THINK big & SMALL Innovative Approach to Pediatric Device Development

Angel Adams

Bridging

the Gap

Lack of Pediatric Innovation

Development Costs

Lack of Funding and Investment

Costs and Risks associated with Clinical Trials

Limited Research and Data

Growth Rate

FDA Regulations

Limited Distribution Channels

Pediatric Needs

Medical Devices

Pharmaceuticals

HealthIT

Improved Patient Care

Access to Resources

Research & Data

Customized Equipment

Pediatric Device

Innovation Process

Unmet NeedsMarket Assessment

Concepts & Ideas Device Design Institution vs. Industry

Management

Funding & Investors

Development Process

RegulatoryPre-Clinical & Clinical

Commercialization

Distribution

Pediatric Needs & Market

Assessment

Needs &

Market

• How do you find pediatric needs?• Who do you contact within the pediatric

industry?• Where do you find pediatric market data and

information?• Can you use adult research and data for

pediatrics?• What is the size of the pediatric market?

Current

Issues

• Limited research and data available within pediatrics.

• Contact physicians directly through social media channels, referrals, and other limited connections.• Institutions are not keen on these methods

unless there is a consultation fee. • Many healthcare providers need to go

through an approval process in order to give expertise and advice unless they state they are volunteering.

Scenarios:

Pediatric Unmet

Needs & Market

Assessment

EXAMPLE: Medical Device Innovation

Students

This program provides students with an overall view of the medical device industry, with an emphasis on unmet needs.

Problem: There is not an easy way to discover unmet needs especially within pediatrics because the needs are widespread.

EXAMPLE: FDA Unmet Needs

Assessment

The FDA is rolling out an unmet needs assessment in 2015, but it is not specifically designed for pediatrics.

Problem: If you look at the unmet needs nationally and globally, the pediatric need is not significant enough compared to the needs of the adult market. Even if they developed a pediatric unmet needs assessment, we would still have the same obstacles.

Pediatric Device

Concept & Device Design

Concept &

Design

• Is this a new concept or modification of an existing adult device?

• Are you currently make-shifting an adult device to fit pediatrics?

• What risks are associated with this device?• Where do you go with your idea or

prototype?• Where do you find pediatric resources and

expertise?

Current Issues

• Healthcare providers are unable to take ideas outside of the institution without approvals and signed agreements.

• Funding is limited within institutions and industry, resulting in limited options for pediatrics.

Scenarios:Pediatric Device

Concept & Device Design

EXAMPLE: Devicix

Devicix specializes in product development: Receive calls from physicians asking for resources and help to develop their concept.

Problem: Devicix has limited options available for them.

EXAMPLE: “Pediatric” Device DesignA device company in

Minnesota developed a device that secures the catheter in place. They sell and promote the pediatric version of this device because of it’s size.

Problem: The smaller version of the device has never been tested on children. The cost compared to the market is too high, so the company will not clinically test it in children.

Industry vs. Institution related to Pediatrics

IndustryProduct

DevelopmentInvestmentDistribution Channels

Institution

ClinicalHealthcare Providers

NeedsFundingStudents

Research & Data

Scenarios:

Industry vs. Institution related to Pediatrics

EXAMPLE: Prevention of an Asthma Attack in Children

A medical student developed a device around a unique sensor, owned by a university, which detected inflammation in the throat before the onset of an asthma attack.

Problem: The university owned the main sensor technology for his device. The release of this technology will be challenging, making it hard to secure investors.

EXAMPLE: Pediatric Device ConsortiumsThere are seven federally funded pediatric consortiums in the United States, and the federal government has allocated $19 million dollars to them since 2009. Since then, they have funded over 330 projects and only two have made it to market.

Problem: Devices are developed within the institution and IP can prevent partnerships with the industry. Guidelines on how to spend grants.

Pediatric Device

Company Manageme

nt Team

Offers & Board of Director

s

• How did you appoint officers?• What experience and skills do you look for?• How do you choose your Board of Directors?• How much diversity do you have on your board?• What is the motivation behind becoming a board member?• How many of your board members are on other boards?

