Smithwise and Catapult have joined teams to become Archimedic! Read More.
Contact
blog-header

MedTech Mindset Blog

MedTech Mindset Podcast: Software Development with Rightley McConnell

By Daniel Henrich on Aug 28, 2019 8:09:04 PM

Rightly_McConnell_MedTech_Mindset_Podcast_Medical_Device_Software

EPISODE 12 - Med Device Software: Agility and Quality with Rightley McConnell

In this episode, Rightley McConnell, VP of Operations at Precision Systems, Inc., covers how to maintain quality and speed when developing medical device software. 

Continue Reading

MedTech Mindset Podcast: Data Flow with Seth Goldenberg

By Daniel Henrich on Aug 1, 2019 7:05:45 AM

MedTech_Mindset_Podcast_Seth_Goldenberg_Data_Flow_Innovation

EPISODE 11 - Data Flow & Medtech Innovation

In this episode, Seth Goldenberg, VP of Vault Medical Device & Diagnostics at Veeva Systems, covers data flow throughout the product lifecyle and how advanced data management can speed devices along the path to market.

Continue Reading

MedTech Mindset Podcast: Securing Funding with Adam Dakin, Part II

By Daniel Henrich on Jun 13, 2019 7:08:00 AM

Adam Dakin PT2 HighRes

EPISODE 10 - Securing Funding, Part II

In Part II of this two-part episode, Adam Dakin, Managing Director of Dreamit Health, covers funding trends in medtech and how to pitch to institutional investors. (Part I available here!)

Continue Reading

The Challenge and Promise of Pediatric Device Innovation

By Daniel Henrich on Jun 7, 2019 9:31:20 AM

375_250-medtech_mindset_dh_mmThis article originally appeared on Med Device Online.

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. 

Continue Reading

MedTech Mindset Podcast: Securing Funding with Adam Dakin, Part I

By Daniel Henrich on Jun 6, 2019 1:57:21 PM

Adam Dakin PT1 HighRes

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 here.)

Continue Reading

Smithwise + Catapult = Archimedic

By Daniel Henrich on May 20, 2019 8:39:11 AM

WALTHAM, Mass., May 20, 2019 /PRNewswire/ -- After announcing their merger last month, medical product development firms Smithwise and Catapult rolled out their new brand today, Archimedic.

Archimedic_logo_full_Color_400w

Topics: In the News
Continue Reading

MedTech Mindset Podcast: Staking Your IP Claim

By Daniel Henrich on May 7, 2019 1:18:49 PM

Podcast Header Greg Bernabeo IP

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. 

Continue Reading

Catapult and Smithwise Announce They're Combining Teams

By Daniel Henrich on Apr 4, 2019 9:26:32 AM

SW and CP LinkedIn Banner

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.”

Topics: In the News
Continue Reading

Overcoming Pediatric Device Innovation Challenges

By Daniel Henrich on Mar 26, 2019 12:38:56 PM

Podcast header Matthew Maltese (2)

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. 

Continue Reading

Building a Better BOM

By Eric Sugalski on Mar 7, 2019 12:34:14 PM

Bill_Of_Materials_BOM_Basil_Leaf_1200w

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.

Continue Reading

MedTech Mindset Podcast: Navigating Regulatory with Monica Ferrante

By Daniel Henrich on Feb 18, 2019 11:46:21 AM

MedTech_Mindset_Podcast_Monica_Ferrante

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. 

Continue Reading

ActiveProtective Announced as Extreme Tech Challenge Finalist

By Daniel Henrich on Feb 15, 2019 7:54:36 AM

Active_Protective_XTC-1R 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.

Topics: In the News
Continue Reading

MedTech Mindset Podcast: Branding in MedTech with Bill Gullan

By Daniel Henrich on Jan 15, 2019 3:44:49 PM

190110_MedTech_Mindset_Newsletter banner

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. 

Continue Reading

Does IEC 60601 govern your device? Don’t be shocked if it does.

By Daniel Henrich on Jan 14, 2019 8:17:27 AM

PCB_60601_1200w

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.

Continue Reading

MedTech Mindset Podcast: Saving Infants in Respiratory Distress

By Daniel Henrich on Dec 4, 2018 12:13:48 PM

NeoVent_Stephen_John_AIMTech

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 stephen.john@aimtechhealth.com.

Continue Reading

Focus on value, mitigate risk

By Eric Sugalski on Nov 26, 2018 1:05:50 PM

Originally posted on Medical Design & Outsourcing

Risk_value_phases_graphic

“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.

Continue Reading

MedTech Mindset Podcast: Clinical Evidence Insights with Joe Popowicz

By Daniel Henrich on Nov 1, 2018 10:11:00 AM

190110_MedTech_Mindset_Newsletter banner

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. 

Continue Reading

MedTech Mindset Podcast: Actively Protecting Seniors with Wamis Singhatat

By Daniel Henrich on Oct 31, 2018 2:27:00 PM

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. 

Continue Reading

Podcast Launch: A Medtech Mindset with Eric Sugalski

By Daniel Henrich on Oct 31, 2018 2:02:00 PM

190110_MedTech_Mindset_Newsletter banner

Launch Episode

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.

Continue Reading

Regulation Meets Collaboration: MDIC Five Year Reflective

By Chris Scholl on Oct 4, 2018 1:51:00 PM

MDIC edit

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.

Continue Reading

Innovation Hurdles: Why Pediatric Devices Don’t Make it to Market

By Daniel Henrich on Aug 23, 2018 3:18:00 PM

CHOP_Pediatric_Medical_Device_Innovation_Panel

Photo Above: Session speakers (from L to R) Dr. Richard S. Davidson (CHOP), Greg Walters (Essential Medical), Adam Dakin (Dreamit Ventures), Matthew Maltese, Ph.D. (CHOP), and Eric Sugalski (Archimedic)

Runaway Train

Imagine there’s a runaway train barreling down the track toward four innocent people. You sit in the railway control room, your hand on the switch that would divert it down an alternate track where it will kill one person instead. Do you flip that switch? This was the question posed last Friday by Matthew Malteseto his audience. With nodding heads and hands raised slowly off their tables, most audience members seemed to agree reluctantly that sacrificing one person to save four others was the ethical choice in this situation. “Alright,” Maltese said as he looked around the room and saw consensus forming, “but how about now?” On the screen behind him, a photo of a little girl had appeared, replacing the faceless silhouette of the single victim the audience had just agreed to sacrifice for the greater good. Not a single hand remained raised.

Continue Reading