Design & Development

Full end-to-end device Design & Development is in our DNA. Our experienced engineering team provides a full suite of design and development services for your medical and drug delivery device programs. Whether just creating simple prototypes or developing your entire device platform from napkin sketch 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.

Our talented and growing team of engineers are here to serve you, accelerating your entire device development timelines into commercialization. Whether we act as an extension to your own project team or as an independent outside skunkworks, we’ll get the job done. Our facilities are FDA registered and are controlled per our ISO 13485 certified quality systems that allow us to work within your systems or ours, the choice is yours.

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

Design & Development is a multi-disciplinary process involving key stakeholders from engineering, regulatory/quality, human factors, and manufacturing.  The decisions you make here will ultimately make or break you. This is an agile and iterative process and you’ll feel confident that you have the right team with the expertise to ensure your medical device or combination product has high success of commercialization.

Human-Centered Design

User research, studies and observations

A thorough understanding of your users’ needs within the clinical environment for your innovative design, whether in the hospital or home, is crucial. Is your device or delivery system self-administered or used by a trained surgeon? What does your user population look like, pediatrics, adults with limited mobility, nurse practitioners with a hectic schedule, field medic for extreme trauma situation? 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, other clinicians, and, yes, even patients and family caregivers. This input is critical in defining the user needs and aligning requirements with clinical use scenarios. It can also be beneficial to perform competitive product evaluations or benchmarking to understand success and/or failure within the target market space. Depending on where you are in the development process and what your device/combination product is, we will suggest an effective human factors activity to evolve your design into its most successful solution. This discipline is multi-faceted and our approach to integrating human factors feedback within your device development will offer the key to user adoption & your commercial success. By bringing user needs into focus early within the design & development process, we deliver devices that users embrace readily, can be operated safely in real-world conditions no matter who your end user is. From early user feedback studies, market evaluation and assessments to formal formative and summative studies, we have you covered for all your human factors & design input needs. We have in-house expertise staged to move the needle for your device usability, including PhD’s specializing in psychology & physiological aspects of product use and a certified pharmaceutical technician. All of this translates into detailed device requirements and opportunities for differentiation, providing a sound foundation for concept development.

Concept Development

Generating novel client owned IP

The concept development stage is iterative, with early research, concentrated brainstorming effort, followed by sketch composites or 3D CAD renderings. The team will present these concepts with thoughtful evaluation criteria (manufacturing techniques used, comparative cost evaluation, design features, etc.) to get your feedback or user feedback for further refinement. This is a space within the development process where our engineers get most energized around. We take pride in bringing in the right talent for structured, yet creative brainstorming sessions that lead to viable, standout ideas. The creative process of creating attractive device concepts and seeing these new novel systems in the commercial marketplace is the horsepower to our continued success. During the early, ideation stages we will present a few potential solutions for your consideration and depending on your needs (big company or inventor) can provide full design packages or presentations including photorealistic renderings or industrial design renderings that take in your branding and commercial look & feel to share with your Marketing or Investment partners.

Because we assign all intellectual property rights to you, you’ll have the peace of mind knowing your device innovation is secure.

Prototyping

Rapid modeling, feasibility and creation

Generating clinical feedback on the performance of your innovative device through prototyping… and doing it quickly… 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 the process, resulting in an effective medical device and drug delivery combination device design process.

Regulatory

Assessments, classification, preparation and filing

Getting regulatory approval of your medical or drug delivery device is critical. We offer early regulatory planning consultations and can guide you into a successful pathway from the start. We’ll support you with all aspects of regulatory approval preparation or work closely with your regulatory partners or IRBs to ensure the decided pathway is aligned with our development plan. A goal during our design and development process is to continually work towards regulatory compliance throughout. This means we’ll at times perform research and identify applicable regulatory requirements, guidance documents and recognized consensus standards that need to be fulfilled. Our team pays special attention to patient safety, risk mitigation and risk management planning, and human-centered design thinking.