Advisory

Board

• Do you have a volunteer advisory board? Why or why not?

• What is the motivation to join an advisory board?

Current Issues

• The founder of the technology appoints himself as CEO.

• The most important step in the process and often the reason a great technology will fail.

• Stakeholders normally appoint Board Members with limited experience within pediatrics.

Scenario:Pediatric Device

Start-Up Company

Founder and Officers Founder CEO

Appoint Officers and Management with no pediatric industry experience

Limited pediatric commercialization experience and expertise

Costs of development are higher because of the lack of resources and expertise within pediatrics

Don’t look at the technology objectively

The long term plan in unclear

Market assessment is inaccurate

Believe they will commercial alone

Investors & Board of Directors

Investors invest in technology and management

Investors appoint Board of Directors without understanding the pediatric market, but the founders often don’t understand the pediatric market either

Pressure on the device company for a return, which can lead to mistakes during development

Advisory Board• Missing in most

start-ups• Benefits are

significantly greater• Motivation to help

get a pediatric device to market

Investors, Grants, and

Crowd-Funding within

pediatrics

Investors

• What is your approach to investors? Do you tailor your approach?

• What amount are you asking for? Why? • Why have you been told no or yes by an investor?• How do you find potential investors?• Do you have a long-term plan?

Grants &

Funding

• Do you know which grant options are available?• How do you apply for grants?• What limitations are associated with federal funding?• What are the guidelines for spending that money?• How much did you spend crowd-funding campaigns?• How much did you raise?• Which media outlets did you use?

Current Issues

• Approaching investors without a good plan and pediatric expertise within management

• Pediatric device development expertise doesn’t really exist

• Asking for an unrealistic and unnecessary amount of money without a thorough market assessment

Scenarios:Investors,

Grants, and Crowd-Funding within

pediatrics

EXAMPLE: Detecting Sleep Apnea in Children

Licensed Technology: Antibody that attached itself to protein in urine.

Clinical Study: Showed it was 96% accurate in children to detect sleep apnea.

Asking for $2 million for the development of the antibody and clinical trials.

Problems: Turned down by investors because the market was too small.

Using one clinical site and one company to develop the antibody.

No innovative approaches taken

EXAMPLE: Lazy Eye Detection Technology

Developed a technology that detected lazy eye in young children.

Received grant award from consortium.

Problems: Turned down by investors because they didn’t have the right expertise on their team.

Didn’t have a plan for distribution or pre-market study.

Unrealistic cost for the device.

Limited access to resources.

Development Process

and Resources

within Pediatrics

Resources

& Processes

• What research and data is available? From where?

• Are you utilizing outside resources during development?

• How much do you spend during development?

Current

Issues

• Access to research and data is limited.• Resources are hard to find. • The industry and intuitions don’t

partner enough.• Companies don’t utilize outside

resources enough.• Not enough out-of-the-box thinking.

Scenarios:

Development Process & Resources

with Pediatrics

EXAMPLE: Pediatric Injector

Prototyped an injector that could fit in your wallet or on the back of a phone. The cost for this device was less than the cost the competitors. They received funding for initial development for adults.

Problem: Pediatric market was included to attract investors.

Not including the pediatric market or increasing the costs to modify their device for pediatrics would decrease investment options.

The amount of epinephrine administered is .3 mg for >66 lbs. and .15 mg for < 66 lbs.

The design was not conducive for pediatrics unless administered by an adult. Children begin to carry their injectors around the age of 12.

Market research showed that current options for children often hit the bone when administered. To change the needle size, the development cost would increase.

The cost was roughly $50 dollars less, but injectors are used infrequently.

EXAMPLE: Pegasus Therapeutics

Developing a bioresorbable flow diverter for children with atrial aneurysms.

Problem: This is a Class III device and the development process will require a significant amount of outside resources. Start-ups have limited access to resources and research.

Regulatory within

Pediatrics

• Which regulatory pathway should a pediatric device company take?

• What relationship do you have with the FDA?

• How much preparation have you done before approaching the FDA?

•The FDA does not recognize research and data from other countries.•The industry doesn’t always have the right approach to the FDA.•The problems within the FDA extend far beyond working with the individual departments. •The risk of using make-shifting adult devices is greater.

