Design & Development

Full end-to-end device Design & Development is in our DNA. Our experienced team provides a full suite of services for your medical and drug delivery device programs. Whether you need a quick prototype or to develop an entire device platform from concept to finished device, we have the experience to get it done. Human-centered design is core to our process, keeping both the end user and design for manufacturability in mind throughout the life of your program.

Integrated with other multidisciplinary teams, our electrical and software engineers are experts at solving complex electronics design challenges. We’ve designed and developed everything from medical apps to complex machines and can utilize our capabilities to develop these electromechanical products from scratch all the way through verification and validation stages.

Our facilities are FDA registered and compliant with ISO 13485, providing us with flexibility to work within our quality system or yours. Our talented and growing team of engineers are here to serve you, accelerating your entire device development timelines.

Human Factors

User research, studies and observations

Concept Development

Generating novel client owned IP

Prototyping

Rapid modeling, feasibility and creation

Regulatory

Assessments, classification, preparation and 510(k) filing

Packaging Design & Development

Primary and secondary, prototype to production

Product & Package Testing

Custom test method development and DV&V execution

Human Factors

A thorough understanding of your users’ needs within the clinical environment is crucial for innovative design. We conduct user research (including focus groups, interviews, observations, contextual inquiry, surveys, and participatory design sessions) with your target users, whether that’s doctors, nurses, surgeons, pharmacists, caregivers, or even patients. By bringing user needs into focus early within the design & development process, we deliver devices that users readily embrace and can be operated safely in real-world conditions. With in-house expertise, including PhD’s and a certified pharmaceutical technician, we’ve got you covered for all of your human factors & design input needs.

Concept Development

The concept development stage is an iterative process including research and concentrated brainstorming efforts, followed by sketch composites and/or 3D CAD renderings. The team will present these concepts with thoughtful evaluation criteria (potential manufacturing techniques, comparative cost evaluation, design features, etc.) to solicit feedback and further refine. Depending on your needs, we can provide a full design package that includes presentations with photorealistic renderings. We’ll even incorporate your branding to give it a commercial look & feel. Most importantly, as an outcome of this exercise, you own all rights to any intellectual property generated! You can have peace of mind knowing that our ideas will be valuable additions to your patent portfolio.

Prototyping

Generating clinical feedback on the performance of your innovative device through prototyping optimizes the final design. We have in-house equipment and capabilities to fabricate rapid prototypes, including stereolithography, CNC, FDM, silicone and injection mold tooling. Prototypes help to advance the design while evaluating the form, fit, and function of the device. Having the ability to build prototypes and make design iterations in-house helps to streamline and expedite the development process.

Regulatory

Getting regulatory approval of your medical device is a precursor to commercialization in most cases. We offer early regulatory planning consultations and can guide you into a successful pathway from the start. A goal during our design and development process is to continually work towards regulatory compliance throughout. We can identify applicable regulatory requirements, guidance documents and recognized consensus standards that need to be fulfilled. Our team continually works towards regulatory compliance throughout design and development. With experience writing 510(k)s and getting them cleared by FDA’s Certified Third-Party Reviewers, we can support you through the submission process.

Packaging Design & Development

The packaging for your device is nearly as important as the device itself. Our talented team of designers routinely handles packaging development in parallel to device development. It’s part of our D&D process to ask questions early around packaging expectations and ensure you have attractive solutions that are effective. We can accommodate branding & product presentation expectation with custom suggestions around attractive packaging options. Our services include providing design, layout, 3D CAD, and photo-realistic renderings. You’ll feel confident that all critical performance and safety aspects of your product are accounted for. Packaging testing is a standard component of our design verification & validation activity. Count on us to help you select the right design, materials, and commercial packaging pathway for your device.

Product & Package Testing

Our team builds upon early prototype iterations and engineering evaluations to create formal test protocols and methods specific to your technology to comply with required ISO and ASTM standards/test methods. Your formal design verification and validation (DV&V) plan will be specific to your device, it’s classification, intended use, and labeling claims to fulfill your FDA or CE mark submission criteria. You’ll feel confident that you are in good hands as we suggest an appropriate DV&V plan for your technology and offer the most efficient path for a successful testing outcome. Even if you aren’t working with us from early stages of design & development, you can feel good about working with us for specific testing activities. We cover a wide range of testing in-house and can handle all of your medical device or drug delivery device testing needs.

Testing Type
Purpose
Testing Attributes
Environmental
Ensure clean room is performing to Class (ISO) 8 specifications
  • Heat
  • Temperature
  • Humidity
  • Bacteria Identification
  • Monitor surfaces, air and devices
Product & Packaging
Meet and exceed standards for components and ensure product performance
  • Metrology
  • Mechanical performance
  • Reliability/lifecycle testing
  • Flow rate and pressure testing
  • Accelerated aging/environmental conditioning
  • Packaging integrity testing, including transportation
  • Competitive/benchmark analysis
  • ISO/DIN/ASTM testing including:
    • IEC 60601, IEC 62304
  • Pre-clinical testing
  • Simulated use
  • Formative and summative studies
  • Biocompatibility testing