Fabdesigns, Inc.

Where are the Wearables?

What Does It mean To Knitting?

 

Why isn’t there more apparel with conductive fibers?

What happened to all that wearable tech apparel we were promised for the last several years?  It’s an interesting question with a very complex answer, most of which is rooted in the business models and skill sets of the companies trying to produce ‘wearable tech.’

Many consumer product companies today just want to purchase off the shelf fabrics, sensors, and conductive materials, and are relying on their vendors for fabric quality and benchmarks. This is not a new way of thinking, for big brands, who make their products in rapid seasonal cycles at contract manufacturing mostly in 5 Asian countries. However, in undertaking and working with products that carry energy into them, and also which remain in close proximity or against the skin, this type of product needs to be developed, controlled, and owned in house.  


All medical and military products that utilize ‘wearable technology’ have been researched, developed, and project managed along a set of guidelines, which also mitigate risks and failures in both manufacturing process and use of the product.  Several huge consumer companies have gotten into major problems because they parrot the techy buzz words, and have R&D processes that are geared to fast tracking consumer products to market.  This rapid process is very different from medical and military R&D processes in many respects, including, scope, risk analysis, testing, timeline, and budget.


The business models are also completely different.  It is expected in the Medical development process that a product might take 3 years or more from concept to launch.  And, during that time, there is also vigorously controlled and standardized clinical trials.  All claims need to be substantiated, and it may take even more time for the FDA to approve the product and its application. Exporting it to other countries requires similar procedures as the FDA, including, submitting documentation, trial data, rick analysis, and claim substantiation. Medical products (all products that make medical, diagnostic or treatment claims) need to be developed and documented according to ISO-13485:2003 standards. There is a focus on what the manufacturer does to deliver safe and effective products.

Manufacturers must prove that their products do what they say they will, are precise, create no additional health issues, that they will last the entire warranty period, and survive a 3rd party audit. Military and aerospace have similar development criteria, and sometime more rigorous and redundant safeguards. The worst thing that can happen with a defective consumer product is that, it is brought back to the store, money is refunded or the item replaced.  With a medical, aerospace, or military product, the situation could be dire. Everyone wonders why medical devices cost so much money and NASA routinely is the butt of many $400 hammer jokes.

The buzz word wearable tech – or conductive materials can mean many different things in consumer products.  There are both passive and / or active components embedded in textiles. 


What are the challenges to creating wearable tech, regardless of electronics being embedded or sewn in?


 There are several issues that challenge designers and engineers alike.  The primary issue is that the skill sets at consumer product companies are very different than those at companies which develop medical, military and aerospace products.  In consumer products the focus is on aesthetics, marketing, margins, and sell-through.  The retail cycles are very predictable and dictated by retailers and end consumer.  This is not to say that medical and military product professionals are not focused on how products look or making a profit.  They do.  However, their primary focus is on safety, precision, and fully functional life of the product and the person using the product.  There are very different protocols, standards, and procedures.


The next biggest challenge is overlapping markets and technologies in medical, sports, military, and consumer product ‘wearables’.  The lines are blurring between what are REAL medical devices and what is ‘Consumer Grade’ sports equipment. 


Which performance characteristics below do you think belong to medical and which to sports equipment?


  •        Performance Enhancing Compression
  •        Muscle atrophy
  •        Endurance
  •        Posture correction
  •        Sports specific brace
  •        Sensors
  •        Diagnostic (Diabetic)
  •       Treatment
  •        Compliance
  •        Vital Statistics
  •        Bio-Feedback
  •        Endurance
  •        Performance
  •        Respiration•       Muscle stimulation
  •        Inserts
  •        Wire harness, battery packs, etc.
  •        Tubing, bladders, gel pads, pain relief, etc.
  •        Components – foam, stay, delivery systems, etc.
  •        MRI compatible stays

The lines are blurring between ‘integrated apparel ‘e- textiles’ and medical ‘wearables’.  Which performance characteristics below do you think belong to medical and which to sports equipment?

  •        Electro stimulation
  •        Muscle stimulation
  •        Bone stimulation
  •        Circulation stimulation
  •        Sensors
  •        Pulse / Pulse Ox
  •        Diagnostic (Diabetic)
  •        Treatment / Therapy
  •        Compliance
  •        Interface with Bluetooth / phone / computer
  •        Inserts
  •        Wire harness, battery packs, etc.
  •        Tubing, bladders, gel pads, etc.
  •        Components – foam, stay, delivery systems, etc.
  •        Sweat mitigation
  •        What effect does sweat have on wearables?
  •        Salt (urea) mitigation
  •        Dissipation of energy
  •        Measuring performance rate
  •        RF, EMF, Faraday shields, static dissipation, Taser resistance

So what is the deal with conductive fibers?


Every medical, military, and aerospace engineer and product designer knows that there are three stages to a wearable device.

  1.        Getting the energy into the product
  2.        Getting the energy to do what it needs to do
  3.        Getting the residual energy out of product (and the person)

Bare conductive wires placed against the skin are a huge red flag.  Sweat contains salts.  These salts on the skin amplify the electronic charge. If a person is wearing synthetic soles, say while jogging, and not dissipating the energy, what happens to that energy?  It builds up in the system of the individual, until it is dissipated, by the person grounding themselves.

