By Matthew R. Maltese, The Pennsylvania Pediatric Medical Device Consortium, and Daniel Henrich, Archimedic
As a society, we seem to regard the lives of children as more innocent, precious, and worthy of protection than those of adults. This superior valuation of child well-being is not limited to people with children of their own, or those in attendance at pediatric device conferences: in an ongoing MIT study of human perspectives on how autonomous vehicles should behave in the event of an unavoidable collision, respondents regularly indicate the vehicle should be programmed to spare child passengers or pedestrians over adults.[i]
However, the medical device marketplace for children does not reflect these values. There are far fewer pediatric devices than adult devices on the market, meaning one of the most vulnerable patient populations also is one of the most underserved.
EPISODE 9 - Securing Funding, Part I
In this episode, Adam Dakin, Managing Director of Dreamit Health, covers funding trends in medtech and how to pitch to institutional investors. (Part II available next week!)
EPISODE 8 - Staking Your IP Claim
In this episode, Gregory Bernabeo, Patent Attorney and Partner at FisherBroyles, covers intellectual property ground rules and special topics in the medtech space.
WALTHAM, Mass., Apr. 4, 2019 /PRNewswire/
Two medical device development firms, Catapult Product Development, Inc. and Smithwise, Inc. announced today they have agreed to a merger in order to offer expanded medical device development capabilities to their clients.
“I’ve long described us as partner organizations,” said Eric Sugalski, Founder and President of Smithwise, “we share the same values and mission, we serve the same customers, and we offer complementary strengths to device innovators.”
EPISODE 7 - Overcoming Pediatric Device Innovation Challenges
In this episode, Matthew Maltese, Executive Director of the PA Pediatric Medical Device Consortium covers why it can be so hard to bring devices to market for kids and what we can do to help fix that.
How a detailed bill of materials sets you up for success in manufacturing transfer
How medical device startups should evaluate contract manufacturers is a topic we frequently address with clients. Selecting a manufacturing partner can be an intimidating process and a lot rides on making the right decision. Developing a detailed bill of materials (BOM) will position you to receive a set of high-quality quotes from prospective manufacturers and conduct an apples-to-apples comparison before moving forward.
EPISODE 6 - Navigating Regulatory with Monica Ferrante
In this episode, regulatory expert Monica Ferrante, VP of Regulatory and Quality at Aspire Bariatrics, talks regulatory strategy and approvals for new medical devices coming to market.
R to L, ActiveProtective CTO Wamis Singhatat, CMO Drew Lakatos, and CEO R. Scott Jones pose after being announced as an XTC Finalist at CES in Vegas last month.
Like many great medtech companies, ActiveProtective started with a clinician recognizing a problem as solvable and working towards a solution. Dr. Robert Buckman wasn’t alone in realizing how devastating a fall can be for an elderly patient. But, as a trauma surgeon who saw patients facing life-threatening consequences after suffering hip fractures, he wanted to find a way to shield those most at risk.
A third of Americans over 65 fall each year and many of those falls result in broken hips. Hip fractures are often associated with a rapid downward spiral for elderly patients, who must endure invasive surgery, recovery time immobilized in bed, and, usually, a less active lifestyle moving forward.
EPISODE 5 - Bill Gullan and Finch Brands
In this episode, branding expert Bill Gullan, President of Finch Brands, speaks with Smithwise Marketing Director Daniel Henrich about what branding is and why's it's critical in the world of medtech ventures.
Bad puns aside, it’s good you’ve come to this post if you’re involved in developing or commercializing a new medical device, especially if that device has a battery or a plug.
In the world of medical device development, there are a number of international standards that apply. ISO standards 13485 and 14971, for example, spell out requirements for quality management systems and risk management processes, respectively. Though these documents can seem long, boring, and repetitive, they contain procedures to which a device company must adhere, beginning in the design phase and continuing throughout the product lifecycle.
A lesser-known, but still critically important, standard is IEC 60601 Medical Electrical Equipment. 60601 was developed to ensure the basic safety and essential performance of electrical equipment that comes into contact with patients during treatment or diagnosis.
On this episode, we sit down with Stephen and Anna John, a brother-sister team of medical device developers, working to bring life-saving respiratory therapy to the developing world. Their device, NeoVent, is a low-cost, mechanical solution to deliver two levels of air pressure to infants in respiratory distress without the need for continuous electric power.
Stephen and Anna grew up in rural Nepal, where their family worked to meet the medical needs of an undeserved population. Their father, Sunil, is a pediatric cardiologist and continues to split his time between practicing in Kalamazoo, Michigan and Nepal. Sunil is serving as a clinical advisor in the development of NeoVent.
They're working to bring NeoVent to market through their company, AIM Tech. You can contact them through their website or by sending an email to firstname.lastname@example.org.
Originally posted on Medical Design & Outsourcing
“I need a prototype.” This is often the kick-off to my conversation with a prospective client. Usually the idea is voiced by a clinical innovator, the CEO of a medical device startup, or perhaps an academic researcher who’s come upon a new technology or technique they’re eager to apply.
This focus on prototyping is understandable—inventors have an idea, often one they’ve been mulling over for years, and they’re eager to get it out of a sketchbook and have something tangible to prove that their technology really works. But, while prototyping is a critical element of the product development process, it isn’t the same thing as the process itself. Instead, a prototype should be viewed as a byproduct, a sign and a test of the hard work that’s gone into charting and maintaining a course in the right direction.
EPISODE 3 - Joe Popowicz and Emergent Clinical Consulting
In this episode, clinical study expert Joe Popowicz, founder of Emergent Clinical Consulting, sits down with Smithwise President Eric Sugalski to talk about clinical evidence strategies surrounding new medtech.
EPISODE 2 - Wamis Singhatat and Active Protective
We're joined this episode by Wamis Singhatat, VP of Product Development and CTO of Active Protective, a medtech company working to bring a really cool new piece of technology to market. Their product is a smart belt that can detect a fall in progress and deploy airbags to cushion the hips of the wearer. You can see a video of the deployment in action below.
Wamis sat down with Smithwise President Eric Sugalski to discuss their strategies for bringing this product to market.
This episode is a great way to tell if this podcast is for you.
Eric Sugalski and Dan Henrich sit down to discuss the big picture of bringing a new piece of medical technology to market. We touch on product development and design, regulatory pathways, clinical evidence, go-to-market strategy, intellectual property, and other important topics.
Last month, I attended a public meeting in D.C. where FDA/CDRH directors, medical device company leaders and academic researchers came together to design new ways to improve U.S. competitiveness in our industry. Pretty lofty goal. The group is called the Medical Device Innovation Consortium (MDIC) and it’s a novel creation, five years in existence, dedicated to continuous improvement for the benefit of patients, manufacturers, and our overall medical knowledge. I went with skepticism and returned a believer that things are truly improving on all these fronts.