by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Medical Device Guidance: Is Partnering with a Third-Party Developer Worth It?

Great ideas are a dime a dozen, as the saying goes. It’s the execution of ideas that determines their long-term success. The same is true for medical device development and medical device guidance, particularly in markets where buyers have plenty of options competing for their dollars.

Reasonably, a medical device that’s steered by a developer with rich market expertise will yield better results than a device whose development is rooted in limited know-how and experience. But is an external development partner worth the investment?

In this post, we explore four considerations for your medical device development, or ways that partnering with a seasoned, impartial developer can pay off in big ways.

Medical Device Guidance

Refining Ideas, Boosting Your Value Proposition

Like any industry, the medical device market is full of hopeful, self-proclaimed innovations that fail to compel users to whip out their credit cards. Creating a device that users will buy, recommend to their patients and peers requires a deep understanding of the user mindset, how they experience the product, and the problems you’re solving for them.

An expert medical device developer helps ensure you’re asking the right questions and considering psychological and physiological principles in your design, for starters. Put another way, they help you think through how humans make buying decisions and use products to create a more compelling offer and experience than your competitors.

(More on product ideation.)

Countering Blind Spots

It’s tough to spot flaws when you’re too close (or personally invested) in your medical device idea. In fact, your expertise can actually hurt you, cautions the Harvard Business Review, citing a decade-long research into top executives.

Two reasons for that: “The first is overconfidence: believing that brilliance in one area leads to competence in another. The second is when deep knowledge and experience leave leaders incurious, blinkered, and vulnerable — even in their own fields,” the author explains.

Put bluntly, blind spots are inevitable when your development team lacks objective insight and real-world experience to overcome market challenges. A reputable development partner can illuminate areas you haven’t considered and pinpoint blind spots before they sink your investment or slow your progress.

Reducing Risks & Uncovering Opportunities

While a zero-risk scenario doesn’t exist, the success of your medical device hinges largely on the level of risk it poses to users.

De-risking considerations include the likelihood and severity of potential hazards, the environment where the device will be used, potential for human error or misuse, supply chain risks, and more. Reasonably, that requires careful testing, risk tracing and mitigation, starting with your prototype.

In looking for ways to reduce risks, your expert device developer can also uncover opportunities to make your device more competitive.

(More on medical device risk reduction.)

Meeting Regulatory Demands

It’s important to know how the FDA classifies your medical device, and what it demands from you. Other regulatory bodies (ISO, ANSI, ASTM) may have additional performance standards you must adhere to.

Your medical device developer can help you assess regulatory considerations so you’re not hit with a costly violation down the road (or worse — hurt a patient). That know-how can also help you discern your acceptable risk level, how much money to invest, and long it will take before you start seeing revenue.

Medical Device Guidance: Expertise as Loss Prevention

All things considered, a reputable medical device development partner is akin to loss prevention, helping you avoid financial, opportunity and reputation hits that could derail your entire investment.

Before attempting to win over your market, ensure you have a winning product. Getting the development of your device right is considerably more economical than launching a flawed product or correcting an oversight post-launch.

>> Related Resource: How to Choose the Right Medical Device Design and Development Partner

>> Follow Us on LinkedIn for Additional Timely Shares on Medical Device Guidance

by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Medical Device Development De-Risking

Risk analysis is an essential component of a Quality Management System (QMS), and a mandatory task for every new medical device set to launch. Medical device development de-risking is best done concurrent with prototyping.

As a medical device start-up, your first priority should be a functional prototype and user feedback. Devices that have been de-risked early on within the initial concept stages and robust clinical trials done are more likely to succeed long-term.

Moreover, it’s important to have guidance from mentors within the industry that understand design for manufacturability, regulatory considerations and device lifecycles. Consultants and collaborative medical device design and development partners, like MedTech Launch, are key to avoiding costly hurdles that may derail or delay your launch process.

De-Risking within Medical Device Development

De-risking within medical device development focuses on risk assessment in the early stages to address critical challenges, rather than avoiding them until late in the project when hurdles could be costly.

The risk assessment phase of product development is critical to the overall health of your new product and preventing unpleasant discoveries late in the game when your device is near launch. Additionally, focusing on risk reduction early on can help fine tune multiple device concepts and aid in advancing your innovative medical device down the pipeline.

What Does the De-Risking Process Look Like?

The de-risking process begins with risk identification, where your design and development team identifies and maps out the likelihood of hazards occurring, and the severity of those hazards. Risks are identified by evaluating the product design and specifications, the environments in which the product is to be used and the intended use (or misuse). All hazards are identified and their risks then evaluated.