Then, we have some people say, ‘ok, I won’t use conductive wires.  I’ll use graphene.  Graphene is good right? Well, not all graphene news is good.  A study at UC Riverside found that graphene oxide is very mobile in lakes and streams, as well as being toxic to fish.  Recent studies also suggest that it may be toxic to humans. https://ucrtoday.ucr.edu/22044


The point is that whether wired in, 3D printed, or inked on, most consumer product designers and engineers, (unlike medical, military, and aerospace engineers) are unaware that the electrical charge if not dissipated may cause a variety of health issues in wearable tech products.  We have also seen several major companies attempt to create consumer products that diagnose or treat medical symptoms, but not know about the FDA requirements. Here are a few examples and studies as to why there is more to wearable tech than most consumer product companies know.


Wearable technology & the immune system
A few basic facts (Johansson, PhD et al, 2007)


Field strength: An electromagnetic field consists of an electrical part and a magnetic part. The electrical part is produced by a voltage gradient and is measured in volts/meter. The magnetic part is generated by any flow of current and is measured in Tesla.

For example, standing under a power line would expose you to an electrical voltage gradient due to the difference between the voltage of the line (set by the power company) and earth. You would also be exposed to a magnetic field proportional to the current actually flowing through the line, which depends on consumer demand.


Both types of field give biological effects, but the magnetic field may be more damaging since it penetrates living tissue more easily. Magnetic fields as low as around 2 milligauss (mG) or 0.2 microTesla (a millionth of a Tesla) can produce biological effects.

For comparison, using a mobile (cell) phone or a PDA exposes you to magnetic pulses that peak at several tens of microTesla (Jokela et al, 2004; Sage et al, 2007), which is well over the minimum needed to give harmful effects. Because mobile phones and other wireless gadgets are held close to the body and are used frequently, these devices are potentially the most dangerous sources of electromagnetic radiation that the average person possesses.

Source: 


The immune system and the impairment electro-hypersensitivity

An increasing number of studies have clearly shown various biological and medical effects at the cellular level due to electromagnetic fields, including power-frequency and radiofrequency/microwave exposures at low-intensity levels.

Source:


Such electromagnetic fields are present in everyday life.  The bio-effects and health impacts are substantially documented.

  •        Children born to women with high exposure to EMFs during pregnancy are more than twice as likely to develop asthma. Source:
  •        Sperm exposed to EMFs lost motility faster and had more DNA damage than sperm that wasn’t exposed. Source:
  •        EMFs may cause suppressed immunity. Source :
  •        DNA is damaged in the presence of EMFs. Source:
  •        Long-term exposure to EMFs is linked to Alzheimer’s disease and dementia.    Source:

Direct effects on the immune system were first reported in relation to people with symptoms of electro-hypersensitivity.  Subjective and objective skin- and mucosa-related symptoms, such as itch, smarting, pain, heat sensation, redness, papules, pustles, etc., after exposure electromagnetic devices such as cell phones, WIFI and other EMF devices were reported. Frequently, symptoms from internal organ systems, such as the heart and the central nervous system were reported. Source:



Things to keep in mind - Wearable technology

  •       Materials such as metals are electrical conductors. They contain free or mobile electrons that can carry electrical energy from place to place.
  •        Modern rubber and plastic-soled shoes act as electrical insulators and therefore block the beneficial flow of electrons from the earth to your body.
  •        Studies have shown that earthing or grounding improves blood viscosity, heart rate variability, inflammation, cortisol dynamics, sleep, autonomic nervous system (ANS) balance, and reduces effects of stress.
  •        Earthing decreases the effect of these potentially disruptive electromagnetic fields.
  •        Your body is somewhat conductive because it contains a large number of charged ions (called electrolytes) dissolved in water. Your blood and other body fluids are therefore good conductors. Free or mobile electrons can also move about within your body.
  •        Sweat amplifies surface conductivity due to the polarity of the water molecules present, but also due to the salt content released during physical activity.
  •        Shielding, dissipation, and grounding should be part of the R&D plan in developing functional knit ‘wearables’.

Electrical Conductivity

  •        Fibers that do NOT conduct electricity create static electricity
  •        Fiber Optic
  •        Polypropylene
  •        Wool

Epitropic Fibers

  •        Synthetic fibers that have small particles of carbon embedded in their surface. These particles conduct electricity

Bi-component Fibers

  •        Electrically conductive sheath or core structure

Dissipation

  •        Static decay testing Federal Test Standard 101C;
  •        Military / industrial standard MIL-B-81705 (decay to 0% of initial charge in =< 2 s;
  •        NFPA99 (decay to 10% of initial charge in .5s)
  •        Note:  IEC 61010 (home use) IEC60601-1-2 (2014) 4th Edition standard, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests. Devices typically include oxygen concentrators, body-worn nerve and muscle stimulators, beds, sleep apnea monitors, and associated battery chargers prescribed for use at home.

Note: Different regulatory standards for risk management apply in different markets – for example, ISO14971:2007 is recognized in the US as part of ISO 13485, but EN ISO14971:2012 is required in Europe.

Fabdesigns, Inc. works with many domestic and international sources for performance fibers.

As in any business decision, give the customer what they want.  If the end customer appreciates the technology, and is willing to pay for it, there’s a practical business reason to use iand find the experts you need to make your product work as expected.

So, in choosing to build wearable technology into products, choose your path wisely.


Connie Huffa – Fabdesigns, Inc.

Copyright © 2017 Fabdesigns, Inc., All rights reserved.


Note: The above excerpt on ‘wearable tech’  is a portion of the seminar presented by Connie Huffa of Fabdesigns, Inc. at IFAI advanced Textiles Expo October 4, 2014 as part of ‘Creating Safety & Protection”

Mailing address: 327 Latigo Canyon Road, Malibu, California 90265

Website: www.fabdesigns.com  

Email questions of comments: info@fabdesigns.com