By Christian S Yorgure

Light Fabrications, Inc.

Introduction

Basic 510(K) process can be overwhelming, especially for higher class medical devices; and additional risks averting pressures can delve untold stress as well.  Multiple successive phases (or gates) that a medical device must satisfy en-route the market is burdensome and calls for a level of expertise that startups lack in most cases. Secondly, lengthened supply chains due to global outsourcing (or globalization) present a causal effect on intellectual property protection. These are legitimate concerns for startups. However, the good news is that organizations such as Light Fabrications, Inc. are positioned to guide startups through this tumultuous maze.

So, in what ways can Light Fabrications, Inc. help?

• 510(K) process

Unlike the past, current 510(K) document must be comprehensive enough to cover device details with functionality testing, safety, and intended use. And of course the equivalence requirement is encouraged to reduce the speed-bumps within the FDA approval process. These are arduous steps that are almost unbearable for startups. Additionally, getting to the point of initiating a 510(K) process involves a lot of research and development hours depending on the device specifics.

• Research & Development/Product Development

Light Fabrications will take your concept and develop it into the product that meets or exceeds your requirements. The process includes material selection, iterative design driven prototyping, capturing of critical design parameters, application of design for manufacturability and assembly (DFMA) principles, and development of quality criteria and documentation.

Several authors have attempted to put the enormous works that go into a medical device into perspective; doing so by phasing steps. Some of the phases, according to medicaldesign.com, include opportunity and risk assessment, Concept and feasibility, design verification and validation, etc. For startups, the knowledge base required to meet these phases might prove challenging to harness from within (in-house), and must seek external sources. The R &D department at Light Fabrications, Inc. was developed to assist startups in these circumstances. 

• Intellectual property and protection

Light Fabrications, Inc. is not a legal firm nor does it make claims to any such professionals. However, experience from practice is the bedrock; Light Fabrications, Inc. is able to advise appropriate timelines for filing patent application(s), type, and to review your application (if already filed) with a view to suggesting design change limitations necessary while avoiding infringements. The worst development a startup wants to entertain is litigation over patent infringement; the ultimate result is the demise of the venture. Light Fabrications, Inc. recognizes this crucial fact and would protect you and your investment.

 So, what must startups note?

1. Choosing the right external source for help does not only guarantee success, it saves you time as well
2. The "America Invents Act", H. R. 1249 recently passed by the Senate is a paradigm shift from what we have come to know of who owns the patent - file early and you own it!