by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Medtech Leaders, Researchers: Innovating in a Pandemic

Want to thrive past the pandemic? Act big, bold and fast, say researchers. Slow or incremental change isn’t your friend at the moment, writes McKinsey.

Innovating in a Pandemic

During a recent virtual discussion, McKinsey interviewed a handful of medtech leaders on innovating in the current landscape. Participants included Benoit Clinchamps (president, MicroPort CRM); Anton Kittelberger (CEO, mySugr); Florian Nickels-Teske (director, Helios Health Institute); and Harmut Schaper (CEO and general manager, Security & Safety Things). Joining the discussion were Ralph Dreischmeier and Chris Llewellyn, senior partners at McKinsey.

We’ve captured key themes below. (You can catch the full exchange here.)

Embrace collaboration as an accelerator

“Speed has taken on a completely different dimension,” says Dreischmeier: “Two years of digital transformation is now happening in two months.”

One way to accelerate transformation amid a pandemic is to embrace collaboration. 

“We’re trying to convince [medical device manufacturers] that it’s better to work together, because none of them has the necessary scale for fast [product] innovation,” says Schaper, who recently founded an association where competitors can talk to each other. 

In an earlier post on finding the right partner, we covered a few benefits of joining forces with someone who’s been down the road you want to travel, including: refining ideas, strengthening your value proposition, countering blind spots, reducing risks and uncovering opportunities that would’ve remained hidden otherwise — to mention a few.

Look at what’s working in other industries

If something has worked in another industry, it’s worth taking a look to see if it could work in yours, says Schaper. While you’re at it, “the best thing you can do is turn something that used to be a strength of your competitor into a weakness, like having them cling to this fully integrated stack and experiencing increasing difficulties,” he adds.

Llewellyn agrees: This is one reason why it’s so important to have a diverse team charting the path forward, he says.

Two angles to consider

Clinchamps offers two approaches to building new offerings or business models: (1) the customer-supplier relationship, and (2) technology innovation.

“We develop complex life-sustaining devices and traditionally offered an intensive service to physicians and hospitals to help them implant these devices. But we are trying to change this model,” he explains: “So we’re introducing deeper training for physicians and cardiologists to better understand the products and make it easier for them to implant these devices. Transferring this type of service to hospitals and other parties allows us to do things with fewer people than our competition.”

On the tech innovation front, Clinchamps’ firm is investing big in remote monitoring. “We must avoid overcrowding in hospitals and waiting rooms, as well as unnecessary trips to the doctor. So remote monitoring is far more important than it was before.”

In any case, he recommends staying close to customers to recognize their needs — a vital ingredient we also advocate in your product ideation process.

Beware of perfectionism

The pursuit of perfection is kryptonite to innovation, especially amid a pandemic. 

“If you have this perfect company where everything is planned down to every minute and every portfolio position, you’re not leaving people space to breathe,” says Schaper. For creativity and new discoveries to flourish, people need resources to try things out and they also need to know they won’t be punished for trying something reasonable that fails, he says.

Schaper is not alone in voicing this warning. According to the Harvard Business Review, an undue fixation on launching the perfect product brings costly side effects, including increased costs, longer time to launch, greater potential for risks and FDA scrutiny, psychological turmoil, and more. (More on that here.)

Failure to move now will cost you later

Medtech leaders should be mindful that this is a unique moment in time and the world will be a very different place coming out of this crisis, says Llewellyn. 

“There’s quite a big risk for many players to get left behind, but my sense is that those that act quickly and with conviction will put clear water between them and competitors,” he says. Key to this will be “not being afraid to get it wrong an asking for forgiveness rather than permission.”

In our own experience at Genesis Plastics Welding, as soon as COVID-19 hit, we shifted resources to hyperbaric oxygen hoods to help patients recover from respiratory distress and avoid risks associated with other devices. We also helped manufacturers boost production speed and savings with custom bioprocessing bags. The point is reacting quickly to market changes, anticipating what’s ahead, and wasting no time to act.

The current operating environment, as chaotic as it is, is no excuse for inaction. Quite the opposite, Llewellyn concludes: “I fear those that don’t seize the moment won’t just be left treading water but will be left looking at up the new Goliaths in the industry, saying, ‘How did we miss our opportunity?’”

Innovating in a Pandemic Related Resources:

by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Birthing Your Medical Device Idea: Ensuring a Healthy Delivery

Birthing Your Medical Device

Creating a new product is a lot like giving birth: You naturally fall in love with your idea and feel no one knows your “baby” better than you. You also tend to overlook flaws as you marvel at your creation and dream of its potential. But even the healthiest of babies can struggle to thrive without expert input, guidance and monitoring. The same goes for your product.

Want a healthy delivery? Just as important: Want your product to thrive past its infancy to live a long, productive (and profitable) life? Then partner with people who’ve produced those outcomes before: specialists who’ve built successful devices, navigated through FDA requirements, and taken medical devices to market.

Your expertise can severely hurt your device’s performance

A few months ago, we posted about a decades-long research that revealed heavy reliance on your own expertise can severely hurt your performance. There are two reasons for this, as the Harvard Business Review reports:

“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 antidote is to approach new challenges with a beginner’s mind, knowing that blind spots are inevitable when your team lacks objective insight or real-world experience to overcome market challenges.

Shielding your product from failure

We won’t repeat the advice we’ve covered about how to discern if you’re at risk of being blindsided and what to do about it. (You can read that here.)

On the flip side, partnering with a reputable, seasoned medical device development firm enables you to identify gaps and opportunities that might have escaped you otherwise. 

