Injury, Fatality, Consumer,
and Recall Data Analysis 

Learning from the mistakes of others is a great way to start a proactive and well directed initiative of any kind. Utilizing injury and fatality data that is publicly available, obtainable via written application, or comments at e-commerce web pages, can all be helpful in determining hazard severity and exposure rates market wide. Understanding the narrative behind the injury/fatality event can further help to generate at-risk user populations. By completing this exercise first, the groundwork for creating data driven and defensible actions can be laid.  

Consumer Complaints
and Incident Survey 

A significant amount of information can be extracted from properly constructed questionnaires and documentation process for consumer call-in, web submitted, or publicly (social media) posted feedback. Engenium has experience in the design of data gathering mechanisms, key feedback questions, data conversion, result interpretation, and potential corrective action or mitigation recommendations.

Hazard Analysis 

To identify potentially hazardous points or features, Engenium can review a physical product or prototype according to Engenium’s internal procedures. Identified hazards will be imaged, described, and reported in a table style format. Hazard severity is determined via medical case study review, medical expert interview, and injury/fatality data mining. 

Airway Obstruction
and CO2 Rebreathing 

Developed through years of research and hands on experience with mechanical airway obstruction and hypoxia mechanisms, Engenium has developed a Respiratory Hazard Model (patent pending) that simulates the breathing patterns, response, waveform, flow, and pressures of various aged consumers. The model can be used to assess potential hazard severity for films, meshes, containers, ingested objects, and potentially CO2 accumulating materials.  

Our model interfaces with products through an anatomically modelled and synthetic mannequin, complete with real-time pressure monitoring and CO2 concentration sampling.   

Human Factors

The discipline and study of human factors contains two underlying parts, 1.) cognitive interaction and 2.) physical interaction. 

Foreseeable Use Assessment 
Foreseeable use is the study of the psychological/cognitive aspects of human factors. In this assessment, defining the intended use and determining the foreseeable use is the end goal. Understanding what constitutes consumer and caregiver perception, attraction, accessibility, and developmental milestones are all leveraged to determine the potential foreseeable uses of the product based upon its features, materials, marketing, instructions, and market presence.

Biomechanic Capability & Interaction Assessment 
Biomechanics is the study of the physical aspects of human factors. In this assessment, defining the user’s capability - their ability to impart force and torque on a product and how the product responds is the end goal. To name a few, end users can bite, drop, twist, tear, and throw to impart their interpreted use mode.    

Food Physical Safety (FPS)

Using a series of assessments designed to model various mechanics of mastication and ingestion, Engenium measures product performance and compares results to a standardized comparator group for relation back to hazard potential. Food products are assessed by Hardness, Toughness, Dissolvability rate, Lubricity, Elasticity, Viscosity, and Tack to name a few attributes of interest.  

Risk Assessment 

Risk is the product of hazard severity and factors of exposure. Determining risk can be achieved in many ways including but not limited to exercises like FMEAs, Fishbone diagrams, fault tree analysis, nomographs, as well as referencing the European Risk Assessment Guidelines. All of these methods share a common concern of requiring some sense of guided subjectivity to determine risk. Oft overlooked is the inclusion in risk calculations holistically considering pertinent factors such as manufacturing failure rates, defect rates observed in market, as well as injury and fatality records on like products as documented in injury databases or online consumer comments. Where data doesn’t exist, SME direction can allot for bootstrapping, Monte Carlo analysis, followed by sensitivity analyses to ensure risk categorization is not impacted by order of magnitude change.  

Quantitative Assessment
and Benchmarking 

Certain data sets about biomechanics and anthropometrics exist, but often rely upon a specific data collection method or technology that limits its utility. When validation of product performance and risk is required, creating customized fixtures and sensors to collect this data can become necessary.  Creating a protocol and apparatus to collect product performance via failure mode observation, or other dependent variable collection, can lead to validation of product design efficacy in a repeatable way.  

Specification Development 

Foundational knowledge discovered during research phases and creating a way of accessing and consuming that knowledge in publication format is only so valuable to a business. Distilling this information into specifications and design requirements are paramount for business success. Creating tools, methods, and tangible outputs from research is key to driving successful design and engineering innovations as specification criteria formed on concrete rationale aligns stakeholders and provides a framework for creative minds to diver deeper into concepts. 

Qualified
Material List 

Similar to specification development, information derived from material investigation, consumer feedback, and use cases can be leveraged to identify in-house approved materials. Such materials should meet or exceed performance and safety goals aligning with company risk tolerance. Compiling a list of preapproved materials aids designers in appropriate selection of materials that may be used for specific use cases and is a preventative measure to control the quality and experience of a product.  

