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

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

logo_sparton.jpgWe 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.

Kevin, Sparton and Novatek both serve as outsourced partners to medical device companies in different areas of expertise. How did you come to know and collaborate with Novatek?

We’ve worked with Novatek both directly and indirectly, at the clients’ request. Amy Castronova and I have known each other through MedTech over the years, and saw a lot of synergies, as many of our clients express an interest in outsourced documentation and training. Both Novatek and Sparton serve medical device manufacturers throughout the product launch process, which makes our collaboration an effective solution to clients’ needs. We know Novatek is extremely thorough, so they are our first call when a client doesn't provide their own solution for documentation.

Sparton's role is more than pure product development and manufacturing, as your services can extend through logistics management. When do you consider documentation and training during product development and product launch?

ISO and FDA each have very specific requirements for documentation, which takes time and expertise. We use a very well-defined checklist and find it’s important to identify accountability for training and documentation in the early stages of product development.  Early engagement with the documentation provider eliminates the risk of delay to market by months, which can be a major factor in product success.

How do you ensure alignment during a product launch, especially with a blend of client departments and outsourced teams?


We make sure we have all the information up front. We understand the development process and evaluate the client’s in-house capacity and outsourcing needs. It is established early on and up-front how comfortable a client is with outsourcing and whose resources will primarily be used – theirs, ours, additional partners, or a combination.

When working in a blended team, I find that a detailed and organized approach works best. Assigning roles, following timelines, and holding individuals accountable are all critical in keeping a project on track. We use well-developed checklists, reviews, and user requirement specifications.

What changes and trends do you see in the medical device industry?

Right now, there is an emphasis on getting the "right" product. Manufacturers are choosing their launches wisely, making sure their device is going to tilt the scale or ensure reimbursement. It’s very strategic versus incremental.

The emphasis, of course, is on reducing risk. For some companies, this means customizing successful existing products for certain channels. Investments are being based on what's truly going to be adopted into the marketplace.

While this outlook works to keep the bills paid and maintain income, it has hindered technology developments because consumer acceptance is an unknown factor.  There has been a lot of hesitation for larger companies and merging companies. We are just starting to see a pickup in speed across the device and technology platforms; I hope to see it continue.

Where are the biggest opportunities in medical device today?

In terms of capital equipment, the focus has been on therapeutic devices. We're now seeing combination diagnostic and therapeutic products as diagnostics slowly move into therapeutic use. As products succeed, they identify different use cases. Understanding the user experience is key, and has implications not just on product design, but on training and documentation.

To make sure you are prepared for all phases of the medical device product launch…

Download our free checklist:
Product Launch Checklist for New Medical Devices 


Topics: outsourcing, regulated industries, medical device launch