Consider, for example, the impact that a single mishap or new discovery in any of these areas could have on your product performance:

  • Market research
  • User experience
  • Product design and key functions
  • Potential hazards, potential for human error or misuse, supply chain risks
  • Prototype testing and de-risking
  • Regulatory/FDA demands
  • Patient safety considerations
  • Materials selection (is there a safer, better, cheaper way to meet product requirements?)
    … and more

The process of bringing a product to life is a complex one, with each phase requiring distinct expertise and mastery. We’ll be blunt: No astute startup trusts their own hunches and limited know-how to navigate this process. Too much is at stake.

Protect your investment by having the right partner bring your “baby” to life.

 

Related posts:

by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Medical Device Pitfalls: Beware of Perfectionism, Excessive Bells & Whistles

You’ve had a stroke of genius and conceived an idea for a medical device that can solve big problems for patients and clinicians — plus generate a healthy chunk of revenue.

You’ve also done your due diligence to confirm market demand for your solution, and you’ve thought through the user experience.

That’s a strong start.

From there, it’s natural to fixate on your product and want to refine it, again and again, until it’s PER-FECT. And that’s when things can go south for some start-up leaders.

Medical Device Pitfalls

When perfectionism leads to missteps

Perfectionism is on the rise, and that’s not good news, argues the Harvard Business Review. Start-up leaders who want the first thing they launch to be the end-all, be-all solution tend to end up with a disappointing product, despite the best intentions.

Not only is perfection an impossible goal, “those who become preoccupied with it inevitably set themselves up for failure and psychological turmoil,” the authors explain. That turmoil often translates into procrastination “because perfectionists cannot fail on tasks they haven’t started.”

Invariably, an undue fixation on launching the perfect medical device brings costly side effects, including:

  • Unnecessary bells and whistles your users may not understand or care about
  • Increased costs
  • Longer time to launch
  • Greater potential for risks
  • Greater scrutiny by the FDA

Missing out on invaluable user feedback

Simon Slade, Success magazine writer, cites another casualty of aiming for a perfect first iteration in a new product: You miss the opportunity to have users co-create the kind of product they really want.

“There is a reason why so many successful start-ups have versions 2.0, 3.0 and so on. By launching with the basics, you can not only start earning money sooner, but you’re also able to collect actual customer feedback to determine the future of your product. You might find that the advanced features you were itching to add don’t actually matter to your customers.”

You might also be putting unmerited value on originality, says Slade:

Originality is not only unnecessary; it can also be detrimental to a startup because it can make it difficult to connect with your customers. New ideas are hard to process for the mass market. Better versions of old ideas? Those resonate — quickly.”

Focus on core functions

The antidote to harmful perfectionism without sacrificing excellence, quality and safety is focusing on a handful of core functions: the essential capabilities you need to deliver key benefits.

Identify a handful of essential functions and focus on refining those — not adding a bunch of extras.

It’s how you keep costs, risks and delays at a minimum, while serving your end users well.

In the weeds on development of a first iteration of a new medical device? Chat with our MedTech Launch division and get back on track for launch success.

by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Boosting Production Speed, Savings with Custom Single-Use Shaker and Rocker Cell Culture Bags

Custom Single-Use Shaker and Rocker Cell Culture Bags

“Better, cheaper, faster biologics production.” It’s how BioProcess Online described rising global needs in biopharma. In recent years, the industry has been moving toward single-use equipment within bioprocessing and bioproduction, especially shaker and rocker cell culture bags. The trend allows for competitive and faster biologics production, especially for R&D, clinical trials and individualized biologics for cellular and gene therapies.

Faster turnaround, lower costs

A few months ago, BioProcess published its Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production. Findings indicated single-use bioreactors allow manufacturers to stay competitive, boost efficiencies and reduce costs. Single-use systems also provide greater flexibility and rapid scaling.

Further benefits identified by survey respondents include:

  • No cleaning requirements, since single-use equipment is used once and then discarded
  • Less time to get a facility up and running
  • Lower capital investment in facilities and equipment
  • Lower risk of cross-product contamination
  • Greater flexibility with a modular approach

2/3 of respondents: single-use equipment led to bioprocessing improvements

“Overall, bioprocessing professionals realize that single-use equipment has improved bioprocessing,” the report reads. “Over two-thirds of survey respondents cited single-use systems as providing some or significant improvement in their bioprocessing within the past year.”

The report cites supporting data from other sources in its conclusion that adoption of single-use systems in biopharma will continue to rise, generally replacing fixed stainless-steel equipment. “In addition, as cellular and gene therapies emerge, we will likely see single-use system technologies created and adapted explicitly for these personalized applications.”

Custom shaker or rocker cell culture bags

Among bioprocessing system components, most survey respondents have moved to adopt disposable fluid and media containment bags. At Genesis Plastics Welding, we’re applying our proprietary radio frequency welding of thermoplastics to produce custom single-use bags suitable for storage, preparation and processing of a variety of liquids including media, buffers, process liquids, and biological products within biotech and pharmaceutical bioprocessing applications.

Why Genesis for Bioprocess Shaker and Rocker Bags?

  • Single-Use Fluid Bag Manufacturing Expertise
  • ISO 13485:2016 Certified
  • Design and Development Consulting Services
  • Medical Grade Material Selection Assistance
  • Class 7 Clean Room Manufacturing
  • Responsive Results-Driven Customer-Centric Team

Looking to improve your bioprocessing system with a custom single-use bag? We’d love to help you clarify next steps and explore a potential solutions.

Contact Michael Finley to discuss your custom shaker, rocker or bioprocess bag.

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