Examples of how we can support in a clearly defined regulatory pathway:

  • Prepare a regulatory assessment specific to your medical device, specifying device classification and how to get your product to market
  • Submit a 513(g) or Pre-Submission package for additional regulatory input from FDA
  • Direct correspondence with FDA about general topics through the Division of Industry and Consumer Education (DICE) or Small Business and Industry Assistance programs
  • Authorship of various regulatory documentation, including:
    • Letters to file
    • 510(k)
    • Technical files (CE mark)
    • Key documentation for their IDE, IND or PMA submissions
    • Implementation of efficient filing practices
  • Interact with regulatory agencies and FDA’s Certified Third Party Reviewers

Packaging Design & Development

Primary and secondary, prototype to production

The packaging for your device is nearly as important as the device itself as it offers the first impression to your device or product and is key to your device or technology functioning as planned. Our talented team of designers routinely handles packaging development in parallel to device design and development. The type of packaging is also multifaceted and largely depends on it’s function along with your distribution or end-user’s expectations. It could range from secondary pouching with moisture barrier properties added to a shelf-pack with multi’s contained in shipper or a custom corrugate with branding or logo elements added. It’s part of our D&D process to ask questions early around packaging expectations and to ensure you have attractive solutions that are effective. The team applies much of our design thinking ‘keeping the end user & end use in mind’, so it’s routine that many aspects of your device release and acceptance testing also includes your device residing in a packaging solution that works.

It’s likely you have expectations around branding & product presentation and our team can offer you custom suggestions around attractive packaging options including industrial design renderings to showcase multiple options if interested. Our team has gone so far as to integrate protective features within the device itself for field use applications. If you in early stages of product release and interested in more off the shelf solutions, we’ve dealt with a wide range and can make appropriate suggestions based on target cost positions, distribution planning, and device protection. It’s important to consider the packaging of your device within your development plan as early as it makes sense (typically when the confidence in your device form factor, configuration (if single-use or combination of reusable and disposable, etc.) and have considered all clinical use settings. We design every aspect of your device packaging including label layout & design, specifications, CAD 2D prints of pack out configurations. You’ll feel confident that all critical performance or safety aspects of your product are accounted for. Package testing is a standard component of our design verification & validation activity and our team is positioned to ensure you don’t miss critical test release protocols as it relates to the packaging of your device and the dependencies between them. Count on us to help you select the right design, materials, and commercial packaging pathway for your device.

Product & Package Testing

Custom test method development and DV&V execution

From the start of the development process of your medical device, you need to make decisions. Design, materials, manufacturing processes, sterilization method, packaging, labeling claims…. the list of decisions can almost seem endless and understanding the critical risks & cost drivers can seem impossible. How do you know if you’ve made the right decisions? Information is the key, and early engineering evaluations & appropriate testing is the way to get it. Seeing a new medical or pharma delivery device make it into the commercial space is no small feat. You’ll feel confident that you have a high success during your development program since our team is continuously evaluating aspects of your design that may present a mechanical, function, or safety risk.

Our team builds upon early prototype iterations and engineering evaluations to create formal test protocols and methods specific to your technology. We’ll suggest a systematic and thoughtful approach to de-risk your device throughout the development process and ensure all required ISO or ASTM standards are covered. Our team is conscientious about your budget and to build confidence in your design and confirm critical performance aspects are met, it’s not uncommon that we’ll suggest pre-dv testing cycles prior to entering a formal DV&V (design verification and validation) cycle. We’ll continuously leverage early learnings along with inputs from formal DFMEAs and UFMEAs (design & user failure modes and effects analysis).

Your formal plan for DV&V will be specific to your device, it’s classification, intended use, and labeling claims to fulfill your FDA or CE mark submission criteria. Again you are faced with many decisions within your DV&V planning…. how many devices will be required for functional testing, sterilization validation, or biocompatibility? How many tests are destructive? What level of packaging testing is necessary? What are your shelf-life claims? How quickly can we get devices into the commercial space? 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 DV&V.

Even if you aren’t working with us from early stage design & development, 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. To make the best decisions and achieve your path to success, you need the right information. Working with us, you get it and you get it early!

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
Microbial
Test bioburden counts on parts and equipment
  • Two-stage bacterial incubation process
  • Anaerobic incubation
  • Probiotic incubation
Product & Packaging
Meet and exceed ISO 594 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
  • Microbiology
  • Biocompatibility testing