United Healthcare
Phone: (714) 364-5229
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SERVICES

From Concept to Manufacturing

The seasoned Development team at United Healthcare combines many years of medical design and development experience. Whether you need a single prototype for initial concept evaluation or a comprehensive product development program, our development staff can assist you in quickly and efficiently reaching your goals.
Utilizing our Product Development Lab, equipped with a full array of processing and testing equipment, United Healthcare can quickly move the development process from design concept, through verification and into manufacturing. Whether you have your own design or want the assistance of our experienced development team, UHC team has the resources to support your product developing.
Developing complex systems in an optimal fashion requires utilization of a systematic approach to the system engineering efforts. Knowing what tools and techniques are available as well as how and when they should be applied is critical to having an efficient program. United Healthcare provides system engineering expertise specializing in areas under very strict regulatory controls, conforming with the requirements of the FDA, CE , ISO -13485 ….Areas in which UHC will benefit your system development needs include:
Specification Development
Embedded Systems
Electromechanical Systems
Critical System Design Techniques for Safety, Reliability, and Compliance
Decision Making/Design
Trade-off Analysis
Engineering Tool and Product Selection
Design for Standards and Regulatory Compliance
 
 
Manufacturing
Manufacturing personnel need to be present at design reviews early in development program. To the extent practical, design output needs to be appropriate for both design and manufacturing needs. Examples include:
By adding vendor test requirements to a component specification, document can be used for both design and mfg.
Most low level electronic and mechanical design drawings/specifications can be converted to documents appropriate for manufacturing DMR
Many elements of design verification protocols can be converted to manufacturing tests
A checklist for manufacturing readiness includes:
Design control elements closed
Field/clinical testing closed
Regulatory approvals in place
Logistics for purchasing, product availability
Manufacturing process validated and released
Labels, manuals, other product materials released
Integrating manufacturing considerations into design
Features which must be addressed at design level:
Ease of assembly
Ease of test
Modularity
Parts count
Manufacturing processes
Supplier considerations

Consulting & Medical Communications

 
 
In the highly competitive biopharmaceutical marketplace, the need to diversify, innovate, and globalize is greater than ever. Drawing on our unique fusion of scientific, regulatory, and business expertise, United Healthcare Consulting provides flexible, strategic solutions designed to fit your specific products, stage of development, and company size and goals. Our services help biopharmaceutical and medical device companies shorten time to market, manage risk, access new global markets to maximize portfolio value, and maintain regulatory compliance. United Healthcare’s Medical Communications translates healthcare discoveries and complex scientific data into motivating communications.

Clinical Research Services

United Healthcare is right where you need us with the global experience, infrastructure, knowledge, and technology to conduct clinical trials and observational research programs of any size. Whatever the size of your study, we can plan and manage your program from beginning to end, including: study design, protocol development, site and patient recruitment, clinical monitoring, database design, document management, clinical logistics, and medical writing. United Healthcare provides a full spectrum of clinical research services from First-in-Human (Phase I) through Phase IV and Post-marketing studies.
 
 
Clinical Trial Strategy / Study Design
We begin the design of your medical device clinical trial with the formulation of appropriate study endpoints. Whether you need to collect data to support an FDA pre-market submission, a scientific publication, or drive physician adoption and market acceptance, these endpoints will support the content of your study and help you to determine the appropriate number of patients and study sites, study duration and length of follow-up.
Clinical studies can also include clinical evaluations of certain design modifications or changes to intended uses for legally marketed devices.
Additionally, the appropriate clinical trial strategy is dependent on where you plan to commercialize your medical device. European medical device requirements for clinical data can differ significantly from U.S. FDA requirements, so it is important to consider all these factors early in the development of your medical device clinical trial.
U.S. Clinical Data Requirements for Medical Devices
Clinical development of a new medical device is normally conducted in two phases; pilot and pivotal studies. In the pilot phase, the goal is to establish medical device safety and to assist in design of the pivotal trial. Medical device pilot or feasibility studies are generally limited to less than 100 patients at one or two sites. After establishing that the medical device is safe in this pilot group of patients, the pivotal trial is conducted to generate data to demonstrate that the medical device is safe and effective, for a defined intended use, within a certain patient population.
To market a class III high-risk (and some class II) medical device in the United States, you will need to demonstrate that the device is reasonably safe and effective. Generally, high-risk, class III medical devices that pose a significant risk of illness or injury will require a premarket apprMore and more, the FDA is requiring clinical data to support intended use statements and marketing claims for some class II medical devices that require a 510(k) premarket notification submission, rather than a PMA. In either case, if the FDA determines that your device is not exempt, you will need to apply for and receive an IDE (Investigational Device Exemption) before beginning any clinical studies.
For first-in-class medical devices, where there is limited data regarding short or long-term outcomes, the FDA pivotal trial would be a prospective, randomized controlled study, adequately powered and involving hundreds of patients at multiple study centersoval or PMA submission, which will include clinical data to support medical device claims.
 
