We have a proven track record of successfully designing and integrating fluidic systems within products ranging from large, complex fluidics instruments to small, highly innovative medical devices.
The accurate delivery of precise volumes of reagents, the control of concentrations and dilutions, and the efficient mixing of fluid and particulate suspensions all play a critical role in the realization of successful biological assays and automated chemistry workflows. Our experience includes developing cutting-edge technology for electrowetting platforms, custom elements for reagent storage and assay automation, and custom measurement solutions such as ultrasonic and thermal gas flow meters.
Our fluidic knowledge is also central to the successful design of fluidic cartridges and consumables. We have played a key role in this field, working with clients to successfully transfer their assay workflows into both low and high-volume consumable products with macro or microfluidics.
We routinely develop optical architectures and integrate those designs into optical systems for point of care and diagnostic instruments that rely on an optical method for detecting a positive or negative result.
Our experience in optical systems design includes:
- Microscopy and microscope design
- Flow cytometry
- Low light level detection
- Autofocus systems
We have dedicated optics facilities for the development and testing of optics systems. These include specialty laboratory spaces, standard and specialized tools for measurement, simulation of expected light emissions, emulation of detector output for electronics optimization, and signal processing development.
Our extensive knowledge has led to the design of multiple generations of optical systems, including modular fluorimeter systems, and systems with high sensitivity and large dynamic ranges using low cost uncooled photodetector technology. This type of experience has allowed us to create preconfigured templates that address common and application-specific risks leading to more rapid development times.
Invetech has unparalleled expertise in this area, overcoming all sorts of motion challenges, from controlling motion at the nanometer level to driving high frame rates and critical focus in automated imaging systems.
A common challenge across projects in diagnostics and life sciences is the requirement for motion and motion control for liquid handling, imaging, optics, focusing and positioning. Through Dover Motion, a division of Invetech since 2014, we have a portfolio of motion solutions and modules, as well as 50 years of experience developing custom motion solutions to meet the specific requirements of our clients’ instruments.
When developing new instrument platforms, the combined capabilities of Dover Motion and Invetech delivers a substantial benefit in terms of design solution maturity, cost of goods advantages, and accelerated time to market. We ensure the successful integration of subsystems and test solutions under real-world conditions of the intended product environment to ensure reliable motion implementation.
Many of the products we’ve developed contain a form of thermal control, and we’ve acquired a wide breadth of experience from creating these systems.
The ever-increasing sensitivity of the technologies within the healthcare field requires matching improvements in thermal control and detection methodologies to achieve product performance requirements. We understand the importance of control algorithms, sensing elements and thermal conductivity in system design, and have designed and built many high performance thermal systems. Our designs have provided some of the fastest PCR cycle times possible, with thermal ramp rates beyond 50⁰F/s (10⁰C/s) achieved while holding steady state performance.
Working with our in-house science team, we combine our engineering knowhow with our clients’ product needs to find optimal solutions. Successful challenges we have solved in the past include:
- Maintaining a constant and precise temperature for cell growth
- Rapid cycling of temperature for DNA multiplication (PCR)
- Sustaining a specific storage condition
- Providing the appropriate thermal environment for sensitive instrumentation
- Ensuring that the internal temperature of an instrument is maintained
Our proven methodologies allow us to achieve excellent thermal control early in the development process, minimizing the risk of unexpected issues in the quality of results, processing speed or functionality of the assay chemistry.
Consumable & Cartridge Design
Consumable & Cartridge Design
We have the in-house expertise to design custom consumables and microfluidic cartridges, producing a truly integrated system through a streamlined development process.
We’ve been involved in the development of more than 100 consumables and cartridges for diagnostics and cell therapy instruments.
Our experience ranges from developing customized bulk fluid storage devices, to fully integrated, completely closed cartridges and disposable sets. We can also produce specialized manufacturing equipment for consumable production, or work with suppliers to procure the equipment required.
Some of our achievements include:
- Surface measurement of temperature in a non-contact method using infrared energy emission and measurement in a point of care instrument
- Use of tissue degradation processes and reagents to target the release of DNA from the cells for PCR analysis
- Real-time measurement of target DNA presence amounts for rapid and sensitive next-generation sequencing from small free cells or DNA in bodily liquids
- Cell type targeting and identification within a sample, then subsequent isolation, and manipulation, in one consumable for autologous cell therapies
Connectivity & Systems Integration
Connectivity & Systems Integration
Most of the instruments we develop require connection to external services including HIS/LIS, remote monitoring, remote status/control and predictive monitoring.
Our software platforms provide provision for connectivity of various technologies, adapted and integrated as part of the development process. Just like we develop laboratory or user workflows driving software behavior, we equally define remote access and other external connections. With IoT, Cloud, Mobile and SaaS technologies becoming expectations, we have adapted to scoping and partitioning solutions appropriately. Considerations include risk segregation, cyber security, HIPPA, failed connection behaviours, audit trails and test tools.
A key to successful connectivity is working with our clients to understand early all external interfaces (captured in interface control documents) ensuring the software is adaptable to change in the future. Examples include new LIS servers, legacy remote service tools and co-developments.
