FDA / ISO 13485 APPROVED

 

Rapid Provision, Planning, & Personalized Medical Devices

Provided in Days, not Weeks

 

3D Printlife has partnered with Insight Surgery to improve patient outcomes in the

United States with the power of their 3d printing technologies.

 

  • Virtual Surgical Planning
                              

  • FDA Cleared Surgical Guides and Models


  • Designed and delivered within a week


  • 30% Average savings over competitors

 

 
From their Texas Medical Center and multiple Point of Care facilities in UK NHS hospitals, Insight Surgery's FDA & ISO Approved Digital Planning, Patient specific guides, models, custom implants and allografts products and services are clinically proven to assist surgical teams in leading US and UK medical institutions with their most complex procedures.

 

SUPPORTED DISCIPLINES: (Adult & Pediatric)

  • ORTHOPEADIC ONCOLOGY

  • ORTHOPEADICS

  • CRANIO-MAXILLOFACIAL

 

 
EXPERTISE:



> Thousands of patient-specific Medical Devices delivered over the past 10 years to surgeons across the globe.

 


> Excell at combining data from MRI & CT scans to accurately replicate patient anatomy in Guides and Models.

 


> Extensive range of products & digital services.

 

 > Clinically proven in improving patient outcomes and optimizing institutional operational expenses. 


 

 > Delivered on-site or remotely to meet your requirements.

                  

SCHEDULE A FREE CONSULTATION

 

We are happy to set up a free consultation with our biomedical engineers to answer any questions you may have.

 

Email us: [email protected]

 

Call us: (800) 201-3249

 

 

SUPPORTED DISCIPLINES IN DETAIL

 

 

ORTHOPEADIC ONCOLOGY

 

SPECIALTIES (ADULT & PEDIATRIC)

  • Upper limb
  • Lower limb
  • Pelvis
  • Thoracic

  • Head & neck

  • Allograft guides

 

“I would now not do these procedures
again without 3D planning and guides
provided by Insight Surgery."

 

           - Dr Rob Pollock

 
British Orthopedic Oncology Society Chairman Senior Consultant Sarcoma Surgeon
Royal National Orthopedic Hospital NHS
 
 

DIGITAL DESIGN & PLANNING

Patient scan data is transformed into 3D models for surgical planning and design of devices

 

ANATOMICAL MODELS

A Digital or physical representation of the patient specific anatomy that can be used for pre / intra planning in a variety of materials and colors.

 

SURGICAL GUIDES

Patient specific surgical guides are designed and manufactured in a sterilizable material in our in-house cleanrooms

 

TURNAROUND IN 5 - 10 DAYS

FDA approved Platform and workflow can be adapted to a variety of timelines with expedited turnround in unparalleled timelines 

 

 

 

BENEFITS: ORTHOPEADIC ONCOLOGY

 

FASTER RECOVERY

Less time in ICU, faster rehabilitation. On average patients stayed 3 less days overall and 1.5 days less in ICU.

 

FEWER POSITIVE MARGINS

In a study with the UK NHS over 26 real world cases, 13 of the cases that did not use guides had 3 positive margins as opposed to 0 positive margins where guides were used.

 

FEWER MAJOR ISSUES

Through the use of surgical guides in complex orthopedic oncology cases. an ~18% reduction in major complications during and after was observed.

 

INCREASED SURGICAL LISTS

Significant time savings in surgery by using digital planning and guides means more procedures can be added to future surgical lists.

 

REDUCED THEATER TIME

Overall, between a 10% to 30% reduction in theater time was observed brought about by the use of digital planning and surgical guides.

 

REDUCED BLOOD LOSS

In studies with the NHS,. an overall decrease of ~13% in blood loss was seen which improved the patient outcomes and lowered operational theater costs.

 



 

ORTHOPEADICS

 

SPECIALTIES (ADULT & PEDIATRIC)

 

UPPER LIMB

  • Clavicle
  • Humerous
  • Forearm / wrist

 

LOWER LIMB

  • Femer
  • Tibia
  • Fibula
  • Pelvis
  • Knee
  • Ankle

 

“The 3D model and planning was fantastic. Only took 5 mins with implant trial components to come up with a definitive surgical plan. Was able to see which implants fit inc. details such as where the best bone stock for screw fixation was.”

 

           - Dr. Rasheed Afinowi-Lutz

 

Senior Consultant Orthopedic Surgeon Nuffield Orthopedic Center
Oxford University NHS Foundation Trust

 

 

 

 

CRANIO-MAXILLOFACIAL

 

 

A full cranio-maxillofacial package of digital planning, guides & implants


Insight Surgery can offer your organisation 3D / CAD modelling and planning services as well as the physical manufacturing of 3D printed surgical cutting guides and implants.

 

Our CMF team comprises of subject matter experts who have worked on hundreds of cases including:
Maxillary and mandibular resections and reconstructions with cutting guides and custom titanium plates.

 

Midface reconstructions (orbital floor reconstruction, midface implants / onlays). Cranioplasties. Orthognathic surgery (Lefort I, BSSO, bi-maxillary osteotomy with or without genioplasty).

 

 

 

PERSONALIZED 3D PRINTED SURGICAL GUIDES

 

Within 5 Days

 

 

"We received word of this urgent incoming osteosarcoma case on a Friday. The scans were with us Monday. The surgeon had our fully segmented, digital model for virtual surgery by Tuesday. With cuts agreed, our engineer had the surgical guide designed, manufactured, and ready for sterilisation by the hospital Thursday morning. The guide was used in surgery that day."

 

           - Henry Pinchbeck, CEO, Insight Surgery

 

Insight Surgery offers a range of surgical guides across multiple disciplines including orthopedics,  cranio-maxillofacial and sarcoma surgery. Manufactured in their FDA / ISO certified clean rooms.

 

BENEFITS

INCREASED ACCURACY

Use of surgical guides allows for more accurate localization


INCREASE IN SURGICAL LISTS

Reduced time spent in theater for surgical procedures means more operations can be scheduled

 

QUICKER PATIENT RECOVERY

Less exposure for patients means patients leave the hospital faster


REDUCED RETURN TO THEATRE RATE

Reduction or total avoidance of further surgical procedures due to accurate surgery

 


CONTROLLED ENVIRONMENT:


Insight Surgery is able to manufacture 3D printed sterilisable surgical guides and anatomical models within its controlled environment facilities.


The controlled environment undergoes regularly scheduled cleaning, monitoring, and maintenance to ensure adherence to ISO 13485 standards, so that our customers can rely on our rapid service.

 

 

ISO 13485 CERTIFICATION

Insight Surgery achieved the vital ISO 13485 quality certification in 2021, ensuring it meets the most current regulatory requirements specific to the design, manufacture, and distribution of medical devices.


It is underpinned by Insight Surgery's Digital Platform, EmbedMedTM, which forms the backbone of its Quality Management System by guiding our engineers' design and production of any medical device through strict processes.


The in-house controlled environment and ISO certification have brought our ability to provide surgical guides down from weeks to days.

 

 

 

SCHEDULE A FREE CONSULTATION

 

We are happy to set up a free consultation with our biomedical engineers to answer any questions you may have.


Email us: [email protected]


Call us: (800) 201-3249