CLINICAL TESTING & VALIDATION REPORTS
By the year 2000, the vast majority of non-invasive health devices on the public market have taken root as part of our global market trend. From simple devices like massagers to neurostimulation equipment to more complex electronics like pulsed electromagnetic frequency, biofeedback, shockwave sonic pulse as well as light‐related energy therapies like cold laser, blue light and infrared just to name a few.

The concept behind ‘CLINICAL VALIDATION’ underscores the safety and ethically regulated commitment of ensuring that the medical device being manufactured will consistently provide the intended benefits for its use condition. Clinical validation is usually done through a series of tests and inspections. Conducting this medical validation can be offered through various protocols, consistent with official standards utilizing an Institutional Review Board (IRB) approved by the HHS and FDA regulations. One protocol that can be available for consideration by the IRB panel is the use of medical grade 3D Doppler Ultrasound imaging. The use of medical imaging technologies like an ultrasound alongside the interpretation of a certified clinical radiologist may offer biometric assessment and analyses of all scanned readings and the collection of ample data to confirm or validate a health device’s effects on the body as marketed.

VALIDATION SUPPORTS PUBLIC CLAIMS
Especially when a product is a health‐related solution, testing is an important and highly critical step from a legal standpoint. This step is directly involved in a developer’s statements and claims about the device. Before any device is to be promoted for a specific use or pathology, a series of formal performance exams must be conducted to suit regulatory acceptance by an outside agency or clinical team approved by a federally backed review board. Considerations for validation include: range of physiological effects, warnings about the possible hazards, physical risk to the user in regular use, adverse reactions (potential side effects)‐ and all these elements are from data acquired during a validation study. To confirm (or validate) that a product is effective within the statements and claims that it provides the public, the manufacturer would need to invest in an exclusive and dedicated lab or agency that is poised to perform this level of testing. Said lab must acquire enough data (according to the IRB board) to support the aspired claims. If/when enough data has proven the hypothesis true, this would add to the product’s marketing credence as well as confirm the device’s ability as a health or wellness product. Any other type of observational testing outside of the authority of an IRB is considered ANECDOTAL and must be established as such‐ which holds no credence as an industrywide claim whatsoever.

See complete IMAGING-BASED PERFORMANCE TESTING*

Image credit: Caudai, C., Galizia, A., Geraci, F. et al (2021). AI applications in functional genomics. Computational and Structural Biotechnology Journal, 19, 5762-5790. https://doi.org/10.1016/j.csbj.2021.10.009 CC BY-NC-ND 4.0 PART 2: USE OF GENE EXPRESSION Everything that happens in the body depends on the code we are born with: the DNA that makes up our genes. That code can vary from person to person, and it’s called genomics. It’s also what makes us each unique, so we respond differently to things that affect health – including diet, our lifestyle, our environment. This is why results can vary between people with the same exact intervention. These life experiences also leave marks on our DNA called epigenetics, which can enable us to adapt to our environment to ensure our survival. Unlike our DNA, these changes are dynamic and can be used to assess whether interventions are improving our health at the epigenetic level. How our genes and epigenetic changes get translated into health relies on genetic expression, and this can be measured directly or indirectly through laboratory technologies. Transcriptomics looks at the RNA sequences produced directly from the DNA code and can identify all of the genes that are being expressed in a particular cell or tissue at that time. Metabolomics is something used every day in clinical medicine – you may know them as blood chemistries, cholesterol, cortisol. Changes that occur with dietary, lifestyle, or healing technology interventions can be measured at the genomic, epigenetic, transcriptomic or metabolomic levels.

FUNCTIONAL GENETIC EXPRESSION: PROFILING & BIOMETRIC DATA
Health and wellness are ultimately the result of balances or imbalances of our biochemistry and cellular biology. While client success stories are great testimonials, health technology companies need reliable scientific evidence to advance their development beyond general wellness and into the clinical realm.

One of the biggest challenges in validating the effects of these technologies is that the exact biological mechanisms by which they exert their healing effects are not always specifically known, or they may not know how to objectively measure them.
Advances in laboratory science and technologies have made it much easier to assess the effects of healing technologies on a genetic and molecular level.

Everything that occurs in our biology is the result of our genetic blueprint that encodes for all of the proteins that run our biochemistry and cellular functions. The ultimate result is called genetic expression. Functional genetic expression is the term for how our genes are expressed and is the result of a complex interplay with our DNA code itself, the impact of errors in that code, how the genetic code gets translated into RNA and then into proteins, regulation by epigenetics and feedback from our environment. While our DNA code remains the same over the course of our lifetime, how it gets expressed is affected by a multitude of processes that result in changes in markers of how our cells are functioning.