 
European Clinical Data Requirements for Medical Devices
In general, to support the European CE marking requirement, you must demonstrate that your medical device is safe, that it performs as intended, and that the level of risk is acceptable when weighed against its medical benefits. Within the European Medical Device Directives, the term “clinical data” encompasses everything from bench testing to clinical trials in human subjects. While some medical devices do require the conduct of a specifically designed clinical investigation, it is often possible, for low- to medium-risk devices (Class I, IIa, and IIb), to prepare a compilation of relevant scientific literature to support the device’s intended use and the techniques employed.
To market a device in the EU, you must demonstrate that the device is safe and that it performs in a manner consistent with the intended use.
Working with your team, we will help you design a clinical study to meet your needs and identify the best data measurements to support your product claims. Our experienced clinical services professionals will advise you on how to best measure the effectiveness of your product, in the most clinically meaningful and cost-effective way possible.

Product Development Services

United Healthcare offers the following design and development services to facilitate your new product market launch:
Early-stage feasibility studies, including design and fabrication of models
Product design
Prototype fabrication and testing
Development of custom product specifications
Design verification, including development of test protocols and testing
Tooling, equipment and fixture design and fabrication
Process development and validation, including documentation and testing
Packaging design and validation support
Sterile validation support
Component and raw material selection and sourcing
Design history file
Biocompatibility testing support
Regulatory support; CE Mark, ISO 13485, GMP, FDA…
Technology Transfer

Developmental Product Testing

Testing strategy
Writing specifications with verification in mind
Testing strategies
Particular strategies for software integration and test
Inspection strategies
Use of standards
Statistical tools
Determination of proper sample size
Single sided, double sided criteria
Normal distributions, other types of distributions, pass/fail tests
Adjusting stringency based on criticality of the selected parameter
Development of a statistical procedure for your quality system
ion testing, how to manage test failures.
Test protocol and V&V Plan development for validation and verification
UHC's services include hands-on development of protocols and V&V plans for medical devices. UHC is highly experienced in developing V&V strategy and protocols for software, electronic hardware, mechanical components, and system level specifications. UHC 's services will address the important technical needs in your V&V as well as the nuances required to deliver robust documentation that can survive a rigorous
Test and V&V Plan execution and documentation of test reports
Execution of protocols and V&V plans require a high degree of discipline for proper execution and proper documentation practices. UHC's V&V personnel have a high degree of discipline, technical skill, and knowledge about how to execute and document the V&V documentation for medical devices. audit.

Project Management

United Healthcare Inc., employs a range of project management tools for tracking and reporting project milestones to our clients and this support can be adapted to meet the needs of your specific project. Regardless of the size or complexity of the project, we encourage and promote open lines of communication between the United Healthcare development team and the client to assure the best project outcome, on time and on budget.
 
 
Mechanical Engineering
Design control compliance services are intended to help companies comply with the design control requirements of the FDA (CFR 820.30), ISO9001:1994/ISO13485, and ISO 9001:2000. The following are services we provide:
Mechanical Systems Analysis
Failure analysis
Trade-off studies
Component Selection
Manufacturing technique selection
Mechanical Design
Concept
Analysis
Design
Solid Modeling
Prototyping
Testing
Manufacturing Process.
Solid and Fluid Mechanics -- Analysis and Testing
Electromechanical Development Material Selection -- Including FDA/ Medical considerations.
Standards Based Design (Examples)
ASTM series standards
UL 94
ISO 10993