Graeme Smith, CEO of Lightpoint Medical, is a medtech veteran with over 32 years of experience in the industry. With ample expertise in American, Swiss, and Australian companies, he truly operates with a global mindset.
After joining Lightpoint earlier this year, Graeme was charged with commercializing its drop-in gamma probe, SENSEI, a revolutionary tool used in surgeries to non-invasively identify the presence of cancer. The gamma probe syncs with other robotic surgery equipment so that surgeons can read SENSEI’s results from a single screen.
In this Medsider interview, Graeme shares his tried and true strategies for successful commercial launches and how to introduce products using a global distribution model.
Graeme Smith is a medtech veteran with over 32 years of experience in the industry. With work experience in the United States, Switzerland, and Australia, Graeme brings a global mindset to his medical device companies and is a seasoned expert in using a worldwide distribution model.
Listen to the Interview with Graeme Smith
If you’ve spent any time in the medtech or healthtech space, you probably understand how expensive it is to run clinical trials. You typically need to commit hundreds of thousands of dollars -- often times millions -- towards clinical research.
But it doesn’t have to be that way. And here’s why: ProofPilot is a new kind of hybrid clinical trial platform that enables you to run decentralized studies at costs that are 40-80% below traditional approaches. This is how they do it:
First, you can easily design a trial in the ProofPilot visual protocol designer using their extensive library of templates.
Get up and running quickly with an annual license fee and launch as many trials as you like with an unlimited number of participants. For the Medsider audience, with an annual contract, ProofPilot will provide IRB approval for your first study at no cost. Some exclusions apply, so check out ProofPilot to learn more.
Key Insights from Graeme Smith
- Designing a successful product launch requires extensive investment in market research, surgeon interviews, and clinical observations. A strong commercial plan is a necessity.
- Regulatory demands differ from market to market. Identifying and partnering with the best clinical research organizations will position you to successfully navigate the variety of differing guidelines.
- Many key stakeholders are involved when launching a product. Strategically approaching your relationships with payers, distributors, and investors will set your company up for a successful launch.
Lean on Partners When Designing Your Commercial Launch
Graeme’s an advocate for using medical distributors as the pathway to sales. He believes it is the best avenue for getting where you want to be, particularly when exploring multiple international markets.
The challenge with launching in multiple markets is understanding the unique needs and regulations within each country. Partnering with distributors ensures that you work with professionals who know the key opinion leaders in their area and have access to the region’s health services. In addition, by piggybacking on a distributor’s foundation of knowledge, medtech companies can hit the ground running, relying on their partner’s unique market expertise to form efficient and profitable relationships.
But Graeme cautions those preparing to launch, “even if you have the best product or technological concept in the world, without a strong commercial launch plan, you will struggle.”
He shares four practices that ensure a successful device launch:
1. Invest in extensive market research and surgeon interviews.
Do not underestimate the need for conducting appropriate and in-depth market research.
Identify the markets you hope to target, understand their specific regulatory requirements, and do the work before you attempt to sell the product.
Surgeon and clinician interviews are essential. Don’t discount their value because they’re worth the time and effort.
2. Address the concerns voiced by hospital managers.
These days, managers closely guard hospital budgets. Therefore, your product needs to be a win for surgeons while also fitting into hospital budget constraints. Ensure that you’re able to speak to these concerns before going to market.
3. Actively promote your product.
When you market your product strategically, the right people with the right professional interests and backgrounds will find you. Assuming you have a high-quality product, your promotional efforts will often lead to investigator-initiated studies.
Historically, promoting medtech products involved attending medical congresses, but the pandemic has required companies to identify new strategies.
With fewer in-person opportunities to connect with the clinical community, Graeme stresses the relevance of social media. “LinkedIn is very, very useful for us. Make sure you’re active on social media and in things like this [podcast].” He also encourages companies to seek out publication in key medical journals.
4. Say yes to investigator-initiated studies (IIS).
Graeme believes that investigator-initiated studies are a sign that your company’s on the right track with its product development.