Our industrial design team creates and drives a user-focused vision from conception through to execution.
At the front-end of a development program, we establish a checklist of product requirements based on our client’s business strategies and their customers’ expectations. This feedback drives the industrial design throughout the project.
When breakthrough solutions are called for, our industrial designers employ creative problem-solving techniques that give our design teams options to evaluate and consider. They often work on many different projects with many teams across the company, positioning them to cross-fertilize ideas during the creative problem-solving process.
Our industrial designers are also well-integrated with the engineering teams, making them technically focused and imbued with a good understanding of manufacturing techniques. This leads to successful outcomes for clients that are practical and immediately usable.
Simplicity is at the center of our experience design practice. We take a holistic view of the entire user experience within the context of use to drive informed design decisions and create intuitive user interactions.
Our multidisciplinary team of experience design professionals initially immerse themselves with the people, challenges and environment. They employ generative research methods and tools to discover the user’s unarticulated goals and pain points. This is followed by an analysis of insights and synthesis of findings in collaboration with our engineers, software developers and scientists to identify the problems we should focus on during development. We also explore solutions and take design concepts into the field to test with real users. This allows us to quickly check key assumptions and identify improvements by observing what works well and where friction or risks exist in the interactions.
Well executed experience design results in:
- Intuitive workflows
- Uncovering insights that lead to innovation
- More engaged users, leading to more loyal customers
- More successful product launches
- Saving time and money by developing the right product the first time
- Preventing a usability issue or other problem from cropping up late in the process
Usability & Human Factors Engineering
Usability & Human Factors Engineering
Planning and designing for usability during the product development process is a key element in ensuring regulatory compliance.
Usability and human factors engineering (HFE) are core components embedded in every biomedical device development project at Invetech. Addressing usability starts at the product definition stage, helping produce a design early on that is inherently innovative and that prevents user errors.
Building on the foundational insights uncovered through experience design research, our multidisciplinary engineering and design teams initiate a process beginning with early prototypes to ensure development of a safe and usable medical device that minimizes the risks linked to use errors. In overview, the process involves the following:
- Identifying anticipated use-related hazards
- Developing and applying measures to eliminate or reduce those use-related hazards
- Demonstrating that the device user interface design supports safe and effective use by conducting usability testing with representative users and in the environment of use
Design for Manufacture
Design for manufacture (DFM) is a key capability for producing reliable, high quality instruments that can be assembled consistently and at a competitive price.
We have developed and manufactured diagnostic instruments and medical devices for over 30 years and understand the regulations and standards required. We design products for simplicity and consistency in manufacture, which directly translates to fewer errors and defects in the field.
DFM work commences at the beginning of a project with our in-house contract manufacturing engineers joining the core project team. Their role throughout the entire project is to ensure we’re producing part designs that are appropriate for the selected manufacturing process, resulting in a cost-efficient manufacturing strategy. This includes identifying critical components and assembly processes early, allowing us to either select different options or address the risk to mitigate. We consult suppliers throughout the part establishment process to ensure that parts and assemblies can be made within the capabilities of the manufacturing equipment. Our process control plans are also documented early so the manufacturing and assembly process can be refined as the design matures.
We have well-established processes for complex development projects in healthcare, diagnostics, life sciences, cell therapy and contract manufacturing.
Our quality systems are:
- Certified to ISO 9001:2015 and ISO 13485:2016
- In alignment with 21 CFR 820.30 and EU medical device regulations
- Based on the IEC 62304 standard for software development processes
- Designed to support our clients’ GMP compliance
Our quality systems are flexible, allowing client specific development plans to be created. This flexibility also provides our clients with the option to make adjustments such as transitioning from a non-regulated environment early in the development project to a regulated environment later on.
In addition to our focus on compliance and governance, continuous improvement activities are core to our quality systems. We utilize the Fortive Business System toolset, feedback from clients and production activities, as well as audits by clients and certification bodies to drive improvement.
Design to Regulatory Standards
Design to Regulatory Standards
We have the expertise and processes required to design, develop and manufacture products for regulated markets.
Satisfying international standards for areas such as safety, risk management, electromagnetic compatibility and materials compatibility is a prerequisite for successfully placing medical devices, biomedical instruments and advanced therapeutic products on the market. From concept to pre-production, we track a product’s alignment with regulatory standards by performing compliance testing and working with regulatory agencies. By designing to the requirements of these regulatory standards early in the development process, we are able to manage risk, cost, and time to market for our clients.
We have helped our clients obtain regulatory approvals including 510(k), PMA, CLIA Waiver and CE marking by incorporating the requirements of the following standards and regulations, amongst many others, into our processes and quality systems:
- ISO 9001 (Quality management systems)
- ISO 13485 (Medical devices – Quality management systems)
- ISO 14971 (Risk management of medical devices)
- IEC 62304 (Medical device software – Software life cycle processes)
- EN 61010 and EN 60601 (Safety for medical electrical equipment)
- GMP and GAMP (Good Manufacturing Practice and Good Automated Manufacturing Practice)