The Novatek Blog

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

Amy Castronova

Recent Posts

Case Study: Cybersecurity Plan , Risk Assessment, and Cyber Awareness Training Helps  Insurance Company Meet  Compliance Deadline

Posted by Amy Castronova on Tue, Mar 12, 2019

When the New York State Department of Financial Services (DFS) mandated that financial services companies take more extensive cybersecurity measures to help safeguard their clients’ data, W.J. Cox Associates, Inc. was unsure how they’d find the time and expertise among their staff to assess their cybersecurity risk and implement a comprehensive plan that recognizes and mitigates that risk. 

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Topics: outsourcing, training solutions, technical writing, regulated industries, documentation, cyber security

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: product launch, regulated industries, medical device launch, documentation, 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, Business productivity, regulated industries

FAQs:  How and Why to Budget for Medical Device Product Documentation

Posted by Amy Castronova on Thu, Sep 27, 2018

When launching a medical device product, providing easy-to-use, accurate instructions are critical  in order to operate, service, or sell the device. But developing highly professional product documentation requires a certain skill set that may extend beyond the manufacturer's internal resources. 

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Topics: outsourcing, controlling cost, product launch, Frequently Asked Questions, medical device launch, documentation, product documentation

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

Outdated Medical Device Documentation Becomes User-Friendly

Posted by Amy Castronova on Tue, Aug 14, 2018

User manuals can be a make-or-break point of customer loyalty for manufacturers. The more user-friendly the product documentation is, the more likely the product will be successful. Technical documentation is especially important in the medical device market where quick, easy implementation of products is necessary to facilitate high quality patient care.

Jan Peartree, Technical Communications Manager, shares how Novatek revamped a customer's documentation to reduce confusion, improve ease of use, and ultimately, help them provide better patient care.

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Topics: medical device launch, documentation, product documentation

7 Quick Steps for Successful Medical Device Product Launch

Posted by Amy Castronova on Mon, Aug 06, 2018

A medical device product launch represents a major revenue investment and profit opportunity for a company. Successful product launches can yield new markets, bring new customers, as well as increase business with existing customers.

As well-versed experts in product launch, Novatek and Launch Team combined their expertise to bring you a collection of resources for medical product launch. From product documentation to marketing strategy, we're sharing insights on how to ensure medical device launch success.

We've previously discussed the top four documentation challenges faced by a new medical device product launch team, including planning, communications, implementation, and follow up. This blog focuses on the implementation and follow up aspects associated with a new medical device product launch from a customer support perspective.

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Topics: product launch, medical device launch

Planning a Medical Device Product Launch: 4 Key Steps to a Successful Process

Posted by Amy Castronova on Fri, Jul 27, 2018

Teams launching a new medical device face four primary challenges: planning, communications, implementation, and follow up. This blog breaks down those challenges, focusing on the planning and communications aspects of a new medical device product launch and offers tips for creating a successful process.

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Topics: product launch

5 Best Practices for Technical Documentation & Standard Processes  Management

Posted by Amy Castronova on Thu, Jul 19, 2018

Developing and using technical documentation and standard processes is a way of life for FDA-regulated companies. The Code of Federal Regulations (Title 21, CFR Part 820) states repeatedly that the medical device manufacturers must “establish and maintain” procedures. To do so, regulated manufacturers should define, document, and implement process documentation. After implementation, it is critical to then follow up, review, and revise these technical pieces as needed.

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Topics: technical writing services, Business productivity, Process documentation

6 Key Project Management Skills for Product Managers

Posted by Amy Castronova on Tue, Jul 10, 2018

Good product managers are continuously looking to looking for opportunities to improve their skills, for themselves and their teams. One of the most important areas for a product manager to develop knowledge is on documentation project management.

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Topics: technical writing, technical writer