Ontogen Medtech

BACKGROUND

Please describe your company and position.

I am the CTO of Madison Scientific

Describe what your company does in a single sentence.

Startup developing an advanced hydrocephalus shunt.

OPPORTUNITY / CHALLENGE

What specific goals or objectives did you hire Ontogen Medtech to accomplish?

• Carry out early R&D
• Define project requirements
• Establish baseline design

SOLUTION

How did you find Ontogen Medtech?

• Referral
• Other

Why did you select Ontogen Medtech over others?

• High ratings
• Close to my geographic location
• Pricing fit our budget
• Great culture fit
• Good value for cost
• Referred to me
• Company values aligned

How many teammates from Ontogen Medtech were assigned to this project?

2-5 Employees

Describe the scope of work in detail. Please include a summary of key deliverables.

• Research & define requirements for an advanced medical device. 
• Perform early R&D ideation, trade studies, and baseline concepts. 
• Identify development risks and mitigations. 

Deliverables include documentation, hardware prototypes, test reports, etc.

RESULTS & FEEDBACK

What were the measurable outcomes from the project that demonstrate progress or success?

• Project dev plan established and milestones being met. 
• Early hardware & software testing yielding positive results and/or important learnings. Prototype feasibility demonstrated. 
• Significant private equity and grant funding raised.

Describe their project management. Did they deliver items on time? How did they respond to your needs?

They are forthright and realistic about what is and isn't possible, and what their team's strengths and limits are. Where gaps exist, they help to find alternatives. They are good communicators and flexible to deal with the surprises that often occur in early development. 

They understand startup needs and have a 'can do' attitude that enables them find ways to make things work. Their extensive experience with medical device development is a great help in building my company as well as my product.

What was your primary form of communication with Ontogen Medtech?

• In-Person Meeting
• Virtual Meeting
• Email or Messaging App

What did you find most impressive or unique about this company?

Strong experience in all phases of medical device development, allow for practical implementation of FDA development guidelines, grounded in good practices, realism, and common sense.

Are there any areas for improvement or something Ontogen Medtech could have done differently?

They are strong in systems, testing, mechanical, and biomedical engineering. Their capabilities in electronics and embedded software are limited, although they can bring in 3rd parties to help in this area if needed.

BACKGROUND

Please describe your company and position.

I am an Executive at Hubly Surgical

Describe what your company does in a single sentence.

Created and sales an advanced, auto-stopping cranial drill with the goal of making neurosurgery safer.

OPPORTUNITY / CHALLENGE

What specific goals or objectives did you hire Ontogen Medtech to accomplish?

• Develop Hubly Drill
• Validation & Verification Testing Hubly Drill
• Receive FDA Clearance for Hubly Drill
• Establish & Maintain Hubly Drill Manufacturing and Quality System
• Develop and test Gen 2 Hubly Drill and additional SKUs

SOLUTION

How did you find Ontogen Medtech?

Referral

Why did you select Ontogen Medtech over others?

• Close to my geographic location
• Pricing fit our budget
• Great culture fit
• Good value for cost
• Referred to me
• Company values aligned

How many teammates from Ontogen Medtech were assigned to this project?

2-5 Employees

Describe the scope of work in detail. Please include a summary of key deliverables.

Developed Hubly Drill, created and maintains Quality Management System, Hubly Drill validation and verification, wrote Hubly Drill 510(k)to FDA, supported FDA interactions, established Hubly Drill suppliers and contract manufacturer, conducts supplier and CMO audits, ultimately achieved Hubly Drill FDA Clearance, developed Hubly Drill Gen 2.

RESULTS & FEEDBACK

What were the measurable outcomes from the project that demonstrate progress or success?

Brought Hubly Drill from very early prototype to final product with FDA Clearance

Describe their project management. Did they deliver items on time? How did they respond to your needs?

They are incredibly communicative and timely. They often achieve deliverables ahead of schedule.

What was your primary form of communication with Ontogen Medtech?

• In-Person Meeting
• Virtual Meeting
• Email or Messaging App

What did you find most impressive or unique about this company?

They are incredibly honest, transparent, and trustworthy. And they charge their clients way less than they otherwise could, because they want to work with smaller clients who share their mission. They're mission-driven toward their client's missions.

Are there any areas for improvement or something Ontogen Medtech could have done differently?

Nope.

BACKGROUND

Please describe your company and position.

I am the COO of Hubly Surgical

Describe what your company does in a single sentence.

Develops and manufactures safe surgical drills.

OPPORTUNITY / CHALLENGE

What specific goals or objectives did you hire Ontogen Medtech to accomplish?

• Design and development through early production
• Establish quality system
• Develop line extensions

SOLUTION

How did you find Ontogen Medtech?

• Referral
• hiring site

Why did you select Ontogen Medtech over others?

• Close to my geographic location
• Great culture fit
• Good value for cost
• Referred to me
• Company values aligned

How many teammates from Ontogen Medtech were assigned to this project?

2-5 Employees

Describe the scope of work in detail. Please include a summary of key deliverables.

Develop product architectures, design/development, testing, FDA submittal support, and establish and execute quality system.

RESULTS & FEEDBACK

What were the measurable outcomes from the project that demonstrate progress or success?

FDA approval, products available for sale, happy customers!

Describe their project management. Did they deliver items on time? How did they respond to your needs?

They did a good job. We have an extremely close working relationship and behave (and are treated as) an extension of our company.

What was your primary form of communication with Ontogen Medtech?

• In-Person Meeting
• Virtual Meeting
• Email or Messaging App

What did you find most impressive or unique about this company?

Focus on services for medical device start ups. This is quite unique.

Are there any areas for improvement or something Ontogen Medtech could have done differently?

Being a small and fast growing company, occasionally lower priority tasks get a bit lost. Additionally, they need to build a network of manufacturing partners. For any design firm, this is always a work in progress.