The Clinical Design Score.

What is Clinical Design?

With modern production technologies and techniques, it can be difficult to determine if a product you are looking at is custom made or not. In general terms, if the shape looks to uniform, neat, tidy or symmetrical… it may well not be based on the original model of the foot you supplied for manufacture.

At the Footprint Hub we look to provide engineering excellence sustainably. This starts with providing you the clarity to choose the design and production methods that best suit your clinical approach and ability to personally direct the clinical shape. As a result, you and your team have access to promote the biomechanical movement you dream up for each and every one of your patients.

To maintain excellence in our products and services, We have identified the need for a transparent system of labelling to help you, make straightforward, confident decisions about the types of products you select. 

The Clinical Design Score is a simple scoring system, that paints a picture of how closely the manufacturing process (design, processes and production) relate to the medical information you prescribe to us each time. At its core, it aims to represent the adherence of manufacturing process to the unique information supplied (prescription variations, foot shapes and their positions in space).

Put simply, it allows the clinical mind to relate to the engineering brain.

Download a copy of our Orthosis Review Matrix here.

Simple. Clear. Objective.

Let's Take a Look at How our Clinical Design Score Works.

What We Rate.

The clinical design scoring system is our unique approach to providing simple, relevant information to those that need it most; you and your customers.

This initiative has been developed in consort with our colleagues at digitorth.com and the upcoming understandings for clinical products produced with 3D techniques and technologies (3DCO.org). The leadership team at the Footprint Hub is consistently looking to advocate, educate and coordinate with our fellow manufacturers to bring you, and our industry consistency of information and a true picture of the products and services you choose.

The Footprint Hub clinical design scoring system provides a overview of the complete manufacturing process that a lab undertakes to produce a given product to give you the confidence to know you are getting what you ask for.

The rating system takes into account 8 key categories for determining the Engineering Design and clinical consideration in the manufacture of any given product.

The 8 categories are:

  1. Form 
  2. Function 
  3. Compliance
  4. Integration
  5. Price Content
  6. Innovation
  7. Process
  8. Communication

How We Rate: Our Clinical Design Score.

Products are rated from 5 (Great) to 0 (Nil) in each of the eight categories. We look at engineering design, the correlation to clinical understandings that make them up as well as several other indicators of design excellence. The product’s average score is then calculated to provide an overall clinical design rating.

Certifications, accreditations and other standard systems play a key role in informing our assessments. Full marks are often only awarded if a product has a credible, third-party certification.

Let’s have a closer look at how the scoring works within each category.

Calculating A Products Overall Clinical Design Score.

To calculate a product’s overall clinical design score, we add together the scores for each category, and then divide this total by 8 (the number of categories) to find the average score.

This average score is then the overall clinical design score for the product. For example, a product receives the following scores under each category:

  • 1. Form – 5 points
  • 2. Function – 4 points
  • 3. Compliance – 3 points
  • 4. Integration – 4 points
  • 5. Price Content – 4 points
  • 6. Innovation – 5 points
  • 7. Process – 5 points
  • 8. Communication – 4 points

Total Score = 34 points.
Average Score: 34 / 8 = 4.25

So the overall design score for this example is 4.25 out of 5.

Girl in a jacket

Category 1: Form.

This category looks at what process the shape of the final device is derived from. It asks the question: is the final form sourced purely from supplied data, a pre-designed algorithm or a hybrid of both?

Clinicians are highly aware of the level of adherence that the final shape has to the original form and its importance to the medical decisions that may stem from it. In a manufacturing setting however, there are practical considerations like processes, tooling and cost to customer, may place pressure to substitute shape adherence for shape homogeneity.

We look to account for production variables such as  accuracy of tool heads, cutting paths, inter-rater repeatability of processes and assumptions within the design and shaping algorithms employed to produce the products. 

The product has to meet one of the features listed below in order to be given the corresponding score.

Great.

  • All automated &/or handmade steps are able to reproduce the orthosis form to a 95% accuracy.
  • Production software and subsequent tool paths to create the shape have been independently tested by a certified agency and adhere to the original with 95% confidence interval.
  • The product will have a recognized certification for this e.g. International virtual human body (VHB) standards from the International Organization for Standardization (ISO) or equivalent industry agreements in the certification of orthoses manufactured with computerised 3D technologies (3DCO.org).
  • Objective repeatability in both inter and intra rater measures.
  • There is nil ambiguity in the measurement and subsequent production systems applied.
Score: 5 / 5

Pretty Good.

