The Novatek Blog

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

Outdated Medical Device Documentation Becomes User-Friendly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

Planning for Outsourced Technical Documentation Services in Medical Device Companies

Posted by Amy Castronova on Wed, Jun 27, 2018

All product managers have carefully designed plans and well thought out strategies to achieving objectives. For medical device manufacturers, technical documentation should be one of those carefully planned strategies needed to achieve product success and regulatory compliance. And a technical writing team is a key player in achieving that goal.

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Topics: outsourcing, technical writing

6 Skills  Needed to Create Successful Technical Documentation

Posted by Amy Castronova on Tue, Jun 19, 2018

Like in any profession, becoming a technical writer requires a mastery of certain skill sets. The following are the top six skills a modern day technical writer needs to bring to the table to be a successfully develop technical documentation:
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Topics: outsourcing, technical writing services, technical writing

3 Reasons Why Outsourced Technical Writing is Your Solution to Product Launch Success

Posted by Amy Castronova on Tue, Jun 12, 2018

Documentation nightmares can be a headache for product managers, instructional designers, or project managers. In our years of experience as an outsourced technical writing company, we have heard a lot of stories about technical documentation gone wrong. We usually hear something that sounds like...

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Topics: outsourcing, controlling cost, technical writing

Documentation of Quality System Processes: Speeding FDA Audits in Medical Device Manufacturing

Posted by Amy Castronova on Wed, May 30, 2018

Working in one of the most regulated industries, medical device manufacturers are subject to stricter requirements and audits by the US Food and Drug Administration (FDA). Quality system implementation and management makes compliance more easily achievable for manufacturers. However, failure to implement can result in product quality and regulatory compliance issues as well as a lack of process improvements.

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Topics: outsourcing, controlling cost, Process documentation

Medical Device Training: Why You Should be Using Blended Learning

Posted by Amy Castronova on Fri, May 18, 2018

Because it's so important to product adoption and success, medical device training can be a big dilemma for many manufacturers. If you're looking for a solution to your training program, consider blended learning. Blended learning combines conventional instructor-led classroom learning with online and mobile learning. This mixture of learning styles provides a more flexible and comprehensive knowledge-transfer experience for participants. Freeing instruction, information, and interaction from time and place is an ideal solution for individuals with access to today’s instant technology. Plus, blended learning programs can provide organizations with cost savings.

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Topics: outsourcing, training solutions, medical device launch