and immersive connection between the operator and the surgical procedure and it can be further enhanced by augmented reality.

The drawback of these teleoperated surgical robots is that most of them do not have haptic feedback, meaning that the operator doesn’t ‘feel’ resistance when touching the tissue. There’s no force feedback control and therefore the responsibility (and the merit of success) is entirely attributed to the surgeon operating the system. Although they don’t possess substantial autonomy, these medical robots are highly robust and are currently the only type of medical device certified to be used in actual medical procedures.

While being a rather sensitive (and highly confidential) topic, we can proudly say that we have acquired some experience in building demonstrators of robots with autonomy on non-critical tasks, robots with limited critical autonomy, robots with high critical autonomy as well as AI-enhanced healthcare use cases.

Several types of robotics and AI systems are currently already present in healthcare, certified and capable of enhancing surgeons’ skills. However, many technologies and advances are popping up as we speak. In our upcoming blogs, we’ll tackle more types of robotic and artificial intelligence applications in the healthcare field.

Nevertheless, if your curiosity is greater than your patience, don’t hesitate to contact us and pick our brains on what we can do for your medical application!

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6 ways digital health is transforming medical devices

Lieven Claeys — Fri, 10 Mar 2023 12:44:34 +0000

Telemedicine, remote patient monitoring, blockchain technology and the internet of things. Chances are pretty high that you’ve already heard about of one of these digital trends before. But how can you implement them in your own medical devices to accelerate adjacent innovation?

Why should you care about digital health?

Digital health is rapidly transforming the healthcare industry to a more patient-centered care system. Technologies like computing platforms, connectivity, software and sensors enable patients to consult real-time health data collected in an application on their phone, smartwatch or other wearables. Successful examples include virtual alternatives for traditional appointments with healthcare providers. This makes it easier to access professional or digital services that leverage the capabilities of machine learning for early disease prediction.

The improved patient outcomes then seem self-evident, but digitalization of your medical devices also comes with strategic advantages. Reducing costs by developing more effective products, new revenue streams by expanding your market and long-term growth potential is just the tip of the iceberg.

How do you innovate by leveraging digital health technologies?

All this information sounds good but you don’t know where to start? Here are some strategies for implementing digital health in medical devices to accelerate adjacent innovation within your organization:

1. Focus on user needs

This not only includes patients but also healthcare professionals and caregivers. By understanding the needs and preferences of the end user, manufacturers can design solutions that are user-friendly and tailored to their users’ specific needs. For companies, this will help ensure product effectiveness, user adoption, and competitiveness, balancing the conflict between regulatory and user needs and ensuring usability for complex devices. Make sure to also check out our perspective on market adoption!

2. Leverage data analytics

Medical devices can collect a vast amount of data, from patient vital signs to medication adherence. Data analytics can also be used to optimize device performance, identify areas for improvement, and enhance patient outcomes.

3. Embrace artificial intelligence

Artificial intelligence is revolutionizing healthcare, and medical devices are no exception. By incorporating AI algorithms into medical devices, healthcare providers can improve the accuracy and speed of diagnoses or enhance treatment recommendations. Another example is the use of AI in medical imaging devices. AI algorithms can analyze medical images and help detect abnormalities that may be difficult for human radiologists to identify. In one study, AI-assisted radiologists were able to detect breast cancer with 90% accuracy compared to 88% for human radiologists alone. This has the potential to improve patient outcomes by enabling earlier detection of diseases and reducing the need for repeat scans.

4. Prioritize patient engagement

Patient engagement is a critical component of digital health innovation in medical devices. By empowering patients with tools and information to manage their own health, medical devices can improve patient outcomes and reduce healthcare costs.

5. Integrate existing systems

Medical devices do not operate in isolation, and it is important to ensure that they can seamlessly integrate with existing healthcare systems. This includes electronic health records (EHRs), hospital information systems (HISs), and other digital health solutions. By integrating with existing systems, medical devices can improve workflow efficiency, reduce errors, and enhance the patient experience.

6. Ensure regulatory compliance

Medical devices are subject to a complex regulatory environment, and it is essential to ensure that any digital health solutions incorporated into these devices comply with all applicable regulations. This includes regulations related to patient privacy and security, data management, and medical device approval processes.

In conclusion, adjacent innovation through digital health provides medical device manufacturers with a range of opportunities to create new products and services that meet the needs of patients and healthcare providers in new and innovative ways. By focusing on user needs, leveraging data analytics and artificial intelligence, prioritizing patient engagement, integrating with existing systems, and ensuring regulatory compliance, we can create digital health solutions that enhance patient outcomes, improve workflow efficiency, and reduce healthcare costs.