  • No certification, but it is made from a majority (>80%) adherence to the supplied foot model, and
  • This is able to be independently verified.
  • The product is able to declare the upper and lower tolerances (±) of all tools and tool paths used.
  • It uses the supplied foot data as the fundamental reference point to work from, not a pre-designed design template.
  • An significant range (50-80%) of variables are able to be altered.
Score: 4 / 5

Fine for Price Point.

  • Some effort has been made to maintain the form of the device for a period up to 6 months typical daily use
  • Not including forces typically seen in mid to high energy sporting activities.
  • Scalar increments have been used, however these are appropriately calculated according to a logarithmic scale (i.e. not arbitrary in nature).
  • An limited range (20-50%) of variables are able to be altered.
Score: 3 / 5

OK, but if we’re Picky.

  • Form follows a typically recognised anatomical shape of the foot
  • Initial comfort of the orthotic form seems to be a priority rather than biomechanical movement alteration.
  • Two or less, orthotic reaction force control points.
  • Form of as-new shape not expected endure past six weeks of typical use.
Score: 2 / 5

Basic.

  • Has been designed once with a designers consideration as to an interpretation of a typical foot shape.
  • Consideration for fit to multiple shoe shapes rather than currently understood biomechanics of the foot.
  • Generally a lower volume / biomechanical impact so as to avoid promoting any movement that may injure those with typical foot mechanics for that product line.
Score: 1 / 5

Nil. None. Nada. Njet. Zip. Zilch.

  • No discernable form design correlation to foot mechanics or human biomechanics.
  • Production company unable to provide testable data or production process information to indicate otherwise.
  • Device appears as a simply layer between foot and shoe.
  • Value may stem from form as padding or attachment for paddings only.
Score: 0 / 5
Category 2: Function.

To what range does the selection of available materials for the device allow adequate functional range for what use the orthosis is to be applied? To what level does the shape applied to the device design reflect current clinical understandings of foot function? To what level does the manufacturing processes employed to create the device alter the function of the final product?

The final function of the device will be under the ultimate control of the dispensing practitioner. This category looks to provide some clarity of  what materials selected, manufacturing process and application of current clinical understandings have been applied to the product under review

A products function score has to correspond one of the features listed below in order to be given the corresponding score.

Great.

  • Evidence Based Design: The combined function of the product has been objectively connected to our current understandings of 3D modelling, materials science, human movement, biomechanics and podiatrics as displayed by reference to specific content in peer reviewed journals in the fields.
  • Materials contained in the product are of durable to maintain function for 3 or more years of typical use. 
  • Shape reproduction promotes the evidence that has been referenced.
  • Specificity of use for activity has been accurately described and applied to the function.
  • Capacity for customisation allows functional adaptions to be made.
  • Error recording and reporting capacity of all process, thinking and interpretation errors throughout manufacture is available.
Score: 5 / 5

Pretty Good.

  • One or two valid forms of evidence based design have been applied. 
  • Direct input from medical practitioners is possible along the entire chain of production to maintain device function.
  • Individual manufacturing processes are sufficiently designed to include clinical thinking and alterations as required.
  • Functional alterations are accurately recorded and managed by prescribing practitioners.
  •  Error recording and reporting is a passive processes and subjective in nature.
Score: 4 / 5

It’s a Start.

  • No evidence base or evidence referred does not objectively relate.
  • Some investment in effective production management techniques has been made in the production of the product;
    • Updates to functional shapes appropriately notified and authorised
    • Records access & management readily accessible
  • Functional durability considered 6 months typical use
  • Overall functional impact of the product is low and requires further customisation to promote therapeutic management.
Score: 3 / 5

Need to be a Little Picky.

  • Minimal effort has been made towards attending to device function outside of original design parameters.
  • The functional nature of the product comes from the base materials used, however the process of manufacture may;
    • Alter the functional properties
    • Contain significant amounts of un-contolled variables
    • Be overly influenced by time and cost considerations
  • Functional durability of device no more than 3 months typical use.
Score: 2 / 5

Some Fundamental Problems.

