Last week Novatek attended the MEDTECH 2017 in Buffalo, N.Y., the largest gathering of bioscience and medical technology leaders in New York State. This year’s event, “DisruptNY: Harnessing the Power of Partnership,” highlighted the power of collaborative innovation and local partnerships in strengthening the bio/med industry.
Two major topics addressed at the conference were cyber security and commercialization. Novatek participated in the startup track, sharing tips and best practices for companies launching their first device. Other sessions explored medical device legislation, regulatory compliance, patient adherence, and strategic partnerships.
Medical Device Cyber Security
Michael McCarthy, co-founder and president of DIGITS LLC, a division of Avalon, delivered the opening keynote which discussed the importance of being able to identify and recover from cyber attacks.
With regard to identifying threats, he warned of the detection deficit which increases the impact on a compromised company. The average time from infiltration to detection is 191 days, and the average time to recovery is 58 days. That means criminals are accessing data for 6 months before anyone is aware! The average cost of recovery is $7.1 million and the hard costs associated with identifying the lost data, responding to agency regulations, and legal fees, put a large number of companies out of business.
Michael also cautioned that it’s not a question of if a cyber attack will happen, but when. Companies should be focused on detection and response rather than prevention.
For personal identity protection, he recommended the following measures:
- use a credit monitoring service (LifeLock, AllClear ID)
- review your annual credit report every year
- service and maintain your home network
- update your malware
Look for our cyber security documentation tips in the next post of the series.
The Road Map to Commercialization
The medical device market is highly competitive, with many companies trying to accelerate their time to market and capture market share. It takes about 18-24 months to bring a new medical product to market, but lack of preparation in areas such as regulatory compliance and customer adoption can lengthen that process.
A two-part panel discussion explored all the steps towards commercializing new medical technologies and the following best practices were shared to ensure a quick time to market:
- Pay attention to device regulations. If you plan early, you can avoid unnecessary compliance issues and additional time required to make corrections, which delays product launch.
- Gather sufficient information about material options and applicability for proper device functionality. Having this knowledge from the onset will help you avoid costly delays in development.
- Start thinking about service and support early on. Adequate preparation will allow you to better serve your customers, win their loyalty, and reach global audiences when your product hits the market.
Proper documentation is a key part of meeting these challenges. During the pre-market submission phase, quality system documentation and product labeling are essential. Examples include:
- Quality policy
- Design procedures
- Production processes
- CAPA procedure
- Document Control & Records Management procedures
- Intended Use
- Instructions for Use/Directions For Use
Due to time and budget constraints, the medical device quality system is often neglected in favor of activities that are perceived to add more value. However, developing a quality management system should be as big a priority as any other part of product development.
After FDA submission, in preparation for product launch, documentation that aids in customer adoption and training takes precedence. Depending on the audience, companies should consider:
- Quick-start guide
- Frequently asked questions
- Troubleshooting guide
- Installation guide
- Service manual
- Sales training
The Novatek team knows that in many companies, departments are spread thin and people take on multiple roles. We often see engineers writing technical manuals or sales people training customers. If companies hit their critical mass with training and technical support, then customer service, retention, and even company growth can suffer.
For medical device startups and smaller companies launching a new product, easy-to-use documentation templates can save time and reduce risk. Novatek’s Instructions for Use Template, for example, can help companies meet premarket notification requirements, prove value to investors, ensure safe and accurate product usage, and increase buyer satisfaction.
If you think your company can benefit from our easy-to-use template...
Learn more about our Instructions for Use template
If you missed the panel discussion at MEDTECH or you'd like to review the presentation in more detail...
Download the presentation slides