of research and product development experts
Charles Albert, founder
With over 25 years experience developing medical device and drug delivery technologies, we understand what often goes wrong in development,
and help you avoid the breakdowns
Ethnographic studies, IDI’s and focus groups, Large scale non-IRB studies supporting developments.
Formative and summative studies including IRB Controlled studies where CGI serves as Principal Investigator. We’ve conducted regional, national, and international studies.
Consistent with HE75 and the FDA/CDRH Feb 2016 guidance
Early conceptualization, 3D Modeling
Model and prototype development, support/procurement
User Experience design
Concurrent Field Research supporting rapid iterative cycles
Package design, development and validation
Product and mechanism design
Materials analysis, assembly design, part design
Analytics including FMEA
Our FDA and ISO compliant quality system helps assure the integrity of our staff, processes and results.
Our document control system is compliant with US and International regulatory guidelines.
Your customers must use your device effectively to receive the benefits of your technology.
We look at the complete product system and vet every point of contact your customers have.
We assure all the parts work in concert to produce the desired therapeutic result.
We design the errors out of your product.
Our methods of integrating customer research with product design help assure you develop an optimal product. Your clinical trials will run smoother, you’ll have a better shot at on-time launch.
Research into market practices and competitors to speed PRD generation.
Design - Build - Test Cycles
Fast design, build, test iterations, evaluated with customers helps development design errors out, and makes clear what what your customers care about, and what they don’t.
Smooth clinic trial
- + Packaging + Instruction
Well developed products* test better in the clinic.
Fewer trial errors means better data, and a better chance of on-time product launch.
*Including clinical kit and instructions.
builds market confidence.
Market confidence = Market Share.
Validating and improving the product by translating research insights into innovative packaging.Read more
Design a Human Factors program which meets Gov't guidelines and confirms the life-saving technology works.Read more
Using research to increase the bandwidth development has with the marketplace.Read more
Assist a technological powerhouse in exploring an entirely new market opportunity.Read more
Transforming a discovered break in the value chain, into a Win-Win for the client and their customers.Read more
Assemble a global advisory panel to support development and assure product success in Europe, North America and Asia.Read more
Producing insights into customers concerns that result in significant improvement in quality of care.Read more
Helping avoid looking like a 'Me-too' product in a crowded marketplace, by creating real added value.Read more
Finding an optimal application of a new technology.Read more
‘There are many moving parts to our novel aerosol technology, deployed by care providers in the most intensive critical care environments, to premature infants as small as 600 grams. We began working with Charles Albert from the inception of the project, getting needed inputs as to the potential value and key concepts required to gain acceptance and provide safe interfaces with both user and patient at the bedside. Having worked with Charles Albert in prior projects we knew we could count on CharlesGroups’ experience to conduct the thorough and rigorous human factors evaluations we needed for each level of development. As designers and researchers, they speak our language. They work well with our engineers and developers to design and implement studies that provided effective and efficient feedback that is directly actionable by our development team, helping us to create a superior product. Their studies are tight and on-point, designed and reported in a way they are easy to incorporate into our Agency submittals.”
“CharlesGroup showed much professionalism and innovation in their approach to research. From the design of analytical tools used to the presentation of findings, they are a class act.
Their recommendations on process improvement and our business opportunities did not fall on deaf ears.
We are enjoying our working relationship with CharlesGroup”
“Excellent research, producing insights into our customers and their assessments of our technology, helping inform both our marketing and development efforts.
CharlesGroup helped us make critical decisions, and kept our process moving quickly giving us confidence in the decisions we make.
“We have trusted CharlesGroup numerous times to design and field large Human Factors studies in accordance with our strict clinical guidelines, which require IRB review and on-site medical oversight.
In todays world, it is rare to find a partner that is personally accountable and truly engaged. CharlesGroup is that rare partner. Their conscientiousness, resourcefulness, responsiveness and creativity make them an invaluable asset to our development teams”
“At a challenging time for our company, CharlesGroups process help unite our team, clarify what we needed to do and helped us make the best decisions. We got a great solution fast”
“CharlesGroup’s method of blending product design and research is a winning combination”