Scenarios:

Regulatory within

Pediatrics

EXAMPLE: Pediatric ENT Device

Pediatric ENT device that prevents children from undergoing general anesthesia during the procedure of placing tubes in the ears.

After 75 successful procedures, the FDA asked for the device to prove it’s success with each topical used.

Problem: Unnecessary costs and time for the device company.

EXAMPLE: Cardiovascular Device Company

A cardiovascular company in CA modified their adult device to fit children. The CEO has spent a lot of time talking to the FDA about the process to get it clinically proven in children.

Problem: The FDA can’t give them a good reason to do it.

Pre-Clinical & Clinical

within Pediatrics

•Are you using outside pre-clinical resources during every stage of your development?•What clinical research have you found in other countries?

•The FDA doesn’t recognize clinical studies done in other countries.•Parents do not want their children in clinical trials.•The cost for clinical trial within pediatrics is high.

Scenarios:Pre-Clinical & Clinical

within Pediatrics

EXAMPLE: American Pre-Clinical Services

APS is a pre-clinical company in MN that has a special interest in pediatrics.

Problem: A majority of the pediatric devices that come in for pre-clinical services are sent back for re-design because they are not small enough to navigate within the body.

EXAMPLE: University Pediatric Clinical Trial

The university is conducting the largest pediatric clinical trial to test the number of pedicle screws needed for a child with scoliosis. The lower the number, the lower the cost.

Problem: They need help with the dissemination of their research and access to more resources.

Distribution and Strategy within Pediatrics

Distribution & Exit

Strategies

• How do you distribute pediatric devices to all of the small markets?

• Can you commercialize your pediatric device on your own?

• Do you plan on selling or licensing your device?

Current

Issues

• The market for pediatric devices does exist, but you would have to hit every small market around the world.

• Large companies take the credit for their pediatric devices.

• Insurance reimbursement for pediatric devices.

What does a pediatric device

company need to

innovate and succeed?

They don’t always know

what they need.

Resources

Pediatric Device

Expertise

Management

Innovative Solutions to

Pediatric Innovation

Pediatric

Device Center

The Pediatric Device Center is dedicated to the advancement of pediatric innovation within the

healthcare and device industry. Our collaborative approach allows us to provide expertise, cost-effective services, and a wide variety of resources with the help of volunteers and members from around the world. We also partner with healthcare providers, FDA, non-profit

organizations, institutions, consortiums, and other industry experts in order to help bring pediatric

innovation to life.

Global Collaboration is Key

Pediatric Device

Companies

Adult Device

Companies

Contract Manufactur

ers

Discounted Services

Pre-Clinical & Clinical Services

FDA Investors Government

IT Services Volunteers Healthcare Providers

Contract Services

Companies

Institutions Policy Insurance Companies

If we had a representative from each of these categories

in this conference room, could we find a solution?

Global Network

& Pediatric Innovation Portal

Pediatric Product Database• Healthcare providers will have access to a pediatric product database,

which includes devices, pharmaceuticals, software systems, and other pediatrics products

• Ability to order products directly from the companies and distributorsPediatric Research

• Consolidation of pediatric research pertaining to devices and pharmaceuticals

• Access to a research database for providers and device companies • Access to current global pediatric clinical trials

Pediatric Needs Assessment• Allow for healthcare providers and others to post pediatric needs • Ability to connect live via the portal to discuss needs with industry

professionals• Pediatric Needs Assessment• Pediatric Provider Database• Access to a searchable database for the industry to connect with healthcare

providers in order to gain feedback and expertiseDiscounted Member Services

• Pediatric device companies will be able to search for services offered by our members

• Access to volunteers and other individuals willing to share and provide their expertise

Grant Funding and Investors• Access to a searchable database for grant funding given by consortiums

and other entities• Start-ups will have access to available investors and venture capitalists • Access to resources to help start-ups prepare for investor presentations• Investors will have the ability to search for start-up device companies

Pediatric Device Center Updates• Post updates on our progress• Post news from our members

Questions?