The Novatek Blog

Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.

Medical Device Innovators:  Get Used to Being Uncomfortable

Posted by Amy Castronova on Tue, Dec 18, 2018

The latest MEDTECH 2018 conference, New York's largest gathering of bioscience and medical technology leaders, brought together experts in regulatory and policy, innovation and technology, and startup/business acceleration. This year’s event, “Building Bridges to Better Healthcare,” served to build greater collaboration among the state’s leading innovators, educators, and advisers to strengthen the region’s bio/med industry.

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Topics: documentation, medical device launch, regulated industries, product launch, product documentation

Reduce Compliance-Related Stress with Effective Project Management Techniques

Posted by Amy Castronova on Fri, Oct 12, 2018

Workplace stress is not uncommon, especially for those who work in a heavily regulated industry, such as medical device manufacturing, where FDA compliance deadlines loom.

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Topics: outsourcing, regulated industries, Business productivity

Writing for Your Audience: 6 Steps for Creating Technical Documentation  That Gets Used

Posted by Amy Castronova on Thu, Sep 06, 2018

Good technical documentation doesn’t just happen. Producing professional content that's both technically accurate and user-friendly is a highly specific skill. While many companies have subject matter experts (SMEs) in-house, they may not have a professional writer on staff who can translate complicated product knowledge into content that's easily understood by the end-user. 

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Topics: technical writing services, technical writer, product documentation, usability, documentation, regulated industries, technical writing, outsourcing

2017 State of Knowledge Survey: Considerations & Insights for Medical Device and Manufacturing Industries

Posted by Amy Castronova on Fri, Apr 21, 2017

A key to keeping up with fast-paced and ever-changing industries is monitoring trends year over year and staying up to date with the leaders of those markets. Novatek's State of Knowledge survey and report helps manufacturers gain insight and share their business perspectives on the coming year.

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Topics: regulated industries, trends, Business productivity

How to Avoid Losing Customers with User-Friendly Technical Documents

Posted by Amy Castronova on Fri, Dec 09, 2016

The #1 reason manufacturers call Novatek after a technical manual is written internally is because it is not user-friendly. As a result, customers regularly complain about the lack of, or difficulty of, the technical manual and customer technical support experiences high call volume. Sales representatives grumble about how much time they're spending educating and troubleshooting versus selling new products. When contracts end or competing equipment or devices become available on the market, customers are quick to leave with no sense of loyalty.

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Topics: technical writing, regulated industries, Business productivity, documentation, product documentation

Lessons from Dilbert: 3 Ways Effective Project Management Can Lighten Workloads

Posted by Aimee Schenck on Fri, Sep 02, 2016

In regulated industries, effective project management requires maintaining several moving parts at one time and ensuring each piece meets necessary standards for success. A large portion of this success is determined by the quality of work done by individual members of the project. Every project manager knows that quality can vary depending on each employee’s workload. Team members who are overworked put projects at risk, in terms of meeting deadlines and meeting necessary quality standards.

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Topics: regulated industries, Business productivity

What We’re Working on: How Novatek is Improving Documentation and Training Effectiveness

Posted by Amy Castronova on Fri, Aug 26, 2016

Jan Peartree, Technical Communications Manager, has had a hand in Novatek’s solution development for the past 11 years. Her comprehensive understanding of instructional design and technical writing, along with previous experience working for manufacturing and medical device companies, has benefited Novatek’s customer base by providing a deep understanding of their challenges and by helping us deliver proven approaches.

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Topics: trends, outsourcing, regulated industries

Outsourcing Product Development & Documentation: Q&A with Sparton Medical Systems

Posted by Aimee Schenck on Fri, Aug 19, 2016

We recently sat down with longtime colleague Kevin Webb, Key Account Manager for Sparton Medical Systems, a division of Sparton Corporation, which specializes in contract development and manufacturing for medical instrumentation and other highly regulated industries.  Kevin has partnered with Novatek Communications, Inc. to bring clients’ new medical devices to market, so we asked him to  share his insights on successfully outsourcing components of product development and product launch.

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Topics: outsourcing, medical device launch, regulated industries

MedTech Annual Members’ Dinner Highlights Bio/Med Climate

Posted by Amy Castronova on Fri, Jun 24, 2016

MedTech is an active association of pharmaceutical, biotech and medical technology companies, their suppliers and service providers, and research universities throughout New York State. The association, founded by Welch Allyn, ConMed, Sensis and Bristol-Myers Squibb, connects New York State’s Bio/Med industry through collaboration, education and advocacy. 

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Topics: medical device tax, trends, regulated industries

Common ISO Hurdles:  Considerations for Creating  a Successful Quality System

Posted by Aimee Schenck on Fri, May 20, 2016

To meet regulatory requirements and establish a quality system, many manufacturers employ the International Organization for Standardization certifications (ISO). These standards are not specific to a single industry, ensuring the shared knowledge, best practices, and technology advances are applicable to any company looking to be ISO certified.

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Topics: Quality System documentation, Process documentation, regulated industries