Medical device is our wheelhouse.
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
Making Great Ideas Thrive
CharlesGroup helps world leaders in the pharmaceutical and medical device space with product definition, development and validation.
Learn more about our process
CharlesGroup is a highly select team
of research and product development experts
of research and product development experts
Charles Albert, founder
CharlesGroup services and regulatory compliance
Research Qualitative Services
Ethnographic studies, IDI’s and focus groups, Large scale non-IRB studies supporting developments.
Quantitative Services
Formative and summative studies including IRB Controlled studies where CGI serves as Principal Investigator. We’ve conducted regional, national, and international studies.
HFE (Human Factors Evaluations)
Consistent with HE75 and the FDA/CDRH Feb 2016 guidance
Design Design
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
Engineering
Systems analysis
Product and mechanism design
Materials analysis, assembly design, part design
Analytics including FMEA
Regulatory Compliance Quality system
Our FDA and ISO compliant quality system helps assure the integrity of our staff, processes and results.
Document Control
Our document control system is compliant with US and International regulatory guidelines.
The need
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.
Charles Group Advantage
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.
Phase 1
Research
Research into market practices and competitors to speed PRD generation.
Phase 2
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.
Phase 3
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.
Phase 4
On-time launch
On-time launch
builds market confidence.
Market confidence = Market Share.
More Stories
Gilead
Validating and improving the product by translating research insights into innovative packaging.
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Aerogen
Design a Human Factors program which meets Gov't guidelines and confirms the life-saving technology works.
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Hewlett Packard
Assist a technological powerhouse in exploring an entirely new market opportunity.
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Roche
Transforming a discovered break in the value chain, into a Win-Win for the client and their customers.
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Novartis
Assemble a global advisory panel to support development and assure product success in Europe, North America and Asia.
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Roche
Producing insights into customers concerns that result in significant improvement in quality of care.
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Ortho-McNeil
Helping avoid looking like a 'Me-too' product in a crowded marketplace, by creating real added value.
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A lot of the value we bring is to identify and supress "surprises" earlier.
Testimonials