In the first of in a series of blogs based around her new book aimed at helping engineers to ensure proper maintenance of medical equipment for FDA, CE, and HIPAA compliance and safety, and anticipate equipment problems and legal issues, and utilize equipment funding wisely, Editor Beth Fiedler discusses the problem of stimulating healthcare innovation.
Getting ahead of the innovation curve is a major component of successful entrepreneurial ventures. But the ability to predict the future without relevant information is futile. So how can you learn to tap into various industries without spending your valuable time flipping from one resource to the next in a continuous string of information that leaves you feeling like you need an aspirin and an ice pack instead of informed? Here are thoughts that could lead to resolution of a local, national, or global problem.
First, what industries are money makers? Let’s face it, money makes the world go ‘round. Right off the bat we know that would be the general area of healthcare and medical devices in particular. The medical device market segment in the United States was reported at $300+ billion or more than half of the world share in a continuously growing market (Carlson, 2014).
Second, what are some areas of need? Talk to physicians and/or focus on particular areas of need often discussed by organizations such as The Commonwealth Fund in the United States or the World Health Organization. Don’t be deterred if you do not have skills in pharmaceutical development to address global immunization coverage. However, you may be a logistics expert who could help solve infrastructure barriers that keep urgently needed medicine from being delivered to cure diseases with existing vaccines. Or, you could be a computer programmer who could help make equipment interoperable with existing clinical workflows or create a script to output data directly to medical records saving physicians and medical transcriber’s hours of dictation and translation time while their expertise is better utilized. The opportunity to address medical device needs for vulnerable population such as pediatrics is an area with huge potential if you are mechanically inclined. In this instance, finding your way to the U.S. Food & Drug Administration website for Product Classification Guidance, Database access, and webinars to increase your understanding of regulatory requirements are recommended to optimize the window of opportunity for new devices (Fiedler & Ferguson, 2016).
Third, ask yourself what are you good at? Learn to translate learned skills from other areas to those where there is greater need.
Establishing relationships with healthcare professionals is a great way to learn about current gaps in patient needs. Even something as small as realizing existing medical devices may need to be altered due to the increasing size of the average American can bring forth solutions to real problems in patient care. If you are a clinician reading this blog perhaps you may be willing to share publicly some gaps in needs for your area of expertise?
Want to read more?
Managing Medical Devices within a Regulatory Framework
Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices
Provides operational and clinical practice recommendations in regard to regulatory changes for risk management
Discusses best practices for equipment procurement and maintenance
Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices
A much needed guide for Biomedical Engineers, Clinical Engineers, Clinicians, Medical Device Developers, and Management in Medical Device Hospital Departments
You can save up to 30% on your own copy when you purchase via the Elsevier store. Simply enter code STC215 at the checkout!
References
Carlson, B. (2014). Kalorama Information Report – Global Market for Medical Devices. From: http://www.slideshare.net/BruceCarlson/kalorama-information-report-global-market-for-medical-devices.
Fiedler, B.A. & Ferguson, M. (2016). Overview of medical device clinical trials. In B.A. Fiedler (Ed.), Managing Medical Devices within a Regulatory Framework.
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