MAY 2018

Background

As it stands, patients can only receive an autism diagnosis after undergoing rigorous behavioral assessments taking up to five years. Clarifi ASD was developed to expedite the diagnostic process for children as young as 18 months with a suspicion of autism. Research validates early access to therapeutic interventions can substantially improve the quality of life. Clarifi ASD is the first biological, molecular test with an objective analysis to enter the market. A new diagnostic test also introduces a new approach. In collaboration with clinical, regulatory, sales, engineering, and product leads, I was tasked with creating a comprehensive web application for both health care professionals and patient families.

Client	Industry
Quadrant Biosciences	Healthcare

Role	Deliverables
User research, Product design	Wireframing, Website

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Problem

Clarifi ASD brings a radical workflow and cutting-edge technology. The current diagnostic process has remained the same for years. Providers have utilized the same approach to diagnose autism—until now. A test like Clarifi ASD requires additional steps to obtain, administer, sequence, and finally produce a report all before reaching the patient. 

HCPs

• Research shows a substantial number of providers depend on paper forms and fax. While there are some who embrace a digital workflow, many have limited access to technology or are uninterested in adopting third party applications into their practice.
• Health care professionals have limited time, energy, and patience, especially when it relates to new products. Onboarding new accounts must be seamless and able to integrate with any system.

Patients families

• Due to the lack of coverage from insurance, cost will likely be an issue for families because the test will be patient-pay in the intermediate.
• After a report is reviewed and shared, families will need adequate resources. Typically parents are left wondering who to contact next and what services or therapies their child will require.

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Discovery

Preliminary research

To kickoff the research, our team analyzed five companies with similar business models and processes; Cologuard, Genesight, Genelex, Fertilome, and uBiome. From a high-level we examined test ordering, required documentation, payment, and reporting. After establishing a baseline, I began to further investigate the diagnostic process and focused on three primary subjects: legal guardians, health care providers, and sales representatives. To start, I conducted remote interviews with internal employees then reached out to organizations and partners affiliated with the company. In total I gathered data from 16 parents, 15 health care providers (2 Psychologists, 4 Pediatricians, 2 Nurses, 3 MDs, 1 Practice Administrator, 1 Procurement Lead, 1 Behavior Analyst, and 1 Lab Director), and several KOLs (key opinion leaders) in the industry.

Questions for HCPs

• Does your practice operate on paper, digital, or both?
• How and when should patient payment be collected?
• Should test kits be shipped or be available in you inventory?
• How and when should demographic questionnaires be completed?
• How should test samples be identified?
• How should the report be sent back?

Questions for patient families

• How many children do you have?
• What is your experience with web applications and electronic form submission? (camp registration, private school enrollment, school/daycare, etc.)
• Please elaborate what you like/dislike about registration?
• Do you prefer registration to be guided or flexible to move back and forth?
• For high cost products or services, do you pay upfront or prefer a payment plan?

Questions for sales

• Walk me through a meeting from start to finish.
• Approximately, how much time do you have at a doctor’s office?
• What materials are most effective?
• Who is the primary contact at each practice?
• How do providers feel about third party applications?
• Are accounts organic or rep-driven?

Initial findings

“Best case scenario, I have 15 minutes to explain the clinical utility, how it benefits patients, and where to order. If I’m lucky I get a few minutes with the actual doctor.”

Internal sales representative

ADDITIONAL INSIGHTS

Skepticism
While there will be enthusiastic early adopters, there are also specialists who doubt the clinical utility of our product.

Limited time
Providers are underpaid for their time and rushing from patient to patient. They have little interest in learning about a new technology let alone implementing a new test into their daily practice.

Frustration
Point blank, parents want the best for their children. They are tired of adding their child to waitlists and are looking for answers.

Lack of financial stability
Until the test is covered by insurance, many families may not be able to afford it.

Apprehension
Despite internal efforts to train external sales reps (effectively contractors) they feel uncertain how to explain the science and clinical utility to health care providers.

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Decide & explore

The core team gathered in-person to review the preliminary research, discuss business goals, and gain stakeholder alignment. I had everyone split into smaller groups and perform cognitive walkthroughs, each sorting through a series of tasks and documenting issues and questions along the way. After weighing the pros and cons of each direction, we put together a first draft of the Clarifi ASD lifecycle. With a prescribed flow in place, I began investigating the following user profiles.

• Legal guardian
• HCPs
  • Office Manager
  • Medical Assistant
  • MD
  • Behavior Specialist
  • School Counselor
• Employee
  • Customer Service
  • Accessioner
  • Internal Sales Representative
  • External Sales Representative

SAMPLE HCP PROFILES

I translated our sticky note brainstorm into a flowchart focused on interactions between patients and providers. I met with regulatory and operations to assemble a HIPAA-compliant process.

HIGH-LEVEL CLARIFI ASD LIFECYCLE

I used Whimsical to conduct remote brainstorms together with our product manager and customer care team. We discussed initial feedback, ideas to test, and added potential features to the roadmap.

To better communicate our decision making, I circulated updated task flows to the broader group. Detailed journeymaps served as a visual reference and empowered other departments to review and submit feedback.

I sat down with the engineering to prioritize which features to build in addition to writing user needs and software requirements.

Feature prioritization for HCPs

Feature prioritization for Parents

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Create

As I iterated on the design, I frequently hosted informal lightning design reviews with small groups of volunteers.

HCP areas of focus

1. Log in or checkout as a guest
Instead of forcing account creation, we lower the barrier of entry and provide two options: an area for returning users to quickly reorder or access reports in a central location or the ability to place an order without logging in.

2. Doctors don’t read large chunks of text
I needed to find balance between informative content and limiting clicks. I explored two options, a single and multipage order form.

3. Save custom addresses
When larger organizations go to order, we account for multiple locations. Administrators are able to set a default address (e.g. headquarters) and save custom shipping addresses.

4. Resources readily available
Providers will not spend an extensive amount of time searching for answers. As part of onboarding, video resources and downloadable pdfs are readily available in their dashboard.

Parent areas of focus

1. Flexibility for parents on the go
The day of appointments are rushed and parents just want to get in and get out as quickly as possible. To accommodate we collect all required information during test registration — with the ability to pause and come back to registration if needed.

2. Multiple tests can be registered under one account
For families with several children close in age, a parent is able to register more than one test.

3. Incorporating intermittent saving
The required medical and demographic questionnaires are extensive and can take a few minutes to complete. Allowing parents to save their progress will avoid frustration.

4. Review test status
Processing time for a test is 3 to 6 weeks. Parents are likely to panic if there is radio silence after their child is tested. To ease concerns, we display the status of their child’s test as well as when a report is available.

5. Unlock supplemental resources
Post diagnosis, most parents will search for answers to better understand what their child is experiencing. Adding supplemental resources to their dashboard will provide families with next steps.

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Reflections

Clarifi ASD was released in early 2020 but there are still outstanding questions and product considerations to be evaluated. Two of the biggest hurdles for families are financial accessibility and locating a provider willing to administer the test. Currently, Clarifi ASD is patient-pay. There is opportunity for organizations interested in cash pay who bundle these services into their practice. For example, if a thorough autism evaluation is done in-house, it may include the cost of Clarifi ASD as well as additional therapies. All of this is heavily dependent on reimbursement and coverage. Another consideration down the road would be to investigate EMR (electronic medical records) integration.