August 28, 2020
by Peter Knauer, Managing Partner and Co-Founder of Sage BioPartners
Design control plays a key role in producing a successful medical device or IVD tool in initial development and through its lifecycle. Learn some tips on how to approach a design control strategy from either FDA or ISO perspectives.
March 28, 2019
by Mike Rigert, Staff Writer, MasterControl
Nothing can result in more frustrations for a medical device manufacturer than the complexities and headaches that occur during the product design approval process. But by developing a comprehensive bill of materials (BOM) strategy that boosts design control, your organization can avoid pitfalls and increase the turnaround time of deliverables.
August 28, 2018
by Edwin Waldbusser, Medical Device Regulatory Consultant, Medical Device SOP Advisors
The design and development of a medical device can be fraught with surprises and challenges for the design engineer. Learn how to avoid these hiccups by implementing solid design controls that can help the process run smoother, and better yet, see the device ready on-time and on-budget.
August 9, 2018
by David Jensen, Staff Writer, MasterControl
The inclusion of software in medical devices is opening up new avenues for health care treatments. However, it also means medical devices are becoming more complex. New innovations in medical device development should compel device manufacturers to revamp their design and development strategies. More time and effort needs to be spent on design control, risk management and cybersecurity. The increase of software in medical devices will a noticeable impact on the approaches to medical device design and manufacturing.
July 3, 2018
by Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting
Medical device manufacturers must rely on more than their buyers or procurement group to provide supply quality. In order to be successful, companies must implement risk-based design controls in order to minimize risk and maximize benefits to their supply quality process.
June 28, 2018
by David Jensen, Staff Writer, MasterControl
Technology companies outside of the health care sector continue to carve out a niche in the medical device industry. This trend makes the competition more flammable. Still, in many ways, disruptive technology developers may need to call upon their incumbent counterparts for assistance with navigating the regulatory pathway to compliance. This article discusses some of the regulatory stumbling blocks that could impact non-traditional medical device developers.
June 19, 2018
by Matthew M. Lowe, Executive Vice President, MasterControl
In the fierce arena of medtech startups, competition is intense and investor confidence is high. A recent Ernst & Young report shows that early-stage medtech firms captured 52 percent of seed funding last year and surpassed the total amount for later-stage companies, the first time it has happened in 10 years. If you’re a startup, is it time to sit back and relax? Hardly.
August 19, 2016
by Walt Murray; CLA, CSSMBB ARC Experts
In psychology, people talk about knowledge and learning in terms of four levels: what we know, what we think we know, what we know we don’t know, and what we don’t know we don’t know. In the life sciences, the fourth level, what we don’t know we don’t know (or unknown unknowns, for short), carries the most risk in quality and compliance. If you are in a leadership position, the risks are even higher. After all, how can you provide the appropriate resources or strategic direction while operating in a knowledge void?
April 12, 2016
Matthew M. Lowe, Executive Vice President, MasterControl
Design control issues represent a key challenge for many medical device firms. This is the reason why in 1996, the U.S. Food and Drug Administration (FDA) added design control principles to 21 CFR Part 820 and required rigorous documentation to demonstrate design control.
March 1, 2016
Beth Pedersen, Marketing Communications, MasterControl
Just like every other aspect of a product, quality is determined by the decisions you make in the design stages. While spending less time on planning upfront might seem to save you money, the costs associated with poor quality resulting from early design decisions can ultimately equate to 40 percent of your company’s total revenue. Correctly understanding the true nature of quality and addressing it in the design stages rather than trying to bring it in as an afterthought is the central premise of Quality by Design (QbD), and adhering to this principle could be the most cost-saving measure your company will ever take.