If used correctly, a QML can speed up the design process and reduce risk associated with unfamiliar materials and reduce cost by optimizing sourcing and supply chain new materials being considered for use in design may then be vetted against known and qualified materials. 

Product Validation 

During production, factors such as tooling, material choice, storage conditions, shipping, expiration, aging, labelling, packaging, and inspection efficacy may change resulting in unforeseen downstream consequences to product performance and consumer experience.  

To verify that production is performing within expectations, Engenium can compare performance metrics, material properties, and inspect build quality. This validation of product expectation can be performed as needed or designed in a statistical sampling plan as desired. Implementations of product validation range from small comparative studies to collaboration with internal quality departments on process and redefinition of specification limits. 

Analysis Techniques 

For comparing product performance, both past, present, and in-market comparators, Engenium utilizes statistical methods to objectively identify differences in key measurables. Examples of such methods may include process capability analysis, clustering analysis (top-down and bottom-up), and regression analysis, etc. 

User Study 

User studies help validate and direct future validation and design intent by having targeted user groups experience products. User studies can be created for a variety of reasons, to evaluate packaging, brand messaging, aesthetics, child attraction, foreseeable use modes, product assembly, or to collect specific biomechanical data related to specific product or action. By leveraging a third-party recruiting firm, the team has experience building consumer networks and collecting data collection at retail stores, children museums, day cares, and even onsite at customer locations. Examples of user studies have included motion capture, play patterns, eye tracking, physical capability, feasibility, and child resistance of packaging. 

FMEA 

Failure Mode Effects Analysis (FMEA) is a standard tool used in engineering to justify correcting potential product failures, process issues, injury modes, or other issues. In identifying such outcomes, weightings are estimated for severity level and likelihood of occurrence to produce a “risk-like” estimation. This general concept can be applied in several capacities, such as: 

• Process FMEA

• Design FMEA

• Manufacturing FMEA

In reviewing the product/process, steps required for the negative outcome to occur are linearized, analyzed, and ranked according to data, literature, case studies, documentation, or expert opinion. Once identified, corrective actions may be taken to address any or all parts of the path to negative outcome.  

Consumer Data Transformation 

Using consumer reported data gathered from internal or external sources, insights can be drawn from emerging trends relating to safety, quality/performance, and experience. Sources such as wellness data, consumer complaints, and social media posts can help focus on the consumer experience. To balance with potential root cause analysis, leveraging data from suppliers, manufacturers, and formulations all present opportunities to visualize in-field product performance and compare current testing or design standards.  

Results can be leveraged to support product redesigns, material changes, specification development, supplier corrective action plans, and quality inspection criteria for continued improvement and risk mitigation. 

Research &
Development 

Research is a necessity to identify, define, investigate, and inform areas of unknown or gaps in knowledge. Research efforts can include root cause investigation, biomechanical studies, hazard model creation, cost-to-performance analysis, etc. all used for providing new or updated information.

Equipment Design/
Development 

For modelling other consumer behaviors, product interactions, and use cases, Engenium can develop new equipment and methodologies at request. Such equipment can be used as needed for product submission or be purchased under a separate scope. 

Medical Expert
Consultation 

Unfortunately, data may not exist or is insufficient to quantify potential hazard severity. In such a case(s), defensible rationales to de-risk product design decisions can be achieved by reviewing medical literature and subsequent interview of medical experts and practitioners. Engenium has a direct link to a preeminent academic/medical research networks with medical experts that hold leadership positions in numerous American Academy of Pediatric Committees and other medical industry associations, no medical expertise is unobtainable. Engenium has existing contacts in otolaryngology, pediatrics, gastro-intestinal, neonatology, pulmonology, and neurology. 

Training & Review 

Engenium specializes in tangible advice fit for need and intent. Onsite product reviews allow engineers, designers, and other stakeholders the opportunity to review product hands-on with Engenium staff. This interaction allows the dynamic flow of creative problem solving and instills consumer centricity and human factors design elements into ideations, concepts, and prototypes. When successfully itemized, in-the-weeds review at these product lifecycle states, allows for direction of action to be more easily received and designed toward.  

Canine Physical
& Mechanical Assessments 

Specifically designed with biomechanical capability and morphology in mind, Engenium assesses canine products and toys using a series of mechanical hazard models: cyclic chew, bite and pull, and gnawing. The models are paired with Engenium knowledge of data bases, literature case studies, veterinary publications, and observational studies to interpret results as potential hazard severity.