Possible Risk Analysis Questions during De-Risking Phase One:

  • Does the current prototype work as intended? The same way every time?
  • Does it work outside of its best case scenario?
  • Is it sensitive to condition changes?
  • Are there potential user misuse?
  • Are there any functions that are higher risk?
  • Is it scalable?
  • Are there any supply chain risks?
  • Regulatory risks?
  • Market risks? Are there risks associated with the healthcare environment and possible insurance reimbursement?
  • Could it work with fewer bells and whistles? What if features were added?

The second step is risk evaluation. Within this step your design and development team establishes criteria and an associated scoring system to evaluate each risk identified within phase one. For example if your scoring level is one to five, risks scoring three and below are acceptable, and those scoring four and five require mitigation. By focusing on the most challenging risks first, the rest of your development process should flow easier.

Step three within the de-risking process would be actual risk mitigation and design and development changes. This phase also could involve design verification testing to prove implemented changes did indeed mitigate the noted risk(s).

For those risks that require mitigation, the risk must be traced and documented to determine if effective changes were implemented in the design phase. Design verification testing may be required to prove that the changes to design details were implemented correctly in the product prototype or final product. Testing one risk source at a time allows your design and development team to understand potential individual failure sources prior to integrated final device performance testing.

MedTech Launch Top De-Risking Tips:

  • De-Risk Early On Within Your Design and Development Process
  • Collaborate with Trusted Design and Development Partners
  • Stay Focused and Document, Document, Document
  • Score and Weigh Your Risks
  • Test, Test and Test
  • De-risk Concurrent with Prototyping, Instead of After

Have a medical device project you’d like to discuss, call us at 317-482-4250 or email our design and development engineers here.

by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Indiana a Hotbed for Life Sciences

Indiana a Hotbed for Life Sciences, Medical Device Development

OEMs looking to strengthen the ROI of their medical devices might benefit from exploring one rising hotbed for life sciences: Indiana. The state’s central location, relatively low cost of doing business, and strong life sciences climate make it a powerful combination that’s fueling demand across the sector, reports BioFutures. But that’s not all.

A few attributes unique to the Indiana market make it particularly attractive to medical device manufacturers. We’ll touch on some of those attributes below.

A data-driven perspective

If health data is king, then Indiana is its throne. The state is home to the nation’s largest health information exchange and the first-of-its-kind 5G Zone, designed to drive testing and development of 5G-enabled technologies.

At the Indiana Connected Health IoT Lab, various sectors (e.g. pharma, manufacturing, insurance, health IT, and more) convene to collaborate on emerging, health IoT technologies. The Regenstrief Institute boasts more than 20 scientists working on numerous health-data-centered initiatives, and the Indiana Data Hub provides a repository of data “available for analysis, collaboration and innovation,” reports BioFutures.

These examples are just a taste of the vast life sciences ecosystem in the state. Altogether, “Indiana has demonstrated a data-driven perspective that others have only recently grasped,” said Euan Cameron, CEO of Cohesion Medical based in Glasgow, Scotland.

A logistics powerhouse

With “Crossroads of America” as its official motto, Indiana is a logistics powerhouse, with nine interstates converging in Indianapolis plus the presence of the second largest FedEx hub in the nation. For OEMs, that adds up to faster, more efficient distribution of products.

Dallas-based Life Science Logistics is among the companies moving to Indiana to take advantage of those efficiencies. “Indiana in general is a great state for distribution, being centrally located to the U.S. population,” said John Blackington, the company’s business development director, to BioFutures. “We can reach about 80% of the population on the ground within a couple of days.”

Heavy investment in research, innovation, talent

Indiana’s heavy investment in research, talent and collaboration in life sciences is apparent in the rapid growth of startups and mid-tier companies in the state.

In 2019, Indiana’s major universities drew record funding for life sciences research, and a record number of Indiana life sciences companies secured venture capital funding, reported BioFutures. The state also continues to attract the attention and investment of organizations beyond the U.S., like the Scottish Life Sciences Association, which partners with Genesis Plastics Welding for medical device manufacturing.

Lifesaving devices Genesis manufactures for brands you’d readily recognize include:

·         Surgical products

·         Wound care products

·         Temperature management products

·         Infection prevention products

·         Oxygen hoods

·         Medical fluid bags
(collection, waste, transfer)

·         Bioprocessing bags

·         Cryogenic storage bags

·         Shaker and rocker bags

“It makes sense that Indiana is home to a large contract services sector,” said Tom Ryder, president and CEO of Genesis Plastics Welding. Tom noted that startups and smaller manufacturers readily see outsourcing advantages, but large manufacturers are increasingly outsourcing functions as well.