Measuring these changes that occur before and after interventions can provide objective scientific data to show how technologies are interacting with our biology at the deepest level to improve parameters of health and well-being. One of the primary ways many of these technologies work is very likely through changes in cell signaling and genetic expression, and there are several ways to directly and indirectly assess this.

All of these can be measured with current laboratory testing technologies. Depending on the goals and of the project and the proposed scientific mechanisms of action of the device, functional gene expression profiling can include:

Image Credit: GTEx Consortium. Genetic effects on gene expression across human tissues. Nature 550, 204–213 (2017). https://doi.org/10.1038/nature24277 CC BY 4.0

"HIGH SCIENCE" BRINGS UNDISPUTED PEACE OF MIND
As genetic reporters, we understand our clients' goals to get their innovation to the finish line. This means bringing innovation(s) to market by offering an integrity-based scientific backbone to confirm (or challenge) their efficacy and performance. The health product development industry recognizes the strength of the output provided by Genetic Expression as engineers and science officers appreciate the level of detail and the granular array of biometric information generated from clinical case studies. Supporting our clients' needs for regulatory acceptance starts with carefully assessing your product and your testing objectives- leading us to selecting the right protocol(s) and management scenario that ensures accurate and effective information to support your claims.

With experience-based foresight and a sound testing blueprint, our clients earn peace of mind from our commitment to detail and the highest clinical distinction of genetic reporting.

INNOVATORS OF SMART IDEAS
Health related products, services or concept developers hold to task a significant list of accountability measures. From road-mapping the red tape of regulation approvals to satisfying industry and public trust by covering all proof of safety compliance, HSI is here to drive you to the finish line efficiently and cost-effectively. We do this with time-managed strategies, proven and battle-tested coordination and a fully trackable program that aligns with current standards. HSI has the combined experience and resources backed by the largest validation firms, processing agencies and industry leaders who help bring health concepts into reality.

CLIENT SUPPORT SERVICES: • Research 1: Performance Testing & Response Validation (trials) • Research 2: Data collecting from industry, markets, user surveys • Clinical Partnerships / Acquisitions / Distribution • Certification Approvals & Compliance • Outsourced Representation / Surveying / Lead Generation • Product Branding, Marketing, Recognition Support Product/Service Business Integration - Business Planning / Blueprinting - Acquire all (Federal/State) Permits, Licenses & Compliance Regs. - Budget Breakdown and resource valuations - Team building, training and management - Get Business Insurance - Projections of growth potential - Seek backers, investors & sponsors Strategic Marketing Plan - Survey client's industry & base - Define Branding - Target Market Research (Review)

HEALTH RELATED EQUIPMENT: SAFETY RESEARCH & COMPLIANCE Since 9/11, an expansion of industries have set into motion countless programs supporting health and safety products into the market. The very same products all underwent strict testing, reviews and evaluation by some (or all) of the following government organizations to ensure public safety compliance while validating accurate claims and efficacy. • EPA: Environmental Protection Agency* • OSHA: Occupational Safety and Health Administration* • FDA: Food and Drug Administration* • USDA: US Department of Agriculture* • CPSC: Consumer Product Safety Commission*
CLINICAL TRIALS & PRODUCT TESTING Assembling product testing labs, clinical investigators and diagnosticians for research teams and studies is a major part of the road to success of any health product. This is the primary way that researchers find out if a new treatment (like a new drug or diet or a medical device or cleaning product) is safe and effective for public use. Testing is also the standard way to discover about any possible adverse reactions like harmful side effects that the product may cause. Where clinical trials may test ways to find a disease or disorders early, sometimes before any apparent symptoms, others test ways to prevent a health problem. A clinical trial may also look at how to make life better for people living with a life-threatening disease or a chronic health problem. Having strong leadership at the collaborative helm of capturing and reviewing scientific data is paramount. HSI has a dedicated clinical investigation team that brings the sound advantage of experience-based perspective to any analytical or diagnostic paradigm.
It's all about PATIENT PROGRESS Medical research protects the relationship between the developer of clinical solutions and the patient community of its treatment or performance claims. Tests performed by an unbiased agencies like the AngioFoundation ensures the acquisition of untainted, unbiased data from a dedicated review campaign.	Who needs CLINICAL TRIALS? Medical device manufacturers/inventors, drug developers, producers of additives and supplements or any entities that create materials that are accessory to healthcare treatments. Also, upgrades and modifications to these products will require further PROOFING or VALIDATION under similar testing.	Uses for ACQUIRED DATA Producers earn the benefits of public confidence from the information harvested in Clinical Trials. To establish performance standards (let it be through regulatory compliance testing or internal quality assurance reviews) is a significant asset for any product being introduced into the market.