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Innovation in the air: how to build strong medical partnerships

Koen Verhaert — Tue, 14 Feb 2023 11:06:56 +0000

High costs, scientific complexity and regulatory restrictions, as an innovator in the medical industry these challenges will probably sound very familiar to you. In the fast-paced world of life sciences R&D, these obstacles often stand in the way of innovation and growth. But what if there was a way to bypass them?

Collaboration. It’s not old news, in fact, it’s more important than ever. Whether you’re working in business, academia, or scientific research, collaboration is the secret weapon that can help you overcome R&D obstacles. Check out our 7 golden rules to make collaboration work in your favor.

1. Build strong relationships

Rome wasn’t built in a day, and neither will your collaboration ecosystem. So start small with trusted partners that share your values, goals, and expertise and let your success stories speak for themselves. In addition, you can outsource your non-core R&D to experts in specific areas can free up resources for your company while expanding your network.

2. Adhere to high-quality standards

Almost everyone has heard the phrase ‘Bad publicity is still publicity’. However, this doesn’t apply to collaborations and networking. Especially in life sciences, it’s crucial to establish trust with your partners and customers through product safety and reliability. For that reason, you have to adhere to the highest standards and state-of-the-art technology.

3. Solve problems together

Collaboration can be messy and unpredictable, so be prepared to adapt and adjust your approach as needed. By defining the objectives and deliverables of the collaboration, you make sure that everyone is aligned on the end goal. This makes it easier to confront challenges head-on and work together to find solutions instead of resisting. Always question “What problem are you trying to solve and how will it help reach our goal?”

4. Partner with the right experts

Claiming expertise in everything is difficult and in some cases even impossible and unnecessary. It could even limit your opportunities for long-term growth and success. Instead, it’s better to focus on your product definition and partner with experts to take on the development capability from product definition to architecture and requirements.

5. Be transparent and accountable

In any collaboration project, you want to stay clear of finger-pointing when misunderstandings and issues inevitably arise. If you want to establish a strong long-lasting relationship with your partners, you should be transparent about progress, challenges, and any other issues that arise. In addition, you should ensure that all parties are accountable for their respective deliverables.

6. Decentralize decision-making

Small decision-making circles have become increasingly popular in organizations, with many leaders seeing the benefits, like being more agile, allowing for faster decision-making and more efficient communication. To avoid a disconnect between decision-makers and those affected by the decisions, establish a clear governance structure that outlines decision-making processes, roles, communication requirements and responsibilities for all parties involved.

7. Stay curious and learn continuously

The life sciences industry is highly dynamic, with new discoveries and breakthroughs happening every day. Staying curious and keeping an open mind can help you adapt to new challenges and opportunities, and drive innovation in your respective field. And because the market is so dynamic, it’s so important to continue challenging, nurturing and expanding your partnerships.

Following these golden rules will help you drive innovation and progress in your R&D projects. Not only by maximizing the strengths of each partner but also by helping you achieve shared goals more efficiently, expanding your market and tapping into new technologies and expertise.

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The power of Human Behavior Engineering in hybrid operating rooms

Wouter Hendrickx — Tue, 17 Jan 2023 17:42:48 +0000

The operating room is one of a hospital’s most critical and complex environments. They require high levels of precision and accuracy for rapid and efficient operations. As the healthcare industry evolves, so do the demands of the OR. The continued development of both minimally invasive procedures and imaging technologies is increasingly pushing traditional ORs to hybrid alternatives. How can Human Behavior Engineering help you develop meaningful and effective solutions?

There are numerous articles, books, blogs, webinars and other content tackling these questions. However, putting them into practice, and applying the theories to your specific case, isn’t trivial.

What is a hybrid OR?

A hybrid OR combines a conventional operating room with an imaging system such as MRI, CT scan, or angiography system and robotic surgery. As a result, the hybrid operating room makes it possible to simultaneously reach a diagnosis and provide treatment during surgical interventions.

However, designing new technology for this OR is not a walk in the park. Even when the innovative solution demonstrates increased efficiency, effectiveness, and/or cost reduction user adoption isn’t guaranteed. A potential catastrophe for the product’s and the company’s success.

So it’s essential to activate a user’s behavior towards your product, in addition to validating your medical device concepts through the conventional usability engineering studies (IEC 62366) to eliminate use-related hazards and misuse. That’s why we advise combining risk-based usability with a de-risking resistance and rejection by the end-user approach in our Human Behaviour Engineering framework.

Human Behaviour Engineering framework

One of the biggest challenges in the hybrid OR is that different teams have to interact and collaborate smoothly and efficiently before and during the surgery. Focusing innovations on sub teams among specialties like surgery, radiology and anesthesiology, for example, can stimulate a potential ‘in-group/out-group’ mentality. As a result, staff may start feeling only responsible for their own sub teams’ roles and tasks, creating longer waiting times, less effective procedures, and an uneven distribution of work.

