Product Development - Contract Manufacturing
Your Vision, Delivered.
Medical Product Development
HDA creates innovative lifesaving and life enhancing products for medical startups and leading medical device manufacturers. We have been developing medical devices since 1982. In that time we have helped our startup clients create hundreds of millions of dollars in value for their stakeholders.
Our quality-driven development process ensures that your product will meet all applicable standards and requirements. Effective planning and diligent program management guarantee that your device will perform well and be completed on time and on budget.
HDA is ISO13485, FDA and California FDB registered.
HDA provides contract manufacturing and compliant pilot production services to the medical industry, building both durable goods and disposables in our FDA registered facility. With on-site engineering support we routinely achieve on-time delivery with no surprises. Whether you need ten units or ten thousand, HDA will build your product for you.
We have the right blend of size, resources and experience to ensure that your product is well made and meets your specifications every time. With each product that we build, our decades of manufacturing experience, craftsman’s eye and dedication to quality continue to earn our customers’ trust.
HDA Technology is ISO13485, FDA and FDB registered.
What our customers say...
We worked with Hunt and his team to build a medical device for use in clinical settings. HDA was highly customer-oriented, efficient, professional, and delivered on time and on budget. HDA is a great partner to work with.
Hunt and his team were critical to the success of our major internal initiative to automate high speed specimen sorting. Their commitment to excellence and deep understanding of the technologies involved were exactly what our program needed. I look forward to working with them again in the future.
Hunt and his talented engineering team reverse engineered our customer’s undocumented and complicated Printed Circuit Board, then designed a new board that performed better and faster. I was impressed with the experience and equipment that HDA has at their fingertips to make this happen. We could not have made our project happen without their help.
It creates always a big smile remembering the successful A380 recovery action several years ago with your professional experience to guide our supplier…
We utilized HDA Technology to develop our customized Doppler ultrasound transceiver for Vascular Control Systems. Hunt’s group did a fantastic job of working with us and our development of custom piezoelectric transducers to optimize the electronics design; maximizing signal and minimizing the noise. When we were done with the development I thought we had one of the cleanest sounding Doppler units available.
HDA provided prototype units, suitable for our testing and evaluation, all documentation to allow an easy transition to a contract manufacturer, and supported our transition to manufacturing.
Our eventual acquirer found HDA’s work product to be consistent with their quality system and retained the firm for further development.
We have worked with HDA for almost 15 years, utilizing their expertise for sustaining engineering, research & development, and regulatory submissions and compliance efforts. HDA has consistently delivered quality solutions within time and budget constraints and are always willing to go the extra mile to assure completion of deliverables and adapt to quick changes in management focus. As design objectives and/or technical issues have arisen over the years, HDA and their team have never failed to support us with new, innovative and “out of the box” solutions. Their ingenious and cost effective solutions have assisted us in maintaining our ISO and FDA compliant manufacturing standards and open new markets for growth.
I have been extremely happy with the support I have received from HDA over the years. Their technical knowledge and experience is exceptional. They bring a dedication and commitment to problem resolution that is superior. They are who I turn to when faced with those “make or break” situations that inevitably challenge any business.
I have worked with HDA on various electro-mechanical and software projects through five different companies (Gish BioMedical, Applied Vascular, Laurus Medical, Opus Medical, Arthrocare) over the last 30 years. Hunt Dabney and his team have always provided high value added services in finding unique, creative solutions to complex problems. I highly recommend using them to help solve your most difficult problems.
HDA specializes in developing and manufacturing Medical Devices. Our experienced team has a track record of successfully accomplishing complex and high technology projects where others fall short.
Because we have the right personnel, equipment and resources we can provide complete product development and sustaining engineering support for our clients. We can design your product, support compliance testing, manage life cycle issues, and produce and service it for you.
Let us help you to focus on your core business – we will take care of design, production and support.
Give us a call!