  • Minimal effort has been made towards the function of the device.
  • The majority of the functional design has considered;
    • first fit comfort
    • cost
    • profit
    • short production times
  • Durability of the functional life is no more than 1 month typical use.
  • Across the board investment in functional device versatility is required.
Score: 1 / 5

Avoid if You Can.

  • The application of this product damages the professional brand.
  • The product is made from materials, processes, and/or clinical thinking that are fundamentally flawed.
  • Clinical function of the device does not seem to have been considered.
Score: 0 / 5
Category 3: Clinical Compliance.

This review category attends to the clinical compliance of manufacturing process and assertions made as to what the product may promote in the clinical situation.

Cure’s Heel Pain!… How has the production process maintained its compliance to prescriptive clinical instructions from an appropriately registered and insured practitioner to meet the currentunderstanding of how to “cure” heel pain?

Great.

  • Has achieved certification
  • Maintains a full time clinical team within the operations of the business
Score: 5 / 5

Pretty Good.

  • One clinical certification
  • The majority of the product’s manufacturing processes adhere to medical manufactured goods in the country of dispense 
  • A single full time clinical professional in a leadership role within business operations
Score: 4 / 5

It’s a Start.

  • Some effort has been made to adhere to clinical process, however no certification 
  • No full time clinical professional however systems in place across the entirety of production.
  • Access to clinical evaluation professional on an ad hoc consultancy basis only.
Score: 3 / 5

Need to be a Little Picky.

  • Some clinically objective systems in place however incomplete across the entire design and production chain
  • No clinical processes within system outside of the original setup and design of shapes & templates
Score: 2 / 5

Some Fundamental Problems.

  • Some rudimentary no-clinical systems in place however application incomplete across the board
  • No clinical review taken at any stage of the design and production process outside of original template design
Score: 1 / 5

Avoid if You Can.

  • Not certified to be a clinical product
  • No systems in place to ensure adherence to clinically made processes
  • No appropriate clinical expertise embedded within products or services
  • Motivated toward mass production as opposed to clinically custom
Score: 0 / 5
Category 4: Integrated Thinking.

This category looks at how well the production process integrates the thinking of all the participants in its production. It considers the chain of manufacture from party to party (practitioner, technician, designer, engineer or manager) and how well the design process produces the “correct” final product.

This measure is highly correlated to production failures, time and resources wasted. It considers three fundamental principles in the chain of manufacture, namely errors of thinking, process and interpretation. This category relates these back to the design process and how well it manages each within the stages of manufacture.

The product has to meet one of the features listed below in order to be given the corresponding score.

Great.

  • Design process contains a recognised error identification system to alert and manage all three manufacturing areas that errors are possible:
    • Thinking
    • Process
    • Interpretation
  • There is a capacity within the production system to alter (and record) mid-process
  • Includes post dispense practitioner feedback systems and active management processes
  • All parties in the design, manufacture and delivery processes have access and capacity to act on errors reported within a time constraint
Score: 5 / 5

Pretty Good.

  • Capacity to prescribe a full custom device with 2/3 of the manufacturing areas where errors are possible in a structed way.
  • Regularly managed consistently
  • All parties in the design, manufacture and delivery processes have access and capacity to act on errors reported
Score: 4 / 5

Fine for Price Point.

  • Capacity to prescribe a full custom device with 1/3 of the manufacturing areas where errors are possible in a structed way.
  • Regularly managed consistently
  • Not all parties in the design, manufacture and delivery processes have access and capacity to act on errors reported
Score: 3 / 5

OK, but if we’re Picky.

  • Manufacturing areas not considered
  • Errors are picked up in a non-structed way
    • No consistency of management
  • Semi-customisable device or process
    • Thinking errors only are presented at practitioner product selection process.
Score: 2 / 5

Basic.

  • Chain of Manufacturing not considered
  • Errors consistently not picked up
  • No consistency of management
  • Non-custom / Prefabricated device or process
    • Thinking errors only are presented at practitioner product selection process.
  • Practitioner and/or sales team able to evaluate, recognise and recommend prefabricated device for popular paradigms.

Score: 1 / 5

Nil. None. Nada. Njet. Zip. Zilch.