The design of a hybrid OR can actually improve this team collaboration by looking at the environment and user profiles. By identifying how your product(s) will influence a certain behavior, you can search for desirability differentiators and build meaningful interactions with the end users. The Human Behavior Engineering framework allows you to define the usability, safety and desirability of your solution, eliminating unintended use (misuse), use-related hazards and rejection. The result: a true fit-to-market medical device!

Design for team collaboration

So how can Human Behavior Engineering help you to improve team collaboration? One approach to this is to map the entire current workflow. Study the dynamics of the OR workflow, such as patient transfer to the operating table, the space required for anesthesia equipment, surgeon and other health care personnel ergonomics, and the nurses’ ability to find equipment. Each of these factors can have a profound influence on the design of the space.

In the next phase, the multidisciplinary team could be guided through a simulation merging the different workflows of the specialties to test assumptions, identify areas of conflict and even find new opportunities for collaboration.

Want to learn more about Human Behavior Engineering? Make sure to check out our perspective and download our study logic!

Download the study logic on behavioral design beyond human factor engineering

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How to set up successful co-creation in innovation? A success story in robotic prosthetics

Lieven Claeys — Wed, 23 Nov 2022 09:54:02 +0000

Academia is often referred to as the breeding ground of innovation. Skilled researchers spend years, blood, sweat and tears to create new technologies and ultimately reach the Eureka moment. The point at which their research can be translated into a physical (or digital) realization, a new product or service. This is an inflection point, where you transition to a new approach, methodology, thinking pattern and mindset. You’re no longer a researcher; you’re a product developer. Where do you start? How do you avoid reinventing the wheel? And how do you ensure that you’re inventing the right wheel?

There are numerous articles, books, blogs, webinars and other content tackling these questions. However, putting them into practice, applying the theories to your specific case, isn’t trivial.

The co-creation journey

Pierre Cherelle, Founder and CEO of Axiles Bionics, reached his inflection point after 7 years of research. An opportunity was evident: the ankle prosthetic market at the time hadn’t seen any significant innovation for over 20 years, even though it was in dire need. With the technology in one hand and a business case in the other – the journey started.

Axiles Bionics activated Verhaert to support them in accelerating their product development, accelerating the time-to-market, and asking the right questions at the right time. Herein, it was Axiles Bionics’ ambition to over time take complete ownership of their technology, hardware and software.

In this co-creation project, Axiles Bionics could leverage the product development experience of Verhaert, the technical support of its engineers and over time phase out the support as it builds up internal capacity and capabilities. Such a partnership requires a structured development approach, in line with Verhaerts’ methodology.

Embracing the new paradigm

After 7 years of research, going back to the drawing board, brainstorming, and challenging the concept was not the expected start. However, it’s essential to challenge ideas, brainstorm, and tackle design issues or address needs from various perspectives. Essential to design the right product, software, or service in that regard.

Peter Ogrodnik defines ‘design’ in his book Medical Device Design as follows:

Design is the use of scientific principles, technical information, imagination, ingenuity, and specific background knowledge to define a product to meet a well-defined need with the maximum economy and efficiency.

Using these principles, information, imagination and background aren’t based on one individual, it’s a collective. A collective with a broad background in expertise and experience. In addition, the well-defined need isn’t that of an individual, but again of a collective – or population. To do this successfully, it’s important to gather the necessary evidence from a technical, user and business perspective.

You often read that the key to success is to “surround yourself with people that are smarter than you “. Smarter may not be the right word, but more inspiring may be more suitable, it’s central to a successful methodology in new product development.

Bringing the challenge home

The brainstorms and conceptualization exercises were fruitful because they led to potential improvements in the business case, product cost and functionality. These however came at a risk. As a result, Axiles Bionics and Verhaert agreed to a de-risking development approach, tackling the largest risks and uncertainties first with limited effort.

Over time the involvement of Axiles Bionics increased, and Verhaerts’ engineers phased out of the project: from daily updates to weekly meetings, to monthly advisory on an ad-hoc basis. The result? The fundamental feasible concepts were integrated into a prototype. Axiles Bionics then took full ownership of the further development and now launched product: Lunaris.

Verhaert very much enjoyed this fruitful collaboration with Axiles Bionics and looks forward to supporting researchers in their inflection point in the future!