Not only are these studies self-funded, but they also give you access to markets that you may not have otherwise pursued.
He stresses: “Be open to the possibility that clinicians may drive your focus.”
Learn from Proven MedTech and HealthTech Experts for Free
No spam, 100% privacy, and your email won't be shared.
Navigating Global Regulations — Develop a Plan for Each Market
Regulations can be complicated and tedious to navigate. Here’s Graeme’s advice: “Don’t underestimate the time, effort, and finances necessary to get through the current international regulatory demands.”
“These days, every market worth approaching has its own unique demands,” explains Graeme. But many companies underestimate the amount of work required to enter multiple markets.
Partnering with the best clinical research organizations will help you collect the clinical data you need for each specific market.
Identify which markets you want to pursue and develop a plan for each geography’s unique clinical needs. It’s vital to approach this step with a plan.
Graeme warns, “there’s a lot of work involved before you’re able to sell a single product.”
How To Create Great Relationships with the Key Players
The process of bringing a fully developed product to market involves several key players. Graeme breaks down the unique strategies that each player requires, sharing his tips for successful relationship-building and roadblocks to avoid.
Understanding the pathway to reimbursement and payment in each country where you hope to launch is vital.
Each country typically requires a different approach. The U.S. is especially tough to navigate, and insurance coverage is key to your success. Identifying compatible codes for your product and ensuring that insurance companies are aware of the appropriate codes must be addressed in your strategy.
Graeme believes that distributors can be a valuable resource for understanding the demands and nuances of a market’s payers. In addition, since a distributor works in a specific market, they are often better in tune with navigating these country-specific practices.
While the distributor model is an excellent strategy to make a rapid global impact, you must partner with the right distributor: one that gives your product the attention it deserves.
Most distributors have extensive portfolios. If your product gets pushed to the back burner, you’re not going to have a successful launch. Ensure that you have a way out of your contract. Doing so will protect you from getting stuck should a distributor not prioritize your product.
Graeme says, “signing a contract is just the beginning.” He encourages companies to approach their work with distributors as a working relationship. It’s up to the medtech company to provide the training and materials necessary for distributors to present the product to interested parties.
Sometimes a fit just isn’t right. When that’s the case, move on and do it quickly. “If a distributor isn’t delivering for you, it’s better to end the relationship and seek distribution elsewhere,” says Graeme.
“Leave no stone unturned when preparing for meetings with investors,” advises Graeme. He is intimately familiar with pitches and talking about his company’s product to potential investors. “You’ve got to know your business plan inside and out,” he explains. And Graeme’s not just talking about you as an individual — your entire team, anyone in the room at the time of the presentation, needs to be prepared.
Graeme believes you need to develop not just Plans A and B but also a Plan C. This thoroughness shows investors that you’ve thought things through and that you’re positioned for success.
Finally, Graeme advises employees: “put yourself in their shoes.” Think about the presentation. Poke holes in it. Ask yourself: What will their questions be? Look at your presentation from their perspective and address the weak points.
Graeme’s learned a lot about launching products over the past 32 years in the medtech industry, but he’s also learned a thing or two about launching a career.
When asked what he’d do differently if he could go back in time and start over, he said he’d be more aggressive in his ambition.
“I was probably a little bit too respectful of my elders,” Graeme laughs.
Big Sky Biomedical is a medtech incubator co-founded by Scott Nelson and a team of serial entrepreneurs and proven operators with a stellar track record of success.
One of their first companies, FastWave Medical, closed on an investment plus milestone-based acquisition agreement within 6 months of forming the entity. Supposedly, that breaks some type of record within the medical device space.
The incubator model is certainly not a new concept within medtech, but the Big Sky team is doing things a bit differently.
First, their entire team has deep domain expertise in the interventional arena and it's the only sandbox they play in. Second, through their partnership with Switchback Medical, they can often shave 6-12 months off a traditional R&D PDP. Third, their wheelhouse is going from zero to one and their team can leverage capital to kickstart projects quickly and efficiently.
If you're interested in learning more or potentially partnering with the Big Sky team, check out their site right here.