  • Non-Customised, Prefabricated device
    • Pre-determined design
  • Nil integration of parties in the prescription, design and manufacture
  • Product considerations weighted to be available at low price point
Score: 0 / 5
Category 5: Price Content.

Where does the money go? Do any premiums charged for the design, device or service reflect the added cost of sustainably supporting inputs (staff, expertise, materials, production, energy, social / environmental levy’s) or is there a disparity between premium paid and the materials, inputs and expertise placed into providing the final product?

A products price content score has to correspond one of the features listed below in order to be given the corresponding value.

Great.

  • Social and environmental transparency of price that details all (5/5) of the following:
    • Recyclable materials
    • Renewable, sustainable, clinically based Design thinking
    • Sustainable processing and production
    • Use of renewable energies
    • Social and enviro sustainability
  • Highly trained and >10 years experience staff
  • Durable, Highest quality inputs
  • Intensive production inputs
  • A taxation levied on non-sustainable, socially unjust inputs
Score: 5 / 5

Pretty Good.

  • Great.

    • Social and environmental transparency of price that has at least three (3/5) of the following:
      • Recyclable materials
      • Renewable, sustainable, clinically based Design thinking
      • Sustainable processing and production
      • Use of renewable energies
      • Social and enviro sustainability
    • Highly trained and >5 years experience staff
    • Durable, quality inputs
    • Intensive production inputs
    • A taxation levied on non-sustainable, socially unjust inputs
Score: 4 / 5

It’s a Start.

  • Social and environmental transparency of price that has at least three (2/5) of the following:
    • Recyclable materials
    • Renewable, sustainable, clinically based Design thinking
    • Sustainable processing and production
    • Use of renewable energies
    • Social and enviro sustainability
  • Appropriately trained and >2 years experience staff
  • Durable inputs
  • Intensive production inputs
  • No taxation levied on non-sustainable, socially unjust inputs
Score: 3 / 5

Need to be a Little Picky.

  • No social or environmental transparency of price
  • Untrained staff with experience in orthosis production >2 years
  • Product durable from it’s innate nature
  • No taxation levied on non-sustainable, socially unjust inputs
  • Profit margin slightly inflated
    • Designed to meet advertised market position of other products without the same depth of inputs
Score: 2 / 5

Some Fundamental Problems.

  • Made from innately durable inputs, however no social, environmental, design, renewability or recyclability built into the price.
  • Non orthosis production (prefabricated product or process)
  • No taxation levied on non-sustainable, socially unjust inputs
  • Profit margin inflated to meet competitors’ product ranges.
Score: 1 / 5

Avoid if You Can.

  • Prices seems to consider speed, profit of manufacture
  • Directly or indirectly ignores or adversely affects the environment from which they are sourced.
  • Non sustainable materials, process
  • Should be avoided
  • Price gouging seems plausible
  • The application of this product damages the professional brand.
Score: 0 / 5
Category 6: Design Innovation.

Does the business, product, design process or consumer interaction bring or promote innovation of products into the orthosis manufacturing industry consistently?

This category recognises the time and investment across the greater profession to maintain competitiveness and relevance in a modern medical device manufacture and clinical practice.

Great.

  • 2 or more recognised third-party product or production innovation awards in the past three years.
  • Objectively evident investment in orthosis manufacturing industry innovation development initiatives.
  • Products and services consistently perform above expectations.
Score: 5 / 5

Pretty Good.

  • At least one recognised third-party award in the past 3 years
  • Continued active participation displayed within industry local to their sales market
Score: 4 / 5

It’s a Start.

  • No recent third-party awards, however, participation in industries innovation and design is objectively evident
  • Engaged in business innovation process within the industry
Score: 3 / 5

Need to be a Little Picky.

  • No recent award or participation
  • Not actively engage in innovation process to the external industry, however
    • business displays internal processes and employee capacity to understand and manufacture under clinical direction, in a repeatable way.
Score: 2 / 5

Some Fundamental Problems.

  • No recent award or participation
  • Not actively engage in innovation process to the external industry
  • > 5 years experience in the industry to produce clinical products
Score: 1 / 5

Avoid if You Can.

  • No recent award or participation
  • Not actively engage in innovation process to the external industry
  • No experience in the industry to produce clinical products
Score: 0 / 5
Category 7: Processes.