Aleks Davis, CEO of B2S Life Sciences, added yet another advantage to working with drug and medical device development contract services in Indiana: It’s considerably “less expensive than places like Cambridge, San Diego and San Francisco.”

“We have seen first-hand how our innovations are changing the lives of patients here and around the globe,” shared Kristin Jones, president and CEO of the Indiana Health Industry Forum. “Whether your company is well established or just entering the market, Indiana offers a collaborative, supportive, interactive and dynamic community that operates at the highest international standards and capacities. We hope to work with you soon!”

Explore Genesis Plastics Welding’s medical device development division – MedTech Launch.

by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Summer 2020 MBA Marketing Internship Opportunity

MBA Marketing Internship Opportunity with Fortville-Based Genesis Plastics Welding

Summer 2020 Paid Undergrad / MBA Internship Opportunity via Indiana Small Business Development Center (ISBDC) Grant:

The purpose of the internship is to help Genesis Plastics Welding expand upon our international sales and marketing product growth.

Position location: Fortville, Indiana (Just East of Indianapolis)

Objective: To develop a proactive export development strategy for Genesis Plastics Welding within the period hired, adhering to the program’s Core-8 Step process and under the guidance of the ISBDC Export Advisor. Duties include substantial foreign market and industry primary and secondary research, weekly interaction and updates with the ISBDC Export Advisor, participation in the Joint EIAP meeting in June, and presenting an executive summary of export strategy during the Exit Presentations Joint Meeting upon program termination in August. Interaction with foreign customers and potential partners is anticipated.

Ideal Candidate: Our ideal candidate must be experienced in marketing strategies, strategic business growth and international market growth, as well as highly self-motivated. The grant allows us to explore both undergrad (rising senior), as well as, MBA students. It is recommended that students are on the Business Track within International Studies.

If you’re interested in learning more, reach out to our Recruiter: 

Shawn Cox | scox@genesisplasticswelding.com | 317-482-4226

About Genesis Plastics Welding:

As an Indiana-based FDA registered ISO 13485:2016 certified contract manufacturer, Genesis Plastics Welding helps global medical device OEMs better care for patients and caregivers through the manufacture of cutting-edge radio frequency (RF) welded and heat sealed thermoplastic products and components. Additionally, we serve clients worldwide within military/defense and other industries.

Our proprietary heat sealing technology, ecoGenesis™, allows RF plastics welding of very thin gauge (down to 0.001 inch) polyethylene, polypropylene and low-loss polymers and can facilitate polyvinylchloride (PVC) and polyurethane (PU) replacement with phthalate-free plastics.

As a provider of comprehensive contract manufacturing services for Class I, Class II and Class III medical devices and components, we pride ourselves in staying abreast of the latest industry trends and technologies and taking the time to understand our clients’ challenges while supporting their business needs and goals. By actively collaborating together, we spark new ideas and produce viable answers that enable innovation.

We currently manufacture surgical products, infection prevention products, oxygen hoods, medical fluid bags (collection, waste, transfer and other custom bags), wound care products, temperature management products, bioprocessing bags, cryogenic storage products, personal protective products and other medical and military products.

In 2018, we announced a new division – MedTech Launch by Genesis Plastics Welding. This division is strategically aligned to assist clients in navigating the product launch process, from initial concept to commercialization, with a focus on design, prototyping, quality management, risk management, regulatory support and overall manufacturability.

Over the last three decades, we have continued to invest in the expansion and improvement of our leadership, facilities, equipment, technologies and employees.

Equal Opportunity Employer: Genesis Plastics Welding is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Meeting Hyperbaric Oxygen Hoods Rising Demand

For 25 years, Genesis Plastics Welding has made hyperbaric oxygen hoods, designed to help patients recover from respiratory distress and avoid risks associated with other devices. We are proud to be leveraging our experience to meet rising market demand amid the Cornovirus (COVID-19) pandemic worldwide.

Need for Hyperbaric Oxygen Hoods

As respiratory illnesses rise, so does the demand for high-impact, low-cost, non-invasive ventilation. Oxygen hoods are plastic, oxygen-filled domes that fit like a helmet around a patient’s head.

How effective are they, really?

UChicago Medicine, a health system affiliated with the University of Chicago, reports a couple of studies that followed critically ill patients requiring mechanical breathing assistance. Patients were randomly assigned oxygen hoods or standard face masks. Read more