Northeast BiomedicalProduct Development Services

Company

Founded

Staff

Focus

Expertise

Location

Private independent company founded in 2011.

Four Direct Employees with Four retained consultants. Combined medical device experience +70 years.

2,700 square feet located at 100 Business Park Drive, Unit 5 in Tyngsboro, MA.

Product development, medical devices, manufacturing, quality management

• Bringing product design and development experience to early stage ideas

• Solving design/development challenges

• Providing high quality service by utilizing an agile and efficient design process

Services

Medical Device Design

Concept Generation

Manufacturing Support and Tooling Design

Product Development Strategy

Quality System and Process Management

Medical Device Design

Specializing in designing durable and disposable medical device components

• Sensor integration into Medical Devices

• Implantable device design: stents, Nitinol structures, membranes

• Spectroscopy/advanced fiber optic systems

• Catheter Design and Development

PROVIDED SOLUTIONS

Concept Generation

White Space Investigation and Discovery

• Problem Identification/ Needs Statement

• Voice of Customer

• Ideation/Brainstorming

• Concept Selection

PROVIDED SOLUTIONS

Prototype Manufacturing

Bridging the gap from design freeze through FDA clearance

• Proof of Concept Devices

• Design Verification Builds

• Breadboards and Circuit Design

• Medical Electronics Packaging

PROVIDED SOLUTIONS

Product Development Strategy

Applying Expertise to Targeted Product Development Requirements

• Clinical Strategy Development

• Quality & Process Management

• Business Plan Development

PROVIDED SOLUTIONS

Manufacturing Support and Tooling Design

Creating Custom Equipment Design

• Specialized Test Equipment

• Custom Automation

• Manufacturing Process Equipment

• Assembly Aides

• Manufacturing Tools

PROVIDED SOLUTIONS

Laboratory and Manufacturing Equipment

• Laboratory Weight Drop Systems

• Heat Shrink Manufacturing Tool

• Custom solutions and Tools

Solving Research and Production Problems

PROVIDED SOLUTIONS

Stage Gated Design Control

• Tailored process to fit your project needs

• Ensures accountability and clear communication of deliverables

Device Production

Concept Generation

Design Verification

Design Validation

Design Feasibility

Previous ExperienceMedical Devices

• Aneurysm sealing devices

• Angioplasty catheters and coronary stent systems

• Aortic valve repair systems

• Aspiration catheters

• Dialysis catheters

• Embolectomy devices

• Endoscopy Devices

• Insulin delivery systems

• Glucose sensing systems

• Point of care devices

• Steerable shafts and catheters

• Smart enabled medical devices

• Injection systems

• Ultrasound catheters

• Elderly assist devices

Specialty Equipment

• Automated assembly equipment

• Fiber optic assembly equipment

• Genomics processing

• Laboratory automation

• Electronic control units

• Machine vision systems

• Industrial robotics

• Precision liquid handling

• Radioactive material handling

• Test stations

Other

• Computer hardware and processors

• Electromechanical devices

• Micro-molded components

• Military hardware development

Contact Information

Tim Looney, President

Northeast Biomedical, Inc.

100 Business Park Drive, Unit 5

Tyngsboro, MA 01879

978-649-5555 X 115 Office

tim@northeastbiomed.com

www.northeastbiomed.com

Our StaffBarry O’Donoghue, Principal Electrical EngineerKatie Pendergast, Office Manager Elizabeth Nelson, Consulting Project ManagerMichael Conti, Consulting Mechanical DesignerKatherine Elwell, Engineering Technician

We also have a wide network of engineers and professionals who participate as

needed.