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The Life Sciences Paradox – Innovation in one of the most purpose-driven ecosystems

Wouter Hendrickx — Thu, 03 Nov 2022 15:52:20 +0000

The life sciences industry is one of the most purpose-driven ecosystems, constantly pushing the boundaries of new ideas and technologies in the search for new added value to ultimately improve patients’ lives forever. This is a tremendous job. To make these innovations happen, you often need to make design choices with very limited information. For many of these challenges, the decision-making process is not so clear, resulting in tough trade-offs. When choosing between these options, there’s always a risk of losing. This is the so-called paradox of choice, that in life sciences making decisions is often intertwined with taking an uncertain activity and making it innovative.

The reimbursement paradox: Are reimbursement systems slowing down innovation or a means to improve innovation effectiveness

Every product or service needs a well-defined business plan to make it at one moment in time profitable. One of the important building blocks is reimbursement. When looking at this, you will know that reimbursement is an umbrella for the process to manage and pay for healthcare services, including benefits coverage, coding, and payment processes. Knowing that the complete ecosystem needs to shift to value-based healthcare how does this impact the way one involves reimbursement system in the innovation or business plan?

Let’s first consider the importance of reimbursement. For example, valuing a product and its underlying technology merely on the estimated sales is difficult and especially when the product is new, less compared to existing products, or delivering completely new values like digital layers or digital products. And here reimbursement jumps in as a tool to value in a comparative way with existing approved reimbursed products. For example, reimbursement identifies the current clinical value of your new product or service through a comparative treatment, revealing the economic assessment and very importantly the current total treatment cost. When showing marginal improvement to an existing treatment, you should expect of course a similar reimbursement. This is just the greatest source of inspiration for life sciences when ideating at the front-end side of innovation to determine improvements in the market. Secondly, reimbursement helps to look differently at the level of innovation, not only in terms of clinical innovation but also by looking at it from the market access point of view. Questions like ‘ What are the savings for the system’ and ‘ What’s the cost-effectiveness or in other words the value for money?

Yet big innovations and big leaps in life sciences are taking very slowly. The reimbursement system even slows down these major steps, as the system itself is inherently by design an incremental stepped system. Deriving information for radical & breakthrough steps from the reimbursement system is hence not obvious, it introduced if not carefully treated an additional bias when blindly using the reimbursement as an innovation instrument without extrapolating to the future and considering unknowns that are introduced compared to the current reimbursable products.

Find out more in our webinar recording on: https://verhaert.com/insights/webinars/the-reimbursement-paradox/

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A new emergency on the horizon: creating a sustainable healthcare system

Lieven Claeys — Fri, 26 Aug 2022 12:26:20 +0000

People worldwide are living longer. Today most people can expect to live into their sixties and beyond. At the same time, we also require more and more care, and we don’t have the necessary resources in healthcare to accommodate this. It’s easy to see that we’re facing a conflict.

Telehealth and digital health solutions have received a lot of interest as innovation opportunities, especially because of and during the Covid-19 pandemic. These solutions are here to stay, and are even crucial for the healthcare system to be able to withstand the significant evolutions and challenges the sector is facing in a sustainable manner.

Reducing time-consuming administrative tasks

It’s estimated that by 2030, we’ll have a global shortage of 15 million healthcare workers. In Belgium alone there are currently 20.000 vacancies for nurses. And in Germany, 1 in 5 physician was born abroad. Innovation across Life Sciences have provided us with solutions to increase our treatment options and life expectancy. Now it’s time to not only focus innovation on life expectancy and quality, but also on care capacity.

Aside from accelerating telehealth and digital health solutions and their adoption rates, Covid-19 also created a substantial backlog in care itself. That’s why current innovation should focus on reducing the hands-on time needed, administrative efforts, and even allowing for autonomous solutions so personnel can completely abandon those tasks. These tasks are often extremely time-consuming and offer little to no direct value to the patient. They’re worth looking into for innovative solutions, so healthcare can focus on their true added value, attending and caring for patients.

Developing digital solutions collectively

In many industries, digital solutions are already proven to be a great success. These systems can execute some of the most complex handlings with utmost care, completely automatically or even autonomously. They’re able to predict, detect and intervene, thanks to AI models. Moreover, they minimize time and human effort, and require less training requirements while optimizing user friendliness.

The public, healthcare personnel, governments and diagnostic, medical device, and pharmaceutical manufacturers, should collectively tackle this crisis and look towards digital solutions. These types of networks allow companies to address each stakeholder, and help focus on value-based preventative personalized medical solutions to prevent, diagnose and treat diseases.

The clock is ticking, so there’s no time to hesitate. Together, we can resolve and prevent enormous global shortages by developing and building on existing healthcare data. This data can help detect and diagnose diseases early on through decentralized and telehealth solutions. By detecting diseases early, we can intervene and treat them early enough. It’s only through collaborative innovation that we’ll be able to work towards a more sustainable healthcare industry.

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