Kapstone Medical

BACKGROUND

Please describe your company and position.

I am the CEO of an R&D company.

Describe what your company does in a single sentence.

We are an R&D Company focused on regeneration.  

OPPORTUNITY / CHALLENGE

What specific goals or objectives did you hire Kapstone Medical to accomplish?

• Develop a QMS System
• Help with the DHF file
• Training

SOLUTION

How did you find Kapstone Medical?

Referral

Why did you select Kapstone Medical over others?

• High ratings
• Great culture fit
• Referred to me
• Company values aligned

How many teammates from Kapstone Medical were assigned to this project?

2-5 Employees

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

Kapstone helped us from scratch develop a QMS within Greenlight Guru that would allow us to pass the tests from FDA perspective.   

RESULTS & FEEDBACK

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

Phase II delivered with high standards necessary to take to any contract manufacturer.    Trainings to our group up that stage were also conducted.   

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

Kapstone is one of the best companies I've worked with in my career in terms of quality and project management skills.  They follow up, respond quickly, adapt to new requirements.  They have a very talented group who have a great deal of technical and also collaborative skills.  The values shown throughout the process made a complex process seem simpler.   Escalation was also modeled correctly and action plans were made according to everyone's input.      

What was your primary form of communication with Kapstone Medical?

• In-Person Meeting
• Virtual Meeting

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

Overall the skills of the group.  They strive to make the project go smoothly and with the utmost quality.   No shortcuts were made.  There was great progress throughout.    

Are there any areas for improvement or something Kapstone Medical could have done differently?

I am not sure if it is an improvement area.   But the cost is quite high, however, the quality was simply superb.  For a start-up it is hard to pay the rate that Kapstone asked.  I think for established companies this would be a perfect fit.   

BACKGROUND

Please describe your company and position.

I am the CEO of Salvin Dental Specialties

Describe what your company does in a single sentence.

Surgical instrumentation and biologic materials for dental implant procedures

OPPORTUNITY / CHALLENGE

What specific goals or objectives did you hire Kapstone Medical to accomplish?

• Mange FDA and Health Canada regulatory registrations
• Represent the company in FDA and HealthCanada audits
• Employee quality training and quality manual management

SOLUTION

How did you find Kapstone Medical?

Referral

Why did you select Kapstone Medical over others?

• High ratings
• Close to my geographic location
• Great culture fit
• Referred to me
• Company values aligned

How many teammates from Kapstone Medical were assigned to this project?

6-10 Employees

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

Design and implement better quality manual and training program.  Assist us in designing new products and registering with FDA 510k and HealthCanada,  Maintain training program.  Represent us in internal and external quality audits

RESULTS & FEEDBACK

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

Developed and registered several new products and successfully got them registered with FDA and HealthCanada.  Passed all internal and external audits.

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

Assigned specific Kapstone employees to projects based on fit.  Very responsive to needs and acted successfully on our behalf with quality manners.  They were our outsourced Quality and Regulatory department.

What was your primary form of communication with Kapstone Medical?

• In-Person Meeting
• Email or Messaging App

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

Kapstone Medical's expertise and experience were impressive.  Follow-through.  Project management.  Training skills

Are there any areas for improvement or something Kapstone Medical could have done differently?

No

BACKGROUND

Introduce your business and what you do there.

I’m the president of ExoToe, a medical device company. We develop a novel extramedullary device for heart fixation, offering a simpler and less invasive alternative to heart procedures in the foot.

OPPORTUNITY / CHALLENGE

What challenge were you trying to address with Kapstone Medical?

We needed help with a change in our implant that required FDA approval.

SOLUTION

What was the scope of their involvement?

Kapstone Medical helped us remediate our quality management system (QMS) and complete a makeover of our design history file (DHF).

What is the team composition?

We worked with 2–3 members of Kapstone Medical’s team.

How did you come to work with Kapstone Medical?

Kapstone Medical was referred to me. I chose them because they were a great culture fit, and their company values aligned with ours.

How much have you invested with them?

The project cost is confidential.

What is the status of this engagement?

We worked together from January 2023–January 2025.

RESULTS & FEEDBACK

What evidence can you share that demonstrates the impact of the engagement?

Kapstone Medical completed our new implant, packaging, and sizers. They also updated our DHF and completed our QMS. Our previous system had gaps we needed to rectify, and the updated QMS helped us achieve FDA compliance.

How did Kapstone Medical perform from a project management standpoint?

We communicated via virtual meetings. Kapstone Medical delivered on time, with some minor delays as expected.

What did you find most impressive about them?

John (CEO) was very hands-on with his team and was always involved.

Are there any areas they could improve?

There was nothing specific to share.