Medical Device Design & Development

Our mission is to connect health care companies, clinicians, and investors

…with cutting edge technology, creative design, and efficient problem solving

…in order to bring innovative solutions to the life sciences market.

Our vision is to make it easier to get solutions implemented, regardless of the product lifecycle phase. Whether you have a clinical problem, device idea, or product/process development problem, we combine experience, innovation, and unequalled focus on customer needs to produce results.

Our values center on welcoming the challenge:

Data DrivenCustomer FocusedResults OrientedOpen Minded

Our services include…

Technology Development / Product Design

  • Identification and characterization of customer needs
  • Problem definition and decomposition
  • Technology evaluation and characterization
  • Intellectual property analysis and creation
  • Product and process design
  • Functional and non-functional prototyping
  • Product Development / Design Controls

Process Development / Validation

  • Gage repeatability and reliability (gage R&R) and test method validation (TMV)
  • Installation qualification (IQ)
  • Operational qualification (OQ)
  • Process and product performance qualification (PQ/PPQ)
  • Software validation (SV)
  • Six Sigma DMAIC and problem solving

Product Development / Design Controls

  • Design and Development Planning (Intended Use, Base Risk)
  • Design Inputs (User and Product Requirements)
  • Design Outputs (Product Drawings, Design Trace Matrix)
  • Design Validation and Verification (Protocols, Testing, Failure Analysis, and Reports)
  • Design Transfer (Vendor Assessment, Supplier Qualification, Process Validation)

Quality Systems / Risk Management

  • 21 CFR 820, ISO 13485, & ISO 14971 deliverables
  • Quality management systems (QMS) development, implementation, and execution
  • Risk assessments and failure mode and effects analysis (FMEA)
  • Handling of non-conformances
  • Auditing and compliance needs
  • Training

About the founder

Precise Device Solutions founder, Tim McSweeney, has been solving medical device design, development, and manufacturing problems for over a decade. Tim started in the medical device industry performing validation and remediation of quality deliverables for Boston Scientific. He then took on direct line support as a manufacturing engineer, where his success minimizing downtime, maximizing yield, and leading both capital and quality projects, resulted in Tim being named as the technical lead for the transfer of the Endovascular, Peripheral Vascular, and Urology guidewires from Boston Scientific Miami to Costa Rica.

Following the transfer of the Boston Scientific Miami plant to Costa Rica, Tim joined HeartWare’s product development team, supporting commercially released and next generation devices. Tim’s success identifying and improving product deficiencies led to him being selected to lead the design and development of the next generation driveline and implantable connection system for HeartWare’s fully implantable system. At HeartWare, Tim established himself as a research and development thought leader, generating multiple patents and leading several exploratory projects. Tim’s passion to improve patient’s lives through thoughtful and creative design and development led to the opening of Precise Device Solutions, with the intent of being a catalyst in bringing clinical improvements to market.

The Co-founder

Nicholas A Gonzalez, CQE CQA

Nicholas is the Co-Founder of Precise Device Solutions in Coral Gables, FL.

Nicholas has expertise and is responsible for regulatory, design control, and design history deliverables for new products, from initial product feasibility to post-market launch.

Over the course of his career, Nicholas has provided his expertise to some of the largest medical device corporations as well as some of the leanest startups throughout the continental United States, including Beckman Coulter, HeartWare, Abbott Laboratories, American Medical Systems, Intelligent Hearing Systems, AngioDynamics, ImmunoSite, and Boston Scientific.

© 2016 Precise Device Solutions. All rights reserved.