Do any of the steps in the manufacturing processes change or affect the intended design? Heat? Matchning Algorithm? Position of reference points? Clarity of descriptors? This category considers the processes contained within the creation of a fully custom device and any hidden distortions that may be imbedded in design or production process.

The product has to meet one of the features listed below in order to be given the corresponding score.

Great.

  • Custom process accurate to production according to supplied foot model.
  • Process considers and records all processes concerned with;
    • Capture of foot modelling data
    • Design
    • Automation
    • Heating
    • Handcraft & trimming
  • Overall process attends to all challenges and able to repeat exact copy of  previous design.
Score: 5 / 5

Pretty Good.

  • Custom process accurate to production according to supplied foot model.
  • Process considers and records 75% of all processes concerned with;
    • Capture of foot modelling data
    • Design
    • Automation
    • Heating
    • Handcraft & trimming
  • Overall process contains some challenges to in repeating exactly to previously produced design(s)
Score: 4 / 5

Fine for Price Point.

  • Fully Custom process accurate to production according to supplied foot model.
  • Process considers and records 50% of difficult to repeat processes concerned with;
    • Capture of foot modelling data
    • Design
    • Automation
    • Heating
    • Handcraft & trimming
  • Processes only partly documented along the production chain
Score: 3 / 5

OK, but if we’re Picky.

  • Fully Custom process accurate to production according to supplied foot model
  • Process considers and records <25% of difficult to repeat processes concerned with;
    • Capture of foot modelling data
    • Design
    • Automation
    • Heating
    • Handcraft & trimming
  • Assumptions / Alterations / adaptions / in house processes not documented at all along the production chain
Score: 2 / 5

Be Aware.

  • Non-Custom process
  • Not accurate to production according to supplied foot model.
  • Process automated to set variables and algorithms
  • Foot model used to gather positional points of reference only 
  • Production output results in a homogenous product, shape and form.
    • Documentation along chain not imperative as product is essentially prefabricated.
Score: 1 / 5

Nil. None. Nada. Njet. Zip. Zilch.

  • Non-Customised, Prefabricated device
    • Pre-determined design never intended to represent a customised device
  • Nil bespoke design process employed outside of original design
  • Product considerations weighted to be available at low price point
Score: 0 / 5
Category 8: Communication.

Is the design process communication clearly documented and readily accessible to all participants in the design process? This is slightly different to Category 4 – Integration. Category 8 – Communication looks at the process of communication not the content and how thinking integrated toward each parties in the manufacturing chain can affect error rates. 

“Lets eat, Grandma” can be communicated well (cat. 8) however how it is integrated along the chain (cat. 4) may be very different; “Lets eat, Grandma.” vs “Lets eat Grandma.”… an example where commas truly save lives 😉.

Great.

  • Live, direct multi-team access from prescribing medical practitioners possible along the entire chain of production, i.e.
    • Direct Message 
    • Email 
    • Online account in production record
    • Integration into medical records possible
  • Active post dispense review and feedback systems
  • Annual reporting of trends across account
Score: 5 / 5

Pretty Good.

  • Two-way communication of design process detailed in all (4/4) of the following areas:
    • Error reporting
    • Practitioner access
    • Prescriptive language
    • objective measurements
  • Active access required; i.e. account login, email, data updates
Score: 4 / 5

It’s a Start.

  • Two-way communication of design process detailed in all (3/4) of the following areas:
    • Error reporting
    • Practitioner access
    • Prescriptive language
    • objective measurements
  • Active access required; i.e. account login, email, data updates
Score: 3 / 5

Need to be a Little Picky.

  • Two-way communication of design process
  • Detailed in 2/4 of the following areas:
    • Error reporting
    • Practitioner access
    • Prescriptive language
    • objective measurements
  • Active access required; i.e. account login, email, data updates
Score: 2 / 5

Some Fundamental Problems.

  • One-way communication of design process
  • No process feedback provided
  • Active access required; i.e. account login, don not reply email, data updates
  •  
Score: 1 / 5

Don’t waste Your time.

  • Single occurrence, one-way communication only.
  • Disjointed departmental interactions
  • Process registers purchase and delivery information at point of sale only.
  • No ability to communicate directly to file once sale has occurred
Score: 0 / 5